Review Delays in FDA Due to Trump Administration Layoffs

Key points:

• The Trump administration's staff cuts have resulted in a reduction of personnel at the FDA, causing a backlog of review tasks and difficulties in completing reviews of medical devices and tobacco products on time.
• Scientists at the FDA Center for Tobacco Products have stated that the workload has increased, leading to the cancellation of some tobacco-related research projects, potentially affecting the review process for products like e-cigarettes.
• Currently, the FDA is reviewing the application for the new generation of Philip Morris International's (PMI) heated tobacco device "IQOS," but the review process is delayed.

According to a report from Reuters on March 27th, some US health regulatory agencies responsible for reviewing the safety and effectiveness of medical devices and tobacco products are struggling to meet deadlines set by Congress due to the Trump administration's layoffs. The US government has indicated that there will be staff reductions in health agencies, including the Food and Drug Administration (FDA), with a previous round of layoffs affecting 3,500 positions.

Two scientists working at the FDA stated that they have been assigned nearly twice the amount of new product application review tasks since their colleagues were laid off in February. They requested to remain anonymous to avoid any professional repercussions.

These scientists stated that they were instructed to put aside other work, including supervision of other reviewers and providing early feedback before the submission of planned product applications. According to a scientist from the FDA Center for Tobacco Products, the center has delayed the initiation of new application reviews and is currently handling existing reviews, which must be completed within 180 days under U.S. law. He noted that some tobacco-related research projects have also been canceled.

"We have 180 days to complete these (existing) reviews, but we simply cannot meet the deadline. It is practically impossible."

Currently, the Center is reviewing some important projects, including Philip Morris International's (PMI) application for its new generation product "IQOS" for heated tobacco devices. A spokesperson for PMI stated that the average waiting time for tobacco product applications is close to 700 days, not 180 days. The FDA did not respond to requests for comment.

The Department of Government Efficiency, led by Elon Musk, fired approximately 1,000 probationary employees from the FDA last month, most of whom were from the Center for Tobacco, Food, and Medical Devices. Some of these employees have since been recalled. Reuters was unable to confirm the final number of employees who were let go. At the beginning of this year, the FDA had over 20,000 employees.

Harvard Medical School professor Ameet Sarpatwari pointed out that losses in FDA personnel and experience could lead to longer review times, causing delays in product approval or potentially reducing the time spent on individual applications, thus increasing the risk of overlooking potential issues.

Eva Temkin, a lawyer at Arnold & Porter, stated that even the product reviewers who were not affected in the next round of layoffs are critical to the product review process, as well as other FDA staff such as policy experts and legal consultants.

"If this plan goes forward, I do expect to see missed user fee goals and commitments."

She mentioned that the FDA has cancelled meetings with some companies and instead is only providing written responses.

An attorney specializing in FDA regulation, who requested anonymity, stated that some of her clients in large medical device companies are deeply concerned about missing deadlines since the FDA began layoffs in February. Medical device industry group AdvaMed said the organization was hearing similar concerns, a spokesperson said.

The FDA last year approved more than 3,000 medical devices, around three-dozen of which were for original, high-risk devices like Medtronic's (MDT.N), opens new tab Affera system to treat atrial fibrillation, and more than 250 applications for tobacco products, according to agency databases.

According to information obtained by Reuters, the government had offered FDA employees (excluding reviewers, investigators, and security personnel) a voluntary separation package of $25,000 before the proposed layoffs.

A scientist stated that after layoffs in the office that resulted in over ten people being let go, he was assigned more complex applications that required deeper research, while some simpler submissions were put on hold. He was also tasked with writing a regulatory memorandum alone, which is typically completed by a team of up to six scientists.

According to another scientist,

Some temporary employees at the FDA Tobacco Center were recruited last year for their knowledge of emerging technologies, such as e-cigarette age verification.

"We needed a greater variety of expertise, and we lost that. And so that has left us scrambling quite a bit."