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Capitol Health Call
April 11, 2007

Generic Biotech Drugs

JAMA. 2007;297(14):1541. doi:10.1001/jama.297.14.1541-b

Identical bills introduced in both houses would open to the door to low-cost generic versions of biopharmaceuticals by giving the US Food and Drug Administration (FDA) the ability to approve such medicines.

At a March 8 hearing by the Senate Committee on Health, Education, Labor, and Pensions, Sen Charles E. Schumer (D, NY), a cosponsor of the Access to Life-Saving Medicine Act (S 623, HR 1038 [http://thomas.loc.gov]), testified that this legislation was needed because of the high costs associated with treating patients with biopharmaceuticals and the lack of a government approval process for lower-cost alternatives. The agency currently has “no statutory authority to approve a lower-cost biologic product even if all the evidence is there to show that the product is just as safe, pure, and potent as the innovator's product,” he said.