H.R. 2430, the FDA Reauthorization Act (FDARA) of 2017
Reauthorizing Critical User Fee Programs, Ensuring FDA has the Tools They Need to Deliver Safe and Effective Drugs
This comprehensive bill reauthorizes four user fee programs that will help patients live better and healthier lives. As Health Subcommittee Chairman Rep. Michael C. Burgess, M.D. (R-TX) and Health Subcommittee Vice Chairman Brett Guthrie (R-KY) wrote in The Hill in June, “The user fee programs – GDUFA, PDUFA, BsUFA, MDUFA – may look and sound like wonky acronyms, but they are critical to patients, drug and device manufacturers, and the millions of Americans who work to deliver new treatments and cures to Americans.”
The Generic Drug User Fee Amendments (GDUFA)
- Improve the fee structure to support small businesses, and provide goal dates for all outstanding generic drug applications.
- Establish priority review timelines for generic drugs.
The Prescription Drug User Fee Amendments (PDUFA)
- Enhance the drug development process by making it more patient-focused and modernize the clinical trial process.
- Dedicate staff to assist in the development and review of rare disease medications.
The Biosimilar User Fee Amendments (BsUFA)
- Continue to build the biosimilars program and support guidance for product developers.
The Medical Device User Fee Amendments (MDUFA)
- Enhance the patient voice in the device development process and support the collection of real world data.
- MDUFA also improves the review process for low- to moderate-risk devices that are the first of their kind.
FACT: FDARA will help lower the cost of important medication and devices
FDARA promotes generic competition and lower drug prices for off-patent drugs. Packaged together, these reforms will help get lower-cost generic drug alternatives and biosimilars to market faster – increasing competition and lowering costs.
FACT: FDARA includes additional reforms that are important to patients and their wallets, and speed how medical innovations come to fruition
FDARA improves and expedites the process for reviewing and approving new treatments and cures for patients, ultimately delivering new and innovative therapies, drugs, and devices to patients more quickly. FDARA also includes provisions to advance pediatric cancer research.
FACT: FDARA is a win for our health care workforce
Millions of Americans work in the health care space, and it is imperative we remain the global leader in medical innovation. FDARA will ensure these critical jobs remain here at home.
For more information, check out our FDARA video series.