Trump's Pick for FDA Commissioner Up For Confirmation Tuesday
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President Donald Trump’s nominee to be the Commissioner of the Food and Drug Administration (FDA), Scott Gottlieb, is facing a confirmation vote before the Senate on Tuesday.
Who is Scott Gottlieb?
Gottlieb, 44, is currently a clinical assistant professor at New York University School of Medicine, an internist at Tisch Hospital, and a resident fellow at the American Enterprise Institute (a conservative think tank). He began his career working as a healthcare analyst at an investment bank before attending and completing medical school with a focus on internal medicine.
He’s very familiar with the workings of the federal government, having worked for the FDA previously to develop its generic drug user fee program, the agency’s Physician Labeling Rule, and its approval of fixed dose combination drugs for treating HIV/AIDS. Following the September 11 attacks, he was a member of the White House Biodefense Interagency Working Group. Currently, he’s a member of the federal Health IT Policy Committee.
What came up in his confirmation hearings?
Gottlieb is no stranger to Capitol Hill, having testified before the House and Senate as an expert witness on issues such as FDA regulation, healthcare reform, and medical innovation. But that didn’t spare him from having to answer some tough questions about his financial connections to over 25 healthcare industry entities that include some of the largest biotech and pharmaceutical firms. Gottlieb asserted that he’d divest himself financially and temporarily recuse himself from decisions involving companies he’s invested in or consulted for.
The FDA’s process for approving new drugs also came up, with Gottlieb — a survivor of Hodgkin’s Lymphoma — saying that Congress should reject the "false dichotomy that it all boils down to a choice between speed and safety." Gottlieb said that he recognizes the importance of maintaining the FDA’s reviews as the “gold standard,” but added that the regulatory process could be modernized and sped up when appropriate.
The "staggering human consequences" of America’s opioid epidemic also came up in the hearing, which Gottlieb considers “the biggest crisis facing the agency.” He said the FDA would work toward approving alternatives to opioids and abuse-deterrent versions of the drugs. When asked about prescription drug pricing, Gottlieb said he favored getting more competition in the market to drive prices down, but didn’t say whether he still opposes drug re-importation.
What does the FDA do?
It is responsible for promoting public health through its regulation of food safety, pharmaceutical drugs, vaccines, blood transfusions, dietary supplements, tobacco products, medical devices, animal foods & feed, and veterinary products. The agency’s $5.1 billion budget is funded in part through user fees, such as the prescription drug fee that’s expected to bring in $866 million in 2017.
Tell your senators what you think of Gottlieb and his plans for the FDA using the "Take Action" button.
— Eric Revell
(Photo Credit: FDA.jpg) / Public Domain)
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