- NHC presents its draft Patient Stratification Tool for organizing patient input on benefit-risk (7/18/2013)
- NHC's letter to the Food and Drug Administration in response to the FDA’s call for comments on its draft benefit-risk plan (May 7, 2013)
- NHC’s proposed framework for patient engagement in drug development and approval processes (May 30, 2012)
- NHC's Executive Vice President and Chief Operating Officer Marc Boutin on BioCentury TV. (June 3, 2012)
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.
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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 Act. The NHC applauded Congress for their quick, bipartisan passage of the user fee legislation.
FDA is already in the early stages of the implementation of a new benefit-risk framework. One of the first steps in this process was to hold a public meeting on benefit-risk on May 18. NHC Executive Vice President Marc Boutin served on a panel of patient representatives and spoke about the need for patient input at various stages throughout the research and regulatory processes. He also presented an outline to determine the 20 disease categories on which the FDA will base 20 meetings that are mandated by the PDUFA agreement.
The NHC has submitted the following comments to policymakers:
- NHC comments on a potential new pathway to expedite the development of drugs and biologics for serious or life-threatening conditions (February 8, 2013)
- NHC comments on the Observational Medical Outcomes Partnership (OMOP) proposed research priorities and tasks for the years 2013-2016 (September 14, 2012)
- NHC applauds quick, bipartisan passage of User Fee Bills (June 26, 2012)
- NHC letter reinforcing the need to include the patient perspective in regulatory decision-making (May 30, 2012)
- NHC urges quick action in U.S. House on FDA User Fee Bill (May 30, 2012)
- NHC urges senate to vote "Yes" on the Food and Drug Administration Safety and Innovation Act (May 18, 2012)
- NHC urges Senate to oppose drug reimportation (May 18, 2012)
- NHC comments on the reauthorization of the Prescription Drug User Fee Act (PDUFA) (October 24, 2011)
- Statement by the NHC on the proposed agreement for the reauthorization of PDUFA (September 1, 2011)
- NHC comments on the Food and Drug Administration’s (FDA) draft guidance on in vitro companion diagnostic devices (August 17, 2011)
- Testimony of NHC EVP and COO submitted to the House Energy and Commerce Subcommittee on Health regarding the reauthorization of the Prescription Drug User Fee Act (PDUFA) (July 7, 2011)
- NHC comments on the Medical Device User Fee Act reauthorization process, including comments on benefit-risk and advanced diagnostics (April 27, 2011)
- NHC comments on the proposed enhancements to the Prescription Drug User Fee Act (PDUFA) (November 16, 2010)
- NHC comments on FDA proposed enhancements to PDUFA (October 21, 2010)
- NHC submitted proposals for enhancements to PDUFA (September 27, 2010)
- NHC comments on the development and implementation of risk evaluation and mitigation strategies (REMS) for drugs (August 31, 2010)
- NHC comments on the FDA Phase II Transparency Report (July 20, 2010)
- NHC comments on the oversight of laboratory developed tests (LDTs)(August 15, 2010)
- NHC comments on the proposed enhancements to PDUFA (January 10, 2010)
To learn more about the NHC’s priority policy areas, please select one of the following issue areas: