FDA deputy commissioner hints at potential changes to PDUFA

The US Food and Drug Administration (FDA) is exploring the possibility of changing the fee structure of the Prescription Drug User Fee Act program (PDUFA) to rebuild trust in the agency, said Grace Graham, the newly named deputy commissioner for policy, legislation, and international affairs at the annual meeting of the Food and Drug Law Institute (FDLI) on 16 May.

Graham mentioned that FDA is considering restructuring the PDUFA program – which will need to be reauthorized before the end of September 2027 when the current program expires – in an effort to restore trust in the agency. She explained that PDUFA was originally designed to facilitate innovation and has since evolved to provide essential funding for FDA.

“As we look towards the next reauthorization, it is time to take a step back and think about if the fee structure and amounts have any unintended consequences. The perception of a company handing over a multi-million-dollar application fee when they are submitting their application may cause some American people to question the outcome of those reviews. It is worth exploring whether and how restructuring and simplifying the user fee program may help rebuild trust in the FDA in its decisions and to take advantage of the upcoming reauthorization to do so,” she said.

Graham also said that FDA is looking at other ways to tweak the program. For instance, she pointed out that under the Generic Drug User Fee Amendments (GDUFA) program, foreign facilities are assessed a higher fee than domestic ones to address the cost difference in assessing those facilities. “That may be a concept worth expanding to other product areas,” Graham said.

FDA recently announced two public meetings in July to discuss the reauthorization of its PDUFA and GDUFA programs for the FY 2028-2032 period. The current legislative authority for the programs expires at the end of September 2027.

Graham stressed the importance of reducing dependence on foreign-manufactured medications. She noted that 73% of all FDA-registered manufacturing facilities of active pharmaceutical ingredients (APIs) and 52% of all FDA-registered finished manufacturing facilities are located outside of the US, with China a leading supplier.

Graham said that “more and more of the innovative products are being developed in China first or other countries, and I think it’s going to take all of us and others outside this room working together to try to reverse this trend of folks moving their trials overseas where it may be faster or cheaper.”

“The FDA plays a part, and we can look at streamlining and modernizing regulations – I think our good laboratory practices haven’t been updated since the 70s,” Graham added.

When drug development occurs overseas, clinical trials may need to be repeated in the US because the data may not represent the US population. This can lead to delays in getting treatments to market, she said.

Graham said that as part of its Make America Healthy Again (MAHA) focus, the Trump Administration has a “renewed focus on chemicals in the food,” which she said has not received much attention since she started working on FDA issues a decade ago.

She emphasized that MAHA is more comprehensive than just food-related matters. Many drugs are used in ways that are not supported by the data collected at the time of approval. Furthermore, since many of these drugs have gone generic, there is little incentive for updating their labels or conducting further studies.

FDA deputy commissioner hints at potential changes to PDUFA

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