Congress Will Consider Prescription Drug Fee Renewal
The federal government is preparing to reauthorize the Prescription Drug User Fee Act before its expiration in 2027.
Updated on Sept. 21, 2026 in Healthcare
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Congress will consider reauthorizing the Prescription Drug User Fee Act, which allows the FDA to collect fees from manufacturers to fund medication reviews. The current program, which has been in place since 1992, is set to expire on September 30, 2027.
Why it matters
This program provides essential funding for the FDA to conduct its review processes for new medications, helping to ensure the safety and efficacy of drugs entering the market. Reauthorization is necessary to continue these operations through 2032.
The FDA collects user fees to support review processes, building on a record of U.S. market influence where 70% of new medicines see their first approval. The program supports an industry that saw $71.4 billion in total research and development investment in 2017 alone.
The players
Food and Drug Administration
This federal agency is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs.
Department of Health and Human Services
This cabinet-level executive department of the U.S. government is responsible for providing effective health and human services.
The details
The legislative process for PDUFA VIII began in July 2025 and included a public meeting held on September 16, 2026, to gather stakeholder input. The Secretary of Health and Human Services is mandated to deliver a final legislative package to Congress by January 15, 2027.
Timeline
1992: The Prescription Drug User Fee Act was initially enacted.
July 2025: The first meeting for crafting the PDUFA VIII program took place.
September 16, 2026: A public meeting was held to collect input on the legislation.
January 15, 2027: The final legislative package is due to be delivered to Congress.
September 30, 2027: The current Prescription Drug User Fee Act program will expire.
Market Landscape
The renewal of this program reflects a consistent industry shift toward user-fee models that accelerate regulatory pathways for new therapeutics. This keeps the U.S. competitive in global drug approvals compared to other major medical markets.
The continuation of this program ensures that the FDA has the necessary resources to process new drug applications without significant delays. This stability helps ensure that consumers gain access to new treatments and medications in a timely manner.
The takeaway
Maintaining the FDA user fee framework is critical to sustaining the research and development pipeline in the pharmaceutical industry. Stakeholders should monitor the January 2027 legislative submission to understand the long-term impact on drug review timelines.
What happens next
The Secretary of Health and Human Services is required to submit the final legislative package to Congress on January 15, 2027, followed by the expiration of the current program on September 30, 2027.
Further reading
For additional context on regulatory developments, visit the Healthcare section.
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Should the federal government continue funding FDA medication reviews through manufacturer fees?
