NHC UPDATE
<< Return to September 2009 Council Currents
Intellectual Property, Biosimilars, and FDA -September 2009
The National Health Council used an extensive literature review and focus group research to develop a set of values used to screen bills on intellectual property law and biosimilars as they have been introduced in Congress. Several of these bills are now being incorporated into the health care reform legislation.
Since June, NHC representatives have met with the staff of key House and Senate members who introduced legislation on intellectual property and 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. To date, both the House and Senate committees have adopted legislation that is closer to NHC values in terms of the length of exclusivity, but neither has 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, is scheduled for publication this fall. 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, intellectual property, and other FDA issues. This includes the creation of FDA-enforced exclusivity periods for non-patentable products with substantial clinical benefit. The team has also begun work on drafting legislation that will help bridge the “valley of death” between basic research and the creation of new treatments and cures. In addition, NHC leadership also met with the new FDA Commissioner and her deputy earlier this month to discuss the priorities of the agency and the needs of the patient community.
The NHC’s primary and secondary research on intellectual property law and biosimilars was funded by grants from BIO, Eli Lilly, Johnson & Johnson, Pfizer, PhRMA, Roche, and Wyeth Pharmaceuticals.
Staff Contact: Dorothy Weinstein, Director, Programs
