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Mass. biotech has a lot at stake as FDA chief abruptly steps down


Scott Gottlieb is a rarity in today's Washington: a Trump administration official who earned the respect of Republicans and Democrats alike. Unfortunately, the popular Food and Drug Administration commissioner said yesterday he would step down after nearly two years on the job.

Why we care. The biotech industry has a lot riding on who ends up succeeding Gottlieb because of the FDA's make-or-break power over which new drugs make it to market. Along with the National Institutes of Health and its $2 billion-plus in annual grants to researchers here, there is arguably no other government agency as important to the life sciences industry.

The background. According to the Associated Press: "President Trump tapped Gottlieb in 2017 to 'cut red tape' at the FDA. But Gottlieb bucked expectations by pushing the agency to expand its authorities in several key ways, including an unprecedented effort to make cigarettes less addictive by requiring lower nicotine levels." He also proposed a crackdown on the marketing of e-cigarettes to minors.

Gottlieb, 46, came to the job with an impressive resume: physician, medical school professor, venture capital investor, conservative think-tank resident fellow, and a previous stint at the FDA as deputy commissioner for medical and scientific affairs. He is also a cancer survivor.

Local impact. My colleagues at STAT explain: "It’s not hyperbolic in the least to say that biopharma loved Gottlieb. He was an FDA commissioner who fully embraced the 'innovation' mantra and was eager to put in place new policies and guidelines that streamlined the review and approval process."

Why is he leaving? "The reason he gave was family and his weariness with commuting to see his wife and three children, who have remained in their Westport, Conn., home since he took office, The New York Times reports. "But his announcement caught many in Washington and the industries he regulates by surprise and raised questions about whether his push to reduce teenage vaping and lower nicotine levels and ban menthol in cigarettes will continue in an administration that generally has a hands-off approach to business."

Was he pushed? "The resignation was not sought by the White House," according to The Washington Post. "A senior White House official said Gottlieb had spoken to President Trump, and that the president liked the FDA chief and did not want him to leave. While Gottlieb had some policy disagreements with the White House, he is well respected, and could even be asked to take another post, said two officials. Gottlieb declined to comment on that possibility."

Bottom line. This is unsettling news for our all-important life sciences complex of medical institutions, biotech companies, and medical equipment makers. Gottlieb was one of President Trump's most qualified and effective regulators. Hopefully, his successor comes with the gravitas and experience needed for the job.

You can reach me at larry.edelman@globe.com and follow me on Twitter @GlobeNewsEd. Sign up for my Talking Points AM newsletter here.