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.
Mitka M. Generic Biotech Drugs. JAMA. 2007;297(14):1541. doi:10.1001/jama.297.14.1541-b