Gottlieb FDA Nomination Approved by Committee, Heads to Senate

The Senate Committee on Health, Education, Labor & Pensions voted 14-9 to approve the nomination of Scott Gottlieb, MD, to lead the FDA. He will now need to be confirmed by the full Senate to become FDA commissioner.

The Committee vote had originally been scheduled for Wednesday morning, but had been pushed back to allow senators to review information Gottlieb had just submitted regarding his financial holdings. The final tally of votes was 14-9, as the nomination was approved by all Committee Republicans and 2 Democrats, Sheldon Whitehouse of Rhode Island and Michael F. Bennet of Colorado.

Democrats’ main objections centered on potential conflicts of interest arising from Gottlieb’s ties to the pharmaceutical industry. Ranking Member Patty Murray, D-Washington, called Gottlieb’s entanglements “unprecedented” for a FDA commissioner nominee and said that she was “deeply disappointed” in the lack of specificity in his written answers to her questions and those of other Committee members.

These concerns were elaborated on by Senator Maggie Hassan, D-New Hampshire, who mentioned that Gottlieb was opposed to the creation of Risk Evaluation and Mitigation Strategies regulations, which she called a “key tool” for fighting the opioid crisis, and questioned whether he had been pressured by the pharmaceutical industry.

Furthermore, she accused Gottlieb of “putting politics ahead of science when it comes to women’s health” because as deputy FDA commissioner he helped the Bush administration delay the approval of emergency contraceptives for over-the-counter use. She said that she hoped Gottlieb “proves to be a stronger commissioner than his record suggests,” but based on this record, she could not support him.

For Republicans, however, this record offered the strongest evidence in support of the nomination. Chairman Lamar Alexander, R-Tennessee, said that the country was “fortunate to have someone as qualified as” Gottlieb, who has “impressive qualifications from nearly every perspective.” He mentioned that the Office of Government Ethics had carefully reviewed Gottlieb’s financial information and found that with his plans to recuse himself from potential conflicts, Gottlieb is in compliance with conflict of interest rules.

Alexander reminded the Committee that former FDA commissioner Robert Califf, MD, had also consulted for many drug and device companies, which was not raised as a concern by Democrats, and that the 3 last FDA commissioners, including Califf, had voiced support for Gottlieb in the role. He said he was “bemused by this argument” that Gottlieb’s experience working with drug companies made him unfit for the role.

“If you’re going to the hospital for brain surgery, you might want to have a doctor who knew something about brain surgery,” he said. “We need in our government people with experience in the types of industries and agencies and activities that they’re in charge of.”

This idea was echoed by Senator Orrin Hatch, R-Utah, who said that in his career he had “seen an awful lot of FDA commissioners,” but could not think of any with more qualifications or stronger integrity than Gottlieb. He agreed that Gottlieb’s experience made him highly qualified and would be a “great advantage to our country.”

It seemed that many stakeholders in the healthcare industry felt the same, as Alexander mentioned the Committee had received 14 letters in support of Gottlieb from 71 groups of physicians, pharmaceutical companies, food companies, and patient advocates. Ted Okon, MBA, executive director of the Community Oncology Alliance, discussed the group’s endorsement of the nomination in an interview this month with The American Journal of Managed Care^® (AJMC^®).

Okon called the conflict of interest accusations “nonsensical” and believed Gottlieb would streamline regulations to get drugs in the hands of patients faster without compromising safety. He also predicted that Gottlieb would become a proponent of drug price transparency and help restructure the system of discounts and rebates.

“He understands the drug industry better than anyone else,” Okon said. “That’s exactly what you want. And he understands some of it from the inside. Why wouldn’t you want that?”

That question and others will next be debated by the full Senate, where the nomination will move after the Committee's favorable report.

AJMC

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after the committee vote.

"I think the second step now is hopefully, in no time at all, the Senate will get him [confirmed], because we really desperately need an FDA commissioner... W

e want to keep the flow of innovative products through the FDA, and that means trying to streamline the system, both the cost for manufacturers and the time and effort manufacturers have to put in."

"I think the first step was obviously getting Scott Gottlieb through the committee," said Okon in comments to