President Donald J. Trump’s pick to lead the Food & Drug Administration, Scott Gottlieb, wants to get new drugs, including low-cost generics, on the market faster.
A physician with leadership experience at FDA, Gottlieb is a favorite of the pharmaceutical industry. But his close ties with drug companies have some critics raising concerns about potential conflicts of interest.
Gottlieb knows FDA. He was FDA’s deputy commissioner for medical and scientific affairs under President George W. Bush. Gottlieb speaks often about FDA regulations as a fellow at the American Enterprise Institute, a conservative think-tank, and he sits on the boards of many pharmaceutical companies, including GlaxoSmithKline.
He also knows Wall Street well. Gottlieb is a partner at New Enterprise Associates—one of the largest venture capital funds in the world.
Pharmaceutical companies, including makers of generic drugs, are welcoming Gottlieb’s nomination.
“His extensive experience as a physician and breadth of health care knowledge will help ensure the FDA continues to play a vital role in protecting public health and innovation in the agency’s review and approval of new medicines for patients in need,” says Stephen J. Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, one of the drug industry’s largest trade groups.
The Association for Accessible Medicines, which represents generic drugmakers, says Gottlieb’s nomination signals that Trump “is serious about increasing access to safe, effective, and affordable medicines for Americans while taking a market-based, competitive approach towards lowering drug costs.”
“Gottlieb has advocated for effectively addressing the backlog of generic drug applications pending at FDA and ensuring that quality products are approved at their earliest possible date, thus increasing competition to lower costs of drugs and biologics for millions of Americans,” says Chester “Chip” Davis Jr., CEO of the group.
Gottlieb, who needs to be confirmed by the U.S. Senate, is the least controversial of all the candidates previously rumored for the top FDA spot. His extensive ties to industry and deregulatory attitudes, however, have some worried.
“Scott Gottlieb is entangled in an unprecedented web of Big Pharma ties,” says Michael Carome, director of the Public Citizen’s Health Research Group, an advocacy group. “He has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry.”