It's been a big week for PDUFA! The FDA completed and submitted its recommendations for three user fee programs intended to speed safe and effective drugs to patients, including the fifth authorization of the Prescription Drug Use Fee Act (PDUFA). Support for PDUFA V comes from all walks of life: government officials, industry, and patients.
- Senators Tom Harkin (D-IA) and Mike Enzi (R-WY), the Chairman and Ranking Member of the Senate Committee on Health, Education, Labor and Pensions (HELP), released a jointstatement in support of the Food and Drug Administration (FDA) agreement on the prescription drug user fees that accelerate the FDA's review of medicines in order to make them more readily available to patients.
- In a BIOtechNOW oped, National Health Council Executive Vice-President and COO Marc Boutin outlines the importance of a qualitative, objective framework in PDUFA V to help provide better patient outcomes and treatment for patients with rare diseases.
- U.S. Food and Drug Administration Commissioner, Margaret Hamburg, wrote a blogoutlining the past successes of PDUFA and the significance that this legislation holds in creating more choices for patients at lower costs.
- Now that the FDA recommendations have been received, the House Energy and Commerce Health Subcommittee announced a series of hearings on the User Fee Acts. A hearing on PDUFA V reauthorization has been set for February 1, 2012.
As the September deadline approaches, I'm looking forward to hearing continued dialogue on this vital legislation. For more information about PDUFA legislation in 2012, please visit the Campaign for Modern Medicines website and follow @modernmeds on Twitter.