FDA job cuts loom with partisan lock in Congress

Published: Sep 08, 2022

By Tristan Manalac

BioSpace

Thousands of FDA employees may lose their jobs if Congress doesn’t reappropriate funding currently in place by the end of the month, according to a report by Bloomberg Law.

The FDA can collect user fees from pharmaceutical companies, medical device manufacturers and other industry players, who make these payments to facilitate the review process by FDA regulatory guidelines. This authority must be renewed every five years and is set to lapse by Sept. 30.

For the  2021 fiscal year, 46% of the FDA’s $6.1-billion total budget was made up of industry user fees and has helped cover more than 18,000 full-time employees’ salaries.

In particular, those whose salaries are budgeted under the Prescription Drug User Fee Act program are likely to be the first affected if Congress doesn’t reissue the FDA’s current appropriations.

Losing these positions may cripple the FDA’s ability to assess new drugs and medical devices. For the industry, this could mean longer review times or delayed action dates—for patients, fewer new medical products.

“After September goal dates will not apply,” an FDA spokesperson told BioSpace. “Whether FDA is able to continue to review applications in line with existing metrics will depend on a number of factors, including the availability of critical staff.”

The spokesperson also told BioSpace the cuts will directly affect the time and attention the agency can dedicate to public health crises, adding, “FDA will always try to prioritize public health needs, but delayed reauthorization would place important public health efforts at risk, such as our ability to ensure access to COVID-19 vaccine boosters and therapeutics and confront emerging diseases such as monkeypox.”

The job cuts will also compromise the FDA’s ability to ensure patients enrolled in clinical trials are safe, and review new treatment applications for diseases with high unmet medical need.

Employees who will be affected by the layoffs will receive their notices throughout the month, said FDA Commissioner Robert M. Califf.

Congressional Action

Lawmakers remain locked in a partisan impasse over whether to reauthorize FDA funding, with the weight of mid-term elections and party-line votes pending.

In June, the House of Representatives passed a bill that would reauthorize the FDA’s user-free programs for prescription drugs, medical devices, generics and biosimilars through the fiscal year 2027. Soon after, the Senate Health, Education, Labor and Pensions Committee signed a similar bill, with strong support from both sides of the aisle.

However, Sen. Richard Burr (R-N.C.), the ranking member of the committee, put forth another bill that removed key additions from the previous version of the Senate measure. In particular, he proposed changes to the accelerated drug approval pathway.

In June, the House voted on a similar bill, granting the FDA more power to ensure biopharma companies conduct follow-up assessments after their accelerated approvals.

The Senate returned from its summer recess Tuesday, giving the lawmakers three weeks to break the stalemate and arrive at a decision regarding the FDA’s funding via user fees.

In a July memo to his staff, Califf wrote:

“We continue to convey to Congress the urgency of reauthorizing the user fee programs in a timely manner. If we have reasonable assurance from Congress that they will act in time to allow us to continue collective fees after September 30th, then we will not need to begin the notification process for PDUFA-funded staff. We are working to obtain such assurance from Congress and I am optimistic that they will not allow our programs to expire.”

The FDA’s response was less optimistic. 

“FDA will continue to explore all legal and operational options to avoid the results of a gap in authorization, but we cannot envision a scenario where a delay would not have very real consequences for our work and the people we serve,” an FDA spokesperson told BioSpace.

Source: BioSpace