Ensuring a Timely PDUFA Reauthorization

Following every divisive election, there’s a short window by which both political parties take time to assess how best to ensure the continuity of public policies that garner widespread support and help Americans. As Washington and the nation prepare for a new Congress and administration, there will be a renewed focus on passing legislation that reinforces this premise, particularly in health care.

The Prescription Drug User Fee Act is a good example. For more than two decades, the program has been instrumental in helping to bring more than 1,500 innovative medicines to patients. During my time at the Food and Drug Administration, I saw firsthand how PDUFA helps enhance the review process, as well as the program’s ability to drive private stakeholder-regulator conversations on improving health care. That reauthorization required greater stakeholder engagement in the user fee negotiation process, setting up broader conversations about the program and FDA’s work. This interaction between the government and constituents is helpful and important to all participants involved — and may be a model for other agencies to consider in order to keep pace with the industries they regulate and Americans they impact.

The United States is at a tipping point of ingenuity and medical breakthroughs. Consider two examples: There are 93 medicines in development for Alzheimer’s disease and more than 300 new medicines in development for autoimmune diseases. With numbers like these in mind, it’s clear that medicines developed by innovators in the U.S. have cured diseases, led to new paths of treatment and most importantly, have improved the quality of life for patients across the globe. A timely reauthorization of PDUFA will enable regulators and the agency to help get safe and effective medicines to patients sooner.

I’ve also witnessed how programs such as PDUFA help initiate and sustain important conversations on health, particularly between patients, the FDA and the biopharmaceutical industry. Through the reauthorization of PDUFA, which has consistently been supported in a bipartisan fashion, we can build on this progress and enhance the FDA’s ability to expeditiously review medicines and make sure that the FDA’s understanding of industry science and research advancements is up to date.

Following the recent enactment of the 21st Century Cures Act, PDUFA reauthorization will help further prioritize patient input in the drug development and approval process while ensuring that the FDA has critical resources and expertise to keep pace with new breakthroughs. Moreover, the program will keep America’s regulatory sector on par with modern, 21stcentury science and medicine by strengthening innovative clinical trial approaches and fostering a strong workforce. Additionally, it will support the FDA’s role as the gold standard when compared with peer agencies worldwide.

By all accounts, 2017 will be a year of transition and adjustment on a number of public policy fronts. However, we have a unique opportunity to reauthorize PDUFA so that the FDA’s timely review of new medicines is enhanced and, above all, that patients directly benefit from the breakthroughs we’re hearing and reading about every day. With industry and regulators working in tandem, the U.S. will maintain its competitive edge and leadership position in global innovation and discovery. Anything less will undermine patients and the health of the nation when it’s clear that Americans expect meaningful actions.


Susan Winckler is the chief risk management officer at Leavitt Partners and former chief of staff at the U.S. Food and Drug Administration.

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