U.S. President, Donald Trump, recently nominated Scott Gottlieb, a doctor, for the position of FDA commissioner, a nomination that most are happy about. According to news reports Gottlieb has a close relationship with the pharma industry as well as ties to Wall Street. Gottlieb is no stranger to the FDA either, having served under President George W. Bush as deputy commissioner of the agency.
The U.S. Food and Drug Administration’s drug approval process has been called “slow and burdensome” by the President, something he hopes will change with Gottlieb at the helm to cut the red tape. The Senate must vote before Gottlieb takes over the FDA, an agency who regulates not only pharmaceuticals but many foods and other products as well.
Since leaving his position as deputy commissioner at the FDA a decade ago, Gottlieb has rotated between health policy consulting, government, and political think tanks and is currently a partner at New Enterprise Associates and a resident fellow at the conservative American Enterprise Institute. He also works as a National Coalition for Cancer Survivorship policy adviser; a managing director at T.R. Winston & Company merchant bank; and is a consultant to the product investment board at GlaxoSmithKline.
In 2012, Gottlieb wrote an article in which he alleged the FDA sets up too many regulatory hurdles; he also argued that requirements for extensive clinical trials on new drugs and therapies made existing drugs “hideously” expensive as these extensive trials limited competition from new market entrants. The 21st Century Cures Act, signed into law in December of last year, was praised by Gottlieb, who feels it would assist in paving the way for quicker approvals of new drug therapies.
Will Gottlieb’s ties to Wall Street impact decisions made at the helm of the FDA? Questions are likely to be asked at the Senate confirmation hearing. Time will tell whether the drug approval process becomes more streamlined, and how it may impact drug prices.
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