Policy, Pharma

FDA commissioner nominee Scott Gottlieb secures Senate approval

Gottlieb takes over a post in which he will be called upon to address escalating drug prices and the opioid epidemic as the FDA faces increasing pressure to greenlight drugs faster and do more with less, if Trump’s budget plans come to fruition.

Scott Gottlieb testifies at FDA nomination hearing by Senate Health, Education, Labor and Pensions Committee.

Scott Gottlieb testifies at FDA nomination hearing by Senate Health, Education, Labor and Pensions Committee.

Scott Gottlieb, President Donald Trump’s nominee for FDA commissioner, secured Senate confirmation in a 57-42 vote. Gottlieb takes over a post in which he will be called upon to address escalating drug prices and the opioid epidemic as the FDA faces increasing pressure to greenlight drugs faster and do more with less, if Trump’s budget plans come to fruition.

House Energy and Commerce Committee Chairman Greg Walden (R-Oregon) and Health Subcommittee Chairman Dr. Michael Burgess (R-Texas) made a statement following the vote on the significance of Gottlieb’s confirmation.

“The confirmation of Scott Gottlieb to be the next FDA Commissioner is an important appointment, particularly as we work to reauthorize the agency’s user fees. We are at a critical juncture in the effort to help accelerate the discovery, development, and delivery of new cures and treatments, and Scott will be an important ally in that journey.

Last month, MedCity highlighted Gottlieb’s hearing, which offered some indication of what his priorities might be as FDA commissioner. But his hearing also offered a sense of the political atmosphere that would accompany his confirmation.

Democrats, for example, expressed concern with Gottlieb’s drug industry ties and his ability to remain impartial, although Republicans viewed it his industry experience as an asset.Although Gottlieb has expressed support for speeding up the drug approval process he noted at the hearing that it needn’t come at the expense of reduced safety.

Although Gottlieb has expressed support for speeding up the drug approval process he noted at the hearing that it needn’t come at the expense of reduced safety.

“We should reject the false dichotomy that it all boils down to a choice between speed and safety,” he said. He noted that the approval process could be improved through adapted clinical trials.

He pledged to do a better job of handling new, complex drugs. Confusion over standard measures for bioequivalence and bioavailability prolongs the exclusivity period of the drug, as generics struggle to break into the market.

To address the opioid crisis Gottlieb has called for opioid alternatives such as pain-relieving drugs that can be given in a more localized way and medical options to help patients stay clean.

Photo: Zach Gibson, Getty Images