EATG » Scott Gottlieb wins confirmation as FDA commissioner

Scott Gottlieb wins confirmation as FDA commissioner

Dr. Scott Gottlieb is headed back to the Food and Drug Administration.

By a vote of 57 to 42, the Senate on Tuesday confirmed Gottlieb, a former FDA deputy commissioner, as the agency’s next chief.

A physician, investor, and consultant to the drug industry, Gottlieb drew criticism from some Democrats and consumer advocates who disapproved of his financial ties to the industry he will regulate. But his nomination also garnered much praise; supporters said his long experience working with drug makers would help him administer the FDA smartly and sensibly.

“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,” Rep. Greg Walden (R-Ore.), chairman of the House Energy and Commerce Committee, and Rep. Michael C. Burgess (R-Texas) said in a statement welcoming the Senate vote.

For his part, Gottlieb, 44, has said he considers his experience valuable for his new job, and has vowed to recuse himself for the coming year from matters involving companies that he worked with.

Gottlieb’s nomination also likely got a boost from the Trump administration’s early flirtation with two other candidates, both libertarians who advocated radical overhauls to the FDA. Compared to them, he came off as downright mainstream.

A resident fellow with the conservative American Enterprise Institute, Gottlieb has a long written record of articles, speeches, and congressional testimony that lay out his vision and explain his priorities. He has expressed concern about the safety of the nation’s blood supply; called for easing restrictions on truthful, off-label promotion of medical products; and vowed to focus on combating the opioid epidemic and ensuring food safety.

He’ll also have to tackle other major tasks, such as implementing the 21st Century Cures Act, a complex directive requiring FDA to speed up and modernize its approval process for drugs and medical devices, among other priorities.

It’s unclear how much President Trump will seek to direct his new commissioner.

Will Gottlieb have to follow Trump’s orders to repeal two regulations for every new one? Will he have to accept deep budget cuts that could affect his ability to implement the 21st Century Cures Act? And how far will Trump push in his stated goal to “slash restraints” at the FDA to speed up what the president has called a “slow and burdensome” process of drug approvals?

By Sheila Kaplan

News categories: EMA/FDA