With the recent news of cuts in FDA funding (most recently reported by Zachary Brennan in an Endpoints News story entitled, “House Committee Raises Concerns on CDER-CBER Misalignment Amid 2025 Funding Markup” (here, subscription required), the question of FDA being asked to do more must be asked, as it now appears it will have to do more with less. Brennan writes “[T]he House Appropriations Committee on Wednesday began marking up the FDA’s 2025 funding bill, offering the agency about 1% less than 2024 and almost 10% less than what President Joe Biden requested.” So, it looks like if things stay the same, the FDA can be expecting funding shortfalls.

The more pressing question (rather than a flat funding for Fiscal Year 2025) is where the funds will come from to support the Agency’s current requirements and agreements with industry and Congress, regarding increases in inspections and so many more areas to support the American public. Do more with less appears to be the message! Remember, there are inflationary costs associated with every new fiscal year, including (among other things) yearly salary increases for FDA employees, increased travel costs for foreign and domestic inspections, and obligations under existing regulations and new legislation, just to name a few.

FDA will also be facing potential increased litigation expenses that will likely come in the form of challenges to FDA regulatory interpretations, which may be impacted and or challenged by the recent Chevron decision (see here for a recent blog on this topic). So where does this leave the FDA? Possibly not filling vacated positions, cutting back on services, and a slowed hiring of essential positions, to name a few. How will the User Fees fare in these lean times? Will User Fee rate increases soar over the next few years, as industry asks FDA to do more to enhance the approval process? And if a new administration takes over in November, will the cuts to funding take an even bigger hit? These are all questions we must keep our eyes on to assure the Agency has the necessary resources to conduct business as usual while not placing an ever-increasing financial burden on the industry, which could hurt smaller firms in generics, medical devices, biologics, biosimilars or even new drugs.