Rare Disease Report

Gottlieb Approved by Senate as FDA Nominee

APRIL 27, 2017
Mathew Shanley
Earlier today, a U.S. Senate panel voted to approve Dr. Scott Gottlieb as the commissioner of the U.S. Food and Drug Administration (FDA). His nomination will be sent for a confirmation vote.

It is anticipated that the full Senate will support the nomination after Gottlieb was approved on a 14-9 vote by the Senate Health, Education, Labor & Pensions (HELP) committee, including 2 "yes" votes from Democrats.

Gottlieb has advocated a lesser list of requirements necessary when it comes to the sanction of new medical products. The former FDA deputy commissioner sits on the boards of several healthcare companies, and is a resident fellow at the conservative American Enterprise Institute, a teammate of venture capital firm New Enterprise Associates (NEA).

Possible conflicts of interest stem from Gottlieb’s work with NEA, and he was asked a slew of hard-hitting questions during a HELP committee hearing earlier this month. The nominee for FDA head has provided funds to or consulted for almost 30 medical device and drug organizations, strongly opposed the Affordable Care Act, and he has previously advised Republican presidential candidates.

Thanks to his existing relationships with the industry, “a level of discomfort” was the term used by Sen. Chris Murphy, Democrat of Connecticut, to describe how the Democratic party felt about President Donald Trump's nomination and his recent approval.

“The worry about impartiality is certainly connected to the private sector experience, but it’s also to your very deep political involvement as well,” Murphy said. “The worry here is that there will be industry-supported reforms that will find a voice inside of the agency because of your connection to the industry.”

Not coincidentally, impartiality was a noticeable theme within Gottlieb's prepared statement.

“If confirmed, I’ll lead the FDA as an impartial and passionate advocate for public health. I know what’s at stake here. People’s lives are literally on the line when it comes to the decisions FDA makes, its oversight, and its enforcement of Congress’s laws,” Gottlieb said.

“We should be reminded always, that we save lives by allowing good things to happen, but we also save lives when we keep bad things from happening. FDA’s enforcement tools are a bedrock of its mission,” he added.

Gottlieb continued to stress his unbiased approach by promising to remove himself from participating in FDA decisions involving more than 20 companies for a full calendar year.

Senator Rand Paul, Republican of Kentucky, inquired with Gottlieb in regard to whether or not company profits would play a role in his decisions on both safety and his effectiveness as FDA Commissioner.

“Absolutely not, Senator,” Gottlieb replied.

About The Food and Drug Administration (FDA):

The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

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