Trump's FDA Staff Cuts Weigh on Agency's Drug Oversight...

Trump's FDA Staff Cuts Weigh on Agency's Drug Oversight Work
[Bloomberg]

Nyah Phengsitth; https://news.bloomberglaw.com/health-law-and-business/trumps-fda-staff-cuts-weigh-on-agencys-drug-oversight-work

• Some agency employees say product reviews to slow down
• Drug industry recognizes reduced staff, Trump’s reform plans

The Trump administration’s moves to shrink the federal workforce put the FDA’s ability to regulate drugs and oversee the pharmaceutical industry at risk, according to current and former agency employees.

President Donald Trump‘s efforts to reduce the size of the US government is taking a toll on the Food and Drug Administration after the firing of probationary staff, offers of early retirement or buyouts, and an executive order requiring agencies to prepare for “large-scale” reductions in force.

Pharmaceutical companies pay millions of dollars to the FDA to uphold its “gold standard” drug review process so that drugs are safe and effective for consumers, but some staff and agency advocates say continued workforce cuts will impact the industry.

“We can’t tell our companies, our sponsors, how many people we’ve lost,” said one drug reviewer at the FDA, who was granted anonymity to speak freely. “We can’t even say if we’re affected, and we won’t be able to help as much for pre-submission work and deadlines for reviewing products.”

Various leading drugmakers declined to comment about the layoffs to Bloomberg Law, however, Johnson & Johnson in February told their investors that agency cuts will slow down medicine approvals. Eli Lilly & Co. also warned about the risks tied to “insufficient staffing levels, expertise, or resources” at the FDA.

Biopharmaceutical innovators, investors, and patient advocates are asking Trump in an openletter to stop cuts to the agency’s staffing.

A spokesperson for the Biotechnology Innovation Organization said that while it’s “critical to retain top-tier talent across government agencies” and that “safety monitoring and reviews continue without disruption,” it also recognizes Trump’s “goals to enable a more nimble and efficient US government.”

Steven Ubl, CEO of the Pharmaceutical Research and Manufacturers, made similar remarks in an interview with CNBC, contemplating the need for a “well resourced FDA,” but also “opportunities for modernizing.”

The FDA did not respond to requests for comment.

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Reviews at Risk

Additional slashes to the workforce add to concerns that a smaller FDA will lead to slower operations and potential disruptions to drug timelines.

“If you assume that there continue to be layoffs, the first thing that tends to fall by the wayside are those engagements, those touch points, those meetings, informal teleconferences, and the ability to seek rapid feedback from FDA,” said Eva Temkin, a former FDA acting policy director in the Center for Drug Evaluation and Research.

“That, in turn, impacts the amount of time that it takes to develop a new drug, the amount of time that it takes for that drug to be reviewed and approved, and ultimately, the amount of time that it takes for medicine to get to the patient,” said Temkin, who’s now a partner at Arnold & Porter Kaye Scholer LLP.

A reduced workforce could also make it challenging for the FDA to operate under the PrescriptionDrug User Fee Act, a law that allows the agency to collect fees from manufacturers submitting human drug applications to review and approve drugs within a certain time frame and hire more people to speed up reviews.

“The reduction in force at the FDA will inevitably slow the review process, delaying the availability of potentially life-saving products to the American public,” Anthony W. Lee, president of the FDA’s union under the National Treasury Employees Union, said in a statement to Bloomberg Law. “These actions will undoubtedly compromise the agency’s effectiveness and negatively impact public health outcomes.”

Industry watchers are also eyeing how a reduced workforce will affect the Trump administration’s plan to carry out an executiveorder addressing the “growing health crisis in America” through the “Make America Healthy Again” commission.

That order requires the US government to evaluate various health topics, including the overuse of medications and certain food ingredients.

“How do you execute an active agenda if you’re diminishing the number of staff you have available to work on those agenda items?” asked Stuart Pape, chair of the food and drug practice at Polsinelli.

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RFK Jr.'s Views

Health Secretary Robert F. Kennedy Jr. signaled changes to the agency during his presidential campaign and then as an ally of Trump, including remarks that “entire departments” in the FDA “have to go.”

Kennedy’s skepticism of the pharmaceutical industry was underscored on his first day as secretary of the Department of Health and Human Services, when he discussed his mission to reverse the chronic disease crisis and said “pharmaceutical interventions” don’t seem to be “alleviating the problem, and in many cases, appear to be worsening it.”

His mission of bringing “radical transparency” to the government also gained support from MartyMakary, Trump’s pick to lead the FDA.

The Johns Hopkins surgeon, who’s taken shots at the the agency’s “cozyrelationship” with drug manufacturers, said he hopes to “ensure the FDA holds to the gold standard of trusted science, transparency, and common sense to rebuild public trust and Make America Healthy Again,” according to remarks prepared for his Senate committee hearing on Thursday, which were obtained by Bloomberg News.

“One of the reasons Americans supported Donald Trump was because they have an appetite for major FDA and pharma reform and accountability,” said David Gortler, a former FDA medical officer.

“Additional firing should take place, but it needs to be laser-focused on specific bad actors” and “determining who requires highly experienced technical experts, which RFK desperately needs as his advisors,” said Gortler, who’s now a senior research fellow at the Heritage Foundation.

The FDA slowing down may also “be a good thing if it means more credible evidence that new drugs actually improve lives,” said Peter Doshi, an associate professor at the University of Maryland School of Pharmacy.

“I think the pendulum has swung too far in the direction of prioritizing market access speed over credible review of evidence, and as a result we have too many newly approved drugs that lack evidence they’re more effective or safer than already approved drugs or that they improve quality of life,” Doshi said.