Gottlieb: FDA Hiring Freeze Lifted, Plans for Increased Generic Competition Coming

While Gottlieb noted that he “wasn’t involved in the formulation of the budget,” as he’s 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 FDA will try to use to increase competition and reduce prescription drug costs.

Among those initiatives are:  “A drug competition action plan,” which 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. FDA in September 2016 put out draft guidance on REMS.

FDA is “evaluating whether to waive the requirement more readily than we have in the past on a shared REMS system,” he said, noting “certain companies extending exclusivity beyond what Congress intended.”

Last summer, a bipartisan bill was introduced and discussed in the Senate to try to stop companies from abusing the REMS system, though some senators have said changing the current law might be a better option.

Gottlieb told the House subcommittee that FDA needs to make sure there is market entry of generic drugs after patents have expired, though he said he does not “want to play whack-a-mole with companies,” noting FDA will hold a hearing soon to hear about where these issues are specifically cropping up.

Rep. Rosa DeLauro (D-CT), meanwhile, grilled Gottlieb on the speed with which FDA is approving medical devices and the 510(k)-approval process in particular, noting a recent recall of St. Jude defibrillators because of battery failures and faulty lead tests, as well as calling on the Agency to use it’s mandatory recall authority.

Gottlieb said in terms of speed vs. safety, “We know review times are short but the question we need to be asking is the overall efficiency of the development process,” adding that FDA needs to learn more about the safety and efficacy of products in the drug and medical device development processes.

REFERENCE:  RAPS; 25 MAY 2017; Zachary Brennan

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