Rep. Henry Waxman - 29th District of California

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In Washington, D.C.
2204 Rayburn House Office Building
Washington, D.C. 20515
(202) 225-3976 (phone)
(202) 225-4099 (fax)

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8436 West Third Street, Suite 600
Los Angeles, CA 90048
(323) 651-1040 (phone)
(323) 655-0502 (fax)

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Issues and Legislation

Health - Generic Biologics

H.R. 6257, "Access to Life-Saving Medicine Act"

On September 29, 2006, Rep. Waxman, along with Senators Charles E. Schumer and Hillary Rodham Clinton introduced H.R. 6257, the “Access to Life-Saving Medicine Act,” which will establish a process through which the FDA will be able to approve lower cost copies of biotech drugs, also known as biologics or biopharmaceuticals. Biotech drugs, which are produced from living cell cultures rather than synthesized chemically, are among the fastest growing and most expensive components of the nation’s drug bill. Currently there is no statutory pathway for biotech drugs, and manufacturers of biotech drugs can charge monopoly prices, indefinitely.

Generic drugs (first made possible under the 1984 Hatch-Waxman Amendments) have been extremely successful in bringing down the high cost of prescription drugs. Generic drugs save patients and payers $10 billion a year. But there is no generic competition for one of the fastest growing and most expensive category of drugs: so-called biotech drugs, also known as biological drugs or biopharmaceuticals. It is common for these drugs to cost tens of thousands of dollars a year, even after patent expiration. Many patients are now denied access to these important drugs because even the co-payments can reach thousands of dollars a year. And the sky-rocketing cost of biotech medicines is imposing increasing burdens on employers, insurers, and the federal government. Introducing fair competition for biotech drugs is essential to keep these life-saving treatments affordable.


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