What Can We Expect From The FDA In 2026?

By Abby Proch, executive editor, Clinical Leader

The timing of the panel discussion “FDA Forecast: What The FDA Has Planned In 2026 for Pharmaceuticals and Biotechnology Products” at RAPS Convergence held last week could not have been more perfect.

We’ve seen how the last nine months of the new Trump administration have affected the FDA — from leadership changes to reduced staffing levels to scientific (?) priorities. We’re also in the throes of a government shutdown. And we’re now squarely in Q4 and looking to the next fiscal year. Thus, a glance into the future is much desired.

Prognosticating on the agency’s plans were The Pink Sheet’s Derrick J. Gingery, AgencyIQ’s Alexander Gaffney, MS, RAC, and Esham Strategies LLC’s Cartier C. Esham, Ph.D.

Staff Reductions And The Shutdown

Conversations first centered on the federal government shutdown, which began Oct. 1 (and is ongoing at the time of publication), and it’s setting off a ticking clock on review timelines. According to Gingery, the FDA has about 10 weeks’ worth of PDUFA funds to continue reviews. Gaffney estimated that the government shutdown could last up to a month, and with that timeline, reviews would continue as expected.

Still, the shutdown paired with the hiring freeze and reduction-in-force (RIF) earlier this year portend troubling times ahead in terms of drug development timelines. The panel volleyed RIF and rehire numbers back and forth, settling somewhere around a 14% reduction in FDA headcount since the beginning of 2025. In fact, part of the fired and rehired contingency were people with regulatory guidance and PDUFA responsibilities, said Esham, to a handful of gasps from the crowd. However, they were ultimately brought back when the administration realized the importance of their roles, she said.

Potential PDUFA Snafu

Further into the PDUFA discussion, the group toyed with the idea that, given the PDUFA reauthorization process is slated to begin in late 2025 and early 2026, any disruption to those talks could cause delays in Congress passing the bill in 2027. One such disruption might be the HHS, by way of Secretary Robert F. Kennedy Jr., said Gaffney. Kennedy has been a vocal critic of the perceived undue influence of pharmaceutical companies on the FDA approval process. Gaffney suggested Kennedy may see this reauthorization period as a time to intervene. Also a factor in PDUFA reauthorization is Congress’ stance on the program’s usefulness, he added.

Now, the problem with delayed authorization or a congressional change of heart is that PDUFA fees account for about 50% of the FDA budget, said Gaffney, and without them, the FDA would shutter. Also at play is the congressional “spending trigger,” which means that if congressional appropriations fall below an FDA baseline set for salaries and expenses, the FDA must refund user fees collected during that fiscal year and not use them to support drug review activities. That means Congress must fund the FDA properly, or else the FDA loses the ability to collect user fees for drug review.

Are CRLs All Bad News?

Complete response letters (CRLs) — wherein the FDA withholds approval of an NDA or BLA and explains in embarrassing detail why — have moved out of secrecy and into the spotlight. They used to be for sponsor eyes only, at least, until a drug gained approval. But this year, the FDA has begun publishing them online regardless of their approval status. It’s one manifestation of Kennedy’s and FDA Commissioner Marty Makary, MD, MPH’s, commitment to “radical transparency.”

The move generated some buzz among researchers, who swarmed the openFDA site soon after. Whether that was to simply keep up on industry gossip or learn from the findings, we don’t know. But according to the panel, the FDA’s decision to share the letters, which do mention sponsors by name, is not appreciated by everyone.

One critic in the audience stepped up to pontificate on how an easy-access CRL might cause irreparable harm to a small biotech’s reputation. After all, if the letters are public, investors can read them, too, she said. Not landing on the side of for or against their publication, the panel acknowledged the potential harm, adding they’d expect to see a jilted sponsor sue the FDA sooner rather than later.

Where Do We Go From Here?

Unsurprisingly, and even with the discussion moderately deftly by Khushboo Sharma, MBA, RAC, formerly of the FDA and now CEO at Accumulus Synergy, it can be tough to predict the movements of the FDA. Still, drug development professionals can expect that all three of these issues (God willing, with the exclusion of the shutdown) will persist into the new year.