AARP wrote to the chief Senate negotiators of the generic biologics bill that is before the Senate Health, Education, Labor and Pensions (HELP) Committee today about their compromise legislation.
Identical letters were sent to Senators Edward Kennedy (D-MA), Michael Enzi (R-WY), Hillary Clinton (D-NY), Charles Schumer (D-NY) and Orrin Hatch (R-UT). The letter to Senator Kennedy follows:
June 27, 2007
The Honorable Edward M. Kennedy
United States Senate
Washington, D.C. 20510
Dear Senator Kennedy:
On behalf of consumers and patients, we thank you for your leadership in developing the Biologics Price Competition and Innovation Act of 2007. Our members need access to safe, lower-priced prescription drug treatment therapies. Your legislation seeks to create a pathway for the approval of generic biologics.
We are pleased that the legislation gives FDA long overdue authority to begin developing a process for approving lower cost generic versions of biologic drugs.
The legislation also provides a rational approach for guaranteeing the interchangeability of biogenerics.
AARP is concerned, however, that the twelve year period of data exclusivity for the brand biologic currently included in the proposed legislation is too long.
While we want to see innovators rewarded for their research and development efforts, a twelve year period of data exclusivity would unnecessarily delay the introduction of generic biologics. Our members cannot afford to wait a minimum of twelve years for medication therapies that aid in the treatment of diseases like Multiple Sclerosis (MS) and cancer. Every day, many forgo medicines they should be taking, but simply cannot afford. The price is even higher and options more limited for individuals who rely on biologic drugs. A person living with MS, for example, might spend from $16,500 to $29,000 each year on their biologic MS therapy.
Moreover, the legislative language as drafted is unclear with respect to whether a brand company could artificially extend this twelve year period of data exclusivity by obtaining FDA approval for a slight change in the drug (for example, a dosage change). Americans have waited too long for generic biologics. We believe that this provision must be clarified. We cannot afford to wait for the courts to determine the legislative intent of the data exclusivity period.
We know that you support giving consumers the opportunity to purchase safe, lower-priced prescription drugs alternatives - regardless of whether these treatments are traditional prescription drugs or biologics. AARP looks forward to working with you throughout the legislative process to improve the legislation to ensure that consumers who need them can afford to purchase their medications.
David P. Sloane
Senior Managing Director
Government Relations and Advocacy