NHC UPDATE
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Targeting Unmet Patient Needs Act -March 2010
The National Health Council (NHC) has made great strides with its members in preparing legislation designed to stimulate the creation of new therapies for areas of unmet need. The FDA Issue Team solicited comments on proposed legislation that will have a dramatic impact on the development of new treatments that will help people with chronic diseases and disabilities. The final legislation is to be introduced to members of Congress and the Administration this month, and will be a major part of the NHC’s legislative agenda for 2010.
The NHC’s initiative to stimulate innovation is based on three core elements. They are:
- Clarify the regulatory approval pathway and evidentiary standards for molecular diagnostic tests. To determine which treatments work for which people, the FDA should clarify the regulatory approval pathway and evidentiary standards for biomarkers for use as diagnostic tools.
- Establish mechanism for granting data exclusivity as an incentive to develop drugs that have been abandoned or deemed commercially nonviable. Under the novelty and non-obvious requirements, promising drugs that are no longer considered “new” simply because they were disclosed in a publication, at a conference, or as part of a broad patent application cannot later be patented. Providing FDA-enforced exclusivity will create the incentives necessary to ensure the development of all promising treatments.
- Ensure that promising ideas and knowledge are quickly translated into treatment used in clinical practice. Better mechanisms are needed to quickly translate good research into practice. There are fewer and fewer instances of a handoff between those in the laboratory and those who seek to apply these discoveries in the clinical setting. This wastes billions of dollars on research that never sees the light of day.
Representatives of the NHC have met with members of Congress and their staff, FDA and NIH staff, as well as the White House Office of Science and Technology Policy to discuss ways to stimulate innovation. The legislative language to move these ideas into reality was the result of these discussions and the contributions and suggestions from NHC members.
Staff Contact: Kevin Cain, Assistant Vice President, Government Affairs and Programs
