Patients, Researchers, and the Makers of Life-Saving Drugs and Medical Devices Support FDA User Fee Bill Passed by the Senate Today 94-1

Posted on August 4, 2017

The four separate UFAs dealing with new drugs, generic drugs, devices, and biosimilars all impact cancer patients, who depend on these products as they battle cancer. …The negotiated agreements represent a strong investment in innovation and we are pleased to see a number of provisions of particular importance to cancer patients.” American Cancer Society.     

 

“The cancer and rare disease patient communities rely on FDA to ensure that innovative, safe, and effective treatments reach those in need. We thank the HELP and E&C Committees for moving forward with these critical funding mechanisms...” National Organization for Rare Disorders.    

 

—Research!America

 

“Passing this bill is a crucial step in reauthorizing four user fee programs that ensure the Food and Drug Administration (FDA) has the tools it needs to deliver safe and effective treatments and cures to people with chronic and rare diseases.” — National Health Council

 

“The Food and Drug Administration’s user fee program is the ultimate public-private partnership that supports life-saving medical treatments while advancing science, research and technological innovation. ... The recently enacted and NAM-supported 21st Century Cures Act will further modernize our approach to the discovery, development, and delivery of medical innovations. The FDA user fee authorizations (UFAs) are necessary and complementary programs that accelerate new medical breakthroughs.”— National Association of Manufacturers.  

—American Autoimmune Related Diseases Association

 

“BIO strongly supports the PDUFA VI user fee agreement and its timely authorization. This agreement was carefully crafted through negotiation between FDA and the biopharmaceutical industry, along with input from patient and consumer organizations, health care providers, and other stakeholders - a negotiation that took place according to statutory requirements, over an approximately 18-month period. … Like the Congressional deliberations and bipartisan work that achieved the 21st Century Cures Act, the process was lengthy, but the goal is worthy. The provisions of the 21st Century Cures Act will make a positive difference to patients waiting for treatments and cures, and the goals of the PDUFA VI agreement will enhance and complement these promises.”— Biotechnology Innovation Organization.    

 

The user fee agreements that FDARA would reauthorize are critical to patient health since they provide resources for the FDA to review and approve medications that patients need. Further, they increase the agency’s ability to gather meaningful patient and caregiver input for decision making – a vital innovation that advances patient-centered treatment and care. Since originally authorized in 1992, the agreements have facilitated the approval of more than 1,500 new treatments and medications. For the more than 5 million individuals touched by Alzheimer’s, ensuring the efficient approval of new medications can be a matter of life and death.”— We Won’t Wait Campaign.