FDA layoffs delaying medical device reviews

FDA layoffs delaying medical device reviews: ©Arakillustrations - stock.adobe.com

Recent layoffs initiated by the U.S. Department of Government Efficiency (DOGE) have significantly impacted the Food and Drug Administration's (FDA) ability to meet congressionally mandated deadlines for reviewing medical devices and tobacco products, according to a Reuters report. Some FDA scientists now face workloads nearly double their previous assignments, leading to delays in product reviews and the cancellation of several tobacco-related research projects.

These staffing reductions are part of broader federal workforce cuts under the Trump administration, which have also affected agencies such as the Consumer Financial Protection Bureau and the Federal Deposit Insurance Corporation. Despite the intention to streamline government operations, concerns have emerged about the FDA's capacity to approve essential medical devices promptly, potentially hindering the introduction of new technologies to the market.

The medical device industry voiced its concerns about any cuts back in February, pointing out that the industry was already paying for the government to perform these new product reviews in a timely manner via a fee agreement. Scott Whitaker, president and CEO of AdvaMed, the medical device industry’s trade group, issued the following statement in February that read in part:

“Device review times were already too long, though they were improving as the result of our latest user-fee agreement. FDA was already struggling to keep pace with our industry’s tens of thousands of new medical technology applications every year, all of which are intended to improve the lives of patients in this country. And in this regard FDA was improving as well (and also due to our latest user-fee agreement). That agreement, for the first time ever, created private sector-like incentives for FDA to be more efficient, transparent, and predictable in its review process. And this was of tremendous benefit to the patients whose lives and health depend on access to America’s leading-edge medical technologies and treatments.

“Unfortunately, as a result of these reductions, FDA will lose hundreds of new employees, the best and most innovative hires under our most recent agreement.”

FDA is now attempting to rehire approximately 300 recently dismissed scientists, including those involved in reviewing applications from companies like Elon Musk's Neuralink. This effort aims to restore the agency's public health mission and ensure the efficiency of its review processes. However, skepticism remains among some experts about returning to positions that may lack job stability.