Drugs :: Bill to create clear pathway for generic biologic drugs

Access to Life-Saving Medicine Act would lower patient drug costs for drugs used to treat diseases like cancer, diabetes, AIDS.

Today Rep. Henry A. Waxman, Sen. Charles E. Schumer, and Sen. Hillary Rodham Clinton, along with Rep. Jo Ann Emerson and Rep. Frank Pallone, introduced the “Access to Life-Saving Medicine Act,” which will give Food and Drug Administration (FDA) the express legal authority to approve safe, lower cost copies of biotech drugs, also known as biologics or biopharmaceuticals.

Biotech drugs, which are produced from living cell cultures rather than being synthesized chemically, are among the fastest growing and most expensive components of the nation’s drug bill. Currently there is no statutory pathway for generic versions of biotech drugs to enter the market, even after all patents have expired. As a result, the manufacturers of biotech drugs can charge monopoly prices, indefinitely. In addition to the members listed above, Senators David Vitter, Debbie Stabenow, Patrick J. Leahy, Susan M. Collins and Representative Rahm Emanuel are original cosponsors of the legislation.

“We learned 22 years ago that generic drug competition brings consumers affordable, safe, and effective medicines,” said Rep. Waxman. “The time has come to apply this competition to biotech drugs. This bill will give FDA the clear legal authority to approve safe and effective copies of biotech drugs.”

“Biologics treat some of the most devastating diseases around and no one should be denied access to them because of they’re too expensive,” said Sen. Schumer. “Generic biologics can be a safe and affordable alternative to high-priced brand name biologics. Our legislation will allow all Americans to take advantage of these drugs by enabling competition in the market to lower the price and ending permanent monopolies over biologic products. It is high time for these vital treatments to become more affordable and our legislation is just what the doctor ordered.”

“We have witnessed dramatic scientific advances over the past twenty years in the field of biopharmaceuticals but our health care system has not kept pace. Biotech drugs hold great promise; however, we break that promise when costs push treatment out of reach for American families and employers. We should bring safe, effective and affordable generic versions of these medicines to patients. It will save money and save lives,” said Senator Clinton.

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