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Trump's FDA nominee says he'd 'be guided by the science'

Trump's FDA nominee says he'd 'be guided by the science'
Dr. Scott Gottlieb, President Trump's nominee to head the Food and Drug Administration, speaks during his confirmation hearing before a Senate panel. (J. Scott Applewhite / AP)

President Trump's nominee to head the powerful Food and Drug Administration told senators Wednesday that tackling the opioid crisis would be a top priority and pledged that science will prevail despite his extensive financial ties to medical companies the agency regulates.

Dr. Scott Gottlieb is a physician turned health consultant who has criticized what he calls unnecessary FDA regulations, and he has what critics call unprecedented financial entanglements. But Gottlieb told a Senate health committee during a 2½-hour-long hearing that impartial science does and must continue to guide FDA's decisions.

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Gottlieb said that as a survivor of Hodgkin's lymphoma, he knows firsthand the importance of "what the FDA does for every one of us" and emphasized the balance between speeding drugs to the market and making sure enough is known about their safety.

"We save lives by allowing good things to happen, but we also save lives when we prevent bad things from happening," Gottlieb said, calling the FDA's enforcement rules "the bedrock of its mission."

Among his top priorities, Gottlieb said, would be tackling opioid addiction, which he described as a "public health emergency on the order of Ebola," through development of nonaddictive alternatives as well as addiction treatments.

Gottlieb is no stranger to the FDA, which regulates products that affect about a quarter of all consumer spending — including new drugs and medical devices, food safety, nutrition labeling, cosmetics, veterinary medicines, tobacco and e-cigarettes. He was a deputy commissioner under President George W. Bush.

"My hope is that you will help move the agency forward so that America's patients benefit from the remarkable discoveries our nation's researchers are working on," said Sen. Lamar Alexander (R-Tenn.), who chairs the health committee.

Gottlieb also previously worked as a senior official at the Centers for Medicare and Medicaid Services. He has written hundreds of op-ed articles about the healthcare industry for publications such as the Los Angeles Times, the Wall Street Journal and Forbes, and often took positions favored by drug and medical-device firms.

Critics have focused on Gottlieb's finances. In 2015, Gottlieb received almost $200,000 from pharmaceutical firms including Vertex Pharmaceuticals Inc. and GlaxoSmithKline, according to a public database run by the federal government.

Gottlieb serves as a partner at venture capital firm New Enterprise Associates, where he said he focused on healthcare services companies. He is also listed as a managing director of investment banking at T.R. Winston & Co., which specializes in healthcare and energy transactions.

In ethics documents filed last week, Gottlieb said that if confirmed, he would recuse himself for a year from decisions involving about 20 companies. He also said he would resign from his positions in the venture capital firm and investment bank, and as a board member or consultant to nine other health-related companies. Gottlieb's day job is as a resident fellow at the conservative American Enterprise Institute, from which he said he also would resign.

Sen. Patty Murray of Washington, the committee's senior Democrat, questioned whether recusals were enough to erase the bias of being a pharmaceutical industry insider when dozens of drugs being developed by those companies could come before the FDA.

"What I'm concerned about is how your involvement with so many companies shapes your priorities," she said.

Gottlieb responded, "I get it. I understand how important the impartiality of this agency is so people continue to have trust in the decisions FDA makes."

"I want to earn and keep the public's trust," he said.

Asked whether he would bow to political pressure from the Trump administration on the FDA's safety and efficacy standards, Gottlieb said, "I haven't been shy about offering my unvarnished advice" in the past, and he said he would continue to offer such advice, even to his bosses.

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"I'm going to be guided by the science," he said. "I'm going to be guided by the expertise of the career staff, and I'm going to be guided by impartiality and what's good for patients, as a physician."

Gottlieb is a graduate of Wesleyan University in Connecticut and earned his medical degree at the Mount Sinai School of Medicine in New York. He has lived in Connecticut since 2010.

Times staff writer Samantha Masunaga contributed to this report.

UPDATES:

11:10 a.m.: This article was updated with additional details from the hearing and with information about Gottlieb's career.

This article was originally published at 9:25 a.m.

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