FDA website shames drugmakers who block generics

May 18, 2018

The FDA has launched a website listing the names of brand name drugs and their makers who have stood in the way of generic drug companies trying to make more affordable alternatives.

“At times, certain 'gaming' tactics have been used to delay generic competition,” says the agency on its website.

The FDA Amendments Act of 2007 gave the agency the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers for certain drugs. REMS programs are designed to help reduce the occurrence and/or severity of certain serious risks, by providing additional safe-use information to patients and providers. Using REMS as justification, some branded companies have established restricted distribution networks, which means manufacturers of generic and biosimilar drugs cannot get access to product samples they need in order to obtain FDA approval and market entry.

FDA Commissioner Scott Gottlieb denied that the agency was looking to shame drugmakers, instead claiming its goal is transparency. To help increase this transparency, the FDA has posted a list identifying all drug products for which FDA has received a reference list drug (RLD) access inquiry related to limited distribution of the marketed RLD, with details regarding, among other things, the RLD sponsor, the drug product, and the number of inquiries we have received.

The website will also be updated “on a continuous basis” to list additional names.

Is your company on the list?

Read more about the challenges facing generic drugmakers in our article, Generic But Mighty

 

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