President Donald Trump announced Friday that he has chosen a conservative doctor-turned-pundit with deep ties to Wall Street and the pharmaceutical industry to lead the powerful Food and Drug Administration.
Dr. Scott Gottlieb would be tasked with Trump's goal of cutting red tape at the FDA, which regulates everything from pharmaceuticals to seafood to electronic cigarettes. Trump has called the FDA's drug approval process "slow and burdensome" despite changes to speed reviews, particularly of cutting-edge products.
Gottlieb, 44, is no stranger to the FDA — he served as a deputy commissioner under President George W. Bush. While he has frequently criticized the FDA for unnecessary regulations and urged changes to get safe and effective drugs onto the market faster, he generally has supported its overall mission.
A Senate vote is required before Gottlieb can take over as head of the agency.
Gottlieb is a resident fellow at the conservative American Enterprise Institute and a partner in the venture capital firm New Enterprise Associates. He has spent more than a decade in Washington rotating between the worlds of government, health policy consulting and political think tanks.
Since leaving the FDA in 2007, Gottlieb has served as a board member or adviser to at least nine pharmaceutical or medical technology companies, according to his LinkedIn profile. Gottlieb is a consultant to GlaxoSmithKline's product investment board; a managing director at T.R. Winston & Company merchant bank, which specializes in health care; and a clinical assistant professor at New York University School of Medicine. He also is a policy adviser to the National Coalition for Cancer Survivorship.
There are likely to be questions at his Senate confirmation hearing about how those ties might affect his decisions at the FDA.
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Federal ethics rules do not require government officials to sell off their investments, but they must recuse themselves from matters that would affect those investments. As part of the federal vetting process, FDA nominees typically disclose and sell stocks, funds and other investments that could pose a financial conflict of interest.
Gottlieb generally supports reduced FDA regulation, particularly for emerging products like health apps and wearable devices like the Apple Watch. But he has never embraced libertarian-leaning proposals that would have the FDA abandon its effectiveness reviews of drugs and medical products. Under those plans, the FDA would simply approve products that appear safe, allowing the private sector to determine how well they actually treat diseases or medical conditions.
Rep. Rosa DeLauro, D-Conn., who serves on the House Appropriations subcommittee that oversees FDA funding, said the nomination sends the message that Trump is committed to "rolling back regulations and opening the floodgates to potentially dangerous drugs and medical devices."
The evaluation of medical effectiveness has been a cornerstone of the FDA's mission since the early 1960s and is universally embraced by its staff and the businesses it regulates.
"If FDA were not in business of evaluating effectiveness then these companies wouldn't be able to say much. Where companies distinguish themselves is by being able to claim that their product actually does something," said Michael Gaba, an industry attorney who specializes in FDA law.