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FDA Names and Shames Drug-Makers Accused of Impeding Generics

News  |  By Steven Porter  
   May 17, 2018

Celgene tops the list of manufacturers being accused of 'gaming tactics' that can impede, or even halt, the development of generics.

The U.S. Food & Drug Administration released a list Thursday of drug manufacturers accused of limiting access to samples of their products to impede the development of generic alternatives to their brand-name drugs.

The summary list of allegations—which FDA notes have not been investigated or confirmed—includes situations in which companies have voluntarily limited distribution and situations in which the FDA has imposed limitations as part of the Risk Evaluation and Mitigation Strategy (REMS) program.

"In some cases, brand drug sponsors may use these limited distribution arrangements, whether or not they are REMS-related, as a basis for blocking potential generic applicants from accessing the samples they need," the FDA list explains.

When generic companies are unable to purchase samples, it can slow down their work or stop it entirely, delaying the arrival of more-affordable alternatives, the FDA says.

  • The list: There are 52 products included in the FDA's list of "access inquiries" from prospective generic applications regarding reference listed drugs. Many of these products have been the subject of multiple inquiries.
     
  • Top company: Celgene Corp., which is cited as the sponsor of three of the 52 products listed, came out on top in terms of the most access inquiries regarding its products. There were eight inquiries regarding Pomalyst (pomalidomide), 10 regarding Thalomid (thalomide), and 13 regarding Revlimid (lenalidomide), for a total of 31 inquiries. All three Celgene products have REMS-related restrictions.
     
  • NPR Health Investigation: Celgene's tactics pertaining to Revlimid, which treats multiple myeloma, appear to have caught the attention of Health and Human Services Secretary Alex Azar, NPR's Alison Kodjak reported Thursday in a lengthy investigation. "Celgene has kept generic competition at bay by constructing an almost impenetrable fortress of patents and grants of market exclusivity around Revlimid, and its sister drug Thalomid, while also taking steps to ensure that generic competitors can't get their hands on enough of the drugs to develop viable alternatives," Kodjak wrote.
     
  • Pro-generic administration: FDA Commissioner Scott Gottlieb—who has championed ramping up approvals for generic drugs as a key tool in tamping down pharmaceutical spending—has criticized manufacturers for getting in the way of this mission by gaming the system. "They exploit loopholes in our system, to delay generic entry," Gottlieb said in a speech earlier this month. "In these ways, they extend a drug’s monopoly beyond what Congress intended."
  • Coordinated effort: The release of FDA's list contributes to a weeklong coordinated effort by federal officials to tackle drug prices. President Donald Trump unveiled a general blueprint of goals and priorities last Friday. Azar gave several speeches and media interviews on the topic in recent days, and the Centers for Medicare & Medicaid Services chimed in with updated drug pricing dashboards to promote transparency.
     
  • Premier praise: Among the organizations praising FDA for its naming-and-shaming initiative was Premier. "We loudly applaud FDA’s proactive leadership to promote competitive markets by calling out manufacturers that abuse well-intentioned programs like the Risk Evaluation and Mitigation Strategy (REMS) so as to maintain market exclusivity," Blair Childs, senior vice president of public affairs, said in a statement. "This is an encouraging development, and we hope it is the start of more such actions to promote transparency."

Celgene reportedly declined NPR's multiple requests for comment.

Editor's note: This story was updated Friday, May 18, 2018, to include a statement from Premier.

Steven Porter is an associate content manager and Strategy editor for HealthLeaders, a Simplify Compliance brand.


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