This post was authored by James Fasules, MD, FACC, senior vice president of Advocacy for the ACC.
Just when you thought you’d learned enough healthcare acronyms to understand what we should care about as cardiologists, they add another one. This time, it’s the UFAs – the User Fee Acts, the quick way insiders refer to the Prescription Drug User Fee Act (PDUFA), the Medical Device User Fee Act (MDUFA) and the new generic drug and biologic user fee programs. Collectively, these programs help to fund the congressionally-mandated mission of the Food and Drug Administration, which is necessary given the dichotomy between what is expected of the FDA and what Congress appropriates for the FDA to achieve those expectations. The first of the programs, PDUFA, came out of the HIV-AIDS crisis when it became clear that the FDA did not have the necessary resources to review new drug applications quickly enough. Industry pays certain fees to have their applications reviewed. In exchange, the FDA commits to reviewing and coming to decisions (approval or otherwise) within certain timeframes.
The programs, created by Congress, sunset every five years, and it is up to Congress to decide whether to reauthorize the program. Thus, without Congressional action, PDUFA and MDUFA are set to expire on Sept. 30. To put it in perspective, funding from the PDUFA program is so important to the Agency today that approximately 2,000 staff reviewers will lose their jobs in the event that PDUFA is not reauthorized and the application review process will come to a grinding halt. Because of differences between the two programs and the two industries, the expiration of MDUFA would lead to the loss of between 200 and 300 jobs for device reviewers.
So why should cardiologists care? After all, if it’s just about approvals for devices and drugs, shouldn’t that be industry’s problem? Well, if you think the FDA is slow at reviewing applications now, imagine how slowing things would move without all of those individuals reviewing the applications. New devices and pharmaceuticals would take even longer to get to market and even fewer patients would have access to them. Just think about how much further behind Europe we would be. It’s not just about TAVR; it’s about all of the new interventions that have been developed in recent years and have helped to reduce mortality resulting from cardiovascular disease.
Over the last two years, ACC’s Advocacy team has been meeting with members of Congress and their staff on these issues, as well as agency officials, industry representatives, consumer groups and public health advocates. Additionally, the ACC is working with a number of physician organizations to promote the passage of the UFAs, as well as legislation pertaining to related issues.
Recently, both the House and Senate overwhelmingly passed their respective versions of bills reauthorizing the UFAs. Over the next month, Committee staff from both chambers will work together to iron out differences between both House and Senate bills before voting on final legislation and sending to the president for his signature. It’s an exciting time to be an UFA!