Access to Life-Saving Medicine Act to give FDA biogenerics framework

Members of both major parties in the US Congress have combined to launch the Access to Life-Saving Medicine Act, which is designed to give the US Food and Drug Administration the legal authority to approve safe, lower-cost copies of biotechnology drugs, also known as biologics or biopharmaceuticals.

These drugs, which are produced from live cell cultures rather than being synthesized chemically, are described by the Bill's sponsors as "among the fastest-growing and most expensive components of the nation's drug bill."

The absence of a statutory pathway for generic versions of biotechnology drugs to enter the market, even after all patents have expired, has been noted by commentators previously (Marketletters passim). Supporters of the new legislation argue that the manufacturers of biotechnology drugs can charge monopoly prices, indefinitely.