Lack of Permanent FDA Chief Delays Big-Picture Work

The lack of a permanent FDA commissioner doesn’t affect the agency’s approval of new drugs and devices, but it will delay work on implementing 21st Century Cures Act provisions and filling job vacancies.

“The FDA needs a confirmed commissioner. The role includes a significant amount of negotiation among the many influential people with views about policy,” Robert Califf, the most recent Senate-approved leader of the Food and Drug Administration, told me. Califf is now a professor of medicine at Duke University.

Two names being floated as potential nominees for FDA commissioner under the new administration are Scott Gottlieb and Jim O’Neill. Both have publicly expressed ideas that would significantly change the way the agency operates.

Gottlieb has worked at the agency as a deputy commissioner and has a medical degree. He is a resident fellow at the American Enterprise Institute. O’Neill is a managing director at the San Francisco-based investment firm Mithril Capital Management. O’Neill held various positions at the Department of Health and Human Services during George W. Bush’s administration.

As of March 8, President Donald Trump hasn’t nominated anyone to lead the FDA. The timing isn’t that different yet from when President Barack Obama took office in 2009, and nominated Margaret Hamburg for the position in March. Hamburg was confirmed in May 2009. Stephen Ostroff is now serving as the acting commissioner. Previously, Ostroff was the deputy commissioner for foods and veterinary medicine.

“The absence of a permanent commissioner creates uncertainty about the agency’s core objectives under the new Trump administration,” Bloomberg Intelligence analyst Brian Rye told me.

“Moreover, leadership will be especially critical this year to begin implementing directives under the 21st Century Cures Act [a 2016 law to speed new drugs and devices to market] and to help shepherd critical, must-pass legislation reauthorizing the FDA’s user fee programs through Congress,” Rye said.

Congress is preparing to consider legislation to reauthorize the laws governing industry-paid user fees, which help fund the FDA. All of the FDA’s user fee programs expire Sept. 30. New legislation will be needed to reauthorize the programs for fiscal years 2018 through 2022. The agency has separate fee programs for prescription drugs, generic drugs, biosimilars and medical devices.

The FDA also has numerous job vacancies, and the agency’s ability to find qualified people to fill those vacancies could be hampered by the lack of a permanent commissioner, as well as the 90-day hiring freeze imposed by the Trump administration.

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