New FDA head Gottlieb outlines plans for more generic competition

The USA’s new Food and Drug Administration Commissioner Scott Gottlieb was in the hot seat last week to defend President Donald Trump's budget plan to the House of Representatives appropriations subcommittee, though the conversation quickly dovetailed away from the billion-dollar user fee increase proposed, and revealed that the FDA as of Thursday is no longer subject to a federal hiring freeze, reported Zachery Brennan on the RAPS (Regulatory Affairs Professional Society) web site.

While Dr Gottlieb noted that he "wasn't involved in the formulation of the budget," as he has only been on the job for two weeks (after several representatives criticized the budget proposal's call to renegotiate the bipartisan FDA user fee reauthorization bill currently making its way through Congress), he offered a number of ideas the FDA will try to use to increase competition and reduce prescription drug costs.

Among those initiatives are: "A drug competition action plan," which Dr Gottlieb said he will unveil soon, as well as a new list of all drugs that are off-patent with no current generic competition, and ways to reform the risk evaluation and mitigation strategy (REMS) regulations to prevent companies from abusing them. The FDA in September 2016 put out draft guidance on REMS.