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UAEM, AMSA and Essential Action Demand AAU Rescind Support of Excessive Data Exclusivity

Submitted by WPimport on Tue, 07/14/2009 - 15:54
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July 14, 2009

Robert M. Berdahl
President
American Association of Universities
1200 New York Avenue, NW, Suite 550
Washington, DC 20005

RE: June 3, 2009 AAU Endorsement of Eshoo-Inslee-Barton Follow-on Biologics Bill

Dear Dr. Berdahl,

We, the American Medical Student Association, Essential Action, and Universities Allied for Essential Medicines, representing consumers and tens of thousands of students at top research universities in the U.S. and abroad, write to demand that you immediately withdraw AAU’s support for the 12 years of brand exclusivity included in H.R. 1548, the “Pathway for Biosimilars Act.” The brand exclusivity term of 12 years in the legislation[i] is unjustifiably long, will cost consumers billions of dollars, and reach beyond our borders to restrict access to lifesaving treatments in developing countries. Your claim that 12 years of exclusivity is necessary for continued innovation is contradicted by economic analysis, including one recent report from the Federal Trade Commission[ii].

As you well know, healthcare costs are out of control, leading to over 60% of bankruptcies in the United States[iii], and government contributions to medicines for developing countries are dropping. Congress is now considering ways to control healthcare costs. It is unconscionable that universities, which are non-profit organizations ostensibly dedicated to the dissemination of knowledge for the public good, support a measure that will dramatically restrict access to affordable medicines and likely cost consumers and the federal government billions of dollars. We strongly believe that developing a process for getting biosimilars to market is a critical step in furthering access to affordable medicines. However, the counter-productive provisions of H.R. 1548 are not necessary to develop such a process. The “Promoting Innovation and Access to Life-Saving Medicine Act” introduced in both the House (H.R. 1427) and the Senate (S.726), and specifically its 5-year term of exclusivity, will open the same doors, without imposing such high costs on consumers.

Universities must take evidence-based stances that benefit society, and not simply act as echo chambers for PhRMA and BIO priorities. Given the lack of evidence and the option to do better, the AAU must rescind its support of H.R. 1548 and its 12 year term of exclusivity.

Signed:

American Medical Student Association
Essential Action
Universities Allied for Essential Medicines

For correspondence contact:
Ethan Guillen
Executive Director
Universities Allied for Essential Medicines
ethan.guillen@essentialmedicine.org

cc:

AAU Member University Presidents
Senator Edward Kennedy
Senator Charles Schumer
Senator Michael Enzi
Senator Charles Grassley
Congressman Frank Pallone
Congressman Nathan Deal
Congressman Henry Waxman

[i] http://www.aau.edu/WorkArea/DownloadAsset.aspx?id=9016
[ii] See Federal Trade Commission, Emerging Health Care Issues: Follow-On Biologic Drug Competition, June 2009. Available at: http://www.ftc.gov/opa/2009/06/biologics.shtm
and Henry Grabowski, Outlook: Follow-on biologics: data exclusivity and the balance between innovation and competition. Nature Reviews Drug Discovery 7, 479-488 (June 2008). Available at: http://www.nature.com/nrd/journal/v7/n6/full/nrd2532.html.
[iii] Arnst, Catherine. “Study Links Medical Cost and Personal Bankruptcy.” BusinessWeek June 4, 2009. Available at: http://www.businessweek.com/bwdaily/dnflash/content/jun2009/db2009064_66....