Drug Safety and the FDA

Donald Trump has nominated and the Senate has confirmed (57 to 42) Scott Gottlieb to head the Food & Drug Administration (FDA). Gottlieb is a physician, an aggressive investor (venture capitalist) in health-care companies, has worked for many years as a consultant and advisor to big drug companies, and is a former deputy FDA Commissioner. Financial disclosures reveal that he earned $645,000 from drug companies and trade groups in 2016. Not surprisingly considering his background, Gottlieb is said to be in favor of allowing drugs to come to market quicker through accelerated FDA approval and against allowing U.S. consumers to import cheaper drugs from Canada or other countries. He also favors allowing doctors to liberally prescribe and drug companies to market drugs for off-label uses, i.e., uses that have not been approved by the FDA. In short, his history reveals he is more focused on making money for himself and drug companies than in the core mission of the FDA, which is safety and efficacy.

As luck would have it, on the same day Gottlieb’s confirmation was reported in the media, the Yale School of Medicine released a study that found nearly 1/3 of all drugs approved for sale by the FDA over a 10 year period were subject to post-approval “safety events” such as changes in warning labels and safety advisories to doctors and the public. The rate of new safety issues was twice as high for drugs that won accelerated approval from the FDA.

According to the Wall Street Journal, “The finding about accelerated approvals raises questions about the push in Congress and the White House for faster approval of new medicines.”

As with so many of Trump’s appointments, this one seems to be a case of appointing someone whose self-interest and strongly held opinions are diametrically opposed to the core mission of the agency they are to run.