Industry Affected by FDA Staff Shortage: Article

Operational challenges for drug companies related to staffing shortages at FDA are unlikely to be resolved in the near term, according to attorney Nathan Downing (Gardner Law), who was interviewed for a PharmaVoice article. The article says CBER and CDER combined had 1,343 fewer employees in September than in the same month in 2024. In June, it says, the agency was looking at a total hiring target for some 2,200 positions, amid reports that agency upheaval is deterring qualified applicants.

“People who were abruptly fired were a little hesitant to go back, and those are the people with the skill set that FDA would hire,” Downing explained. He also noted that the professionals FDA uses often can make more money working for a private company. The newsletter also cites a Stat report that a human resources reorganization at FDA has slowed the onboarding process for new hires.

While staff shortages don’t affect all FDA divisions to the same degree, Downing said, there are cracks visible in small work habit changes, such as emails being sent well outside traditional business hours. He said he can now receive emails late into the night, something that wouldn’t have happened two or three years ago. He believes it signals that staffers are under a lot of pressure.

“They’ll sometimes, kind of acknowledge it’s been tough and they’re really busy,” he said. “They’re professionals; they’re not sitting there and saying anything inappropriate. They’re just acknowledging that there’s a lot going on.”

The article notes that drug companies have voiced concerns about communication difficulties with FDA. Downing said it’s harder now to get informal feedback from agency officials. “In the past they’ve been pretty good at a quick one-off phone call to say, ‘Hey, let’s solve this issue,’” he said. With that avenue increasingly limited, drug companies have more burdensome alternatives.

“You may have to do another Q submission, pre-submission, pre-NDA, whatever it might be, to account for a lost one-off interaction, which adds time, and obviously that creates a financial burden,” Downing said.

Smaller drug developers may feel the burden of these slowdowns more acutely because they have less financial wiggle room to withstand delays.

The article recommends that regulated companies be more careful when preparing submissions and engaging with FDA.

“To attract and retain top talent, FDA will need to be able to reassure candidates and current staff that decision-making will continue to be driven by science and the law,” according to Elizabeth Jungman (Hogan Lovells). “Decision-making that reflects those principles, and rhetoric that celebrates public service, could help FDA attract highly qualified staff who have options elsewhere.”

Downing concluded that fewer FDA resources may have a silver lining for companies. “One good thing about FDA being under pressure is they’ll also have to look at what’s really necessary in a review and what might not be,” he said. “And so maybe there’s a chance for some efficiencies on their side as well that come out of this.”