Scott Gottlieb, a doctor with ties to the drug industry, is picked to lead the FDA
President Trump said Friday that he would nominate Scott Gottlieb, a conservative physician with longstanding ties to the drug industry, to be the commissioner of the Food and Drug Administration.
If his nomination is confirmed, Gottlieb, 44, will oversee America’s largest regulator of medical and consumer products at a time when the president has vowed to slash regulations to ease burdens on America’s companies.
Gottlieb has previous regulatory experience. He served as an FDA deputy commissioner during the George W. Bush administration. More recently, he has worked with venture capital firms engaged in financing healthcare start-ups and as a resident fellow at the American Enterprise Institute, a conservative think tank.
For years, Gottlieb has worked to advise the drug industry. In 2015, he received nearly $200,000 from four large pharmaceutical companies — including giant GlaxoSmithKline — for consulting, travel and making speeches, according to the most recent figures in a public database.
Gottlieb, who lives in Connecticut, is a venture partner at New Enterprise Associates. And he is listed as a managing director of investment banking at T.R. Winston & Co., which has offices in Los Angeles and other cities.
He has also worked as a senior official at the federal Centers of Medicare and Medicaid Services, where he focused on work that determined how much the agency should pay for new medical technologies.
The FDA, with 16,000 employees, regulates not just food and prescription drugs, but also tobacco, cosmetics, medical devices, dietary supplements and veterinary medicines.
Trump’s vow to reduce regulations has been hailed by corporate executives and investors, but has worried some experts and consumer groups who say a strong FDA is essential to the public’s health and safety.
The president has spoken most enthusiastically about the need to make it easier to get experimental medicines approved. In his speech to a joint session of Congress on Feb. 28, Trump attacked the FDA and what he called its “slow and burdensome approval process.”
Gottlieb holds similar views. In articles for the Wall Street Journal and other publications, he has argued that the FDA needs to speed up its approval of medicines and medical devices.
But experts point out that Congress has already repeatedly changed the law to get lifesaving drugs to desperate patients faster.
For example, the FDA now frequently approves medicines for serious diseases like cancer before studies show they extend or improve lives. Eventually some of those drugs are shown to be effective, but others continue to be sold without that proof.
Some ineffective drugs have eventually been taken off the market, but it can take years.
A drug called Mylotarg was pulled from pharmacy shelves in 2010 — 10 years after the FDA approved it for acute myeloid leukemia, a bone marrow cancer.
Over the years, some medicines have harmed thousands of patients before being taken off the market. David Graham, an FDA scientist, testified in Congress that the pain reliever Vioxx, which was removed from drugstores in 2004, had caused heart attacks that killed as many as 55,000 Americans.
In his writing, Gottlieb has often taken positions favored by the drug and medical device industries.
For example, in a March 2016 article for Forbes, he argued against allowing patients to import medicines from foreign countries — a proposal, aimed at lowering medicine costs, that the drug industry has long fought against.
Instead of allowing the imports, Gottlieb argued that high drug prices in the U.S. were caused by failures at the FDA that had increased the cost to manufacture generic medicines.
Follow @melodypetersen on Twitter
UPDATES:
4:35 p.m.: This article was updated with Trump administration confirmation of the nomination.
The original article was published at 3:35 p.m.
