Biotechnology Issues Hot in 2009

With all eyes on healthcare reform in Washington D.C. this summer, biotechnology issues are gaining in visibility before the federal Congress. On July 29, Gillian Mullins, Director of Government Relations and Grassroots Programs for the Biotechnology Industry Organization (BIO), briefed the Chamber's Life Science Council outlining three priority areas for BIO: the Small Business & Innovation Research (SBIR) grant program, follow-on biologics and patent reform legislation.

Mullins provided an update on the status of the SBIR program, which is set to expire in September. The House and Senate had drafted separate bills that would reauthorize the program with a few differences. While the House version (H.R. 2695) would reauthorize the program through only 2011 with $28 million in annual program funding, the Senate version (S. 1233) would reauthorize the program through 2023 and would increase the amount of each participating agency’s R&D budget set aside for the programs starting in fiscal year 2011. Both bills would also overturn venture capital owned restrictions for small companies, which would enlarge the pool for potential applicants. Last month, the House and Senate each passed their separate version of the legislation. Now, the two bodies of Congress will have to create a new compromise version that will hopefully pass before September.

The follow-on biologics issue took a major step forward when the House Energy & Commerce Committee adopted an amendment by Representative Anna Eshoo (D-CA) on July 31that would create a pathway for the FDA to approve generic versions of biologics, cancer therapeutics and vaccines. Since biologic drugs are living organisms that cannot be easily reproduced like chemical compounds, Congress has been thoroughly debating the issues for generic biologics, including the length of data exclusivity for clinical testing by original manufacturers. The Eshoo amendment would allow for 12 years of data exclusivity before a generic can utilize the data, a role which BIO supports. The amendment has been added to the House version of the healthcare reform bill, H.R. 3200, which is now pending a vote before the full House of Representatives.

Finally, Mullins discussed patent reform legislation, particularly the compromise created in April by the Senate Judiciary Committee. While the compromise bill, S. 515, seemed to provide agreeable solutions to many of the issues that have thwarted its progress in prior years, such as the damages awards, it seems that the issue is currently losing momentum in the House. The prospects for patent reform legislation in future years remain strong.

The Chamber will continue to offer educational programming and host speakers on important topics for the life science industry for the remainder of the year. For more information on the Chamber’s Life Science Council, contact Jane Edson at jedson@dallaschamber.org or
(214) 712-1937.