Dr. Gottlieb Picked to Lead Trump’s FDA

If Congress approves, Scott Gottlieb, M.D. will become the new head of the Food and Drug Administration (FDA).

His job will be to translate into policy what his future boss, President Trump, wants him to do about “slashing restraints” of a “slow and burdensome approval process” at the FDA.

The White House announced the nomination of Gottlieb on March 10.

Gottlieb is only 44, but his career has taken him from hospitals to Wall Street, twice to the FDA, once to Centers for Medicare and Medicaid Services (CMS) and back to Wall Street. He was the FDA’s deputy commissioner for medical and scientific affairs in 2005 under Commissioner Mark McClellan.

He’s currently a resident fellow at the American Enterprise Institute, a conservative think tank.

What does his appointment mean for the agency’s dual mission of protecting and promoting public health?

Gottlieb has a track record as an advocate for deregulation and was on President Trump’s transition team almost since the beginning. Earlier, he was a senior adviser to the presidential campaign of Wisconsin Governor Scott Walker.

He’s also been an advocate of speeding the approval process through shorter trials.

“Longer, larger trials that require drug makers to evaluate ‘hard’ endpoints (like how long a cancer patient lives) rather than ‘surrogate’ endpoints (like a drug’s ability to shrink tumors) give FDA reviewers more statistical confidence. Reviewers prefer these drawn-out trials because they insulate the FDA from critics who say that it isn’t focused enough on safety. But bigger trials increase the time needed to develop a drug, keeping it out of the hands of patients,” he wrote in the Wall Street Journal in 2010.

Consumer advocates worry about his connection to the pharmaceutical industry.

“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.”

Friends and former colleagues speak highly of him.

Paul Howard, a senior fellow with the Manhattan Institute, reportedly said, “Scott is an exceptional choice for FDA commissioner. 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.”

Gottlieb is a venture partner in New Enterprise Associates, which invests chiefly in early-stage companies in information technology, medicine, and life sciences. He’s 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.

He is also currently an adviser to GlaxoSmithKline, Cell Biotherapy, and Bristol-Myers Squibb. He stopped working with Vertex Pharmaceuticals in 2016.

STAT, an online newsletter, reported on March 10 that before he was nominated, he told them 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.

But his first act might be to check his morning tweets to see what his boss wants.