NHC Update
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Doubling the Treatment Pipeline -December 2009
The National Health Council developed a set of values used to screen bills on intellectual property law and biosimilars as a part of the health care reform legislation.
NHC representatives have met with the staff of key House and Senate members who introduced legislation on biosimilars. The NHC suggested changes to the two major biosimilars bills introduced by Representatives Waxman and Eshoo to reflect NHC values. The NHC also worked with Senate Health Education Labor and Pensions (HELP) Committee members to suggest changes as the committee considered these issues during the debate on health care reform. Both the House and Senate committees have adopted legislation that is closer to NHC values in terms of the length of exclusivity, but neither used exclusivity periods to create incentives for research into disorders with limited or non-existent treatments.
The NHC’s booklet on biologics and biosimilars, presenting case studies of patients and their family caregivers, will be published before the end of 2009. This booklet will be used as an educational tool to inform policymakers about the importance of biologics and biosimilars in the treatment of chronic conditions.
The FDA Issue Team will continue to work on biosimilars, and other FDA issues. To ensure that advances in science translate into gains in clinical development for patients, policymakers must promote novel research that could lead to breakthrough treatments. The NHC has identified three limitations influencing the development of new treatments for patients, and proposed solutions:
- Widening gap between basic research and clinical development. Despite sizable investments in biomedical research, commensurate gains in new drug and diagnostic approvals have not been realized. To maximize the nation’s investment in basic research, better mechanisms are needed to ensure that promising ideas and knowledge are quickly translated into treatments used in clinical practice.
- Forgotten drugs are often abandoned or ignored due to their ‘un-patentability.’ Under the standards of novelty and obviousness, potential products that are no longer considered “novel” simply because they were previously disclosed in a publication, at a conference or as part of a broader patent application cannot later be patented. Similarly, promising drugs that are now “obvious” due to scientific advances are not patentable and potential new treatments whose patents may have expired may not be commercially desirable to medical product manufacturers. As a result, many potential innovations are simply never pursued.
- Ambiguity of a regulatory approval pathway and evidentiary standards for molecular diagnostic tests. Far too often treatments under development work well for some, while providing marginal benefit or causing significant harm to others. Molecular diagnostic tests could allow us to better target treatments to those who will benefit and reduce costs determining safety and efficacy of related medicines. However, because the current regulatory approval process is uncertain and evidentiary requirements have not been clearly delineated, it is difficult for innovators to attract funding to support the development of these diagnostics.
The NHC will be working to deliver legislative solutions for these three issues. The NHC’s primary and secondary research on innovations to reach unmet needs and biosimilars was funded by grants from BIO, Eli Lilly, Johnson & Johnson, Pfizer, PhRMA, Roche, and Wyeth Pharmaceuticals.
Staff Contact: Kevin Cain, Assistant Vice-President, Government Affairs and Programs
