NYT: Senate Confirms Scott Gottlieb to Head F.D.A.
May 16, 2017
The Senate voted 57 to 42 on Tuesday to confirm Dr. Scott Gottlieb as commissioner of the Food and Drug Administration, where he will be responsible for regulating drug companies to which he has had close ties in recent years.
Dr. Gottlieb, 44, has promised to divest himself from several health care companies and recuse himself for one year from decisions involving those businesses, but that was not enough for many Democratic senators, including Patty Murray of Washington.
“He has not convinced me he can withstand political pressure from this administration, or that he will be truly committed to putting our families’ health first,” Ms. Murray said during the debate before Tuesday’s vote. “I’ve grown increasingly concerned about whether he can lead the F.D.A. in an unbiased way, given his unprecedented industry ties.”
In a statement, Tom Price, the health and human services secretary, said Dr. Gottlieb’s “background will be crucial” for maintaining the F.D.A.’s high standards for safe treatments “while advancing new, innovative solutions” to the nation’s public health challenges.
Dr. Gottlieb was seen as a moderate choice of President Trump’s, compared with other candidates he was reportedly considering, including Jim O’Neill, a libertarian who previously advocated doing away with the agency’s requirement that companies prove that a drug works before it is approved.
To the drug and biotech industries, Dr. Gottlieb is a known quantity, both because he has written prolifically on F.D.A. policy as a fellow at the conservative American Enterprise Institute and because he often worked for those industries. Over the years, Dr. Gottlieb has been a frequent consultant to drug companies, serving on advisory boards for large pharmaceutical companies like GlaxoSmithKline and Daiichi Sankyo. He has also invested significantly in the health care industry, most recently through the venture capital firm New Enterprise Associates and T. R. Winston & Company, an investment bank.
For Dr. Gottlieb, this is a return to the agency: During the administration of President George W. Bush, he held various jobs at the F.D.A., including deputy commissioner. He will take over a sprawling agency that regulates everything from tobacco to food to drugs and medical devices: Products regulated by the F.D.A. account for 20 cents of every dollar spent by American consumers each year.
Supporters of Dr. Gottlieb’s nomination have said his business experience will serve him well as head of the F.D.A., and friends and associates have described him as an independent thinker who will not always side with industry.
Dr. Gottlieb will also have to navigate his relationship with Mr. Trump, who has not hesitated to call out the pharmaceutical industry over high drug prices, even as he has also promised to ease regulations at the F.D.A. and to make sure that drugs reach the market more quickly. Critics have said that bringing drugs to market without the proper safeguards could expose the public to dangerous drugs that have not been properly vetted.
At his confirmation hearing in April, Dr. Gottlieb told senators that he believed in upholding the F.D.A.’s reputation as the world’s “gold standard” for drug approval. If confirmed, he said then, he would be “an absolutely objective regulatory watchdog” and would not do anything that could “besmirch the agency” or undermine public confidence in its work.
One of Dr. Gottlieb’s biggest jobs will be putting in place the 21st Century Cures Act, a law signed by President Barack Obama late last year that directs the F.D.A. to speed up drug approvals. He also said he would make addressing the nation’s opioid epidemic a top priority.
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