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New drugs and devices will still get approved as the FDA waits for a new leader, but the lack of a permanent commissioner 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 Bloomberg BNA in a Feb. 25 email. 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. Gottlieb declined to comment, and O’Neill didn’t return a request for comment.
As of March 2, President Donald Trump hasn’t nominated anyone to lead the FDA. The timing isn’t that different from when President Barack Obama took office in 2009, and nominated Margaret Hamburg for the position in March. Hamburg was confirmed in May 2009. Califf took over after Hamburg resigned, and he was confirmed by the Senate in February 2016.
Stephen Ostroff is serving as the acting commissioner. Previously, Ostroff was the deputy commissioner for foods and veterinary medicine.
When contacted by Bloomberg BNA, the FDA said in a statement that it “continues to work to protect and promote public health.”
“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 Bloomberg BNA.
“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 user fee legislation “must be developed by this spring and must be passed by May or June in order for the agency to have the money to be able to continue to function on Oct. 1. And the agency needs leadership in terms of that,” Wayne L. Pines, president of health care at APCO Worldwide, told Bloomberg BNA. APCO Worldwide is a global public affairs and strategic communications consultancy. Pines also served 10 years in senior positions at the FDA.
Jeffrey N. Gibbs, director of the law firm Hyman, Phelps & McNamara PC in Washington, told Bloomberg BNA the FDA “has a lot of work and always has new issues to deal with and being rudderless at the top doesn’t help. Having an acting commissioner is good, but it’s not the same thing as having someone who is authorized to serve as commissioner.” Gibbs advises FDA-regulated companies, and previously worked at the agency.
Gibbs said if the FDA isn’t “working on regulations or guidance documents required under 21st Century Cures, will they be able to meet the deadlines?”
“Right now even routine functions like publishing Federal Register notices about upcoming meetings, as I understand it, have been put on hold,” he said. “The agency has had acting commissioners before; it’s not at all uncommon. But this is certainly an unusual transition and I think that there’s probably a higher level of concern.”
While the lack of a permanent commissioner could have an impact on big initiatives, it doesn’t affect the daily business of approving drugs and devices, updating product labels and inspecting manufacturing facilities.
“So the basic work of the FDA and the work that actually is most visible to the patient community and to the medical community goes on,” Pines said.
“When FDA lacks a permanent commissioner, the work of the agency continues, but new initiatives are not started and stakeholders are unlikely to see a change in direction,” Jennifer L. Bragg, an attorney with Skadden, Arps, Slate, Meagher & Flom LLP in Washington, told Bloomberg BNA in an email.
Bragg advises FDA-regulated companies, as well has hospitals and health-care systems, facing government investigations and FDA enforcement challenges.
The lack of a permanent, confirmed commissioner also affects communications between the FDA, the HHS and the White House.
“There is some risk that FDA’s ability to provide substantive input to HHS is diminished since the commissioner serves as the point of communication within the Executive Branch,” Bragg said.
Without a permanent commissioner, “the relationship with the HHS and the White House tends to be somewhat different when you have an acting commissioner who is just a permanent member of the FDA staff rather than someone who is selected by the administration,” Pines said.
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.
As part of the Cures legislation, the FDA was given explicit hiring authority. This was a key part of Congress’s efforts to spur new medical treatments. The agency also was given more money to hire people under Cures.
The vacancies are “a problem that will really need to be solved at some point. The 21st Century Cures Act helps a little bit with that by providing higher salaries for FDA people, but that’s going to require real commissioner leadership,” Pines said.
Another factor affecting the agency’s leadership is that the head of the FDA’s drug center is doing two jobs.
Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, is also now the head of the Office of New Drugs. She took over the position when John Jenkins left the agency in January to join the regulatory consulting firm Greenleaf Health.
Woodcock “is an amazing person, but those are two full-time jobs” and “she can’t be expected to provide overall agency leadership on some of the other issues” when she holds two positions, Pines said.
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