Rare Disease Report

Senate Approves Gottlieb as FDA Commissioner

MAY 09, 2017
Mathew Shanley
As the result of a 57 to 42 vote, Dr Scott Gottlieb was confirmed by the US Senate as Commissioner to the US Food and Drug Administration (FDA) on Tuesday.

In April, Gottlieb was approved by the Senate Health, Education, Labor & Pensions (HELP) committee, including 2 “yes” votes from Democrats.

The support of the full Senate was expected at the time of the approval.

Hand-picked by President Donald J. Trump, Gottlieb, 44, is a practicing physician and a resident fellow at the American Enterprise Institute. The selection will make him responsible for regulating companies within the pharmaceutical industry, including some with which he has been closely involved in recent years.

Concerns regarding Gottlieb’s closeness with the pharmaceutical industry created a minor stir, however, before confirmation, Gottlieb was sure to stress an impartial approach. He even went as far as to suggest that he would remove himself from participating in all FDA decisions involving more than 20 companies for a full calendar year.

Still, though, the decision has been met with both criticism and praise, as Gottlieb has promised to uphold the FDA’s reputation as the world’s “gold standard” for drug approval.

“I understand why people can look at things he has written and have a lot of concerns, but he’s going into a different role as FDA commissioner,” said Joshua Sharfstein, who was deputy commissioner during the Obama administration and is now a professor at the Bloomberg School of Public Health at Johns Hopkins University, to the Washington Post. “When you have an opinion and express it, you aren’t responsible for the consequences, but as commissioner, you are responsible.”

The new position will not be Gottlieb’s first as a part of the FDA. In President George W. Bush’s administration, he served as both deputy FDA commissioner and a high-ranking official at the Centers for Medicare and Medicaid Services. While his laundry list will undoubtedly include action items from President Trump, most notably addressing the nation’s opioid epidemic.

One of his most immediate moves, though, will be putting into place the 21st Century Cures Act – a law signed by President Obama in 2016 that directs the speeding up of drug approvals.

As it pertains to rare disease, Gottlieb’s past criticisms of the FDA’s slow and outdated drug approval process have provided hope among the community that he will provide more voice for the patients’ stories, in addition to more credence to alternative outcome measures during the review process.

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