February 15, 2007--Rep. Henry Waxman, Senators Charles Schumer and Hillary Clinton, along with House Members Jo Ann Emerson and Frank Pallone, introduced the “Access to Life-Saving Medicine Act,” which would give the FDA the express legal authority to approve safe, lower-cost copies of biotech drugs.

Currently, there is no statutory pathway for generic versions of biotech drugs to enter the market. These products are not subject to the 1984 law that first authorized the FDA to approve generic drugs. The EMEA, which is Europe's equivalent of the FDA, has had a legal framework in place for approval of such “biosimilars” since 2004. EmpireStateNews.net