FDA issued draft guidance aimed at boosting generic drug competition

PoliticoPRO: By Sarah Owermohle

​The FDA released draft guidance today aimed at boosting generic drug competition by clarifying manufacturers must disclose whether approved products are on the market.

The guidance calls for updating approved generics’ marketing status in the FDA’s “Orange Book,” a database of generic drug details, so potential manufacturers can see how many versions of one product are on the market. Currently, the database doesn’t distinguish whether an approved generic was never launched or has been discontinued, but Congress cleared FDA to impose the new requirements in the agency’s last reauthorization in 2017.

Commissioner Scott Gottlieb said the move would help FDA understand why generic companies never marketed a product after receiving agency approval.Today’s guidance is the first of several steps the agency is planning this year to encourage generic competition.

FDA is also asking for comments on how to improve the Orange Book, including whether outside patents — such as those for digital applications tied to the approved medicine — should also be included in the database so would-be manufacturers have a better idea of potential hurdles.

“The FDA must work to make generic drug development more efficient and predictable,” Gottlieb said.​