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Tuesday, October 15, 2019  Spokane, Washington  Est. May 19, 1883
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Trump’s pick to lead FDA is confirmed by Senate

By Anna Edney Bloomberg

WASHINGTON – The U.S. Senate confirmed Scott Gottlieb as President Donald Trump’s nominee to lead the Food and Drug Administration, putting in place a commissioner who has ties to pharmaceutical industry and has talked about using the agency’s powers to target drug costs.

The upper chamber backed Gottlieb in a 57-42 vote Tuesday. The former FDA deputy commissioner will now take over an agency that oversees more than $2.4 trillion worth of pharmaceuticals, food, medical devices, veterinary products and tobacco.

Gottlieb, 44, takes the helm just as Congress is working to renew industry fees that helped make up more than 40 percent of the FDA’s $4.7 billion budget in fiscal 2016. The fees, levied on drug and device manufacturers to fund new product reviews, expire every five years and the amounts must be renegotiated and approved by lawmakers.

The new FDA head, who served as deputy commissioner for two years until 2007, will also be responsible for carrying out Trump’s vision for the industry. The president has called for deregulating the drug industry and bringing treatments to market faster.

At his Senate confirmation hearing last month, Gottlieb rejected what he called a “false dichotomy that it all boils down to a choice between speed and safety.” The agency can improve efficiency by leveraging new technology and better science can improve efficiency and safety, “and also remain faithful to FDA’s gold standard for regulatory conduct,” he wrote in prepared remarks.

Gottlieb is a proponent of policies to approve generic drugs faster, which could help lower drug costs, one of Trump’s priorities. Gottlieb is particularly focused on complex medicines that combine old drugs with newer delivery devices, such as the EpiPen from Mylan NV and asthma inhalers, as well as those with unusually complicated formulations. Often these are expensive drugs that don’t have generic competition because regulations for generic-drug development were crafted based on older, simpler formulations.

Gottlieb has ties with the pharmaceutical industry, having received more than $413,000 from 2013 to 2015 from companies including Vertex Pharmaceuticals Inc. and GlaxoSmithKline Plc, in consulting and speaking fees, according to a government database that tracks company payments to doctors. He also received $1.85 million for his work as a managing director at T.R. Winston & Co., an investment bank that raised money for a number of public companies.

If confirmed, Gottlieb said he would resign from the firm, divest interests in more than a dozen businesses and temporarily recuse himself from making decisions on at least 20 companies where he has financial interests or was paid consulting fees.

Gottlieb was trained as a physician and completed his residency in internal medicine at Mount Sinai Medical Center in New York after graduating from the Mount Sinai School of Medicine in 1999. He earned a degree in economics from Wesleyan University in 1994.

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