The FDA says it is hiring more than 1,000 new employees and rolling out a pilot communication program in an effort to speed up the review of new drugs.
“FDA announced over 40 job announcements for mission critical positions to support 1,050 allocation selections,” an agency spokesperson told Fierce Biotech. “FDA is actively working through hundreds of selections to expedite onboarding,” with the positions including reviewers, inspectors and criminal investigators.
There are currently no open FDA positions listed on the U.S. government's official job board. As of publication, the agency hadn't responded to Fierce's questions about where the new positions are posted.
The move follows mass federal layoffs by the Trump administration, which were expected to affect around 3,500 FDA workers. Past officials have warned against the cuts, noting that the workforce changes could disrupt the drug review process. Some efforts have since been made to rehire laid-off workers, and the current scale of the agency’s downsizing is not entirely clear.
As for the new communication program—launched in October but officially unveiled in a Nov. 19 release—new drug sponsors will be able to email questions to staff at the FDA’s Office of New Drugs after meeting with the agency. Staff will then respond to questions, via email, within three business days.
“In this industry, time is a precious commodity. Numerous drug developers have told me that a quick touchpoint or clarification opportunity with the FDA team could spare them months of guesswork,” FDA Commissioner Marty Makary, M.D., said in the release.
“Our goal is to give sponsors prompt, clear feedback so they can focus on what they do best: delivering more cures and innovative treatments to the American people,” he added.
Sponsors have already used the program to answer questions arising from official meeting minutes sent to them by the FDA, according to the agency.
The FDA has missed several review deadlines this year under the second Trump administration. The agency has canceled meetings with biotechs to discuss trial plans, delayed multiple approval decisions and thrown up new obstacles for treatments that it previously showed support for.
FDA leader Makary has announced a host of new programs meant to quicken the pace of drug reviews, with the agency even floating the idea of dismantling expert review panels for new drug submissions. These new programs include proposed regulatory pathways for rare diseases and customized therapies such as bespoke CRISPR gene editing, as well as a “national priority voucher” program that promises to shorten review times to just one or two months for recipients.
Launched in June, vouchers have since been awarded to two batches of companies, including Novo Nordisk for an oral version of Wegovy (semaglutide) and Eli Lilly for its star oral GLP-1 candidate orforglipron.