The Trump administration’s layoffs have led to delays in the progress of FDA tobacco product audits or difficulties in completing the review tasks. Scientists at the FDA’s Center for Tobacco Products said that the review backlog was serious, some research projects were canceled, and the approval progress of new IQOS, vapes and other products were affected.
Key points:
1. The Trump administration’s layoffs have led to a reduction in FDA staff and a backlog of review tasks, making it difficult to complete reviews of medical devices and tobacco products on time.
2. Scientists at the FDA’s Center for Tobacco Products said the review workload has increased, some tobacco-related research projects have been canceled, and the review progress of tobacco products such as vapes may be affected.
3. Currently, the FDA is reviewing the application of Philip Morris International’s (PMI) new heated tobacco device “IQOS” next generation product, but the review progress is delayed.
Reuters: Trump administration layoffs hit FDA
Reuters reported on March 27 that some U.S. health regulators tasked with reviewing the safety and effectiveness of medical devices and tobacco products are struggling to meet Congressionally mandated deadlines because of layoffs by the Trump administration. The U.S. government said it would cut jobs at health agencies, including the Food and Drug Administration, on top of an earlier round of layoffs involving 3,500 jobs.
Two scientists working at the FDA said that since their colleagues were laid off in February, they have been assigned nearly twice as much to review new product applications. They spoke on the condition of anonymity to avoid professional repercussions.
The scientists said they were instructed to set aside other work, including oversight of other auditors and providing early feedback on planned product applications before they were submitted for review. According to a scientist at the FDA’s Center for Tobacco Products. The agency has delayed the start of new application reviews while they process existing ones, which must be completed within 180 days as required by U.S. law. He says some tobacco-related research projects have also been canceled.
- “We have 180 days to complete these (existing) reviews, and we simply can’t do it on time.” It’s just impossible.”
Review progress for new IQOS and other tobacco products may be significantly delayed
Currently, the Tobacco Center is reviewing a number of important projects, including an application for a new generation of Philip Morris International (PMI) heated tobacco equipment “IQOS”. A PMI spokesperson said the average waiting time for tobacco product applications was closer to 700 days, rather than 180 days. The FDA did not respond to a request for comment.
Elon Musk’s Department of Government Efficiency last month laid off about 1,000 probationary FDA employees, mostly from the tobacco, food and medical device centers, before recalling some employees. Reuters could not confirm the final number of workers being laid off. At the beginning of this year, the FDA had more than 20,000 employees.
Ameet Sarpatwari, a professor at Harvard Medical School, noted that the loss of staff and experience at the FDA could lead to longer review times, resulting in delayed time to market, or less time spent on individual applications. Increase the risk of missing potential problems.
Review progress for tobacco products such as e-cigarettes may be affected
Eva Temkin, an attorney at Arnold & Porter, said that even if product reviewers are not affected in the next round of layoffs, other FDA employees, such as policy experts and legal counsel, are critical to product reviews.
- “If this plan continues. I expect the user payment targets and commitments will not be met.”
She noted that the FDA has canceled meetings with some companies, instead providing only written responses.
A lawyer specializing in FDA regulation, who asked not to be named, said some of her clients at large medical device companies have expressed deep concerns that the agency will start missing deadlines after layoffs in February. A spokeswoman for AdvaMed, the medical device industry group, said the group had heard similar concerns.
Last year, the FDA approved more than 3,000 medical devices, including about three dozen for new high-risk devices such as Medtronic’s Affera system to treat atrial fibrillation, and more than 250 applications for tobacco products, according to the FDA database.
According to agency emails reviewed by Reuters. The proposed cuts come after the administration offered $25,000 in voluntary severance packages to FDA employees, excluding auditors, investigators and security guards.
One scientist said that since more than a dozen layoffs in his office, he has been assigned complex applications that require more in-depth research, while some simpler submissions have been put on hold. He was also assigned to write a single regulatory memo, which is typically done by as many as six scientists.
According to another scientist,
Some probationary employees in the FDA’s Tobacco Center were recruited last year for their knowledge of emerging technologies, such as age verification for vapes.
- “We needed a broader range of expertise, and we lost that, and that put us in a bind.”
