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Setting an FDA Benefit-Risk Balance that Meets the Needs of Patients 
Addressing Unmet Needs of Patients 
Prescription Drug User Fee Act

Setting an FDA Benefit-Risk Balance that Meets the Needs of Patients



Addressing Unmet Needs of Patients 

Health care technologies, including drugs, devices, and diagnostics, have improved the diagnosis and treatment of many diseases. Today, advances in science continue to hold promise for the development of new treatment strategies in the future. Billions of dollars are spent annually on research, and development, and clinical trials to develop new health care products, yet patients may not be reaping the full return on investment. The creation of new treatments in both the public and private sector is vital to addressing these unmet medical needs.


To learn more about this initiative click here.

Prescription Drug User Fee Act

In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA). PDUFA is an agreement between the pharmaceutical industry and the FDA. Industry agrees to pay fees to the FDA in return for FDA meeting certain benchmarks, most notably faster review times. PDUFA has been reauthorized four times since the original agreement was passed by Congress. It was most recently reauthorized in July 2012, as part of the FDA Safety and Innovation Act.

During the negotiations for PDUFA, the NHC supported the provisions related to benefits and risks in the FDA decision-making process, biomarkers and patient reported outcomes in clinical trial design, and expanded resources for rare disease product development. All three provisions were included in the agreement between industry and FDA. The NHC also advocated for the inclusion of provisions in the Medical Device User Fee Act related to benefit-risk, the qualification of biomarkers, and the development of companion diagnostics.

On July 9, 2012, President Barack Obama signed into law the 
Food and Drug Administration Safety and Innovation ActThe NHC applauded Congress for their quick, bipartisan passage of the user fee legislation.

Click here to read a joint advertisement by patient and provider groups supporting PDUFA reauthorization. 


Click here to read archived NHC letters of support and position statements.    


To learn more about the NHC’s priority policy areas, please select one of the following issue areas:


Health Care Reform
Federal Appropriations
Policy Issues (home)