The Honorable Harry Reid

U.S. Senate
528 Senate Hart Office Building
Washington, DC 20510-0001

Dear Majority Leader Reid:

I am writing on behalf of Business Roundtable, an association of chief executive officers of leading U.S. companies with over $4.5 trillion in annual revenues and more than 10 million employees. Member companies provide health insurance coverage to more than 35 million Americans, including retirees.

Business Roundtable encourages you to pass legislation to create an expedited regulatory pathway for the approval of safe and effective follow-on biologics. At the same time, Congress needs to support drug research and development, and provide intellectual property protections, including data exclusivity, for all biologics to ensure continued innovation. Business Roundtable believes that continued competition in the marketplace – not price controls or rationing – will give Americans access to innovative and affordable prescription drugs.

Currently, the Food and Drug Administration (FDA) does not have clear authority to approve new follow-on biologic products. We encourage Congress to find a solution that creates an appropriate regulatory route for FDA approval of these products. We believe the solution should grant the FDA the authority to use its discretion and scientific expertise to evaluate follow-on biologic products on a case-by-case basis while ensuring product integrity and patient safety. These scientific decisions should be made by FDA scientists, not by Congress.

We believe a bill that permits the FDA to use their scientific judgment to approve follow-on biologic products, while supporting broad intellectual property protections, should be passed this year. Thank you for your support.

Sincerely,

John J. Castellani

cc: Members of the U.S. Senate