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Dive Brief:
Biotech executives and venture capital investors are banding together to press Congress to act on Food and Drug Administration layoffs they say are already impacting drug development.
In a letter to Bill Cassidy, R-La., the head of the Senate’s health committee, dozens of executives and investors said the Senate needs to identify how the FDA has been affected “in order to quickly preserve and restore its core functions.” Drug development timelines, feedback for industry and regulatory judgment are all at risk, they said.
Institutional knowledge may be irretrievably lost because of the cuts, according to the group. “American patients, American industry, and American biomedical leadership will bear the consequences,” they wrote.
Dive Insight:
Health and Human Services Secretary Robert F. Kennedy Jr. has overseen a chaotic round of job cuts in his department. In March, Kennedy announced plans to fire 10,000 people at HHS, including 3,500 at the FDA. The ensuing April 1 layoffs were filled with errors, and Kennedy admitted that about 20% of the personnel let go would need to be rehired.
Key officials at the FDA have also resigned, some in protest over Kennedy’s policies. That includes the agency’s top vaccine official, Peter Marks, who left on March 28 and cited his concerns with Kennedy’s false claims about the dangers of vaccines.
The biotech industry is already feeling the effects, according to the letter. It cited examples like a Massachusetts biotech whose dispute resolution process was suspended because the company’s FDA contact “wasn’t confident there would be any senior staff to review it.” Another drugmaker is trying to work through a clinical hold but isn’t sure if any of its FDA project managers are still at the agency.
Larger policy issues are at play as well. The industry is set to begin negotiations with the FDA this year to renew the Prescription Drug User Fee Act, a critical tool that provides funding for the agency and speeds up approvals of medical products. But the FDA has fired key negotiators, and the broad layoffs may put the overall program in jeopardy by violating the statute’s minimum staffing levels.
In the letter, some biotech executives and investors laid out recommendations, including the rehiring of specific agency officials. They named Chris Joneckis and Betsy Valenti to keep the user fee program on track, Yaeming Chae and Isaac Dorfman for capacity planning and workload analysis, as well as four other critical employees: Andy Kish, Patrick Zhou, Emily Ewing and Josh Barton.
The FDA should also lift the hiring freeze to fill the jobs of head of human tissue, head of clinical evaluations and head of cell and gene therapy, the group said. And the agency can use the RARE disease hub model for other pilot programs to see if it makes sense to merge the centers that oversee drug evaluation and biotechnology, they suggested.
Peter Kolchinsky of RA Capital Management, the founder of No Patient Left Behind, is the lead signatory on the letter, which follows two others focused on defending science and warning about FDA budget cuts. Cassidy has called on Kennedy to testify about the cuts, but a planned hearing didn’t happen this week. HHS staff plan to brief members of a House committee on Friday, Politico reported.
