NHC UPDATE
Intellectual Property, Biosimilars, and FDA -June 2009
In winter 2009, the firm Akin, Gump, Strauss, Hauer & Feld completed a literature review on intellectual property law and biosimilars, focusing on how both issues could affect patients. Akin Gump also analyzed legislation on both topics to assist the NHC in its work to direct research into disease areas that have seen little progress, such as several neurologic and autoimmune diseases. The NHC worked with Akin Gump to develop tools to screen bills on these topics when they are introduced in Congress.
In addition, the research firm Balch Associates is just completing a series of focus groups with patients with chronic diseases and disabilities and their family caregivers on the broad area of innovation, addressing pharmaceuticals, biologics, and devices.
Using information from these various sources, NHC representatives have met with the staff of key House and Senate members who have introduced legislation on intellectual property and biosimilars. To date, the NHC has been able to suggest changes to the two major biosimilars bills introduced by Representatives Waxman and Eshoo to reflect NHC values and has met with key staff working on this issue.
The NHC will soon publish a booklet on biologics and biosimilars, presenting case studies of patients and their family caregivers. 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 these issues, as well as the creation of the Reagan-Udall Foundation and other governance issues facing the FDA. The NHC has received an invitation to meet with the new FDA Commissioner and her deputy as soon as schedules allow.
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.
