💊FDA Seeks Stakeholder Participation for PDUFA Reauthorization
Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
Summary
The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders--including patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts--notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). The statutory authority for PDUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next PDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The document discusses the reauthorization of the Prescription Drug User Fee Act (PDUFA), which requires stakeholder participation from businesses in the pharmaceutical industry for continued user fee collections. Participating stakeholders will influence future regulatory frameworks, which directly impacts business operations and financial models in this sector.