Patient Groups and Emerging Biotech Companies Highlight Need for Substantial Data Exclusivity for Innovators
WASHINGTON, D.C. (May 2, 2007) -- A diverse group of patient advocacy organizations has joined the Biotechnology Industry Organization (BIO) in urging that patient safety and continued biomedical innovation stand as critical components of any statutory effort to establish a pathway to approve development of follow-on biologics. The patient groups and leaders of BIO’s Emerging Companies Section (ECS) Governing Body sent letters this week to members of the House Energy and Commerce Committee in advance of today’s hearing on follow-on biologics in the Subcommittee on Health.
The Alliance for Aging Research, American Autoimmune Related Diseases Association, Christopher and Dana Reeve Foundation, Cutaneous Lymphoma Foundation, Kidney Cancer Association, National Spinal Cord Injury Association and RetireSafe co-signed a letter to the Subcommittee’s Chairman and Ranking Member stating, “Any statutory pathway for follow-on biologics should include a substantial period of data exclusivity to ensure that medical innovation continues…To undermine incentives to invest in biomedical innovation could potentially slow progress in the development of breakthrough therapies to improve the health and lives of patients suffering from currently untreatable conditions.”
Representatives of BIO’s ECS wrote to the Committee Chairman and Ranking Member to encourage them to embrace BIO’s key principles for follow-on biologics, stressing that for the vast majority of BIO’s membership which do not have products on the market, incentives for innovation are vital in order to be able to attract capital.
“Failure to provide for substantial data exclusivity and intellectual property protections will be particularly disastrous for emerging biotechnology companies. In the absence of existing product revenue, BIO’s smaller member companies’ ability to invest in cutting edge research is dependent on our ability to attract capital,” wrote the representatives on behalf of the section. “The development of a new biotech therapy is a high-risk investment that is only undertaken based upon the expectation that a future FDA-approved product will provide an attractive return on investment.”
BIO’s ECS includes more than 600 small biotechnology companies that are developing their first commercial product and have fewer than 350 employees; 80% of these companies have fewer than 50 employees. Small biotech companies, all but the top ten, account for two-thirds of the industry’s clinical pipeline.
“In order to ensure that new pioneer biotechnology products continue to reach patients and physicians, any pathway for the approval of follow-on biologics must protect patient safety and preserve incentives to innovate,” stated BIO President and CEO Jim Greenwood. “Significant data exclusivity is a necessary component of any pathway for follow-on biologics.”
The letter from patient groups to the Chairman and Ranking Member of the Subcommittee on Health is available at http://bio.org/healthcare/followonbkg/20070501.pdf.
The letter from leaders of BIO’s ECS Governing Body to the Chairman and Ranking Member of the Energy and Commerce Committee is available at http://bio.org/healthcare/followonbkg/20070501BIO.pdf.
David Schenkein, M.D., vice president of Clinical Hematology/Oncology for Genentech, will testify on behalf of BIO in today’s hearing in the Energy and Commerce Subcommittee on Health. His testimony is available at http://bio.org/healthcare/followonbkg/SchenkeinTestimony.pdf.