ASHINGTON — President Trump will nominate Dr. Scott Gottlieb, a longtime drug industry financier and advocate for deregulation, to run the Food and Drug Administration, the White House said Friday.
Gottlieb, 44, is a physician and resident fellow at the conservative American Enterprise Institute. He trained at Mount Sinai School of Medicine, then pursued an unusual career that has taken him from hospitals to Wall Street to the FDA and back to Wall Street. A prolific writer and speaker on medical innovation, Gottlieb served as an FDA deputy commissioner under George W. Bush and has frequently testified before Congress.
His opposition to many regulations at an agency entrusted with protecting consumer safety could draw scrutiny from Democrats on the Senate’s Committee on Health, Education, Labor, and Pensions, which must approve nominations at the FDA. The nomination of the current FDA commissioner, Dr. Robert Califf, was stalled for months, with some lawmakers arguing that his close ties to the drug industry should have disqualified him from the job.
Gottlieb has the support of many former coworkers, who believe his FDA experience and medical background are strong credentials. An author of dozens of articles and speeches on health care regulation, he is a known entity in Washington at a time when few people know what Trump plans to do at the FDA.
“I worked with a lot of commissioners,” said John Taylor, a lawyer who spent 20 years at the FDA and now works at Greenleaf Health, a consulting firm. “I think Scott is absolutely qualified. He has good professional credentials and personal integrity, and a track record that shows the ability to make difficult decisions.”
Paul Howard, a senior fellow with the conservative Manhattan Institute, also praised Gottlieb. “Scott is an exceptional choice for FDA commissioner,” Howard said. “He has led investments in new medicines and in new approaches in therapeutics. It’s extraordinarily helpful for someone who is leading the agency at a time of tremendous technological change to have that kind of vision and experience.”
What Howard views as a resume enhancer could also be seen as a political vulnerability. In addition to his large health care investment portfolio, Gottlieb has worked for many years as an adviser to pharmaceutical firms, and serves on some of their boards.
He is currently a venture partner in New Enterprise Associates, which invests chiefly in early-stage companies in information technology, medicine, and life sciences. Gottlieb is also a senior principal at TR Winston, a health care-focused merchant and investment bank, and a senior adviser and partner to Arcoda Capital Management, a health care-focused hedge fund.
Gottlieb is currently an adviser to GlaxoSmithKline, Cell Biotherapy, and Bristol-Myers Squibb. He stopped working with Vertex Pharmaceuticals in 2016.
Diana Zuckerman, president of the National Center for Health Research, a Washington research advocacy group, said she was troubled by the potential for conflicts of interest.
“Scott Gottlieb’s conflicts are much worse in that he’s on the board of so many companies,” she said. “He’d clearly need to divest his own stock and resign from the boards, and unless he swore on a stack of Bibles that he wouldn’t return to boards, investments, etc., it would be a good example of the ‘swamp’ that Donald Trump promised to drain.”
Gottlieb served two stints at the FDA, from 2003 to 2004, before going to the Centers for Medicare and Medicaid Services, and then back in 2005 as deputy commissioner for medical and scientific affairs under Commissioner Mark McClellan.
He is a cancer survivor, having been successfully treated for Hodgkin’s lymphoma. Shelley Fuld Nasso, CEO of the National Coalition for Cancer Survivorship, said she believes this experience adds to his qualifications for the job.
“His treatment was much easier than what some people have to endure, but I’ve found that physicians who have a cancer experience understand the human side of things and how treatment impacts individuals and families,” she said.
Gottlieb’s track record as an advocate for deregulation has put him at odds with some Democrats and public interest groups.
“Scott Gottlieb consistently has advocated, among other things, further loosening FDA’s standards for approving medical products and lifting restrictions on the promotion of these products for unapproved uses,” said Michael Carome, director of Public Citizen’s Health Research Group. “His nomination would confirm Trump’s plans to move forward with a dangerous deregulatory agenda at the agency.”
Gottlieb has been on Trump’s transition team almost since the beginning, but recused himself from the “landing team” talks with the FDA. Earlier, he was a senior adviser to the presidential campaign of Wisconsin Governor Scott Walker.
Before he was nominated, Gottlieb told STAT that his first acts in office would focus on ensuring the safety of the blood supply and cracking down on unsafe foods, which he views as issues that deserve higher priority. Based on his writings, he would be expected to ease off-label marketing restrictions, and revamp the generic drug program to speed approval of complex generics.