PDUFA
The Prescription Drug User Fee Act: Promoting the timely availability of safe and effective medicines to patients
America’s predictable regulatory environment ensures patients have more medicine choices than patients living anywhere else in the world, thanks in part to the Prescription Drug User Fee Act (PDUFA). For 34 years, PDUFA has helped the U.S. Food and Drug Administration (FDA) fulfill its central mission – to protect and advance public health – by allowing the FDA to keep pace with the number and complexity of innovative medicines entering the review pipeline. In large part because of PDUFA, the United States leads the world in the introduction of innovative new medicines, and the FDA’s human drug review program is the global gold standard for regulatory review and approval.
Since 1992 when the program was first enacted, PDUFA has enabled timely access to more than 1,700 novel new drugs and biologics – nearly double the 570 drugs approved in the 31 years prior – including treatments for cancer, rare diseases, cardiovascular, neurological and infectious diseases.
PDUFA continues to play a critical role in strengthening the FDA’s ability to review human drug applications. The program also provides biopharmaceutical companies with greater regulatory predictability, which fosters industry investment in research and development. At each five-year reauthorization of PDUFA, FDA and the biopharmaceutical industry can advance initiatives that further support innovation and enhance the regulatory review process and that are captured in the PDUFA goals letter.
The Prescription Drug User Fee Act (PDFUA VIII)
PDUFA VII
History of PDUFA
The PDUFA user fee program was first created in response to a bottleneck of new medicine approvals that left patients waiting for years for an under-staffed and under-funded FDA to review new drug applications. Before PDUFA, it often took the FDA more than two years to review new medicines, and more than 70% of medicines were first approved outside of the United States.
In 1992, Congress, recognizing these challenges, passed the first PDUFA as a bipartisan approach to increasing the efficiency of U.S. prescription drug review. Over 30 years later, the average review time for a new medicine that is ultimately approved is 10 months for standard applications and eight months for priority review applications. Since the first PDUFA, the majority of new medicines are now first approved in the U.S. including close to 70% of new medicines in 2025 alone. The program continues to play an essential role in strengthening the FDA’s ability to support innovation while maintaining the FDA’s high standards for scientific rigor and patient safety.
History of PDUFA
How PDUFA Works
PDUFA supplements budgetary funding for review of new drugs by increasing FDA resources through user fees collected from the biopharmaceutical industry.
The FDA, Congress, the biopharmaceutical industry and patient advocacy community work together to reauthorize the PDUFA program every five years.
PDUFA includes negotiated performance goals and procedural commitments to facilitate timely review and patient access to safe and effective new medicines.
PDUFA does not replace the need for annual budgetary authority. Importantly, the agreement does not alter FDA’s statutory requirements or standards for drug review and approval.
Since 1992, Congress has reauthorized PDUFA six times—always with strong bipartisan support.
PDUFA VIII will support efficient, predictable, science-based regulatory review to the benefit of American patients
The current user fee authorization (PDUFA VII) expires on September 30, 2027 and must be reauthorized by Congress (PDUFA VIII). Over the last year, the proposed PDUFA VIII goals letter was negotiated by the FDA and the biopharmaceutical industry, with input from patient advocacy groups and other stakeholders. PDUFA VIII builds upon previous iterations with a renewed focus on strengthening FDA’s critical capabilities, improving efficiencies in drug review and driving innovation for patients.
What will PDUFA VIII do?
- Timely and more predictable reviews: PDUFA VIII will reduce avoidable delays and help identify potential issues earlier in the development and review process.
- Keeps pace with scientific innovation: Medical innovation is advancing rapidly. PDUFA VIII helps enable the FDA to evolve alongside it.
- Greater accountability and transparency: PDUFA VIII includes new measures to help strengthen public trust and ensure the program continues delivering results.
PDUFA is Accomplishing
Related Resources
Why PDUFA VIII keeps patients first and strengthens America's biopharma leadership
The big picture: When patients are waiting for new treatments, safety and speed both matter. For over 30 years, the Prescription Drug User Fee Act (PDUFA) has delivered both — helping establish the U.S. as the first stop worldwide for most new medicine approvals and helping support the FDA's reputation as the global gold standard for regulatory review.
What it is: PDUFA allows the FDA to collect user fees from biopharmaceutical companies to help ensure the agency has the expert staff, scientific resources and modern infrastructure needed to conduct timely, rigorous reviews of new medicines. In return, the FDA commits to meet certain performance goals, as outlined in the PDUFA goals letter.
- Importantly, the PDUFA agreement does not change the FDA's statutory requirements and scientific standards for drug review and approvals or independent regulatory decision-making.
- PDUFA user fees supplement, but do not replace, the FDA’s funding through Congressional appropriations.
- Every five years, the FDA and industry negotiate an agreement for the next reauthorization of PDUFA, with input from patient groups and other stakeholders.
What’s new?
- The negotiations process just concluded for PDUFA VIII and the FDA is preparing to transmit the commitment letter to Congress for reauthorization.
- Tomorrow, September 16, 2026, the FDA will hold a public meeting to discuss the proposed recommendations for the reauthorization of PDUFA VIII.
Why it matters: Since 1992 when patients led the charge with Congress to enact PDUFA, the program has helped create a more efficient, predictable and science-based prescription human drug review process. Before PDUFA, over 70% of medicines were first approved outside the U.S. Currently, close to 70% of new medicine are first approved here. The program benefits patients waiting for new treatment options and supports America's leadership in medical innovation.
What will PDUFA VIII do?
- Timely and more predictable reviews: PDUFA VIII will reduce avoidable delays and help identify potential issues earlier in the development and review process.
How:
- Provides opportunities for more timely FDA feedback during drug development and review.
- Enhances consistency, quality, and timeliness of FDA-sponsor interactions on pivotal clinical trial protocols, labeling and manufacturing that can affect review timelines.
- Establishes a new program intended to help address manufacturing and facility issues earlier, reducing the risk of late-stage setbacks.
- Keeps pace with scientific innovation: Medical innovation is advancing rapidly. PDUFA VIII helps enable the FDA to evolve alongside it.
How:- Incorporates modern evidence, technology and regulatory science tools, such as real-world evidence, innovative trial designs and patient-focused drug development, into standard review practice.
- Advances rare disease drug development, including for pediatric patients, through enhanced stakeholder engagement and scientific collaboration.
- Enhances FDA surveillance and capabilities, including through improving existing FDA tools for post-marketing safety data, with the aim of reducing the need for additional studies after approval.
- Greater accountability and transparency: PDUFA VIII includes new measures to help strengthen public trust and ensure the program continues delivering results.
How:- Improves transparency around how user fees are spent and how the program performs.
- Introduces independent third-party assessments to evaluate FDA performance and identify opportunities for improvement. For example, a third-party assessment will evaluate the new manufacturing facilities program's effectiveness as a more proactive approach to timely address manufacturing facilities deficiencies.
The stakes: The next breakthroughs patients need depend on a strong FDA. PDUFA VII expires on September 30, 2027. Congress must move quickly to reauthorize the PDUFA VIII program. Without it, American patients and innovation will fall behind.
The bottom line: PDUFA VIII builds on a proven framework that helps patients, supports innovation and strengthens America's regulatory ecosystem. It also builds on efforts to modernize clinical development, advance domestic manufacturing and maintain the FDA's position as the global gold standard for regulatory review. PDUFA VIII is how America keeps its promise to patients and its edge in global medicine.
Learn more at PhRMA.org/PDUFA.
Lucy Vereshchagina, PhD
PDUFA creates an efficient drug review process that benefits American patients
The Prescription Drug User Fee Act (PDUFA) is essential to maintaining America’s leadership in drug development and ensuring patients have timely access to new treatments.
As policymakers consider the next reauthorization in 2027, and in advance of the draft PDUFA VIII commitments being released later this year, they and all stakeholders should understand how user fees contribute to a predictable and reliable regulatory review process.
What you need to know:
- PDUFA strengthens the U.S. Food and Drug Administration’s (FDA) ability to protect and promote public health by supplementing Congressional funding.
- The program allows the FDA to collect user fees from biopharmaceutical companies to support the agency’s review of new medicines.
- This funding model improves review efficiency without compromising the agency’s scientific integrity or regulatory independence – and all of this contributes to America leading in medicine innovation.
Faster access to new medicines.
Before PDUFA was enacted in 1992, FDA reviews of new medicines often took more than two years. Today under PDUFA, standard reviews take about 10 months, and priority reviews for certain drugs for serious conditions take about 6 months—helping patients access treatments sooner.
PDUFA has also helped make the U.S. the global leader in first approvals of new medicines. In 2025, 70% of new drugs were approved first in the U.S., reversing a pre-PDUFA trend when most were approved in other countries first.
Predictability that supports innovation.
Drug development is complex, time-consuming and resource intensive. PDUFA is intended to provide predictable review timelines and interactions between biopharmaceutical companies and the FDA. These can help improve the quality of drug applications, reduce the risk of costly late-stage failures or review delays, and enable companies to better plan their development programs.
PDUFA is not simply a funding stream; it commits the FDA to specific performance goals and metrics.
Every five years, the FDA and industry negotiate review performance goals and timelines, often referred to as “goals letters” or commitment letters. These agreements outline FDA performance goals related to review processes and commitments to specific initiatives such as development of regulatory guidances on key scientific or regulatory topics.
Examples of topics covered under the current PDUFA VII include:
- Hiring and retention of specialized review experts—including clinicians, statisticians, pharmacologists, chemists and toxicologists—who assess the safety, effectiveness and quality of new therapies
- Data systems and IT infrastructure needed to evaluate new drug applications and monitor the safety of FDA-approved medicines
- Pre-approval inspections of manufacturing facilities
- Monitoring of research conducted in connection with the review of new drug applications
- Development of regulatory science tools and guidance to facilitate the use of new technologies and innovative approaches (e.g., digital health technologies, innovative statistical methods)
- Patient-focused drug development initiatives that incorporate patient experience data into the review process
The FDA reports publicly on its progress against these commitments and program resources annually, and Congress regularly reviews program performance.
And importantly, user fees do not influence regulatory decisions. There is no connection between a fee paid to submit an application and the independent review outcome for that application by FDA review experts.
The stakes for patients.
Congressional appropriations alone do not cover the full cost of maintaining the scientific workforce and infrastructure required for timely drug reviews. In fact, user fees cover about three-quarters of the FDA’s human drugs program budget, and only one-quarter of the budget is appropriated by Congress. If PDUFA was eliminated, there is no guarantee that Congress could replace the funding user fees provide.
PDUFA helps ensure the FDA has the resources it needs to conduct reviews and keep pace with scientific innovation and evaluate new treatments efficiently for the benefit of patients. The program has helped create a system that is faster and more predictable and transparent, while preserving the FDA’s independent decision-making and rigorous scientific standards, maintaining the FDA’s global gold standard.
America’s leadership in medicine research and development powers global innovation and domestic economic growth. To keep this edge against rising international competition, we must continue to prioritize and protect the ecosystem and legislation like PDUFA that makes American innovation possible.
The bottom line: Without user fees, the greatest cost would fall on patients waiting for the next generation of medicines.
Learn more at PhRMA.org/PDUFA.
Lucy Vereshchagina, PhD
The Prescription Drug User Fee Act Fact Sheet
For nearly 30 years, the Prescription Drug User Fee Act (PDUFA) has played a critical role in strengthening the U.S. Food and Drug Administration’s (FDA) ability to help ensure the availability of safe and effective medicines. First created in response to a bottleneck in the drug approval system that left patients waiting for years for an under-staffed and under-funded FDA to review new drug applications, PDUFA has helped meet urgent patient needs for more timely review and approval of life-saving medicines.
Because of PDUFA, the United States now leads the world in the introduction of new medicines, and the FDA human drug review program is the global gold standard for regulatory review and approval.
Read more about this important legislation with this fact sheet from PhRMA.
PDUFA Fact Sheet
Fact Sheet
The Prescription Drug User Fee Act: Ensuring the Timely Availability of Safe and Effective Medicines for Patients
The Prescription Drug User Fee Act (PDUFA) was first enacted to help speed the FDA’s review of drug applications so that all Americans could receive timely access to safe and effective medicines. Today, PDUFA plays an important part in positioning the United States as a global leader in biopharmaceutical innovation.
FDA,PDUFA
Fact Sheet
Website Updated as of March 2023