FDA Commissioner Nominee Faces Limited Opposition From Senate Committee

Posted 05 April 2017 By Zachary Brennan

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The Senate Health, Labor, Education & Pensions Committee on Wednesday offered praise and only a few muted attacks against Scott Gottlieb, President Donald Trump's nominee to be the next commissioner of the US Food and Drug Administration (FDA).

While Democrats focused their questions in the hearing on Gottlieb’s conflicts of interest, how he’ll bring down drug prices and solve the opioid crisis, his work as a consultant and employee of pharmaceutical and biotech companies did not seem to be a sticking point, particularly as Gottlieb made clear that he will work with the Department of Health and Human Services’ ethics officials to ensure he’s in compliance with federal rules.

"I recognize the importance of maintaining my impartiality in this role," he said, noting he understands the importance of FDA’s impartiality, too, and that his background and understanding of the industry will likely aid his work at the agency.

And unlike several other Trump nominees, Gottlieb made clear that he would not be afraid to offer conflicting views with the administration. He also pledged his full support for the agency’s mission, calling for a "bottom up" approach with new ideas coming from career staff and guided by "the science and what’s good for patients."

"There is one standard for safety and effectiveness, and no commissioner can change that," he added, noting his previous work at the agency as part of two different administrations.

Other Specifics

When questioned on his views related to vaccines, Gottlieb, a physician and former cancer survivor, offered unequivocal support for the research indicating no established link between vaccines and autism.

On the topic of the opioid epidemic sweeping across the US, Gottlieb called it his "highest immediate priority," comparing it to the recent Ebola and Zika virus outbreaks and noting that FDA’s actions in the past may have been too incremental, though he does not blame the agency for the crisis.

On drug pricing, Gottlieb declined to comment on his views on the government negotiating further with the biopharmaceutical industry, though he noted that he thinks there are two general problems with generic drug approvals: One, which he believes is solvable, is that in certain markets competition has fallen and approvals have been stagnant, leading to companies taking advantage of monopolies.

The other and potentially more difficult problem he cited is that for some complex generic drugs, standard bioequivalence studies used for other types of generics might not be sufficient in showing that the generic and brand name version are identical copies.

Gottlieb also touched on FDA's breakthrough therapy designation, noting there have been "some inconsistencies," though the more recent uniformity is positive because of the designation’s impact on patients with unmet medical needs.

Over the next several weeks, the committee will vote on Gottlieb's nomination after he answers follow-up written questions. If approved, he will then face another vote from the full Senate.

Video of Hearing

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Tags: Scott Gottlieb, FDA commissioner, Senate HELP hearing

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