Drug makers deserve to be publicly shamed for thwarting competition from generics
Pharma often thwarts competition by refusing to turn over the samples a generics company needs to get a cheaper product approved. The FDA is cracking down.
When David Mitchell learned he had an incurable blood cancer seven years ago, the out-of-pocket cost for a month’s supply for one of his medicines was $42. By 2016, it had jumped to $250.
A lower-cost generic wasn’t an option because Celgene, the drug’s manufacturer, refused to provide samples to generics makers for the product testing they need to do to win marketing approval. Why? The company cited constraints imposed by a regulatory program meant to ensure drug safety.
To many, this explanation appeared to
