The statutory authority for the Prescription Drug User Fee Act (PDUFA) is set to expire in September 2012. At that time, new legislation will be required for the Food and Drug Administration (FDA) to continue collecting user fees for the prescription drug program. Without new legislation to reauthorize the program, FDA will no longer be able to collect user fees to fund the human drug review process. These funds are crucial for ensuring that drugs and medicines are tested for safety and effectiveness in a timely manner before patients receive them.
Consequently, the Federal Food, Drug, and Cosmetic Act require that FDA consult with a range of stakeholders in developing recommendations for the next PDUFA program. The act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry.
Accordingly, FDA last week issued a notice for meetings on the reauthorization of the PDUFA, and a request for notification of stakeholders who intend to participate. The request is being made to public stakeholders including patient and consumer advocacy groups, health care professionals, and scientific and academic experts to ensure continuity and progress in these discussions by establishing consistent stakeholder representation.
Those interested must submit notification of intention to participate by June 25, 2010.
The first stakeholder meeting will be held on July 1, 2010, from 9 a.m. to 11 a.m. Stakeholder discussions will continue at least monthly during reauthorization negotiations with the regulated industry.
To submit notification of intention to participate in monthly stakeholder meetings, e-mail PDUFAReauthorization@fda.hhs.gov. The first stakeholder meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, rm. 1503C, Silver Spring, MD 20993.
Your e-mail should contain complete contact information, including name, title, affiliation, address, email address, phone number, and notice of any special accommodations required because of disability. Stakeholders will receive confirmation and additional information about the first meeting once FDA receives their notification.
FDA first initiated this process of consultation on April 12, 2010, by holding a public meeting where stakeholders and other members of the public were given an opportunity to present their views on reauthorization
For more information contact Patrick Frey, FDA, Center for Drug Evaluation and
Research, 10903 New Hampshire Ave., Bldg. 51, rm. 1174, Silver Spring, MD 20993,
301-796-3844, FAX: 301-847-8443.