Senate to Vote on FDA Head Dogged by Financial Questions

WASHINGTON (AP) — Dr. Scott Gottlieb is on track to win Senate confirmation to head the Food and Drug Administration despite Democratic questions about his financial ties to medical companies the agency regulates.

Senators are slated to vote Tuesday on the nomination of Gottlieb, a physician-turned-health consultant who has criticized many FDA regulations as unnecessary and has faced criticism from Democrats over his financial entanglements. At his confirmation hearing in April, he pledged that science will prevail at the agency. He said he is a cancer survivor who understands firsthand the importance of the FDA.

The FDA regulates products that affect about a quarter of all consumer spending — everything from new drugs and medical devices to food safety, nutrition labeling, tobacco and e-cigarettes, animal drugs and cosmetics.

Democratic senators focused on Gottlieb’s finances, citing government data showing he received hundreds of thousands of dollars in consulting or other fees from several FDA-regulated companies in recent years. That’s on top of income from positions in a venture capital firm and investment bank that also fund health companies.

In ethics documents, Gottlieb said that if confirmed as FDA’s commissioner, he would recuse himself for a year from decisions involving about 20 companies, including drug giant GlaxoSmithKline, and would resign positions including as a board member or consultant with nine other health-related companies. Gottlieb also is a resident fellow at the conservative American Enterprise Institute, from which he said he also would resign.

At the hearing, Democratic Sen. Patty Murray of Washington questioned whether recusals are 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. On the Senate floor Tuesday, Democratic Sen. Ed Markey of Massachusetts said Gottlieb “would be nothing more than an agent of big Pharma.”

Gottlieb has said opioid addiction is the biggest crisis facing the agency. He said the issue will “require dramatic action,” including finding ways to spur development of non-addictive alternative painkillers as well as addiction treatments.

He also stressed the balance between speeding new products to market and making sure that good science continues to guide the FDA’s decisions.

“We should reject a false dichotomy that it all boils down to a choice between speed and safety,” Gottlieb said. At the same time, “we need to make sure we’re getting the most bang for our regulatory buck,” he added.

Gottlieb was a deputy FDA commissioner under President George W. Bush.

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