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Morning Briefing

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Monday, Mar 13 2017

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Trump Picks Bush Alum With Deep Ties To Pharma, Wall Street As FDA Nominee

Scott Gottlieb, a physician who left the Food and Drug Administration in 2007, is a consultant to GlaxoSmithKline鈥檚 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.

President Trump announced late Friday that he will nominate Scott Gottlieb, a conservative physician and businessman with deep ties to the pharmaceutical industry, to be commissioner of the Food and Drug Administration. If confirmed, Gottlieb would bring a strong pro-industry, deregulatory approach to an agency that Trump has criticized as being overly restrictive. But he is also likely to support one of the agency's basic functions: to ensure that drugs are proven safe and effective before they are sold. (McGinley and Johnson, 3/10)

Gottlieb, 44, is no stranger to the FDA 鈥 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. (Superville and Neergaard, 3/11)

An internist and hospitalist, Gottlieb has played leading roles in various government health agencies, including as deputy commissioner for medical and scientific affairs at the FDA during the George W. Bush administration. Before that, he was a senior policy adviser at CMS working on the implementation of Medicare's then-new drug coverage for seniors. (Neel, 3/10)

The selection of Dr. Gottlieb, 44, who served as a top official at the agency during the administration of President George W. Bush, drew praise from industry executives, who had previously expressed concerns that another top contender, Jim O鈥橬eill, held radical views that would have gutted standards for drug approval trials and testing. 鈥淚 think Scott is science-based, he鈥檚 patient-focused, he鈥檚 got strong management skills and he鈥檚 intellectually tough, so he will use all of that to make sure the F.D.A. and industry are all acting in the interests of patients,鈥 said Dr. Leonard S. Schleifer, the chief executive of Regeneron Pharmaceuticals. (Thomas, 3/10)

Gottlieb is a more mainstream nominee than some of the other candidates who were said to be under consideration. He鈥檚 a partner at one of the world鈥檚 largest venture capital firms, New Enterprise Associates, which has a portfolio of more than 300 businesses in the technology and health-care industries, according to its website. (Edney and Langreth, 3/10)

Gottlieb hasn鈥檛 advocated聽radical, baby-with-bathwater reforms, but he has proposed a tweak that would shake things up. As it stands, FDA drug reviewers are tasked with both vetting clinical data and making final decisions on applications. Because of that, Gottlieb wrote in 2012聽in National Affairs,聽鈥渞eviewers feel an enormous weight of responsibility,鈥 subject to 鈥渟imultaneous and countervailing pressures to both speed up approval and prevent misuse of new drugs.鈥 (Garde and Scott, 3/10)

Democrats mostly held their fire after President Trump on Friday nominated Dr. Scott Gottlieb as FDA commissioner. Gottlieb has close ties to, and has been widely endorsed by, the pharmaceutical industry. That鈥檚 been a red flag for Democrats in the past. But leaders of the left in Congress were largely quiet about the pick, perhaps because they know Trump had flirted with far more radical choices 鈥 including a libertarian who once proposed replacing agency scrutiny of new medications with a 鈥淵elp for drugs.鈥 (Kaplan, 3/11)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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