Right now, the U.S. Congress is considering the FDA Reauthorization Act of 2017, legislation that will reauthorize the pharmaceutical, medical device, generic drug, and biosimilar user fee agreements. The five-year deal is one of the most important health care bills Congress will vote on this year.
While it is important, this legislation has not generated the same level of attention other health care legislation has received.
This post will introduce you to this bill, and why it matters to you.
Question 1: What exactly is this legislation?
The FDA Reauthorization Act of 2017 is legislation that authorizes the federal government to charge fees to companies in the pharmaceutical, medical device, and other industries. This legislation had its genesis in 1992 with the authorization of the Prescription Drug User Fee Act (PDUFA). Prior to the enactment of PDUFA, the United States lagged behind other nations in the review of new medicines and medical products. In the 1980s, 70 percent of new medicines were marketed overseas before being approved in the United States. The basic idea of the program was this: In exchange for user fee funding, the FDA agreed to set and meet performance goals for the review of medical products.
Due to the success of PDUFA, the user fee program has grown to include the Generic Drug User Fee Agreements (GDUFA), the Biosimilar User Fee Agreements (BsUFA), and the Medical Device User Fee Agreements (MDUFA).
The current reauthorization act is set to expire on September 30, 2017. When reauthorized, the new legislation will extend the user agreements to 2022.
Question 2: How does it benefit the FDA?
These fees were introduced to help supplement the work of the FDA, with a goal of getting therapies, medical devices, and other products more quickly to market. They assist the FDA in expediting its review process, offer the agency resources to hire critically needed staff, and fund new programs to help the agency respond to the always changing medical and health care landscape.
This new legislation is the result of years of negotiations between the FDA, industry representatives, and the patient community. Throughout the process, the FDA has held public meetings to gather input on how it could build upon what is included in the current agreement. This resulted in updates that will be beneficial to patients, medical professionals, and public health at large. For instance, the PDUFA portion of the bill gives the FDA resources to maintain processes across the human drug review program that allow patients timely access to safe and innovative treatments, particularly in areas of unmet need like Alzheimer’s disease and sarcopenia. It also ensures that the FDA can hire and retain a strong scientific and medical workforce to advance its mission to protect and promote public health.
Question 3: What do the payers of the user fees get out of this?
In return for payment of user fees, the FDA offers a list of deliverables that aims for essential therapies and medical devices to come to market in a more efficient, timely manner. Thus, the FDA has a level of accountability to make the best possible use of these fees. For example, since the introduction of PDUFA in 1992, the average review time of a new drug has decreased from 29 months to 11 months.
Question 4: Where are we at in the legislative process?
The bipartisan bill has passed the full House. However, Senate leadership has indicated the chamber will not vote on the user fee legislation until it votes on a replacement package for the Affordable Care Act (ACA).
Another potential hurdle is the Trump Administration’s preference that user fees play a much larger role in funding the FDA. For its part, Congress has disagreed with this approach. However, President Trump will still need to sign the legislation into law.
Congress needs to pass the legislation by August 1; otherwise, the FDA will be forced to send layoff notices to over 5,000 of its employees.
Stay tuned to this blog and the Alliance’s Twitter page for updates.
Question 5: What does it mean to me?
In addition to helping the FDA get life-changing therapies to the American people more quickly and efficiently, the program funds patient-safety and patient-centered programs. The latest iteration of the bill will strengthen the FDA’s Sentinel Initiative, an electronic system proactively monitoring the safety of medical products after they are approved and marketed to the public. It also gives patients a greater voice in the development of new medicines. It funds programs such as the Patient-Focused Drug Development Initiative as well as advancements in the use of real-world evidence and patient-focused methods in regulatory decision making.
The Alliance supports the passage of this legislation. If you agree with us, we encourage you to contact your representative in the Senate and tell them to support this bill. We also invite you to contact the White House and tell them you support the FDA Reauthorization Act of 2017.