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Prescription Drug Regulation in the United States

Throughout the last century, consumers of prescription drugs have been subjected to high

prices for the medication, many unliked side effects, and they high addictiveness of the drugs.

Many prescription drugs include various opioids: like Flomax, Lipitor or Plavix that are on the

drug market today. The regulation of prescribed drugs create conflicts within the government,

public health, economy, and society in the U.S. Within government regulation the prescription

drug monitoring programs and the pharmaceutical companies are in charge of regulation of

prescription drugs but that doesn't mean the U.S government isn’t involved in the drug market.

Furthermore, explaining how these companies and programs are related to the current opioid

epidemic in the U.S.

U.S government dedication to regulation prescription drugs as a whole. Furthermore

analyzing the involvement of the U.S government even after having set up PDMPs so their

involvement will be limited. In an article called “Government Commitment And Regulation Of

Prescription Drugs” by Richard Frank a professor of Health Economics in Department of Health

Care Policy at Harvard Medical School states that the U.S is trying to hide their involvement in

the prescription drug market even by denying that they purchase and sell the prescription drugs.

“ In the prescription drug market, when the government is both purchaser and regulator in an

industry with high fixed cost and low marginal costs, the commitment problem may be

especially important to take into account. The U.S government is a major purchaser of

prescription drugs. 140 billion dollars industry, spending on P.D’s has been growing at rate 15-

percent per year over the past few years. The industry spent about 30 billion sole in research in

the department.”(pg 47) P.Ds benefit the country but are highly expensive for both the consumer
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and the purchasers of the drugs. But it’s becoming overly complicated, the prescriptions drugs

have helped against many major diseases but they can also bring more harm than good due to the

many side effects and the different way that human bodies recant to medication.

Prescription drugs market is one of the highest and most expensive markets we have

today. With the opioid crisis, we have today more strict regulation of the prescription drugs

should be carefully placed into effect. The U.S buys the P.Ds themselves while also regulation

the rations that will be given out to each pharmaceutical company. America is a country that is

built on Western medicine, which the major problem today. According to John Gibb, a medical

doctor in an article called Prescription Drugs vs. Natural Alternatives “ More and more people

are considering natural alternatives to prescription medication. What has caused this shift is the

fact that many medications prescribed for serious health conditions have side effects. While

many side effects tend to subside once your system has become adjusted to the medication, and

many serious side effects are rare, many people don't want to take a chance with prescribed

medication”

It’s stated that the government is becoming too responsible in regulating the drug market

and the prescription drugs by controlling rations, the people who could buy them, and the

pharmacies they sold too, while this article is stating that the state laws are not effective enough

which is leading to the abuse of P.Ds. In an article by Andrea M. Garcia who has a Master of

Laws degree, called “State Laws Regulating Prescribing of Controlled substances: Balancing the

Public Health Problem of Chronic Pain and Prescription Painkiller Abuse and Overdose”.
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Alana Semuels a writer for the Atlantic a magazine that focuses on literature, political

sciences, foreign affairs highly exclusive magazines called “Are Pharmaceutical companies to

Blame for the Opioid Epidemic?” states that inadequate work of the pharmaceutical companies

and their regulation has failed and led to the increase in opioid abuse for nonmedical reasons.

“Pharmaceutical companies who marketed the drugs and downplayed their addictive nature can

be held legally responsible for the crisis.” (pg 2) Because of the aggressive marketing tactics of

the companies that can mislead the consumers. “Lawyers say that you can't blame the companies

for the consumer's abuse of the painkillers, however according to Samuels the aggressive

advertising from the company's lead to misuse due to them advertising the drug as trivial. (pg 3)

. Due to the aggressiveness and demandingness from the pharmaceutical companies, many

Americans believes that it’s okay to take as many painkillers not realizing they are addicted.

In an article called “Drug Regulation: History, Present, and Future” written by C.j van

Boxtel, B. Santoso and I.R Edwards who are all administrators for IOS Press and Uppsala

Monitoring Center it states that the PDMPs are involved in the process in the regulation of the

government drug control. It explained how the PDMPs are the sole way that the government

regulates drugs because it helps shift some of the political challenges away from the government.

“Misleading information will create a wrong perception of the efficacy and safety of the

medicine among the consumers and lead to the significant increase demand for the drug among

the populations”. (pg 68) The PDMPs are in charge of the regulation of the drug on the market

and when there's a high consumption of the opioid it increases the demand for the drugs. The

function of the PDMPs is challenging because they have to consider how the drugs will affect the

economy, the markets, society and politics before they can dispute the drugs. Also to make sure
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that the drug will not cause a problem for the consumers like the period crisis we have currently

today in America.

If the prescription drug monitoring programs fail it will continue to increase the death

rates increasing the opioid mortality rates. In an article by Prescription Drug Monitoring and

Death Rates from Drug Overdose by Leonard J Paulozzi, MD, MPH, Edwin M Kilbourne, MD,

and Hema A. Desai, M Med Sc state how the clear effect of the PDMP and their control of the

prescription drugs have losses in the last century. Leading to the rise in overdose and addiction to

opioids. “ the abuse of prescription opioid analgesics and other controlled substances have

increased in number as the volume of such drugs prescription in the U.S. The increasing numbers

of opioid-related death were associated with parallel increases in both the prescribing of opioid

and the self-reported non medical use of these drugs.” (pg 747).​ People misuse the drugs for

nonmedical reasons which lead to abuse and the opioid-related death have increased due to

inadequate regulations by the PDMPs. The PDMPs have to maintain a huge market and that's a

hard job for a sole program in each state.​ Knowing how, when and what to disturb to three

companies that will be sold to the public is a tough job but it's also their responsibility to make

sure the drugs are safe enough for the consumer to take so it won’t lead to high drug/overdose

drug rates.

The pharmaceutical companies failed to create less addictive drugs but if they were less

addictive would that lead to more side effects and less effectiveness? The significant blame goes

to the companies for being highly successful in selling P.Ds. Solution to this would be

promoting an institution that buys drugs effectively and is able to facilitate reliable information

to the consumers through trustworthy advertising and setting rules that will decentralize drugs.
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Word Count: 1236

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Work Cited

Garcia, Andrea M. "State Laws Regulating Prescribing of Controlled Substances:

Balancing the Public Health Problems of Chronic Pain and Prescription Painkiller Abuse
and Overdose." ​Journal of Law, Medicine & Ethics​, vol. 41, Spring 2013 Supplement, pp.
42-45. EBSCO​host​, doi:10.1111/jlme.1203

Frank, Richard. “Government Commitment to Drug Regulation.”

​Heatlh Affairs​, 2011, www.healthaffairs.org/doi/pdf/10.1377/hlthaff.22.3.46.

Rothstein, Mark A. "The Opioid Crisis and the Need for Compassion in Pain Management.
​American Journal of Public Health​, vol. 107, no. 8, Aug. 2017, pp. 1253-1254.
EBSCO​host​, doi:10.2105/AJPH.2017.303906.

Paulozzi, Leonard J., et al. “Prescription Drug Monitoring Programs and Death Rates from Drug
Overdose | Pain Medicine | Oxford Academic.” ​OUP Academic​, Oxford University Press,
12 May 2011, academic.oup.com/painmedicine/article/12/5/747/1909814.

University of Kentucky, Department of Pharmacy.

Review of Prescription Drug Monitoring Programs​. 2016
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taU&v=1&r=http%3a%2f%2fchfs.ky.gov%2fNR%2frdonlyres%2f85989824-1030-4AA6-9
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p=DevEx,5068.1.
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