Scott Gottlieb confirmed as FDA commissioner

The U.S. Senate confirmed Scott Gottlieb, MD, as the new commissioner of the Food and Drug Administration (FDA), bringing the former deputy commissioner back to lead the agency.

Gottlieb was confirmed by a vote of 57 to 42, with some Democrats questioning his financial ties to the pharmaceutical industry he’ll now be regulating. For Republicans, his experience with drug makers and promises to speed up the FDA review process made him an easy pick to support.

"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,” House Energy and Commerce Committee Chairman Greg Walden, R-Oregon, and Rep. Michael Burgess, MD, R-Texas, said in a statement after the Senate vote. “We can think of no one better to be at the helm than Scott. He’s a trusted physician, former FDA official, and cancer survivor. Scott’s experiences in all of those capacities make him well-equipped for the vast challenges that await him.”

Gottlieb has promised to divest from his healthcare stocks and recuse himself over the next year from matters concerning companies he was involved with, which included GlaxoSmithKline, Bristol Myers Squibb and Vertex Pharmaceutical. Those industry ties, however, led at least one Democrat to doubt he’ll do enough to address opioid abuse through the FDA.

“At this time of crisis, we need a leader at the FDA who recognizes the dangers of prescription painkillers, who will stand up to big pharma and reform the FDA to prevent addiction before it takes hold,” U.S. Sen. Ed Markey, D-Massachusetts, said before the vote, according to POLITICO. “Dr. Scott Gottlieb is not that individual. Dr. Gottlieb's nomination signals a continuation of FDA policies that have cultivated and fueled the opioid epidemic."

There are clues as to how he’ll led the agency. As a fellow from the American Enterprise Institute and contributor to Forbes, he’s given his opinion on many FDA-related policies, including criticizing then-candidate Donald Trump’s plan to lower pharmaceutical prices by importing drugs from countries where they’re less expensive.

“The debate over drug pricing isn’t new,” Gottlieb wrote in March 2016. “Nor is the call for importation as a way to try and circumvent some of these costs. But the evolution in these two issues reveals why the Trump plan–while perhaps good politics–will offer consumers little relief.”

""
John Gregory, Senior Writer

John joined TriMed in 2016, focusing on healthcare policy and regulation. After graduating from Columbia College Chicago, he worked at FM News Chicago and Rivet News Radio, and worked on the state government and politics beat for the Illinois Radio Network. Outside of work, you may find him adding to his never-ending graphic novel collection.

Around the web

Compensation for heart specialists continues to climb. What does this say about cardiology as a whole? Could private equity's rising influence bring about change? We spoke to MedAxiom CEO Jerry Blackwell, MD, MBA, a veteran cardiologist himself, to learn more.

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals. 

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”