FDA Names and Shames Drug-Makers Accused of Impeding Generics

  • FDA Names and Shames Drug-Makers Accused of Impeding Generics

FDA Names and Shames Drug-Makers Accused of Impeding Generics

The FDA released a list Thursday of brand-name drug companies it says are blocking the development of generic drugs by refusing to give generic drugmakers access to samples of brand-name products for use in clinical trials needed for approval.

"It's no coincidence that the country's most profitable pharmaceutical companies from Celgene to Gilead are the same ones gaming the system", said Tahir Amin, co-founder of Initiative for Medicines, Access & Knowledge, a group that sues to limit drug company patents around the world.

Celgene has had 13 complaints about its practices related to its cancer drug Revlimid, and gotten four letters.

FDA Commissioner Scott Gottlieb has previously said brand-name drug companies' to stall and that the competition must stop and sent out a statement that the website would highlight "where drug makers may be pursuing gaming tactics to delay generic competition". Gottlieb said regulators had received more than 150 inquiries from generic drug developers for federal assistance to obtain branded drug samples.

To contact the reporters on this story: Cynthia Koons in NY at ckoons@bloomberg.net, Anna Edney in Washington at aedney@bloomberg.net.

In a statement, Celgene emphasized the importance of the FDA safety rules, pointing out that the multiple-myeloma drug Thalomid (thalidomide) is associated with severe birth defects. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them.

They may cite the presence of a Risk Evaluation and Mitigation Strategy (REMS) - a program the FDA applies to certain drugs to ensure their benefit outweigh their risks - to refuse distribution, or impose conditions on sales that generic makers can not meet. But the FDA, which approves REMS programs, says it does not consider it a violation of the program for drugmakers to provide samples to generics makers.

In some cases, Gottlieb said drugmakers restricted prescription drug distributors, wholesalers or specialty pharmacies from selling branded samples to generic drug developers for testing. "Even in the case of limited distribution programs such as those required by certain REMS, there should be a path forward for generic drug development".

The FDA is planning to update the lists semi-annually.

"I'm not looking to shame drug companies", Gottlieb said at a breakfast with reporters Tuesday. Interestingly neither Merck nor Johnson & Johnson appeared on the list, but investors must have been wary of the FDA's promise to "continue to look at more ways to expand upon today's action and call public attention to situations where the careful balance that Congress sought between product innovation and access may be being disrupted".

"It is important to differentiate between those products for which FDA has received complaints as opposed to those products for which it has received a request for a safety determination letter", PhRMA continued.

The FDA has followed through on plans to identify pharma companies they believe have tried to block generic copies of their brands, for example by making it hard to acquire medicines for bioequivalence studies. Makers of the copycat drugs say that in some cases they've been unable to get samples of the drugs due to safety programs that were created to protect patients, but that have been used instead to prevent competition.

The spokesman also said the agency should post additional information, like how long it took a review a given company's defense or the number of requests granted and denied.