PAN Encourages FDA to Ensure Patients' Concerns are Prioritized in PDUFA Reauthorization Negotiations

Becca O’Connor, PAN’s Director of Government Relations

The Prescription Drug User Fee Act (PDUFA) authorizes the Food and Drug Administration (FDA) to collect fees from companies that produce certain human drug and biological products.  Since the passage of PDUFA in 1992, user fees have played an important role in expediting the drug approval process.  PDUFA is up for reauthorization every five years, and will expire in the fall of 2012 if not reauthorized by Congress.

The Parkinson’s Action Network (PAN) and other patient advocacy groups are participating in meetings at the FDA to ensure this reauthorization reflects patients’ interests -- including ensuring that patients have input in important discussions on topics such as how the FDA evaluates and balances benefit-risk, and what opportunities exist for patients to provide input and feedback to FDA reviewers.

On October 24, the FDA hosted a public meeting on proposed changes to PDUFA.  Patients, consumer advocates, healthcare professionals, and industry representatives were provided the opportunity to share their views on the proposed changes.  Among the topics explored were enhancements to the drug review process, how to encourage the development of drugs for rare diseases, and improving communication between the FDA and patients.

On behalf of PAN as the unified voice of the Parkinson’s community, I addressed a panel of FDA representatives at this meeting.  We applauded the FDA’s efforts to establish a five-year plan to address patient concerns, and expressed PAN’s support for efforts to engage patients in the decision-making process.  We also emphasized the importance of establishing a drug review process that is transparent and timely, because to have any real impact, meetings and discussions between patient advocates and the FDA must be correlated to correspond to the timing of FDA decision-making.  And, we believe it is imperative that patients understand and be engaged in discussions regarding how the FDA evaluates the risks and benefits of a new treatment.

PAN continues to monitor the PDUFA reauthorization and will provide ongoing updates.  If you have questions about this topic, call toll-free 1-800-850-4726.

November 2011 Monthly Message