CREW: Food and Drug Administration - Plan B: OL7

DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration

Rockville MD 2085 7
The Honorable Anna G . Eshoo

House of Representatives
Washington, D . C . 20515-051 4 MAY 1 1 200 6
Dear Ms . Eshoo :
Thank you for the letter of January 19, 2005, co-signed by fifty-one of your colleagues, in
which you express your views about the Food and Drug Administration's (FDA or the
Agency) processing of the supplemental new drug application from Barr Laboratories (now
owned by Duramed Research, Inc .) that proposes to change the marketing status of the drug,
Plan B, from prescription only to over-the-counter (OTC) . We would like to take this
opportunity to clarify below the current status of the Agency's activities concerning this
application .
As you know, FDA is charged by Congress with reviewing new drug applications (NDA) to
determine a proposed new product's safety and effectiveness for the uses put forth by the
manufacturer in the application. As a science-based agency, it is FDA that must make that
final determination on whether an application for a product adequately demonstrates that the
data presented supports the proposed uses stated by the manufacturer in the proposed labeling .
A product cannot be approved until FDA determines that the product is safe and effective for
the indications stated in the proposed labeling .
Your letter referenced the 23-4 vote taken at the joint advisory committee meeting in
December 2003, recommending that Plan B be sold OTC . Advisory committee opinions are
advisory in nature and are not binding on the Agency . Since the final determination on any
NDA always is the responsibility of FDA, it is up to the Agency to clarify any unanswered
questions that may remain after the close of an advisory committee meeting or that were
identified during the meeting, even though a vote may have been taken on the main
question(s) before the committee . The busy schedules of the committee members require that
advisory committee meetings be scheduled well in advance . We certainly value the input
from advisory committee members and the opportunity to hear an exchange of ideas on
proposed new products from experts in their respective scientific fields . It should not be
presumed, however, that a favorable vote by an advisory committee automatically means that
a product is ready to go to the pharmacy shelves .
In May of 2004, FDA completed its first review of the NDA to switch Plan B to OTC, and
concluded that the application could not be approved at that time because : 1) adequate data
were not provided to support a conclusion that young adolescent women can safely and
effectively use Plan B for emergency contraception without the professional supervision of a
licensed practitioner, and 2) an amended proposal submitted by the sponsor during the review
Page 2 - The Honorable Anna G . Eshoo
cycle to chan ge the requested indication to allow for marketing of Plan B as a prescri ption
only product for women under 16 years of age and a nonpresc ri ption product for women 16
years an d older was incomplete and inadequate for a full review. This message was
conveyed to the sponsor by the then-Acting Director of FDA's Center for Drug Evaluation
and Research (CDER) with a full explanation of the reasons behind FDA's decision in a Not
Approvable le tt er dated May 6, 2004, (copy enclosed) and available online at :
www.fda . gov/cd er/drug/infopage/planB_NALetter . pdf.
That decision by the Acting Director of CDER was made after full review of all the
underlying data and an alysis and after discussions with all of the appropri ate Agency
personnel . This decision was based on his assessment that the data in tlie supplemental
application did not contain sufficient information about whether younger adolescent women
could understand the label and use the product safely and effectively for emergency
contraception without the professional supervision of a licensed practitioner . Therefore, the
data in the application did not suppo rt approval of the supplement . In its Not Approvable
le tter to the sponsor, FDA outlined some additional information that would be required for
approval to market Pl an B as an OTC driig . The issuance of a Not Approvable le tter did not
mean that a supplemental application could not or would not be approved in the future .
In July 2004, the drug's sponsor amended its supplemental application seeking to make
Plan B an OTC product for women age 16 and over, and to have it remain presc ription only
for women under age 16 . The comp any also sought to market Plan B in a single package,
and sold either as presc ription only or OTC, depending on the age of the purchaser .
In August 2005, FDA wrote a letter to the Duramed Research, Inc ., (copy enclosed and
available at : http ://www.fda .gov/cder/drug/infopage/planBlPlan B_Ietterr20050826pdf)
stating that FDA had completed its review of the application and that the scienti fi c data
supported the safe and effective use of Plan B as an OTC product for women ages 17 and
over . FDA also stated, however, that it was unable at that time to reach a final decision on
the approvability of the application due to unresolved issues that related to the application .
In the letter to the sponsor, FDA identified three difficult and novel issues presented by the
application, issues for which the Agency is committed to a process for resolving . That
process was initiated with the publication on September 1, 2005, of an Advance Notice ;o f
Proposed Rulemaking (ANPRM) in the Federal Register seeking comment on questions
related to section 503(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act (Title 21,
United States Code , section 353(b)) . The questions the interested parties were asked to
respond to concern when an active ingredient of a drug may be simultaneously marketed as
both a prescription and as an OTC drug product, whether and how OTC availability of a
product could be restricted to a particular subpopulation, and whether the same packaged
product could be sold either as prescription only or OTC, depending on the age of th e
purchaser . A related concern is how, as a practical matter, an age-based distinction could be
enforced .
As the Agency has said many times during the course of the review of this application, the
questions that FDA was asked to answer, and the proposal that was put forward by the
~_,
Page 3 - The Honorable Anna G . Eshoo
sponsor, presented the Agency with many very difficult and novel policy and regulatory
questions . In some cases, the questions requiring an FDA response were unprecedented for
this Agency .
An ANPRM is a mechanism to ask for public comments on whether the Agency should
initiate a rulemaking to codify our interpretation of section 503(b) of the FD&C Act regarding
when an active ingredient can simultaneously be marketed in both a prescription drug product
and an OTC drug product for the same indication, strength, dosage form and route of
administration. Although the Agency typically solicits public comment for a minimum of 90
days when initiating this type of process, in the interest of moving quickly on this issue, the
comment period was shortened to 60 days for this ANPRM . The public comment period on
these questions closed as of November 1, 2005, and FDA is reviewing 6_66mments and
letters it received . While we cannot put an exact timeline 0-6-16 w long it will taketo process
these comments, we are committed to moving forward as quickly as possible .
Notwithstanding the outcome of the rulemaking process, there remain deficiencies in the
sponsor's application . For example, as set forth in the letter FDA sent to Duramed Research,
Inc ., on August 26, 2005, while the application sought approval for the-switch for ages 16 and
older, CDER found that the data supported only for ages 17 and older . Moreover, the
outcome of FDA's rulemaking process may impact the approvability of the proposed
packaging and the use of age as a criterion on which to base a distinction between OTC and
prescription use . Accordingly, Duramed may need to amend its supplemental application .
Please note, however, that as FDA's August 26 letter to Duramed describes, CDER has
completed its scientific review of their pending supplemental application .
The Agency has found that considerable misinformation has circulated about this application
and the reasons FDA has taken the actions it has to this point . So-there' will be no confusion
about the public statements FDA actually has made concerning the Barr/Duramed Plan
B/OTC application, in addition to the two letters to the sponsor mentioned above, we are
enclosing copies of the two press releases dated May 7, 2004, and August 26, 2005, that the
Agency issued concerning this application .
Thank you again for your interest in this ma tter . If we can be of further assistance, please let
us know . A similar response is being sent to each of the other co=signers of your letter.
Sincerely,
rid W ., Boyer
Assistant Commissioner
for Legislatio n
4 Enclosures
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Se rvice
Rockville . MD 2085 7
NDA 21-045/S-01 I
Barr Research, Inc .

Attention : Joseph A . Carrado, M .Sc ., Ph .D.
Senior Director, Regulatory Affair s
One Bala Plaza, Suite 324
Bala Cynwyd, PA 19004-140 1
Dear Dr . Carrado :
Please refer to your supplemental new drug application dated April 16, 2003, received April 22 ;
2003, submitted under section 505(b) of .the Federal Food, Drug, and Cosmetic Act for Plan B®
( 0.75mg levonorgestrel) tablets .
We acknowledge receipt of your submissions dated July 25 ( 3) an d 31, August 8 (2),

September 4, 8, 9 ; and 15, October 6, 10, 15 (2), 17, 21, 24, 29, 30 and 31, December 3 and 9,
2003 ; and January 9 and 30, February 6, 10, 13, 20 and 24, and March 1 I and 26, 2004 . '
This supplemental new drug application proposes nonprescription (over-the-counter (OTC))

availability of Plan B (0 .75mg levonorgestrel) tablets for emergency contraception to reduce the .
chance of pregnancy after unprotected sex (if a contraceptive failed or if birth control was not
used) .
We have completed our review of this supplement and, for the reasons described below, find
that the supplemental application is not approvable at this time under section 505(d) of the Act
and 21 CFR 314 .125(b) .
You propose OTC status for Plan B for both adults and children based primarily on an actual
use study in 585 subjects . Only 29 of the 585 subjects enrolled in the study were 14-16 years
of age, and none was under 14 years of age .
In a December 16, 2003 joint meeting, the Nonprescription Drugs Advisory Committee and
the Reproductive Health Drugs Advisory Committee considered your proposal to switch Plan
B to nonprescription status . Although the Joint Committee recommended that your proposal to
switch Plan B be approved, some members of the Joint Committee, including the Chair, raised
questions concerning whether the actual .use data were generalizable to the overall population
of nonprescription users, chiefly because of inadequate sampling of younger age groups .
Based on a review of the data, we have concluded that you have not provided adequate data
to support a conclusion that Plan B can be used safely by young adolescent women for
emergency contraception without the professional supervision of a practitioner licensed by
law to administer the drug . In your March .1 1, 2004, amendment, you proposed to change
the indication to allow for marketing of Plan B as a prescription-only product for women
NDA 21-045/S-0i 1 -
Page 2
under 16 years of age and a nonprescription product for women 1 6 years and older . This
preliminary proposal did not include draft product labeling to demonstrate how you
propose to comply with both the prescription and nonprescription labeling requirements in
a single packaging configuration . Because of the preliminary and incomplete nature of the
proposal, we did not conduct a complete review of this amendment during this review
cycle .
Beforethis application can be approved, you would have to provide data demonstrating
that Plan B can be used safely by women under 16 years of age without the professional
supervision of a practitioner licensed by law to administer the drug . Alternatively, you
could supply additional information in support of the revised indication to allow for
marketing of Plan B as a prescription-only product for women under the age of 16 years
and a nonprescription product for women 16 years and older, including draft product
labeling . If you take the latter approach, your response to this letter would have to include
details of how you propose to implement simultaneous prescription and nonprescription
marketing of Plan B for women of different ages in a single packaging configuration while
complying with all relevant statutory and regulatory requirements for labeling and
marketing of this product . We will have to assure ourselves that your proposed approach is
consistent with our statutory authority . If you pursue the alternative approach, we also
would request details of your proposed program to educate consumers, pharmacists, and
physicians about the dual marketing of Plan B as both a prescription and nonprescription
product, as well as your proposed program to monitor implementation of this novel
approach .
Wide availability of safe and effective contraceptives is important to public health . We

.look forward to continuing to work with you if you decide to pursue either of these options .
When you respond to the above deficiencies, include a safety update as described a t
21 CFR 314 .50(d)(5)(vi)(b) . The safety update should include data from all . non-cl inical and clinical
studies of the drug under consideration regardless of indication, dosage form, or dose level .
1 . Describe in detail any significant changes or findings in the safety profile .
2 . When assembling the sections describing discontinuations due to adverse events, serious adverse
events ; and common adverse events, incorporate new safety data as follows :
• Present new safety data from the studies for the proposed indication using the same format as
the original NDA submission .
• Present tabulations of the new safety data combined with the original NDA data .
• Include tables .that compare frequencies of adverse events in the original NDA with the
retabulated frequencies described in the bullet above .
• For indications other than the proposed, indication, provide separate tables for the frequencies
of adverse events occurring in clinical trials .
3 . Present a retabulation of the reasons for premature study discontinuation by incorporating the drop-
outs from the newly completed studies . Describe any new trends or patterns identified .
NDA 21-045/S-01 I
Page 3
4 . Provide case report forms and narrative summaries .for each patient who died during a clinical
study or who did not complete a study because of an adverse event . In addition, provide narrative
summaries for serious adverse events .
5 . Describe any information that suggests a substantial change in the incidence of common, but less
serious, adverse events . between the new data and the original NDA data .
6 . Provide a summary of worldwide experience on the safety of this drug . Include an updated
estimate of use for drug marketed in other countries .
7 . Provide English translations of current approved foreign labeling not previously submitted .
Within 10 days after the date of this letter, you are required to amend the supplemental application,
notify us of your intent to file an amendment, or follow one of your other options under 21 CFR
314 .120. If you do not follow one of these options, we will consider your lack of response a request to
withdraw the application under 21 CFR 314 .65 . Any amendment should respond to all the deficiencies
listed : We will not process apartial reply as a major amendment nor will the review clock be
reactivated until all deficiencies have been addressed .
Under 21 CFR 314 .102(d), you may request an informal meeting or telephone conference wi th the
Divisions of Over-the-Counter Drugs and Rept•oduct'ive and Urologic Drug Products to discuss what
steps need to be taken before the application may be approved .
This product may be considered to be misbranded under the Federal Food, Drug, and Cosmetic Act if
it is marketed with this change before approval of this supplemental application .
If you have any questions, cal I the Regulatory Project Manager at (30 I) 827-4260 .
Sincerely,
(See appended electronic signature page ;
Steven Galson, M.D ., M .P .H .

Acting Director
Center for Drug Evaluation and Research
This is a representation of an electronic record that was signed electronically and
this page is the manifestation of the electronic signature .
/s/
-------------------
Steven Galson
5/6/04 04 :56 :02 PM
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Department of Heatth and Human Service s

Public Health Servic e
Rockville, MD 20587
NDA 21-045/S-011 '
Duramed Research, Inc.

Attention: Joseph A. Carrado, M .Sc., R .Ph .
Senior Director, Regulatory Affair s
One Belmont Ave, 11 th floor
Bala Cynwyd, PA 1900 4
Dear Mr. Carrado :
Please refer to your supplemental new drug application dated April 16, 2003, received April 22, 2003,
submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (the Act) for Plan B O
(levonorgestrel) Tablets, 0 .75 mg .
We acknowledge receipt of your submissions dated April 16, July 25 (3), and 31, August 8 (2),
September 4, 8 ; 9, and 15, October 6, 10, 15 (2), 17, 21, 24 ; 29, 30, and 31, December 3, and 9,
2003, January 9, and 30, February 6, 10, 13, 20, and 24, March 11 and 26 ; May 6 and 11, June 30,
July 21, 2004, and January 6, 12, 13, 14, 18, 19 and 21, 2005 .
Your submission of July 21, 2004 constituted a complete response to our May 6, 2004 Not
Approvable action letter .
The resubmitted supplemental new drug application provides for a switch from Rx only status to Over
the Counter (OTC) status for women ages sixteen years and older . Plan B would remain Rxtonly for
women under sixteen years of age . In addition, you have proposed that both the Rx and OTC version
of Plan B be marketed in a single package .
The Center for Drug Evaluation and Research (CDER) has completed its review of this application, as
amended, and has concluded that the available scientific data are sufficient to support the safe use of
Plan B as an OTC product, but only for women who are 17 years of age and older . However, the
Agency is unable at this time to reach a decision on the approvability of the application because of
unresolved issues that relate to your NDA discussed below .
Your application has presented us with three difficult and novel issues . Specifically, you have
proposed that Plan B be marketed in a single package, and sold either as Rx or OTC, depending on
the age of the patient . While the Agency has allowed the same active ingredient to be marketed both
Rx and OTC based on indication, strength, dosage form and route of administration, the Agency has
never determined whether a drug may be both Rx and OTC based on the age of the individual using
the drug. A related concern is how, as a practical matter,-an age-based distinction could be enforced .
In addition, we have never been confronted witb whether the Rx and OTC versions of the same active
ingredient may be marketed in a single package .
As you may be aware, questions have arisen over the years about whether there are any conditions
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under which an active ingredient may be simultaneously marketed in both a prescription drug product
and an OTC drug product. Notwithstanding our haying allowed the practice in those rare instances
where there is a meaningful difference in the indication, strength, dosage form or route of
administration of the two products ., we recognize that FDA's interpretation of section 503(b) of the Act
has not been explicitly set forth in any of the regulations that discuss the process by which FDA
classifies (or re-classifies) drugs as OTC or prescription . See 21 CFR 310 .200 and 310 .201 .
In this case, we have decided that the appropriate course is to ask for public comments on whether
we should initiate a rulemaking to codify our interpretation of section 503(b) regarding when an active
ingredient can be simultaneously marketed in both a prescription drug product and an OTC drug
product . To this end, we have decided to publish an advance notice of proposed rulemaking in the
Federal Register . In addition, the notice will seek public comments on questions related to the
marketing of Rx and OTC versions of the same active ingredient in a single package .
At this time, the drug product may not be legally marketed OTC. In the future, you will be notified in
writing regarding changes in the status of your application .
Under 21 CFR 314 .102(d), you may request an informal meeting or telephone conference to discuss
what steps need to be taken before the application may be approved .
Sincerely ,
Lester M . Crawford, DVM, PhD

Commissioner of Food and Drug s
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FDA Statemen t
Media Inquiries :
FOR IMMEDIATE RELEASE
Suzanne Trevino, 301-827-6242
Statemen t Consumer Inquiries :
August 26, 2005 888-INFO-FDA
FDA Takes Action on Plan B

Statement by FDA Commissioner Lester M . Crawford
Thank you for coming today .
We are announcing the action we took today of sending a letter to Barr Labs concerning their
application to allow Plan B to be sold over-the-counter .
I want to start by making sure everyone is clear on what this drug is. Also, it's important that we
define what the FDA has been asked by Barr Labs to address with respect to this drug . .
Plan B has been referred to as emergency contraception . It contains one of the same active
ingredients used in ordinary prescription birth control pills - only in the .case of Plan B - each pill
contains a much higher dose and is taken in a different way .
Like ordinary birth control pills, Plan B is currently available to all women as*a prescription drug .
There is a second drug called Preven that is similar to Plan B . That drug is also soicTwith a
prescription . Preven was first introduced on the market before Plan B .
The question we have been asked to address is whether Plan B should be available without a
prescription on a pharmacy shelf, similar to the way other over-the-counter medicines like some
cough syrups and allergy pills are sold, for women age 16 and older, and remain prescription-only
for those under the age of 16 .
The issues that we were asked to resolve, and the proposal that was put forward by Barr Labs,
presented us with many difficult and novel policy and regulatory issues .
In some cases, the questions we were asked to answer were unprecedented for this agency . In
particular.
Can age be used as a criterion on which we decide whether adrug should be prescription or over-
the-counter, as has been proposed in this case ?
Can the prescription and over-the-counter version of the same drug be marketed in a single
package ?
In addition, if we do use age as the only criterion on which we decide whether a drug is sold as a
prescription product, or an over-the-counter product, how, as a practical matter, would such a
limitation be enforced ?
These are profound regulatory decisions that cut to the heart of our work . The answers to these
questions can establish very broad and far-reaching policies that could have a significant effect on
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the way FDA regulates many different drugs .
In fact, the answers to these questions could establish pathways that could make many more
products available as over-the-counter drugs .
That could be a positive public health step, and one that I would support as the agency's
Commissioner if it means we could safely make many more effective medicines more easily .
available .
We believe these novel regulatory issues should be considered in an open, public process .
Rather than answering these questions in the context of a decision on a single drug, we need to
have an open process to solicit public comment .
These regulatory and policy questions are too profound and cut across too many different
products to be made behind closed doors .
And so today we are also announcing that we are taking the action of publishing an advance
notice of proposed rulemaking to initiate an open public process to consider these important
regulatory and policy questions .
This notice will speak only to the regulatory and policy issues raised by this application .
The resubmitted supplemental new drug application that the FDA was asked to review provides
for a .switch from prescription only status to Over the Counter status only for women ages sixteen
years and older.
Plan B would remain prescription only for women under sixteen years of age .
The FDA's drug center, the Center for Drug Evaluation and Research or CDER, completed its
review of this application, as amended, and has concluded that the available scientific data are
sufficient to support the safe use of Plan B as an over the counter product, but only for women
who are 17 years of age and older.
What we are saying today is that the Agency is unable at this time to reach a decision on the
approvability of the application because of these unresolved regulatory and policy issues that
relate to the application we were asked to evaluate .
We need to resolve these policy and regulatory questions before we can reach a final decision on
the underlying science that was presented to us .
FDA is both a scientific and a regulato ry agency. And what we are saying today is that there are
unique regulato ry issues that need to be addressed before we can take a final actioii _on the
application .
We are beginning a process that will address the regulatory questions today, but we believe we
can only decide these issues in an open, public process .
Through this process, all interested parties can weigh in on the questions of whether a drug may
be both prescription and over the counter based on uses by different subpopulations and whether
the prescription and over the counter versions of the drug may be marketed in a single package .
There is precedent for this kind of careful, public policy making inside FDA and inside many
federal agencies . This action ensures that the rules that an Agency like ours sets are done so in
an open fashion . These rules have lots of implications that aren't always easy to anticipate at first
blush .
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Today I am making the commitment that we will work with our stakeholders to make sure that this_
process is expeditious and .thorough .
Before I close, I want to step back and give you a little more detail on the regulatory pathway that
led us to our current action .
And I want to help explain why the question of whether a drug can be sold simultaneously both
over the counter and as a prescription product, in the same dosage, for the same indication, and
in the same package, and with age as the only deciding criteria, is so profound .
FDA used to prohibit products from being both over the counter and prescription at the same time .
They had to be one or the other . The idea was that if an active"ingredient was safe and effective
without a practitioner's supervision it had to be over-the-counter . If it needed a prescription for one
group of people, then it needed a prescription for all people .
That was FDA's practice for a very long time.
In the late 1970s, FDA formed a task force to undertake a formal process to consider changing
that policy, to determine whether a drug could be sold prescription and over-thecounter in different
settings, for example, for different medical indications .
But ultimately, this task force rejected changing the policy, and so the policy continued . And from
the 1950s until the 1980s . drugs were either only prescription or only over-thecounter.
There was no molecule that existed on the market as both a presc ri ption drug and an over-the-
counter product .
Then in the 1980s. the agency was challenged on an application . FDA decided to allow the
molecule to be sold as a prescription product for one use and an over-the-counter product for
another .
Since then, there have been only a small number of ingredients approved as both prescription and
over-thecounter and in these cases there was a meaningful difference in the way the two products
are used .
In the Plan B application, we are grappling not with the same question but with a different
question : whether we can have the same molecule exist as both a prescription and over-
thecounter product for the SAME indication ?
And if FDA were to attempt to limit sale of an over-thecounter product to a particular sub
population, would FDA be able to enforce such a limitation as matter of law, and could it do so as
practical matter and then how ?
Moreover, we are being asked to determine whether a product can be labeled for over-the-counter
and prescription us and be sold in the same package .
I am committed to expediting this rule-making process, and in order to do so, I have ordered a 60-
day comment period instead of the usual 90 to 120 day comment period . FDA will process and
post the comments as they come in to us and finalization of this regulatory and policymaking
process will be a personal priority of mine .
The action FDA took today underscores the Agency's commitment to public health and safety .
As an agency and as its Commissioner personally, I want to say that FDA remains committed to
making safe and effective contraceptive products available to women and men who choose to use
them .
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JOHN M. MGItKiH, NEW YORK . MALONEY. NEW YORK 1CAROLmo
JOHN L . NICA. FLORIDA E3;W W E. CUMMOM, MAINLAND
GIL GUTKNECHT, MINNESOTA DENNISJ . KtJCRNCli OHID
MARK E. SOUDER. INDIANA DANNY K. DAVIS . KJ.NDB-. . . . .
STEVEN C . LATOURETTE. CH*
TODD RUSSELLPLATTS. PENNSYLVANIA
joouge of Repregentatibeg VM. LACY CLAY . ►16SOUR1
DIANE E. WATSON. CALIFORNIA
CHRIS CANNON. UTAH STEPHEI(F LYNCH . MASSACHUSETTS
JOHN J. DUNCAN. JR .. TENNESSEE CHRIS VAN HOLLER, MARYLAND
CANDICE MILLER. MICHIGAN COMMITTEE ON GOVERNMENT REFORM ... . .LINDA T. SANCHEZ CALIFORNIA
MICHAEL R. TURNER OHIO C.A . DUTCH R134TER29SEPAIER.
DARRELL 168A . CAUFORNV I 2157 RAYBURN HOUSE OFFICE BUILDIN G MARYLAN D
VIRGINIA8ROWNAVARE. FLORIDA 9RIAN {9OOIN8. NF1YY YGRK .. .
JON C. PORTER . NEVADA EtA1iNOqTIDLMEB N0RT014. . . .. . ... .
KENNY MARCHANT. TEXAS WASHINGTON, DC 20515-614 3 DISTRICT OF COLUMBIA
LYNN A. WESTMORELAND. GEORGIA
PATRICK T. Md1ENRY. NORTH CAROLINA MNOKnr R02) 225-SD7
CHARLES W. DENT, PENNSYLVANI (IIO¢{ 426-oY74
1Fwea - B RhMw SANDERS . VERMONf.
A VIRGINIA FOXY, NORTH CAROLINA ONE HUNDRED
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httpJ/retorm .house .goV
August 26, 2005
Lester M. Crawford, D .V .M ., Ph .D .
Commissioner
U . S . Food and Drug Administration
5600 Fishers Lane
Rockville MD 20857-000 1
Dear Dr . Crawford :
Secretary Leavitt has promised that the Food and Drug Administration would announce a
decision by September 1 about whether to a ll ow emergency contraception, such as Plan B, to be
sold in pharmacies without a presc ription .
As you are aware, the Food and D rug Administration last year denied a request from Plan
B's manufacturer to allow over-the-counter,, sale of this drug combination . The FDA based-its'-
decision to deny this request on two issues, as reported by the Agency :
1) Adequate data were not provided to support a conclusion that young adolescent
women can safely use Plan B for emergency contraception without the professional
supervision of a licensed practitioner an d
2) a proposal from the sponsor to change the requested indication to allow for marketing
of Plan B as a prescription-only product for women under 16 years of age and a
nonprescription product for women 16 years and older was incomplete and
inadequate for a full review . I
The FDA has also concluded that it is not "well _•.

understood" that
.. . . ._ . . .~:.,..,~~.,~._ .~_~Plan
~.~ .~..~B__._
is . "not for ~ :„,~,,: ,_ h .: . ..,
.P . ..~. ..~~„,
regular use," should not be used if there is unexplained vaginal bleeding, or that one should get
medical help as soon as possible where there is severe abdominal pain after taking the drug .2
These are serious issues that justify requiring a prescription for Plan B .
FDA's Decision Regarding Plan B : Questions and Answers, available at

http•//www :fda .gov/cder/dni¢/infovaee/alanBlRlanBOandA .htm (last visited August 25, 2005) .
. , . . .~_ .~ ~
Karen Lecbter, J .D ., PhD, Division of Suiveillance, Researcli
it and~Conuaunicahon
._ 5upport, Office of rug y ;
Wet
Food and Drug Administration, in a presentation before the December 16, 2003 meeting of the FD A
Nonprescription Drugs Advisory Committee in Joint Session with the Advisory Committee for Reproductive Health
Drugs . Transcript is available online at http :/lwww .fda .gov/ohrms/dockets/ac/03/transcripts/4015T1 DOC (last
visited August 26, 2005) .
2 vo 5- ' 5-6 40
8-26-05 ;3 :03AM ;
I share the concerns that millions of Americans have

-: :. about allowing emergency
products to be sold over-the-counter. without .contraepi a prescription, an lope that the
FDA once again denies the request to distribute Pl an B. without aprescri ption:
The FDA requires that typical, standard oral contraceptives-which _contain the same
hormones as emergency contraception but in much lower doses-be given by prescription only,
under the supervision of a physician . This a necessary safety measure, considering the
dangerous possible side effects of oral contraceptives, which include increased risk of „
developing liver tumors, liver cancer, breast cancer, heart attack, stroke or serious blood clots . 3
Such risks are even higher among women who smoke . 4
In arguing for over-the-counter availability of emergency contracepti ves, advocates rely

on the fact that emergency contraceptives and oral contracep tives are made of virtually the same
ingTedlents . In fact, Planned Parenthood has made available on their website t he num
,
ber of ora l
~.~.~- ~ .xt.<~: .,.,•
contraceptive pills needed of va rious bran ds for the "off label" use of those prescription pills as a
form of emergency contraception .s
Although emergency contraceptive drugs such as Plan B contain

. . _ ._ . ..__the
._.....same
.. .. .~..,.. ._ :hormones that :.:.,. .a,.- w .__,_,., ., ... .
..:.~......~,_~,~
compose standard oral contraceptives, emergency contraceptives contain a much higher dosag e
than oral contraceptives. Specifically, the dosage ofprescription-only oral contraceptives
equivalent to one dose of Plan B is twenty pills, followed by twenty more pills 12 hours later . 6
But over-the-counter availability of Plan B would remove the necessary safety

precautions required for standard oral contraceptives, and would allow the widespread
distribution of this powerful drug without any physician supervision, and without any checks o n
the frequency of use for any particular patient, despite the fact that Plan .B's manufacturer says it
does not have any data on overdosage of this powerful drug . 7
Moreover, allowing over-the-counter sales would also give adolescent girls uncontrolled
access to this drug . The FDA's own administrative rules allow approval for pediatric use of a
drug "based on adequate and well-controlled studies in adults, with other information supporting
pediatric use ." 8
3 See Medline Plus, by the U .S . National Library of Medicine and the National. _Institutes
. of Health, at
~,:,:
htto ://www.nlm.nih.gov/medli~phis/drueinfo/medmaster/a601050 .htmI#s ide-eff ects (last visited August 25, 2005).
Id.
For instance, Planned Parenthood recommends taking "5 pink pills" of the Alesse brand oral contraceptive pill
manufactured by Wyeth-Ayers as the dosage needed for its off-label, use as, an emergency contraceptive . See
httv://www.vlannednarenthood .orpJvn2/portaUfiles/oortal/medicalinfo/ec/fact-emer¢encv-contracegtion xml (last
visit ~
6 Van Look, Pau1 F .A . & Felicia Stewart. ( 1998) . "Emergency Contraception ." Pp. 277-295 in Robert A . Hatcher et
al., eds ., Contraceptive Technology, 17th edition . New York : Ardent Media (as cited by Planned Parenthood, at
http•//www plannedparenthood orgfp,p2/oortal/files/portaUmedicalmfo/ec/fact-emergencv contraception xm1 , last
7 Ban- Pharmaceuticals information about Plan B, available at htti) ://www.Eo2nlanb .com/PDF/PIanBPI .pdf (last
visited August 25, 2005) . . . .. .. ..
8 21 C.F.R. 314 .70 .
6-26-05 : 3 :03AM ; # 4/ 4
In addition to the fact that there is a lack of information out overdosage of Plan- B, Plan
B's manufacturer has not established the safety of the drug for pediatnc use . 9 It would be highly
irresponsible for the FDA to allow, adolescent girls to have unchecked access to this drug by
approving Plan B for over-the-counter sales, particularly when there is inadequate information as
to whether the drug is safe for pediatric use .
Finally, the experience in Britain with emergency contraception has demonstrated other
serious negative consequences of allowing over-the-counter sales of this drug, including
increased rates of sexually transmitted diseases corresponding to over-the-counter availability of
emergency contraception,i° as well as the discovered increase in ectopic pregnancies related to
emergency contraceptive use . t t
Commissioner Crawford, based on the known health risks for prescription-only oral
contraceptives and the lack of information-available on adolescent use of emergenc y
contraceptives, I would be very disappointed if the FDA approved over-the-counter sales of this
drug . Such a decision would expose women and girls to grave risks without any physician
supervision .
I hope these important factors regarding the health and safety of women and adolescent .
girls are part of a decision against allowing the over-the-counter sale of ern_ergency
contraception.
Sincerely,
Mark E. Souder
Chairman
Subcommittee on Criminal . Justice ,
Drug Policy and Human Resource s
Government Reform Committe e
9 Barr Pharmaceuticals information about Plan B,_ available at http•//www go2planb com/PDF/P1anBPI p df (last
visited August 2 5 , 2005). ~ __ ._ __ .. . ._ . .
10 "Teen Sex Epidemic" Daily Ma il (London) March 8, 2004, reporting that the number of new cases of sexual,
diseases rose by almost two-thirds in fi ve years . Available a t
htM J/www .dailvmail.co uk/naees/live/articles/health/womeufarr iilv.btmhin article id=299672&inpage id=1799
W _ ~~, ~ , . :- _. . ~ . : ,, _ ~ . ~ - =•, .
(last visited August 25, 2005).
~~"UK warns of ectopic risk with 'morning-after' pill" Reuters Health, London, Janua ry 30, 2003 .
Congreog; of the Eniteb ~tate g
=tt4ittgton► 38QC 20515
July 25, 200 5
Commissioner Lester Crawford

5600 Fishers Lane
Rockville, Maryland 2085 7
Dear Commissioner Crawford,
We want to congratulate you on your recent confirmation as the Commissioner of the

Food and Drug Administration (FDA). We look forward to worlang with you to advance the
health of our nation.
To that end, we w rite to you concerned about the pending decision on the over-the-
counter status of the morning-after pill, commonly called "Plan "l As you know, OnMay 6 ,
counter
2004, Barr Laboratories, maker of Plan B, was issued a non-approvable letter for its inrtial
application to make the morning-after pi ll available over the counter based on the insu fficient
data regarding its effect on children under the age of 16 . However on July 21; 2004~ 'Barr
submitted a new application for the morning-after pill. The new proposal 'would allow girls and
women age 16 and older to buy the drug over the counter, but girls 15 and younger would still
need a prescription. This unprecedented, bifurcated approach for a prescription drug is highly
alarming and puts many of our nation's women, especially young women and girls, at risk. We
urge you to reject the peti tion currently before you to make the morning-after pill 'as accessible to
our nation's teenage daughters as candy bars and hairspray .
We ask you to weigh the se ri ous implications of allowing teenaged girls access to a
powerful drug without the knowledge of their parents or family pnysician, the very people who
are most familiar with the minor 's health needs and histo ry . Even under this bifurcated
approach, there would be no assurance that the parents of a girl as young as 16 would have any
knowledge of the powerful drug she is taking or the risky behaviors siie is engaged in. Because
of the important safety concerns and lasting heath effects on a girl's body, we beli eve it is
essential parents are involved in these decisions .
This concern is highlighted by the fact the FDA never tested the e ..._ of
,_. . . ...~_ _ .. ffect ~Plan
~B _on'
_ : .,.F . . . .
young women when initially approving the drug for p re scnptzon safes 1:lnder tiie pediatric rule,
the FDA is re quired to gather information on each age group that will be affected by a drug tha t
is pending app roval. This information
_ must include safety
. and effectiveness datafor the age
group and dosage recommendations forpr oduct : According to the F~ a waiver to . ..->s rule
. ._b
may be granted only in cases where it can be proven that the ef~'ects on a younger population
would be similar to the effects of the drug on an adult . Plan B will certainly have a different
effect on girls who are at a younger developmental age . Plan B can contain as much as eight
times the daily hormone dose of the average birth control pill . The effects of these liormones on
the development of a young woman would be very different than the effects on an adultwoman .
However Plan B was granted a waiver from the pediatric rule, under the Clinton
Administration's Secretary of Health arid 14 unian 5ervices; Donna S'6xlata: This shoulci never
have happened. The fact that the FDA does not know the effect of this drug on younger women,
combined with the possibility of eliminating the parents from this important health decision ; is' "
reason for significant alarm .
We are also very concerned about the impact the over-the-counter status for the morning
after pill would have on sexually transmitted disease (STD) rates . There is very little data
available to suggest what impact over-the-counter status would have on the sexual behavior of
adolescents or what the subsequent impact would be on adolescent sexual health. According to
Food and Drug Administration documents, when initially approving Plan B for prescription use,
only the drug's safety and its effect on pregnancy were considered. The FDkcTid not consider---
the significant impact over-the-counter availability this product may have on the "sexu .aY' lieafth-of
adolescents and young people .
Part of the population that would be able to buy Plan ,B over the counter, adolescents and
young adults (16-24), are the very same age group most at risk for contracting SM's :
Approximately two-thirds of all people who acquire STD's are under the age of 25 and each year
15 million new cases are diagnosed . The Centers for Disease Control states that adolescents and
young adults are at greater risk of acquiring a sexually transmitted infection because of their
immature physiology and immune systems, the increased probability of adolescents having
multiple sexual partners, and the greater likelihood of adolescents engaging in high-risk sexual
activity.
In addition to these safety issues, we are also concerned about Plan B's package insert .
As approved by the FDA, the insert may not clearly explain how the drug regiirien works, -
possibly p reventing women from exercising complete informed consent . It is crucial that drug
literature is not misleading or ambiguous especially when it comes to the effects of a drug on a
woman or on a human embryo inside of her.
According to FDA documents, the morning-after pill : "act[s] by delaying or inhibiting

ovulation, and/or altering tubal transport of sperm and/or ova (thereby ' iniiib'iting fertiliza tion),
and/or altering the endometrium (thereby inhibiting implantatson) ."1 Similarly, the Plan B
manufacturer had admitted on its website, "In addition, it may inhibit itnplantation by altering
the endometrium. "
Though both the FDA and the manufacturers say the morning after pill may "inhibit
implantation," it is not-clear that women are fully informed tlia't-tliis phrase means a human
embryo inside them may be adversely affected by this drug . In order to ensure that women have .
completely informed consent, it is crucial that the FDA revisit and review current pack aging
inserts and other literature .
As you know, in order to qualify for over-the-counter status, a drug must be proven safe
and effective for use without a doctor's supervision and must have an easily understood label .
We believe that the concerns show that Plan B has not been proven safe and effective and- we7'
have further reservations that the labeling may not be accurate .
Federal Register, Vol. 62, No. 37 ; 8611 ; FDA . "Prescription Drug Products ; Certain Combined Ora l
,. ~ . -. . ; ..__ .. . ., .._ .
Contraceptives for Use as Postcoital Emergency Contraception' ; Febiuary ~0, 1997
I
Lastly, we want to draw your attention to language that was included in the FY2005
Agriculture and Rural Development Appropriations Bill and was made a part of H .R . 4818 ; the
FY2005 Consolidated Appropriations Act .
Section 744 states, "None of the funds made available in this Act may be used to restrict
to prescription use a contraceptive that is determined to'be safe and effective for use witfiout the
supervision of a practitioner licensed by Iaw to administer prescription drugs under sectio n
503(b) of the Federal Food, Drug, and Cosmetic Act ."y
We contend that an accurate re ading of this language

_ would conclude that .. _ ._the
contraceptive must be found safe to be made available w.,tthout a prescripti o_n._ .If a drug is
deemed safe for some groups but not for all, this language-does not provide room for that drug to
be made available over the counter for these select popula ti ons. Section `744 simply states
--that
the drug must be effective without the supervision of a practi tioner, arguably precluding the FDA
from considering the bifurcated application submitted by Barr Labs .
The morning-after pill is a powerful drug that should not be on pharmacy shelves next to
chewing gum and cough drops . Barr Labs has not submitted new..information
_.~ . . . ~ regarding th e
safety or effectiveness of Plan B . If the-drug was not safe before, it is not safe now, and the FDA
should reject its appli cation.
Thank you for considering these views and for the work you do to ensure the safety of all
Americans.
,
i .m ~o3 n1y 25, ~4
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1 - 1 9-OS ; 3 :SSPM ;U .S . REP . JAY INSLE E ;202 226 1606 # 2/ 7
Congreo g of the Vniteb Otateg

uastUirtgton, M 20515
January 19, 200 5
The Honorable Lester M . Crawford

Commissioner
U.S . Food and Drug Administration
5600 Fishers Lane
Dear Dr. Crawford :
We would like to voice'our support for Barr Laboratories' application to make the
emergency contraceptive pill Plan B available over-the-counter (OTC) to women ages 16
and older. We recognize access to emergency contraception (EC) as having a critical role
in the goal to prevent unintended pregnancies and reduce the need for abortion in the
United States .
While we support unrestricted access to EC for all women, we believe that making Plan
B available OTC to women 16 and older is a significant step in the right direction .
Already, several states recognize the importance of timely access to Plan B by allowing
pharmacists to directly dispense the contraceptive to women .
In December 2003, two independent expert FDA advisory panels overwhelmingly

recommended making the emergency contraceptive, Plan B, available over-the-counter
by a vote of 23 to 4. The switch to OTC status is scienti fi call y and medically justified'
and meets the criteria for an OTC dru g product : it is safe, effective, and easily self-
administered .
As you know, approved for use by the FDA, EC is a concentrated form of the same
hormones in daily birth control pills that prevents unintended pregnancy when taken after
unprotected sex or contraceptive failure . If taken within 72 hours, EC can reduce the risk
of pregnancy by 89 percent . Whether "pro-life" or "pro-choice" we all recognize the
need to reduce unintended pregnancy . Experts estimate that widespread use of
emergency contraception could prevent as many as half of the nearly 3 million
unintended pregnancies that occur in the U .S . each year, including as many as 700,000
pregnancies that now result in abortion. '
Furthermore, in order to be effective, a woman must take EC within days of unprotected

sex - and the sooner, the better . Because of this narrow window of effectiveness,
timely OTC access to EC is a critical aspect in preventing pregnancy and reducing the
need for abortion.
It is also important that we draw your attention to a study published in the Journal of the
American Medical Association published January 5 ; 2005, which indicates-that ready
access to EC increases its use, but does not make women more likely to engage in sexua l
THIS STATIONERY PRINTED ON PAPER MADE OF RECYCLED FIBERS
r~c;~.4•a .
1 - 19 -05 ; 3 :SSPM ;U .S . REP . JAY INSLEE ;202 226 1 606 yc 3/ 7
risk taking behaviors or acquire STDs .°' These findings undermine claims that making
EC more available to teens and adult women will increase risk-taking behaviors such as
unprotected sex .
As you review the data on Plan B, we urge you to consider that a woman's access to EC
plays a critical role in preventing unintended pregnancy and reducing the need for
abortion . We support the approval of Barr Laboratories' application. Thank you for your
consideration of this request .
Sincerely,
go,* 4&tQ
DIANA DEGETTE JA EY `"- ZGIIISE SLAUGHTER
Member of Coggress A er of Congress Member of Congress
' Trussell J, et al . Emergency contraceptive pills ; a simple proposal to reduce unintended pregnancies .
Family Planning Perspectives 1992; 24: 269-273 . (Note: Trussell et al based their calculations on higher
rates of unintended pregnancy and abortion than current rates . The specific numbers of unintended
pregnancies and abortions that could be averted by widespread knowledge and use of EC are based on more
recent data, found in Henshaw SK . Unintended pregnancy in theUrritedStates, Family Planning
Perspectives, 1998, 30(1) :24-29 & 46) .
" Task Force on Postovulatory Methods of Fertility Regulation . Randomised controlled trial of
levonorgestrel versus the Yuzpe regimen of combined oral contraccptives for emergency contraception .
The Lancet. 1998 ; 352 : 428-433 .
"' Ellertson C et al. Extending the time limit for starting the Yuzpe regimen of emergency contraception to
120 hours. Obstet Gyneco12003 ; 101 : 1168-1171.
" Von Hertzen, H et al . Low dose raifepristone and two regimens of levonorgestrel for emergency
contraception : a WHO multicentre randomized trial . The Lancet 2002 ; 360 : 1803=181 0 .
" Rodrigues I, Grou F, JolyJ . Effectiveness of emergency contraceptive pills between 72 and 120 hours
after unprotected intercourse . Am J Obstet Gyneco12001 ;184(4) : 531-537.
" Raine T. et al, Increased Access to Emergency Contraception and Impact on Pregnancy and STIs : A
Randomized Controlled Trial, Journal oJthe American Medical Association, 2005 ;293:54-62 .
1-19-05 ; 3 :S5PM ;U .S. REP . JAY INSLEE ;202 226 1606 # 4 /
, 4~ 7T '
ADAM SMITH CAROL B . MALONEY
Member of Congres s Member of Congress
MCDERMOT T CAROLYN MCCARTHY

Member of Congres s Member of Congress
HILDA L. SOLIS PATRICK J . KENNEDY

Member of Cong re ss Member of Coneress
DENNIS J . KUCINICH SHERROD BROWN

Member of Congress Member of Congress
1-19-OS ; 3 :55PM ;U .S . REP. JAY INSLEE ;202 226 1 606 qY S /
~
STEVE ISRAEL TIMY HOP
Member of Congress Mengo& of C res s
Member of Congres s
Member of Congress
SAM FARR ROSA L . DELAURO

Member of Congres s Member of Congres s
11 tit . I&
ENR A . WAXNIAN
Member of Congres s
DANNY 4,C. DAVIS NANCY¢.. JORVSON

1-19-05 ; 3 : 55PM ; U . S . REP . JAY INSLE E ;202 226 1 606 # 6/ 7
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MES P . MCGOVERN
ember of Congress Member of Congres s
SUSAN A . DAVIS
Member of Congres s
LOIS CAIPS PETE FORTNEY STARK

Member of Congres s Member of Congres s
NEIk,ABERCROMBIE GARY X/. ACKERMAN

_ .__ .._ .__ . .. _# . . 7 ..
t-19-OS ; 3 :S5PM ;U. S . REP . JAY INSLEE ; 202 2'26 -i 606' ;-~ .-
SHELLEY BER
Member of Congress
GEORGE MILLER
Member of Congress
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):11',:l A HLU11 eo1FI-ttW . MINUR(TY ::TPFF DIRECTOR AND COUNSEL
GOV511NMENTAL AFFAIR S
WASHINGTON, DC 20510-6 250
September 27, 200 4
Dr . Steven K . Galson
Acting Directo r
Center for Drug Evaluation and Research
U .S . Food and Drug Administration
Rockville, M'D 2085 7
Dear 0r. Galson :
The purpose of this letter is to inquire about the basis for a recent decision by the
Center for Drug Evaluation and Research (CDER) of the U.S . Food and Drug
Administration (FDA) to deny the sale without a prescription of an emergency
contraception product known as "Plan B . "
The key regulation for conferring over-the-counter status to a regult ► ted drug is 2 1
CFR 310-200(b) which provides : "Any drug limited to prescription use under Section
503(b)(1)(C) of the Act shall be exempt from presc ri ption dispensing requircments when
the Commissioner finds such requirements are not necessary for the protection of public
health by reason of the drug's toxicity or other potentialities for harmful effects, the
method of its use, or the collateral measures necessa ry to its use, and he finds that the
drug is safe and effective for use in self- inedication as directed in the proposed labeling ."
This regulation essentially allows a drug t o be sold over the counter if it is determined by
the FDA to be safe and effective .
In December 2003, the Nonprescription Drugs Advisory Committee (NDAC) met

in joint session with the Advisory Committee for Reproductive Health Drugs (ACRHD)
to discuss conferring ovcr-the-cotint cr status to Plan B . At the meeting, the FDA Medical
Officer who conducted the primary clinical review of the Plan B submission reporte d
that "the FDA review of the sponsor's clinical trial safety data did not find any safety
signals of concern," After his presentation, the joint Committee voted 23-4 in favor of
conferring over-the-counter status to Plan B . In the next stage of the process, the FDA's
own scientific staff agreed with the Committee's recommendation to approve Plan B for
over-the-counter use . Despite these determinations by the advisory committee and
FDA
staff, your decision was to deny Plan B over-the-counter status .
To increase my understanding of the basis for this decision, please provide the
following information by no later than October 2 5 , 2004 .
PERMANENT INVESTIGATION S
`~ 10/06/04 WED 16 :47 FAX 202 224 197 :
Over the last ten years, please i ndicate the number of occasions on
which the recommendation of FDA staff to move a prescription drug to
over-the-counter status has been overruled by a Director or Acting
Director of CDER or by the FDA Commissioner . In each instance in
which a recommendation w as overruled, please provide the name of the
drug, the date on which the decision was made, an d a b ri ef summary of
the circumstances .
2) Please descri be the process you used in making your decision, including
whether you or your immediate staff discussed the matter with persons
other than members of the NDAC or ACRHD .
3) If you or your immediate staff communicated with persons other than

members of the NDAC or ACRHD in reaching the decision to deny
over-the-counter status to Plan B, please provide the name an d
professional affiliation of each person with whom you or your
immediate staff discussed this matter .
(a) Please include in your answer a description of any contact

between you or your immediate staff and former FDA
Commissioner, Dr . Mark McCllellan, on this matter . Please
indicate whether Dr . McCllcllan ever offered his opinion as
to whether Plan B should be sold over-the-counter and, if so,
please describe the ilate, participants, and circumstances of
that communication and what he said .
(b) Please include in your answer any contact you or your

immediate staff had with any Administration official or his or
her staff.
4) Please cxplain why you decided to overrule the recommendations of the

adviso ry committee and FDA's scientific staff and deny over-the-
counter status to Plan B .
5) You were quoted in a New York Times article dated May 8, 2004, as
saying with respect to your decision, : ` 61 am not trying to convey this
decision as being common or usual ." Please indicate whether this
quotation is accurate and, if so, what you meant .
6) You have indicated that one reason for the decision w as that the drug
manufacturer had not shown that Plan . B was safe for girls under 17,
.'chiefly because of inadequate sampling . "
(a) Over the last ten years, please indicate the number of
occasions on which the FDA has required a showing for
7
1 10/06/04 WED 16 :48 FAX 202 224 1972 PER M ANENT INVESTIGATION S 12100 4
children under 17 in a proceeding considering a prescription

drug for over-the-counter status . In each instance in which
this showing was required, please provide the name of the
drug and a brief summary of the circumstanccs .
(b) Please identify any legal precedent for requiring such a

showing in the Plan $ matter, any specific scientific or legal
basis for requiring research focused on this age group, and
whether CDER plans to require other drug manufacturers to
conduct similar research for this age group in other
proceedings .
7) Please provide copies of all documents (including correspondence,

memoranda, summaries of meetings or telephone conversations,
handwritten notes, or electronic mail) in the possession or control of
your office (including your immediate staff) related to your decision to
deny over-the-counter status to Plan B .
Thank you for your assistance in this matter. If you or your staff have any
questions about this request, please contact Laura Stuber of my staff at (202) 224-
9505 .
Sincerely,
Carl Levin
Ranking Minority Membe r
Permanent Subcommittee on Investigation s
CL :ls
cc : The Honorable Norm Coleman, Subcommittcc Chairman

09/20/2004 10 :55 PAX SE 11002/00 3
JOHN CORNY N
rpxaS
Vnit.eb `' f>a.fesr z,enate

WASHINGTON, DC 20510 -4305
June 16, 200 4
Associate Commissioner fbr Legislation

Food and Drug Administratio n
FDA, U .S . Department of Health and Human Services
Parklawn Building
5600 Fishers Lane, Room 15-47
Rockville, Maryland 20857-000 1
My constituent has sent the enclosed communication . A response which addresses his/her
concerns would be appreciated .
Please send your response to the following address :
Office of Senator John Comyn

Occidental Tower
5005 LBJ Freeway, Suite I 150,
Dallas, Texas 75244-619 9
ATTN : Suzanne Schutze

(972) 239-334 9
(972) 239-2110 (Fax )
E-mail : Suzanne_Sch.utze@jcornyn.senate .gov
Enclosure
Qoay - St (4 Ce
b 9/20/2004 10 :55 FAX SE R009/00 9
(b) (6)
May 28, 200 4
Senator John Cornyn

^ : .L '.,r
U-S . Senate
517 Hart Senate Office Building
Washington, DC 20510-000 1
Re : FDA Ruling on Emergency Contraception
Dear Senator Cornyn :
I am writing to voice my concern about the FDA's decision to deny Plan B emergency
contraception (EC) over-the-counter status . Unintended pregnancies are a ::ignificant problem in
the United States and women deserve a second chance to prevent this from happening . Easier
access to Plan B will also help to reduce the need for abortion .
I am very disturbed about this decision . This is clearly a political decision seeing as how
the FDA ignored not one but two scientific panels charged with evaluating, Plan B . Both panels
determined that Plan B met the criteria for over-the-counter, status . This decision is particularly
appalling considering that . women in 33 other countries currently have this option which American
women will not have .
I believe the FDA should represent the highest scientific standards and not just reflect the
right wing political agenda of the current administration .
I implore you to join your colleagues in seeking an investigation into the FDA's motives
and rationale with regard to allowing substandard health options for Americans in order to
promote a narrom- ideological agenda .
(b) (6)
Q1 002/00 3
6e% 09/20/2004 10 :54 FAX SE
JOHN COpNY N
TEXAS
~~.if:eb .St a te s Z .en:a#e

WASHINGTON, DC 20510- 430 5
June 15, 2004
Associate Commissioner for Legislation

FDA, U .S . Department of Health and Human Services
Parklawn Buildin g
5600 Fishers Lane, Room 15-47
Rockvillc, Maryland 20857-000 1
My constituent hits sent the enclosed communication. A response which addresses his/her
concerns would be appreciated.
Please send your response to the following address :
Office of Senator John Cornyn

Occidental Tower
5005 LBJ Freeway, Suite 1150,
Dallas, Texas 75244-619 9
ATTN : Suzanne Schutze

(972) 239-3349
(972) 239-2110 (Fax )
E-mail : Suzanne_Schutze@cornyn.senate.gov
Enclosure
09/20/2004 10 :54 FAX SE Q003/00 3
3%
(b) (6)
May 14, 200 4
Senator John Cornyn

U.S. Senate
Washington, DC 205 10-0001
Subject : Call for an Investigation into FDA Ruling on Emerge ncy Contraception
Dear Senator Gxrnyn:
I am writing to voice my concern about the FDA's decision to deny Plan B emergency
contraception (FiC) over-the-coizbor status. Unintended pregnancies are a significant problem in
the United States and women deserve a second chance to prevent this from happening. Easier
access to Plan B will also help to reduce the need for abortion .
I am appalled that the FDA would sully its reputation by ignoring the recommendation of two
scientific panels in favor of right-wing ideology . Comprehensive scientific data shows that Plan
B meets the FD .Vs criteria for over-the-counter status . Women here deserve this same
unencumbered access that women in 25 other countries around the world already enjoy .
The FDA decision is a major public health setback for American women. We cannot allow
conservative ideology to corrupt science . Please join your colleagues in calling for an
investigation into the Fl)A's willingness to sacri fice the health and li ves of women and teens to
promote a narrow ideological agenda .
(b) (6)
.,~
~+~•no
Rockville MD 2085 7
DEC - 2 ,_.. .. .
The Honorable John Cornyn
United States Senator
Occidental Tower
5005 LBJ Freeway, Suite 1150
Dallas, TX 75244-619 9
Dear Senator Comyn:
Thank you for the letter of June 15, 2004, on behalf of your constituent,
o -, awilis who is in opposition to the decision of the Food and Drug Administratio n
(FDA or the Agency) to issue a "Not Approvable" letter to Barr Research, Inc ., sponsor of the
application proposing to make the Plan B presc ri ption emergency contraception product
available as a non-presc ription (over-the-counter (OTC)) product .
On December 16, 2003, TDA held a public joint advisory committee meeting with members
of the Non-prescription Drugs Advisory Committee and the _, ,Advisory
.. ___ . Committee
. . fo r
Reproductive Health to consider the safety and effectiveness data provided in support of the
application proposing non-prescription use of Plan B . Although most of the joint committee
members recommended that this product be sold without a prescription, some members of the
committee, including the Chair, raised questions concerning whether the actual data were
generalizable to the overall population of non-prescription users, chietly because of
inadequate sampling of younger age groups .
As you may know, recommendations of FDA advisory committees are only advisory in
nature. FDA is not bound to follow their recommendations . The Agency makes its own
final decision on whether a product should be approved after evaluating all data as well as
considering the recommendations of the advisory committee .
Following the advisory committee meeting, FDA requested additional information from the
sponsor relating to adolescent use . The supplemental application that was submitted
proposed OTC status for both adults and children based primarily on an actual use study in
585 subjects . Only 29 of the 585 subjects enrolled in the study were 14-16 years of age, and
none was under 14 years of age .
After completing review of the supplemental application, FDA concluded that the application
could not be approved at this time because : 1) adequate data were not provided to support the
conclusion that young adolescent women can safely use Plan B for emergency contraception
Page 2- The Honorable John Corny n
without the professional supervision of a licensed practitioner and 2) a proposal from the
sponsor to change the requested indication to allow for marketing of Plan B as a prescription-
only product for women under 16 years of age and a non-prescription product for wome n
16 years and older was incomplete and inadequate for a full review . Therefore, FDA
concluded that the application was not approvable during this review cycle .
In its letter notifying the sponsor of this decision, the Agency stated the following :
"Before this application can be approved, you would have to provide data
demonstrating that Plan B can be used safely by women under 16 years of age without
the professional supervision of a practitioner licensed by law to administer the drug .
Alternatively, you could supply additional informationin Support of th e revised
indication to allow for marketing of Plan B as a prescription-only product for women
under the age of 16 years and a nonprescription product for women 16 years and older ,
. If you:includgraftpolbeing take the latter approach, your response to thi s
letter would have to include details of how you propose to implement simultaneous
prescription and nonprescription marketing of Plan B for women of different ages in a
single packaging configuration while complying with all relevant statutory and
regulatory requirements for labeling and marketing of this product . We will have to
assure ourselves that your proposed approach is consistent with our statutory
authority. If you pursue the alternative approach, we also would request details of
your proposed program to educate consumers, pharmacists, and physicians about the
dual marketing of Plan B as both a prescription and nonprescription product, as well as
your proposed program to monitor implementation of this novel approach . "
The Agency believes the availability of safe and effective contraceptives is important to
public health . Further, we continue to be committed to providing thorough. reviews of-new
drug applications based on adequate scientific data for all populations for which the product is
being considered . We look forward to working with the sponsor of the application if they
decide to pursue making this product available without a prescription .
Thank you again for your continued interest in this matter . If we can be of further assistance,
please let us know .
Sincerel y
atrick Ronan
for Legislation
T_
07/08/2004 12 :22 FAX 202 224 156 0
Steven Galson, M .D . Lester M. Crawford, Ph .D

Acting Director Acting Commissioner
Federal Drug Administration Federal Drug Administration
Center for Drug Evaluation and Research 5600 Fishers Lane
5600 Fishers Lan e Rockville, Maryland 2085 7
Dear Dr. Gralson and Dr_ Crawford
Recent press reports indicate that the scientists responsible for determining the safety
and efficacy of Plan B recommended strongly that Barr Laboratories application for the over-the-
counter status be approved . In fact, reports based on internal Federal Drug'Adnnixiist.ration
(FDA) documents seem to imply that the major reasons given for rejecting the application were
resoundingly rejected by the scientists responsible for analyzing the data .
We are deeply concerned that political concerns overrode scientific evidence in this
process, a state of affairs that sets a dangerous precedent for all Americans' health .
Therefore, as members of the Senate Health, Education, Labor, and Pensions Committee,
with oversight responsibilities over the Food and Drug Administration, we would like to invite
you to meet with us for a forthright, and hopefitlly, productive conversation about this situation _
Our staff will be in touch with your office to schedule a time that is mutually agreeable .
Sincerely,
61cf - 3 9>r s`"

07/08/2004 12 :23 FAX 202 224 1560 SENATOR CLINTON [a 002
. ';.
Page 2
R
JOSEPH 1 . LIEBERMA N SENATE OFFICE BUILDING
•A ' -- CON"1ECTICUT
WASHINGTON, DC 20510
(202)224-404 1
COMMITTEES :
STATE OFFICE!
ARMED SERVICES
'United *tatcs $enat e

ONE CONSTITUTION PLAZA
7TH FLOOR
ENVIRONMENT AND PUBLIC WORKS
HARTFORD . CT 08103
GOVERNMENTAL AFFAIR S 860-549-846
SMALL BUSINESS WASHINGTON, DC 20510 -0 703 : 1-800-225-5605
3TOLFRE
INTERNET ADDRESS:
senator_I ieberman @ lieberma n .senate .gov
HOME PAGE '
http :llf ieberman.senate.gov
June 4, 2004
Dr . Lester M . Crawford
Deputy Commissione r
U .S . Food and Drug Administration
5600 Fishers Lan e
Rockville, MD 2085 7
Dear Dr. Crawford :

£ca
I am enclosin ~_ , an e-mail which I recently received from one of my
constituents, ~~~~ , regarding her support for FDA approval of over-the-
counter access to Plan B, an emergency contraceptive pill .
I would greatly appreciate it if you would provide me with a response to the

attention of Vicki Holleran that addresses the concerns my constituent has raised .
Thank you for your attention to this matter .
JIL :vdh
Enclosure
I / -7 Q ~~
.
Sna pi~hot Report : Incoming Constituent Message

Imported through Webrespond Daemon
Report Date : 3/9/2004
Assign Staff: vdh

Address To (b) (6) (b) (6)
Name
Address
USA
Email Addr URL :
Home Phone' Cell Phone :
Work Phone : Fax :
(b) (6)
Salutation : Dea In Type : EML Reply Ltr :
Interest Code : MA Org Name : Assign Ltr:
Classification : P . Code : Category 1 :
Ref. Number: Grp Id : Category 2:
Title : Category 3 :
Message Body :
Subject Desc : Health
Date Received : 3/6/2004 2 :33 :32 PM
Sent: Saturday, March 6, 2004, 02 :32 P M

Start : I am writing to ask your support in urging the FDA to grant over-thecounter status to Plan __
B, an emergency contraceptive pill (ECP) . I am concerned that political pressure from opponents
of emergency contraception is overshadowing the scientific evidence demonstrating the safety and
effectiveness of Plan B . This evidence convinced _FDA adviso .ry committees last November t o
vote 23-4 in favor of making Plan B available without a prescription . A final decision last month
was delayed because of interference by politicians who wish to limit women's reproductive options .
American women clearly need the improved access to .EC that would be gained by selling Plan B
over the counter . Nearly half of all pregnancies in this country are unintended . Researchers have
estimated that if ECPs were widely available, rates of unintended pregnancy and abortion could be
reduced by half . A recent analysis estimated that EC helped to avert more than 50,000 abortions
in 2000-2001 in the United States .
Research from countries w.here . EC is available without a prescription does not support the fear
that enhanced availability of EC will lead to . reckless sexual behavior, especially among
adolescents . For example, a study published in the May 2002 issue of British Medical Jo_urna_I_
concluded that British teens who had received instruction about EC showed an improved
understanding of the method, but had no change in sexual activity when compared to teens who
had not received such instruction .
I urge you to alleviate the public health and social burdens of unintended pregnancy by working to
assure that Plan B becomes an over-the-counter product as soon as possible .
Sincerely,
(b) (6)
Lf'
DEPARTMENT OF HEALTH & HUMAN SERVICE S

Rockville MD 2085 7
T he Honorable Joseph I . Lieberman

United States Senat e AUG 2 2004
Washington, D .C . 20510-0703
Dear Senator Lieberman :

(b) (6)
Thank you for the letter of June 4, 2004, on behalf of your constituent,
of l onnecticut, regarding the Food and Drug Administratio
Agency ecision to issue a "Not Approvable" letter to Barr Research, Inc ., sponsor of the
application proposing to make the Plan B prescription emergency contraception product
available as a non-prescription over-the-counter (OTC) product .
On December 16, 2003, FDA held a public joint advisory committee meeting'with " inembers
of the Non-prescription Drugs Advisory Committee and the Advisory Committee'fo r
application proposing non-prescri ption use of Plan B . Although most of the joint committee
members recommended that this product be sold without a presc ription, some members of the..
generalizable to the overall population of non-presc ription users, chiefly because o f
As you may know, recommendations of FDA advisory commi ttees are only adviso ry in
nature . 'FDA is not bound to follow their recommendations . The Agency makes its ~own
1
proposed OTC status for both adults and childrenbased 'rimaril on an actual use stud Y iPY in
585 subjects . Only 29 of the 585 subjects enrolled in the studywere 14-16 years of age, and
without the professional supervision of a licensed practitioner and '2) a proposal from the
sponsor to change the requested indication to allow for marketing of Plan B as a presc ription-
Page 2- The Honorable Joseph I . Lieberman
only product for women under 16 years of age and a non-prescription product for women
the professional supervision of a practitioner licensed,by law to administer the drug.
Alternatively, you could supply additional informationin support of the revised
under the age of 16 years and a nonprescription product for women 16 years and older,
including draft product labeling. If you take the latter, approach, your response to this
assure ourselves that your proposed approach is consistent with our statutor y
authority . If you pursue the alternative approach, we also would request details of
your proposed program to monitor implementation of this novel ; approach . "
public health. Further, we continue to be committed to providing thorough reviews of new
being considered . We look forward to working with the sponsor of the application_ if they
decide to pursue making this product available without, a prescription .
Thank you again for your continued interest in this matter . If we

. . ,can
. . be of further
. ~__... . . assistance,
. ~ ..~~ :
please let us know,
atrick Rdfian
for Legislation
. ~/ TED STEVENS . ALASKA, CHAIRMA
y Ne,
TNAD COCHRAN. MISSISSIPPI ROBERT C- BYRD, WEST VIRGINIA
. PENNSYLVANIA DANIEL K- INOUYE, HAWAII 'ARLENSPCT
PETE V. DOMENK:I, NEW MEXICO ERNEST F . HOLLINGS . SOUTH CAROLINA
CHRISTOPHER S. BOND. MISSOURI PATRICK J . LEAHY. VERMONT
MITCH MCCONNELL, KENTUCKY TOM HARKIN, IOWA
CONRAD BURNS, MONTANA BARBARA A. MIKULSKI, MARYLAND
RICHARD C. SHELBY, ALABAMA HARRY REID. NEVADA
JUDO GREGG, NEW HAMPSHIRE HERB KOHL, WISCONSIN
Illftnited ~$tateu& *nate
ROBERT F. BENNETT, UTAH PATTY MURRAY, WASHINGTO N COMMITTEE ON APPROPRIATIONS
BEN NIGHTHORSE CAMPBELL. COLORADO BYRON L . DORGAN . NORTH DAKOTA
LARRY CRAIG . IDAHO DIANNE FEINSTEIN . CALIFORNIA WASHINGTON, 'bC 20510-602 5
KAY BAILEY HUTCHISON . TEXAS RICHARD J . DURBIN. ILLINOIS
MIKE DEWINE. OHIO TIM JOHNSON, SOUTH DAKOT www.sen ate .gov/-ap propri ation s
. KANSAS MARY L . LANDRIEU. LOUISIANA ASMBROWNACK
JAMES W. MORHARD. STAFF DIRECTOR

TERRENCE E . SAUVAIN. MINORITY STAFF DIRECTOR
May 20, 2004
Amit Sachdev
Associate Director for Legislative Affairs
6600 Fishers Lane
Dear Amit : (b) (6)
Enclosed is a copy of a letter I re ceived from

would apprepiate any information that you can provide me so that I may respond to Mrs .
(b) (6)
Thank you for your assistance .
With best wishes,
Cordially ,
TED STEVEN S
, i -, e-> ,, ,
I
Eames, Seth (Stevens)
wn~
From : Nobody [nobody@www.senate .gov]
Sent: Thursday, April 08, 2004 9 :57 P M
To : Stevens, Alaska Correspondence (Stevens)
Subject : www email
<APP>SCCMAIL
<PREFIX>MRS</PREFIX>
<FIRST' -FIRST >
<LAST >
<ADDR1 >
<ADDR2> <
<CITY >
<STATE >
<ZIP>
<HPHO RPHONE >
.<WPHONE > PHONE >
<EMAIL > /EMAIL >
<MSG> I am outrage d y news reports that political considerations led the FDA to postpone
its decision to make Plan B emergency contraception available over the counter (OTC) .
The FDA should follow the strong scientific evidence, unprecedented medical consensus, and
the recommendation of two FDA expert advisory committees that voted in support of the OTC
switch at their December meeting . This recommendation is supported by the American Medical
Association, the American Academy of Pediatrics, the Society of Adolescent Medicine, the
American College of Obstetricians and Gynecologists and over a dozen other leading medical
.and public health organizations .
Over-the-counter access to Plan B would represent a tremendous advance in women's health .

I urge swift FDA approval of Plan B's OTC application without restrictions and without
further delay . Politics should not get in the way of women having a second chance to
prevent an unintended pregnancy .
Womans issues is not even a topic you allow in the dropdown part of your website . </MSG>
<TOPIC>Housing</TOPIC> </APP>
I
Ic
[ ~S[!VKlj - . _ . .
♦ =J~
47
_ .~ . DEPARTMENT OF HEALTH & HUMAN SERVICES
'~. .
Rockville MD 2085 7
The Honorable Ted Stevens

United States Senate AUG 2 2004
Washington, D .C . 20510-602 5
Dear Senator Stevens :
Thank you for the letter of May 20, 2004, on behalf of your constituent, Ms .
laska, regarding the Food and Drug Administration's (FDA or tlie Agency )
ec sion to issue a "Not Approvable" letter to 13arr Research, Inc ., sponsor of the application
proposing to make the Plan B prescription emergency contraception p roduct available as a
non-prescription over-the-counter (OTC) product .
On December 16, 2003, FDA held a public joint advisory committee meeting with member s
of the Non-prescription Drugs Advisory Committee and the Advisory Committee .. for-
:
Reproductive Health to consider the safety and effectiveness data provided in supp4 o.:rt
:of the
-__.~ . .__: ~. __..
application proposing non-prescription use of Plan B . Althou ~1~ most of the joint c ommittee
members recommended that this product be sold without a prescription, some members of th e
committee, including the Chair, raised questions concerning whether the actual data'- were
generalizable to the overall population of non-prescription users, chiefly because of
As you may know, recommendations of FDA advisory committees ~~__ are only advisory in
nature . FDA is not bound to follow their recommendations . Tlie Agen-~cy makes its own
final decision on whether a product should be approved after evaluating all data as welt as,
-
could not be approved at this time because : 1) adequate data were not provided to support th _ e
♦
Page 2-- The Honorable Ted Steven s
16 years and older was incomplete and inadequate for a full review. Therefore, FDA
concluded that the application was not approvable du ring this review cycle .
demonstrating that Plan B can be used safely by women under 1 6 years of age without
Alternatively, you could supply additional information in support of the revised
including draft product labeling . If you take the latter approach, your response to this
public health . Further, we continue to be committed to providing thorough reviews of new
'rick Rona n
for Legislatio n
TED STEVENS, ALASKA. CHAIRMAN
?ifAD COCHRqN, MISSISSIPPI ROBERT C. BYRD, WEST VIRGINIA

ARLEN SPECTER. PENNSYLVANIA DANIEL K . INOUYE, HAWAI I
PETE V. DOMENICI, NEW MEXICO ERNEST F . HOLLINGS, SOUTH CAROLIN A
CHRISTOPHER 5. BOND . MISSOUR PATRICK J. LEAHY. VERMONT
MCCONNELL KENTUCK Y IMTCH
CONRAD BURNS, MONTANA
RICHARD C. SHELBY, ALABAMA
JUDD GREGG. NEW HAMPSHIRE
TOM HARKIN. IOWA
BARBARA A. MIKULSKI, MARYLAND
HARRY REID, NEVAD A
HERB KOHL WISCONSIN
IaLlntted ~5tatl%uap *nat e
ROBERT F. BENNETT . UTA PATTY MURRAY . WASHINGTON COMMITTEE ON APPROPRIATIONS
H BEN NIGHTHORSE CAMPBEL . COLORADO BYRON L . DORGAN, NORTH DAKOTA
LARRY CRAIG, IDAH O DIANNE FEINSTEIN, CALIFORNIA WASHINGTON, DC 20 510-6025 .
KAY BAILEY HUTCHISON, TEXAS RICHARD J. DURBIN, ILLINOIS
MIKE DEWINE, OHI O TIM JOHNSON, SOUTH DAKOT www.senate.gov/-appropriation s
SAM BROWNBACK . KANSAS . LANDRIEU, LOUISIAN A
AMRYL
JAMES W. MORHARD, STAFF DIRECTOR

TERRENCE E . SAUVAIN, MINORITY STAFF DIRECTOR
May 20, 2004
Amit Sachdev
6600 Fishers Lane
Dear Amit :
Enclosed is a copy of a letter I received from ' of J

would a iate any information that you can provide me so that I may respond to Mrs .
With best wishes,
Cordially,
TED STEVEN S
,
.. ,
Yarmon, Joel (Steven s
From : nobody@www .senate .gov
Sent: Monday, April 05, 2004 4 :48 PM
Subject : www emai l
<APP>SCCMAIL
<PREFIX>Mrs .< PREFIX>
<FIRST IRST>
<LA
<AD (b) (6)
<ADDR2 >
<CI (b) (6)
<ST
.<ZI
<HP
<WP
<EMA
<TOP
<TR NUMPARTY>April 01, 200 4
Senator Ted Steven s

Washington, DC 20510-020 1
Dear Senator Stevens ,
Please urge the Food and Drug Administration to approve over-the-counter sales of
emergency contraception, often called "the morning-after pill . "
Emergency contraception pills are special doses of hormones used in birth control pills
that reduce the risk of pregnancy if started within 120 hours of unprotected intercourse .
The sooner EC is administered after unprotected intercourse, the better it works, making
timely access critically important . Studies show that women do not rely on emergency
contraception as a regular method of birth control . Research also indicates that
widespread availability of EC could prevent 1 ' 7 million unintended pregnancies and 800,000
abortions each year in the U .S .
It would greatly benefit women to have the drug available "over-the-counter ." The sooner
the drug is taken, the more effectiè . The need to visit a doctor for a prescription may
inhibit some women from getting contraception to prevent pregnancy from ever occurring .
On December 16, 2003, a joint hearing of the FDA Nonprescription Drugs and Reproductive
Health Drugs Advisory Committees voted
_. 24 . to
.~ . . 3 to recommend that the FDA make EC available
over the counter . virtually all major medical and'Health care organizations, including the
American College of Obstetricians and Gynecologists, support theìnove .
I urge you to take a leadership role on this matter, and not allow the FDA to play
politics with the lives of low-income and young women . Thank You .
Sincerely ,
(b) (6)
(b) (6)
</TR_NUMPARTY>
<>Submit Information</>
</APP>
124
DEPARTMENT OF HEALTH & HUMAN SERVICE S
, .. : .:_ .:. .. . ..,
`~
Rockville MD 20857


(b) (6)
Thank you for the letter of May 20, 2004, on behalf of your constituent,
of Juneau, Alaska, regarding the Food and Drug Administration's (FDA or the Agency)
decision to issue a "Not Approvable" le tt er to Barr Research, Inc ., sponsor of the applicatio n
proposing to make the Plan B prescri ption emergency contraception product available as a
non-presc ri ption over-the-counter (OTC) product .
On December 16, 2003, FDA held a public joint advisory committee meeting with members
of the Non-prescription Drugs Advisory Committee and the Advisory Committee for
nature . FDA is not bound to follow their recommendations . The Agency makes its own
consideri ng the recommendations of the advisory commi tt ee .
sponsor relating to adolescent use. The supplemental application that was submitted
i
41
Page 2- The Honorable Ted Steven s
the professional supervision of a practitioner licensed by law to administer the drug.
prescription and nonprescription marketing of Plan Bfor women of different ages in a
The Agency believes the availabili ty of safe and effective contraceptives is impo rtant to
public health . Further, we continue to be committed to providing thorough reviews of ne w
Sincerely,
atrick Ronan
for Legislation
SUITE 709
', BABBAFiA A . MIKULSKI HART SENATE OFFICE BUILDING
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(202)224-465 4
TDD: (202) 224-5223
Mnited o$taorWff o$ennte

WASHINGTON, DC 20510-2003
May 10, 200 4
Mr . Amit Sachde v
5600 Fishers Lane, Parklawn Building
Room 15-4 7
Dear Mr . Sachdev :
I am writing to request your consideration of the attached

corresponden ce f Please respond
directly to d send a co 7y Manly of .my
staff . If you have. any questions, please cal7 . Ms . Manly a t
(202) 224-4654 .
0( V Thank you for your assistance .
Sincerely ,
Barbara A . Mikulski
United States Senato r
BAM :km
Enclosur e
SUITE 400 SUITE 202 SUITE 406 SUITE 1, BLDG . B

1629 THAMES STREET 60 WEST STREET 6404 IVY LANE 94 WEST WASHINGTON STREET 1201 PEMBERTON DRIV E
BALTIMORE, MD 21231 ANNAPOLIS, MD 21401-2448 GREENBELT, MD 20770-140 7 HAGERSTOWN , NA D 217401~4804 SALISBURY, MD 21801-2403
(410) 962-4510 1410) 263-1805 1301) 345-551 7 (301)797-2826 (410) 546-7711
Mtp :/,'mikulski .senate.gov!
tW - 30)9
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#12 7210569 - Miss Jessica Miller, In ID: 2435352, Out ID : 2681978

(b) (6)
From :
Date: 4/27/2004 3 :50 :19 PM
Subject:www emai l
February 18, 200 4
Sen . Barbara Mikulski

Washington, DC 20510-6133
Dear Sen . Mikulski ,
Please urge the Food and Drug Administration to approve over-the-counter sales of emergency contraception, often called
"the morning-after pill . "
Emergency contraception pills are special doses of hormones used in birth control pills that reduce the risk of pregnancy if
started within 120 hours of unprotected intercourse . The sooner EC is administered, after unprotected intercourse, the better
it works, making timely access critically important. Studies show that women do .not rely on emergency contraception as a
regular method of birth control . Research also indicates that widespread availability of EC could prevent 1 .7 million
unintended pregnancies and 800,000 abortions each year in the U .S .
It would greatly benefit women to have the drug available "over-the-counter ." The sooner the drug is taken, the more
effective . The need to visit a doctor for a prescription may inhibit some women from getting contraception to prevent
pregnancy from ever occurring.
On December 16, 2003, a joint bearing of the FDA Nonprescription Drugs and Reproductive Health Drugs Advisory
Committees voted 24 to 3 to recommend that the FDA make EC ayailable oyer the counter. Virtually all major medical and
health care organizations, including the American College of Obstetricians and Gynecologists, support the move .
I urge you to take a leadership role on this matter, and not allow the FDA to play politics with the lives of low-income and
young women .
Thank You .
Sincerely,
(b) (6)
Original Formatted Message Starts Here
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Rockville MD 20857
(b) (6)
JUN 1 4 2004
Thank you for your letter of February 18, 2004, addressed to Senator Barbara A . Mikulski,
regarding the Food and Drug Administration's (FDA or the Agency) decision to issue a "Not
Approvable" le tter to Barr Research Inc ., sponsor of the application proposing to make the
Plan B presc ri ption emergency contraception product available as a non-presc ription over-the-
counter (OTC) product . Senator Mikulski asked that we respond directly to you.
members . recommended that this product be sold without a prescription, some members of the
As you may know, recommendations of FDA adviso ry committees are only advisory in
consideri ng the recommendations of the adviso ry committee .
none were under 14 years of age.
could not be approved at this time because : 1) adequate data was not provided to support the
3 6 7 f --
I
. . ..
~' . TED STEVENS. ALASKA. CHAIRMAN _
.. . _ . . . .. . . _ : .
. . .
. 41
THAD COCHRAN . MISSISSIPPI ROBERT C . BYRD, WEST VIRGINI
. INOUYE . HAWAII ARLENSPCT,NSYLVAIDEK - - - -
PETE V . OOMENICL NEW MEXICO ERNEST F . HOLLRVGS, SOUTH CAROLIN
. BOND, MISSOURI PATRICK J . LEAHY, VERMON ACHRISTOPE
KENTUCKY 70M HARKIN, IOW A TMRCNOEL,
CONRAD BURNS. MONTANA BARBARA A. MHCULSKI, MARYLAN
. SHELBY, ALABAMA HARRY REID, NEVADA DRICHA
JUDD GREGG, NEW HER B
ROBERTF .EIENNEIT.UTAHH~ ATTYMHURRAY,.CW. ~4,S NGTON COMMITTEE ON APPROPRIATION S
BEN NIGHTFIORSE CAMPBELL, COLORADO BVRON L. OORGAN, NORTH DAKOTA
LARRY CRAIG . IDAHO DIANNEFEINSTERi, CALIFORNIA WASHINGTON, DC 20510-602 5
KAY BAILEY HUTCHISON, TEXAS RICHARD J. DURBIN. ILLINOIS - -
DEWME, OHIO TIM JOHNSON, SOUTH DAKOTA -MIKE WWW58N8t@ .90V/-appropriation s
SAM BROWNBACK, KANSAS MARY L .LANDRIEU.LOUISIANA
JAMES W. MORHARD. STAFF DIRECTOR

TERRENCE E . SAUVAIN, MINORITY STAFF DIRECTOR
May 20, 2004
Amit Sachde v
6600 Fishers Lane
Dear Amit : P 6
Enclosed is a copy of a letter I received fro am - f

would appreciate any information that you can provide me so that I may respond to Ms..
~
With best wishes,
Cordially,
TED STEVEN S
to,(- D13
. . . *.
Eames, Seth (Stevens )

From : Nobody [nobody@www .senate .gov]
Sent : Saturday, May 08, 2004 3 :59 P M
Subject : www emai l
<APP>SCCMAIL
<PREFIX IX>
<FIRST FIRST>
<LAST> ST>
<ADDR1>~ 4725</ADDR1 >
<ADDR 2
<CITYAIE CITY>
<STAT STATE>
<ZIP> </ZIP>
<HPHONE><JHPHONE >
<WPH
I just read in the New York Times that Dr . Steven Galson,acting director of the food and
drug administration for drug evaluation and research, denied the Barr Pharmaceuticals
request to sell the morning-after pill Plan B over the counter . He rejected their request
over the recommendations of the drug evaluation advisory board and his staff
recommendations . 'Since the quest to sell the drug received overwhelming support from both
the advisory committee and his staff, I can only believe that his decision was based not
on scientific fact but on his religious and moral convictions . . As a woman, a mother of
two girls and a practicing Catholic, I find his action infuriating . I would appreciate
knowing if there is anything that can be done to overturn is decision . I appreciate your
assistance .
I
DEPARTMENT OF HEALTH & HUMAN, SERVICES _t

Rockville MD 2085 7

W ashington, D .C . 20510-602 5
Thank you for the letter of May 20, 2004, on behalf of your constituent, M s
of garding the Food and Drug Administration's (FDA or the Agenc y
decision to issue a "Not Approvable" letter to Barr Research, Inc ., sponsor of the application
proposing to make the Pl an B prescri ption emergency contraception product available as a
non-presc ri ption over-the-counter (OTC) product .
members, recommended that this product be sold without a prescription, some members of the
generalizable to the overall population of non-prescription users, chiefly because o f
Following the advisory committee meeting, FDA requested additional information from th e
«
.. . . SUITE 709
F BARBARA A . MIKULSKI HART SENATE OFFICE BUILDING
,
MARYLAND WASHINGTON, DC 20510-2003
11202)224-4654
'Hnid $tares vSenar

e TDD: (202) 224-5223
WASHINGTON, DC 20510-200 3
May 4, 200 4
Mr . Amit Sachdev
5600 Fishers Lane, Parklawn Building
Room 15-4 7
Dear Mr . Sachdev :

correspondence from Mr . 0 . Please respon d
directly to Mr . ~"àn 77 d send a copy to Katie Manly of my
staff . .If you have any questions, please call Ms . Manly at
(202) 224-4654 .
Sincerely ,
~
BAM :km
Enclosure
SUITE 400 SUITE 202 SUITE 406 -SUITE 1, BLDG . B

1629 THAMES STREET 60 WEST STREET 6404 IVY LANE 94 WEST WASHINGTON STREET 1201-PEI'318ERTON-DRRIE
BALTIMORE, MD 21231 ANNAPOLIS, MD 21401-2448 GREENBELT, M D 20770-140 7 HAGEhSTOWN; M D I Y740=4804' -SALt~B~~?Y MD 2'18~1 '240?" "
1410) 962-4510 (410) 263-1805 Ml', 345-5517 (30i) 797-2826 (410) 546-771 1
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(b) (6)
From: (b) (6)

Date: 4
Subject:
(b) (6)
(b) (6)
Dear Senator Barbara A . Mikulski :
I am contacting my members of Congress regarding an issue of concern to

me. FDA seems poised to approve the "Plan B" morning after
contraceptive for over the counter sale . As a physician and citizen, I
am strongly opposed to this action. My reasons include : -Plan B has
much more serious side effects than typical over- the -counter
medications, including abdominal pain, vomiting, diarhea, nausea,
fatique, and dizziness . -Plan B may be used repeatedly as a form of
birth control, encouraging sexual promiscuity and slowing the use of
conventional birth control methods, some of which help prevent HIV and
venereal diseases . -Plan B is already available as a prescriptio n
drug -Plan B will in many cases, especially if taken late, be an
abortifacient in preventing implantation of a live human embryo . I am
morally opposed to any form of abortion-related technologies .
Please also forward this letter to the senators from the state of
Virgina and the Representative from Orange County, as Virginia is our
legal residence (we are an active duty uniformed services family) .
Thank you for your consideration Sincerely ,

(b) (6)
Original Formatted Message Starts Here -
(b) (6)
httn-//miknlcki_in-R(1(Utc acn/ima tPYt r~nniin v7 -9Y„V-ann.sn 1 Q RY ni 4-') A 7(KRSR.rn• :,_n A i1 7i1 nnn
♦
~` .. / . DEPARTMENT OF HEALTH 8s HUMAN SERVICES

s
r,y
J~
Rockville MD 20857
(b) (6)
JUN 1 4 200 4
.,
e
c.P
Thank you for your letter of April 15, 2004, addressed to Senator Barbara A . Mikulski,
Approvable" letter to Barr Research Inc ., sponsor of the application proposing to make the
Plan B prescription emergency contraception product available as a non-prescription over-the-
counter (OTC) product . Senator Mikulski asked that we respond directly to you .
On December 16, 2003, FDA held a public joint advisory committee meeting with members-'
585 subjects . Only 29 of the 585 subjects enrolled in the study were 14-l5 years of age, and
none were under 14 years of age .
without the professional supervision of a licensed practitioner and 2) a proposal
_. . .. . from th e
sponsor to change the requested indication to allow for marketing of PTan B as a prescription-
r
(b) (6)
demonstrating that Plan B can he used safely by women under 16 years of age withou t
including draft product labeling. If you take the latter approach, your response to this
The Agency believes the availability of safe and effective contraceptives is import ant to
Thank you again for contacting Senator Mikulski conce rn ing this matt er .
Sincerely ,
atrick Ronan
for Legislation
cc : The Honorable Barbara A . Mikuiski

Unite States Senate
1
SUITE 70 9
BARBARA A . MIKULSK HART SENATE OFFICE BUILDING
IMARYLND WASHINGTON, DC 20510-2003
(202)224-4654
TDD: (202) 224-6223
lurid ~5tateuis ~5enate
WASHINGTON, DC 20510-2003
April 22, 200 4
Mr . Amit K . Sachdev
Associate Commissioner of Legislation
U .S . Dept . of Health & Human Services
5600 Fishers Lane
Room 15-4 7
Dear Mr . Sachdev :
I am writing request p the attached

correspondence from Ms .(b) (6) ~res fon d' directly
to Ms .(b) a copy to Katie Manly of my staff . If you
(6) questions, please call Ms . Manly at (202) 224-4654 .
have any
Sincerely ,
BAM :km
Enclosur e
SUITE 400 SUITE 202 SUITE 406 SUITE 1, BLDG . B

1629 THAMES STREET 60 WEST STREET 6404 IVY LANE 94 WEST WASHINGTON STREET 1201 PEMBERTON DRIVE
BALTIMORE, MD 21231 ANNAPOLIS, MD 21401-2448 GREENBELT, MD 20770-1407 HAGERSTOWN, MD 21740-4804 SALISBURY, MD 21801-240 3
(410)962-4510 (410)263-1805 1301)345-5517 (301) 797-2826 1410) 546-771 1
. Mtpatmikulski .senate .gov!
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C/ ~/3

Rockville MD 20857
(b) (6)
JUN .1 4 2004
Thank you for your letter of March 11, 2004, addressed to Senator Barbara A . Mikulski,
Plan B prescription emergency contraception product available as. .a_ non-presc ri ption over-the-
counter (OTC) product. Senator MikuIski asked that we respond, directly to you .
Reproductive Health to consider the safety and effectiveness data provided in support of the'
nature . FDA is not bound to follow their . recommendations . The Agency makes its own
none were under 14 years of age.
sponsor to change the requested indication to allow for marketing of Plan B as a presc ri ption-
.C2- r/3 : - -
(b) (6)
under the age of 16 years and a nonprescription product for women 1 6 years and older,
Thank you again for contacting Senator Mikulski concerning this matter .
Sincerely ,
' atrick Ronan

for Legislation
cc : The Honorable Barbara A . Mikulski

United States Senate
Washington, D .C . 20510-2003
_T
A
BARBARA A . MIKULSKI SU(TE 709
HART SENATE OFFICE BUILDING
^k ~ MAFjYLAND WASHINGTON, DC 20510-2003
united *tatts *tnatt

WASHINGTON, bC 2051 64003 LL
April 22, 200 4
Mr . Amit K . Sachdev
Associate Commissioner of Legislation
U .S . Dept . of Health & Human Services
5600 Fishers Lane
Room 15-4 7
Dear Mr . Sachdev :

correspondence from Mrs .( respond
b
directly to Mrs . (b) (6) a send a copy to ~atiemanly of m
)
. If you have any questions, please call Ms . Manly a
ystaf t
(202) 224-4654 . (
6
)
Sincerely ,
A
BAM :km
Enclosure
SUITE 400 SUITE 202 SUITE 406 SUITE 1, BLDG. B

1629 THAMES STREET 60 WEST STREET 6404 IVY LANE 94 WEST WASHINGTON STREET 1201 "PEMBERTON DRIVE
BALTIMORE, MD 21231 ANNAPOLIS, MD 21401-2448 GREENBELT, MD 20770-140 7 HAGERSTOWN,ÀAD`21740-4804 SACiSBURY, MD21ff01-2403
_
(410)962-4510 (410)263-1805 (301)345-551 7 (301) 797-2826 (410)546-7711
h ttp://m'rkulski . senate.gov!
I
N)iew e :lemailobj\20040111\1913?:Ì 9.txt Page 1 of I
(b) (6) mailobj\200401 \1\19133619 .txt
Fr
Date : 1/9/2004 1 :36:14 PM
To : webmait@mikulski-iq .senate .gov
Subject: www emai l
Last month, two Food and Drug Administration (FDA) panels overwhelmingly recommended (23-4) that the emergency
contraceptive Plan B be sold over the counter . FDA Commissioner Mark McClellan will issue his final decision within the
next couple of weeks .
I urge you to contact FDA Commissioner Mark McClellan to ask him to support over the counter access to emergency
contraception .
(b) (6)
-- Original Formatted Message Starts Her e
(b) (6)
<MSG> Last month, two Food and Drug Administration (FDA) panels overwhelmingly recommended ._ . (23-4) that the
emergency contraceptive Plan B be sold over the counter. FDA CommissioneiMark McCleIlan wiIl issue his final decision
within the next couple of weeks .
I urge you to contact FDA Commissioner Mark McClellan to ask him to support over the counter access to emergency
contraception .
(b) (6)
View e : lemailobjl20040111 f191336I9 .txt - KATIEM '
h ttp ://mikulski-iq :800/tc_asp/view_webmail .asp?object id=e%3A%SCemailobj%5C2004 . . : 4/21/2004

I
aJ+*' SL`mCtt.` '
J
_• ~ 4 DEPARTMENT OF HEALTh & HUMAN SERVICES

Rockville MD 20867
(b) (6)
JUN .1 4 2004
Thank you for your letter of January 9, 2004, addressed to Senator _Barbara A .._Mikiilski
.. , ..~.._.._. .. ,_ .~_._ ~,. . . __
regarding the Food and Drug Administration's (FDA or the Agen c-) decision to issue a"Not
Plan B prescription emergency contraception product available as a non-prescription over-the-
counte
counterr (OTC) product . Senator Mikulski asked that we respond directly to you .
On December 16, 2003, FDA held a public joint advisory committee meeting with members <__ .
As you may know, recommendations of FDA advisory committees . . .,- are only advisory in
nature. FDA is not bound to follow their recommendations . The Agency makes its own
proposed OTC status for both adults and children based primarily on anactuaI use study in
585 subjects . Only 29 of the 585 subjects enrolled in the *studywere 14-16 years of age, and
none were under 14 years of age .
could not be approved at this time because- :' 1) adequate data was not provided to support the
sponsor to change the requested indication to allow for marketing of Plan B'a's a prescription-
-a ~~s
Y X
aiioaizOna yNY08!'Aa
1 FA , . .. t, o oo l
„'RECEIVED"`
Feb 09,2004 15:50 :57 WSIi 0
OFF
X"O e" 61 the ll n 't e b * til rr.!5
E OF THE T~Y
ICORRESPONDENC Uld.o f)ittgtnn, DIE- 2051:+
CONTROL CENTER
Janua ry 9, 2004
The Honorable George W . Bush

President of the United States
1600 Pennsylvania Avenue, N .W .
Washington, DC 2050 0
Dear Mr . President,
We thank you for the remarkable job you and your Administration are doing during these
challenging days . We are writing mow regarding a very urgent and important mattei'that
will affect the health and welfare of millions of Americans . A joint advisory panel of the
Food and Drug Administration has voted to recommend the availability of the morning-
after pill levonorgestrel, or Plan B, without a prescription . We urge you and the
Commissioner of the Food and Drug Administration to reject this recommendation .
We are very concerned that no data is available to suggestwbat impact this decision will
have on the sexual behavior of adolescents and the subsequent impact on adolescent
sexual health . We are concerned that adolescent exposure to sexually transmitted
infection will increase because of the availability of levonoraestrel over-the-counter .
This availability may ultimately result in significant increases in cancer, infertility, and
HIV/AIDS .
According to Food and Drug Administration documents, only the drug's safety and its
effect on pregnancy were considered -without considering the signi Ficant impact over-
the-counter availability of this product may have on the sexual health of adolescents and
young people .
Adolescents and young adults (15-24) are the age groups at the greatest risk for acquiring
sexually tran.smitted infections (S'1'Is) . Approximately two-thirds of all people who
acquire STIs are under the age of 25 and each year 1 5 million new cases are diagnosed .
The Centers for Disease Control states that adolescents and young adults are at greater
risk of acquiring a sexually transmitted infection because of their immature physiology
and immune systems ; the increased probability of adolescents having multiple sexual
partners, and the greater likelihood of adolescents engaging in high-risk sexual activity . '
Compared to older women, tecn girls have a higher rate of chlamydia, a disease that is a
common cause of pelvic inflammatory disease (P .T.D), which can lead to infertitity . At
least ten percent of all sexually active teens are infected .with this disease. Among
woincn, gonorrhea rate .-; are highest among teen girls ages 15-19 ." And the risk of pelvic
inflammatory disease is as much as I 0 times greater for l5-yelr-old females than for 24-
year-old females . P1D can result in sterility ." '
vA urnn oA; : :u• ._. .o rarn

REC E IVEn BY
JAN 12 2004
LL~~~~~
er*-q
0)/i2%04 ~ON 08 :3~, FAX
0 7 08/2004 9 ;2X b'A
"' RECEIVED "' 49 ""~~ ~p 002
Feb 09,2004 15 :50 :57 WSx 06
OFFICE OF THE SECRETARY
CORRESPONDENCE
CONTROL CENTER
Moreover, many STIs are difficult to treat . Herpes simplex virus infection (HSV-2) is
typically asymptomatic and yet is highly contagious . Twenty two percent of the United
States population age 12 and older (45 million) is infected with HSV-2 .
Furthermore, age of initiation of sexual activity is a strong predictor of exposure to and

contraction of a sexually transmitted infection . Anything that affects the sexual behavior
of adolescents has significant public health consequences in terms of pregnancy and
acquisition of sexually transmitted infections, including HIV/AIDS . The CDC estimates
that 50% of all new HIV in .fections occur among people under 25 years old, with the
majority being infected sexually- "
Determining how the over-the-counter availability of levonorgestrel may affect

adolesccnl sexual health is a reasonable and minimal public health qucstion that we feel
must be determined before any decision is made . Unfortunately, this important public
health information was not considered as part of the review process .
We urge you and Commissioner McClellan to reject the recommendation of the joint
advisory panel . Current public efforts to inform young persons of risk have not
effectively reduced prevalence of sexually transmitted disease . Moreover, data on
adolescent risk-taking indicates that young people are risk-takers and will engage in risky
behaviors that increase their chances of acquirinb STDs, becoming pregnant and
participating in drug, alcohol and nicotine abuse . We have attached a new; article froin
the Uuited Kingdom that indicates the over-the-counter availability of levonorgestre] as
causing significant increases in STIs among adolescents .
We are hird-pressed to understand how the over-the-counter availability of Plan 5 will

enhance adolescent sutual health and reduce the incidents of scxually transmitted
infection . Therefore, we urge you in the strongest of terms to reject the joint advisory
council recommendation and protect the hcath and lives of American adolescents .
Sincerely ,
, ~~'- ~
: 31 FAX '•' RECEIVED
01/12%04 MON 08 ••• ~ 003
viius~~uua ty : zs ~na Feb09,200415 :50 :s7VNS#06 , . .. . . ,
CORRESPONDENCE
CONTROL CENTER
~ 1% M ts t- ..4 - I
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U/ u N/ Z u 4 !► t Z P A Feb 09,200415 :50 :57 WS# 06 IN u u a i u f
OFFICE OF THE SECRETAR Y
CORRESPONDENCE
_ • CONTROL CENTER
ZAotw~~
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FAX "' RECEIVED " ' LW urro rrl 005
oi%orit~no4 G4 hÀ1C Feb 09,2004 15 :50 :57 WS X 06 /
CORRESPONDENCE
CONTROL CENTE R
ixiun or ~W I'rerention . Scauulfr Tierr :.rmiltta! Dlzettse Swwrilluqtr 1999. Dc.panment cif Health Lind Humon
iccs, A llantu: Center For L)ise•.ase Control and Yn:rentiun LCLXj, ticplemper 30(l0 .
'Ulvieion nf STD Pre vcnlfon . Srxua!!v 71•tutrmr7red Di.r e nse Surveillance 1999 . [h;lntrlmrnt of Hcathh and Humnn
Sen•1 c ns, .Allanla : Contcr for Qisease Control and )'' rcvention ((:DC) . SeplGntxr 2(.100.
p1 Westroln L. Incidence, Prcvalen ce . und Trends or Acute Pclvic lnflmmmalory Discasc and Its Conscqucnccs in
) ndt~clrrali,crd Cuonrrics . ;lmericun ,luru rl~l of pbsrctrirs and GYnr•r.Wng}•, 1960: 138 . 6$0.9 3 .
rrCenlurs for [)ice :ur Cjinlml mid hrv enlinn . HlY1'+erenriun StrurC4ic Plan Thrnu,::6 2 003 . September 2000
01/12/04 1!l)N 08=32 FAX
(.11 /08/2004 19 :24 bAb
"'RECEIVED"' ig 007/0%7 OB
Feb 09,2004 15 :50:57 W Sf106
CORRESPONDENCE
Page 2 CONTROL CENTER
Dave Weldon
J .D. Hayworth
Jim Ryuc 1
Ron Lewis
Tim Holden
Don Muntullo
Paee 3
Petc Hockstra
Lee Terry
Mike Pence
Virgil Goode
Sam Gr..tYc.-,
Melissa Hart
Robert Aderholt
Stevc King
Mirk Souder
Marilyn Musgrave
John Hostettler
Mac Collin s
Tom Tancredo
)o Ann Davis
Zach Wamp
Roger Wicke r
Pane 4
Roscoe Bartlett
John Dolittlt:
Henry Hyde
Jim Delvlipt
Kevin Brad y
es
,WalterJon
Rick Renzi
Thaddeus McCotter
David Vitte r
John Sullivan
Todd Akin
Rod Bishop
Robin HKves
Jeff Miller
Eric Cantor
Tom Feen L }•
Page 5
Patrick. Toomey
Sue M y rick
Chip Pickering
Tim Murphy
Ernest lstaok
Wtilly tJer; er
Duncan Hunter
CIiFF Stearns
Chris Smith
Todd 1'iNut
John Shimk-us

CREW: Food and Drug Administration - Plan B: OL7

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

The Honorable Anna G . Eshoo

Barr Research, Inc .

We acknowledge receipt of your submissions dated July 25 ( 3) an d 31, August 8 (2),

This supplemental new drug application proposes nonprescription (over-the-counter (OTC))

Wide availability of safe and effective contraceptives is important to public health . We

1 . Describe in detail any significant changes or findings in the safety profile .

(See appended electronic signature page ;

Steven Galson, M.D ., M .P .H .

Department of Heatth and Human Service s

NDA 21-045/S-011 '

Duramed Research, Inc.

Dear Mr. Carrado :

i~ttn•//www f(ia onv/hhe/tnnics/NF.Wq/200 .5/duramed ltr .html 10/ 1 2/2005

Lester M . Crawford, DVM, PhD

FDA Website Management Staf

http ://www.fda .eov/bbs/topics/NEWS/2005/duramed ltr .html 10/12/2005

FDA Home Page I Search FDqSite I FDA A-Z Index I ContactFDA

FDA Takes Action on Plan B

Thank you for coming today .

httn•//www frla .unv/hhs/tonics/NEWS/2 0 05/N EW0 1 22 3 .ht m( 10/12/2005 .

the way FDA regulates many different drugs .

httn_//www .fda .uw/hhs/to nics/NFWS/2005/NFW0122 i .html

That was FDA's practice for a very long time.

Media Inquiries : 301-827-6242

? ..abs ; Outlines Pathway for

:'. :,A1 ir :-d that it has issued a'No t

. :OTC use of the product amon g

J ) a .~ :{ 'u ' : G r(-t provide adequate data to support

valuation and Research (CDER) ,

.;lications because they contai n

and answer format, on the web at

TOM DAVIS. VtR61MN. MEN" A. WAXMAN . CALIFOW4A

C ottgrem;g of _t b*e ?"Uttiteb - a tateg

httpJ/retorm .house .goV

August 26, 2005

The FDA has also concluded that it is not "well _•.

FDA's Decision Regarding Plan B : Questions and Answers, available at

I share the concerns that millions of Americans have

In arguing for over-the-counter availability of emergency contracepti ves, advocates rely

Although emergency contraceptive drugs such as Plan B contain

But over-the-counter availability of Plan B would remove the necessary safety

July 25, 200 5

Commissioner Lester Crawford

Dear Commissioner Crawford,

We want to congratulate you on your recent confirmation as the Commissioner of the

According to FDA documents, the morning-after pill : "act[s] by delaying or inhibiting

We contend that an accurate re ading of this language

L 3s~seph ;PiCts b. Todd Akin

11 .Wally, Herger : P'.. ' .Dave Weldon

3S . Scott Garrett : 41 . Trent Fr~ks

Congreo g of the Vniteb Otateg

The Honorable Lester M . Crawford

Dear Dr. Crawford :

In December 2003, two independent expert FDA advisory panels overwhelmingly

Furthermore, in order to be effective, a woman must take EC within days of unprotected

THIS STATIONERY PRINTED ON PAPER MADE OF RECYCLED FIBERS

MCDERMOT T CAROLYN MCCARTHY

HILDA L. SOLIS PATRICK J . KENNEDY

DENNIS J . KUCINICH SHERROD BROWN

SAM FARR ROSA L . DELAURO

DANNY 4,C. DAVIS NANCY¢.. JORVSON

6HN F. TIERNEY BRIAN BAIR D