Last night, the Prescription Drug User Fee Act (PDUFA), was reauthorized by the House of Representatives. PDUFA provides the U.S. Food and Drug Administration (FDA) with necessary resources to meet performance goals for the regulatory review of new medicines. PDUFA has helped the U.S. maintain its global leadership in regulatory review and introduction of safe, effective new medicines.
Reauthorizing of PDUFA will enhance FDA’s efficiency and bring innovative, lifesaving treatments to patients. Already, thanks in part to the PDUFA program, more than 1,500 new drugs and biologics, including treatments for cancer, rare diseases, cardiovascular, neurological and infectious diseases have been brought forward to patients.
As the Senate now considers this important legislation, here are a few resources to help better explain why PDUFA is good for patients:
- Find out how PDUFA benefits patients and advances medical innovation in this fact sheet.
- Get the facts on how PDUFA harnesses real-world evidence to provide patients with innovative, new medicines.
- Read about ways PDUFA seeks to incorporate the patient voice into the drug evaluation process, and learn why this critical to developing new medicines.
America’s biopharmaceutical researchers and scientists are continually working to advance science and find new treatments and cures for some of the most vexing diseases of our time. PDUFA along with the Biosimilar and Generic Drug User Fee Acts is crucial to patients in need of life-saving treatments and enhancing the competitive market in biopharmaceutical innovation.
Learn more and get the facts at PhRMA.org/PDUFA.
Andrew Powaleny
Andrew Powaleny is the Deputy Vice President of Public Affairs at PhRMA, where he leads communications on scientific, regulatory and intellectual property issues, highlighting the biopharmaceutical industry’s efforts in developing innovative medicines and vaccines while promoting an environment that encourages necessary risk-taking. For five years starting in 2019, he launched and led PhRMA’s grassroots initiative, Voters for Cures, bringing patients and caregivers together to advocate for access to medicine and biopharmaceutical innovation. He also co-founded and co-chaired PRIDE Umbrella, a resource group for LGBTQ+ individuals. Prior to joining PhRMA in 2015, Andrew worked as a communications consultant in Washington, D.C., and as Deputy Press Secretary for the U.S. House Committee on Energy and Commerce under Chairman Fred Upton. He holds a degree in public policy and government from Eastern Connecticut State University, with a minor in music. Outside of work, Andrew enjoys exercise, musical theater and mentoring college students through The Fund for American Studies alumni association.
Andrew Powaleny
Why PDUFA VIII keeps patients first and strengthens America's biopharma leadership
Mass compounding puts patients at risk
PDUFA creates an efficient drug review process that benefits American patients
Advancing patient care: A look at new medicines approved in 2025
Knockoffs of FDA-approved drugs put patients at risk
PDUFA: Essential to America’s edge in drug development and patient access
Major drug compounder is spending millions on misleading Super Bowl ad
Preventing and fighting disease: A look at the biopharmaceutical progress made for patients in 2024
More oversight needed of unapproved medicines that threaten patients’ health
The use of real-world data in drug development
New analysis: Accelerated approval pathway is changing lives in underserved communities
Novel treatments and vaccines approved for U.S. patients in 2023 reach five-year high
Florida’s importation plan puts patients in danger
The Biopharmaceutical Industry Still Needs Clarity from the FDA on Orange Book Listings
Decentralized clinical trials and the future of drug development
How FDA’s modernization strategy could improve drug development
Setting the record straight on accelerated approval
FDA should remain the authority on the safety and effectiveness of medicines
Novel medicines approved in 2022 offer increased treatment options for patients
What you should know about real-world evidence and drug development
Three things to know about the accelerated approval pathway
PDUFA and BsUFA reauthorizations are wins for patients
Timely reauthorization of PDUFA and BsUFA is vital to the FDA’s review of medicines
Word of the Month: Biomarkers and surrogate endpoints
Ensuring timely reauthorization of PDUFA and BsUFA
ICYMI: New resource catalogs biopharmaceutical industry lessons learned from COVID-19
The accelerated approval pathway: Helping patients with serious or life-threatening diseases
The importance of timely PDUFA and BsUFA reauthorization
ICYMI: New approvals by the FDA in 2021 offer greater treatment options for patients
World AIDS Day: Remembering those we’ve lost and exploring the continued fight against HIV/AIDS
Biosimilar User Fee Act (III) Performance Goals Letter will help increase options for patients and promote competition
Meeting Tomorrow: Looking ahead to PDUFA VII
The impact of monoclonal antibodies and COVID-19 recovery
PDUFA VII is critical for future biopharmaceutical innovation and for patients
3 things that support robust biopharmaceutical research and development
How strengthening the biosimilar marketplace benefits patients
The FDA Office of Minority Health and Health Equity: Working to advance health equity through diversity in research
2020 FDA approvals show innovation despite COVID-19 pandemic challenges
Nearly 400 cell and gene therapies in development to target a broad range of diseases
ICYMI: 2019 brings innovative medicines to patients
PhRMA comments to Congress on Cures 2.0 call to action
Guest Post: Using the patient voice to go boldly
IP Explained: How Hatch-Waxman successfully balances affordability and innovation
Clinical Trials Awareness Week: Celebrating innovation in clinical research
Guest post: Hearing from patients on Rare Disease Day
Rare Disease Day: Unmet medical need inspires biopharmaceutical innovation
Why state drug importation pilot programs don’t work
Putting 2018 medicine approvals in context
FDA needs best and brightest to advance a new era of medicine with America’s biopharmaceutical companies
Balancing innovation and competition in the biologics marketplace
New analysis shows that more medicines worldwide are available to U.S. patients
Bringing innovation to clinical trial design
Spending on medicines grew less than one percent in 2017
Rare Disease Day: Unmet need inspires innovation
Innovation comes in many forms, including new and expanded uses of existing medicines
ICYMI: Why 2017 medicine approvals matter
New surveys find payers and providers want more data from biopharmaceutical companies
Supporting opportunities for enhanced competition in the marketplace
VIDEO: PhRMA CEO discusses industry response to opioid crisis on Mornings with Maria
The next five years of PDUFA VI: Driving the availability of innovative treatments for patients
Opportunities to build upon enhanced competition for medicines in the marketplace
A critical opportunity to prevent prescription drug abuse
Guest Post: The importance of a modern FDA in drug discovery
Why reauthorization of PDUFA matters
FDA
PDUFA
Why reauthorization of PDUFA matters
Why reauthorization of PDUFA matters