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Wednesday, May 10 2017

Full Issue

Despite Senators' Concerns Over Ties To Pharma Industry, Gottlieb Confirmed To Lead FDA

Dr. Scott Gottlieb was seen as a moderate choice of President Donald Trump, compared with other candidates he was reportedly considering.

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. (Thomas, 5/9)

Gottlieb, a physician and venture capitalist with long ties to the pharmaceutical industry, served as a deputy聽FDA commissioner and a high-ranking official at the Centers for Medicare and Medicaid Services during the George W. Bush administration. He assumes the agency's helm as it faces mounting pressure from President Trump and other Republicans to further accelerate its drug-approval process and to take a more aggressive role in combating the nation's opioid epidemic. (McGinley, 5/9)

Gottlieb is a far more traditional candidate than others Trump initially considered for the job, including associates of activist financier Peter Thiel, who pledged to blow up the entire approval process by no longer mandating drugs demonstrate effectiveness before they can be sold. However, Gottlieb is still expected to push the boundaries of FDA reviews and using new authority under the 21st Century Cures Act to speed up evaluations. (Karlin-Smith and Griffiths, 5/9)

鈥淒r. Gottlieb has the necessary experience to serve in this key role. Not only has he worked in hospitals, interacted directly with those affected by disease and treatment, but he also has developed and analyzed medical policies in both the public and private sectors,鈥 said Majority Leader Mitch McConnell, R-Ky. (Siddons, 5/9)

Gottlieb is expected to speed up the approval of new drugs and devices, a process he has called too slow and burdensome. He has also advocated for greater physician autonomy to decide to administer experimental drugs for patients. (DIckson, 5/9)

At the FDA, one of Gottlieb鈥檚 top priorities will be confronting the opioid crisis. Several Democrats have raised concerns about the FDA鈥檚 role in responding to rising rates of opioid addiction across the nation. At his Senate confirmation hearing in April, Gottlieb said tackling the opioid epidemic was the 鈥渂iggest crisis facing the agency.鈥 (Reid, 5/9)

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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