New FDA lead ushers in new era

Scott Gottlieb, MD, was sworn in as the new FDA commissioner, ushering in an era of expected faster drug approvals.

Gottlieb, a former acting FDA deputy commissioner who also sits on the board of small drug and biotech companies and is an adviser to GlaxoSmithKline, said he would divest himself of all conflicts of interests with pharmaceutical manufacturers.

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In Gottlieb’s confirmation hearing, Senate Majority Leader Mitch McConnell (R-Ky.) said Gottlieb was committed to the development of groundbreaking treatments, while Sen. Lamar Alexander, (R-Tenn.) chairman of the health committee, said it was a plus that Gottlieb has had extensive experience with “the industry he will be in charge of,” Washington Post reported.

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However, Senators Edward J. Markey of (D-Mass.) and Maggie Hassan (D-N.H.), criticized Gottlieb’s previous opposition to FDA risk evaluation and mitigation strategies (REMS), which are meant to reduce the safety risk of some drugs, including opioids.

At the same time, experts believe Gottlieb is likely to speed up FDA’s approval of new drugs.

"Scott Gottlieb has more experience  and success in modernizing the FDA than anyone else nominated for that position in recent history,” Medical Economist Robert Goldberg, PhD, co-founder and vice president of the Center for Medicine in the Public Interest, told FormularyWatch in March. “His experience as a practicing physician and a cancer survivor also means he brings a unique perspective to the job that others have not possessed.”

The Pharmaceutical Research and Manufacturers of America also said in mid-March that it "looks forward to working with Dr. Gottlieb in his new role and engaging with him and the Agency as they seek to modernize the drug discovery and review process,” a spokesman told Reuters.

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