FDA Names Drugmakers Accused Of Blocking Generics - Drug Discovery and Development

Last week, Trump and Health & Human Secretary, Alex Azar, stated they were going to crack down on the drug manufacturers that “play” the system by blocking competitors from developing cheaper, generic versions of their products. The idea is that this would increase competition in the pharmaceutical industry, which would help lower the cost of drugs. With the FDA’s new webpage, which names the makers of more than 50 brand-name drugs that are under scrutiny, it seems they are delivering on that promise.

In what appears to be an effort to improve transparency—another crucial aspect of Trump’s drug cost plan—the page also details the number of inquiries the FDA has received from generic drug manufacturers who claim they are struggling to get access to specific brand-name drugs when developing their own products. Typically, to develop a generic drug with identical ingredients and effects, a generic drug company needs 1,000 to 1,500 units of the brand-name drug.

However, sometimes these brand-name manufacturers refuse to provide this access. In a statement made earlier, FDA Commissioner and Trump Adminstration staff member, Scott Gottlieb, says, “We have heard that some drug makers have either refused to sell samples of products with REMS with Elements to Assure Safe Use (ETASU) impacting distribution to potential generic competitors, or have imposed conditions on the sale of such samples that generic companies find hard or impossible to comply with.”

The FDA’s list is extensive and includes some big players, such as Novartis and Bayer. To view the entire list and the FDA’s statement, visit the page here.

While it is unclear at this time what this scrutiny will lead to, Gottlieb claims that the FDA will “continue to look at more ways [they] can 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. [They’ll] also continue working with the FTC where there may be anticompetitive business practices at play. And [they’ll] continue to strengthen our internal processes for handling inquiries related to problems generic drug developers report having in obtaining samples of brand products.”

(Source: The U.S. Food & Drug Administration)