Concerns Grow Over Potential Delays in FDA Drug Approvals Amid Government Cuts

In response to Managed Healthcare Executive’s annual Pharmacy Survey, Jeffrey Casberg, M.S., vice president of clinical pharmacy at IPD Analytics, offered his perspective on a hot issue: whether recent government efficiency cuts, particularly at the FDA, are causing delays in Prescription Drug User Fee Act (PDUFA) target dates.

Survey results showed that 66% of respondents believe PDUFA dates could be delayed due to the cuts, while 26% disagreed and 8% weren’t sure.

Casberg agreed that this is a fair concern but mentioned that the situation is still evolving.

“So, we haven't seen a big impact yet, but first I'd like to say that the PDUFA date that's publicized is not a required date. It's more of a target date,” he said. “So, there is a little wiggle room in that but it's not supposed to miss by months.”

Casberg noted that IPD Analytics has been monitoring several recent cases that may hint at early signs of disruption from the FDA cuts.

One example he gave involved Stealth BioTherapeutics’ drug elamipretide, a treatment for Barth syndrome, a rare condition affecting around 150 people in the U.S.

When the FDA delayed its decision on the drug, Casberg said there was no explanation given, such as the common reasons of safety or manufacturing concerns.

Related: Jeff Casberg, M.S., Says GLP-1s Are Poised to Drive U.S. Drug Spending Over the Next Three Years

He also pointed to delays in decisions for the Novavax COVID-19 vaccine, which was finally approved May 16 after a 6-week delay, and a drug from Vanda Pharmaceuticals for gastroparesis called tradipitant.

In Vanda’s case, Caberg said the FDA acknowledged the delay could be partially related to cuts and even staffing and resource issues.

While these examples don’t yet point to a widespread trend, Casberg stressed that the situation could worsen over time.

He added that an area of focus is clinical trial staffing. If trials get backed up, that could slow approvals for years.

While the FDA is holding steady for now, the potential for future disruption is real and worth watching out for based on Casberg’s perspective.