New FDA Commissioner Confirmed by Senate

On Tuesday, the US Senate confirmed Scott Gottlieb, MD, to head the US Food and Drug Administration.

Dr Gottlieb was confirmed by a 57-42 vote, with 5 democrats—including Senator Michael Bennet (D-Colorado), Senator Tom Carper (D-Delaware), Senator Chris Coons (D-Delaware), Senator Heidi Heitkamp (D-North Dakota). and Senator Bill Nelson (D-Florida)— breaking from party lines.

President Trump relieved nervous industry experts in March when he nominated Dr Gottlieb, who previously served at the FDA as deputy administrator under President George W Bush and has strong ties to the pharmaceutical industry.

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“With the remarkable discoveries our nation’s researchers are working on, there has never been a more important time to have the right person leading the FDA,” Senator Lamar Alexander, said during floor debate on the nomination on Monday. “Dr Gottlieb understands the importance of driving forward research to take advantage of these extraordinary medical miracles that have the potential to affect every American family. He has impressive qualifications from nearly every angle, and I look forward to the Senate voting to confirm him.”

Dr Gottlieb is expected to put policy in place to speed up the process for approving new drugs at the FDA. During his confirmation hearing, he acknowledged the need for the FDA to maintain its “gold standard” safety review process, but he argued that there is currently a widely held “false dichotomy that it all boils down to a choice between speed and safety.”

“We can have better efficiency and better safety and also remain faithful to FDA’s gold standard for regulatory conduct,” Dr Gottlieb said during his confirmation hearing in April. “If we are doing our jobs right, we can have our cake and eat it too.”

During the 2017 PBMI Drug Benefit Conference in February, Dr Gottlieb also expressed an interest in retooling the way complex generic drugs are approved, in order to get competition to the market faster, and reduce price burdens.

“For all of these drugs the traditional process for approving generic drugs doesn’t work real well,” Dr Gottlieb said at PBMI. “The generic drug law was written at a time when most drugs were simple chemicals—you swallowed them, they got into the blood, and got to the desired organ. But if the drug works locally on the tissue, measuring how the drug gets into the bloodstream isn’t going to approximate its effect. So, we have this whole category of complex drugs, where companies frankly have monopolies in perpetuity, because competitors cant bring a generic drug easily onto the market.”

Dr Gottlieb suggested harnessing new technologies and more efficient systems, like those currently used to fast track certain oncology medicines, across the entire spectrum of drug categories, in order to hasten the FDA review/approval process.

“If FDA is leaning forward in these areas of new technology, if it’s investing in good tools for doing its work, and better science for evaluating regulatory questions—in other words, if we are doing our jobs in leveraging the authority you have given us in your congressional mandate, we can have better efficiency and better safety, and also remain faithful to FDA’s gold standard for regulatory conduct,” Dr Gottlieb testified during his confirmation hearing in April.

During floor debate on Monday, some Democratic Senators expressed concern over Dr Gottlieb’s potential conflicts of interest. Due to his work within the pharmaceutical industry as a consultant, Dr Gottlieb previously announced that if nominated he would recuse himself from making rulings for more than 20 companies.

“The high cost of prescription drugs and the opioid epidemic are two big challenges in our health care system,” Senator Diane Feinstein (D-California) said during debate. “Addressing these issues requires a willingness to act independently—without conflicts of interest—and I simply don’t believe that Dr Gottlieb would do that.”

—David Costill