Gottlieb would assume oversight of the agency responsible for approving new drugs
The FDA also supervises medical products, vaccines and cosmetics
President Donald Trump plans to nominate Scott Gottlieb, a conservative physician with deep ties to the pharmaceutical industry, as commissioner of the Food and Drug Administration, a White House official said Friday.
Gottlieb would assume oversight of the agency responsible for approving new drugs, as well as regulating food safety and tobacco products. The FDA also supervises medical products, vaccines and cosmetics.
Gottlieb worked at the FDA during President George W. Bush’s administration in deputy roles. He’s currently a partner at venture capital firm New Enterprise Associates and has served as a consultant to several drug companies and biotechnology firms. He also sits on several boards and serves as adviser to several pharmaceutical companies, including GlaxoSmithKline, one of the world’s largest.
Gottlieb is seen as a more mainstream pick from the pool President Donald Trump was reportedly considering, but one some liberal groups are still expressing disappointment in the pick.
“President Trump’s FDA pick Scott Gottlieb is entangled in an unprecedented web of Big Pharma ties. He has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry and the US Senate must reject him,” said Dr. Michael Carome, director of the Public Citizen’s Health Research Group, in a statement.
But Gottlieb’s advocates, like Jim Shehan – head of FDA regulatory practice at Lowenstein Sandler LLP – pushed back on the idea of conflict of interest due to his ties with the pharmaceutical industry.
“You have to be active in the industry. Without ties to the industry you lack credibility,” he said.
Trump has vowed to lift regulations on the FDA that he claims are making it harder for new drugs to come to market. He renewed those calls during last month’s address to Congress, underscoring his point by inviting a young woman with a rare disease whose life was saved by a new drug.
“Our slow and burdensome approval process at the Food and Drug Administration keeps too many advances, like the one that saved Megan’s life, from reaching those in need,” Trump said. “If we slash the restraints, not just at the FDA but across our government, then we will be blessed with far more miracles like Megan.”
A senior administration official said Gottlieb would be tasked by Trump with eliminating some of the regulatory burdens at the FDA.