Congress’s PDUFA Delay Puts Patients at Risk

By: Brandon M. Macsata, CEO, ADAP Advocacy Association 

As Congress returned from their August recess, Americans could be forgiven for thinking that major healthcare legislation is off the table for the rest of the year following the passage of the Inflation Reduction Act – the budget reconciliation bill that included numerous healthcare-related provisions. However, Congress must pass legislation that has enormous ramifications for prescription drug availability and the development of new medications by September 30th: if lawmakers don’t act by this deadline, current and future patients dependent upon effective treatments could pay a very steep price. Despite a last-minute deal amongst squabbling lawmakers, it cannot be stressed enough how important is this legislation.

Photo Source: Physicians Committee for Responsible Medicine

Those of us who are alive today because of pharmaceutical innovation and a well-funded U.S. Food and Drug Administration (FDA) understand the stakes involved here. I’m a 20-year HIV long-term survivor, and I’m only alive today because of the safe, effective medications that were brought to market in a timely manner. Today, my HIV is undetectable. Recently, I also initiated long-acting agent therapy so that, instead of taking pills every single day, I receive two injections every other month. Other patients may not be so lucky if, this fall, the FDA must start laying off professionals and operating short-handed because of a lack of funds. 

Every five years, Congress reauthorizes the Prescription Drug User Fee Act (PDUFA), which provides critical financial resources to the FDA so it can hire the experts who review and approve new treatments and therapies. Each iteration of PDUFA also contains provisions to modernize the drug development and approval process, to keep the FDA on top of rapidly changing science and technologies. Congress has reauthorized PDUFA on a timely and strong bipartisan basis every five years since 1992. It is crucial that today’s Congress uphold this precedent and recognize the important role PDUFA plays in upholding the FDA’s drug review program as the worldwide. 

It is not enough for Congress to reauthorize PDUFA in a timely manner, though. It is also imperative that they pass a bill free of provisions that have nothing to do with supporting the FDA or the drug review and approval process. Some Members of Congress even want to go so far as attach proposals that would undermine drug safety, such as enabling the wholesale importation of prescription drugs from Canada.

Photo Source: NBC San Diego

This is a bad and unworkable idea on its own merits and certainly shouldn’t be included in a bill intended to properly fund the FDA and support the drug review process. We already know that the Canadian government has said it won’t participate in a drug importation plan, given that country’s ongoing trouble with drug shortages. And, at a time in which many of our communities and our law enforcement agencies are already overwhelmed with an influx of counterfeit medications containing deadly doses of fentanyl, it would seem particularly unwise to welcome medicines of unknown foreign origin that have not been part of our closely-protected prescription drug supply chain. 

We are quickly approaching the deadline to reauthorize PDUFA and any debates around including irrelevant or controversial policies like importation will only slow an already delayed process down further. We do not have time to waste. Missing the reauthorization deadline for legislation that has broad bipartisan support is egregiously irresponsible. We are nearing the point at which staffers at the FDA will begin receiving notices that they are going to be furloughed due to the expiration of the current user fee law. Some of these talented people may choose to pursue positions in the private sector rather than have their salaries put at risk by political gamesmanship. 

If we lose regulatory expertise at the FDA, this is not an easily replaceable commodity. Patients like me will lose access to new treatments as the FDA finds its ability to study and approve new drugs and assure the public of their safety and effectiveness severely undermined. This is unacceptable. 

The clock is ticking. With Congress back in Washington, it needs to pass PDUFA without extraneous and irrelevant attachments. It’s not hyperbole to say that lives depend on it. Stop playing politics and put patient care first!

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.