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New Bill Would Clear the Way for Generic Biologics

Americans who are now forced to pay tens of thousands of dollars for “biologic” drugs that battle cancer and other devastating diseases may see some price relief from a bipartisan bill, introduced today, that would permit the Food and Drug Administration to approve less expensive generic copies of these drugs.

The bill, “Promoting Innovation and Access to Life-Saving Medicine Act,” introduced by Rep. Henry Waxman, D-Calif., and three other House members, would authorize the FDA to set up a process for approving generic versions of biologics. These cutting-edge prescription drugs are engineered from living cells instead of chemicals, which are the traditional basis for drugs.

“I believe this bill will lead to healthy competition and long-term savings” for patients and for the health care system, Waxman said in a statement.

A similar bill introduced in the Senate in 2007 never made it out of committee. But in its budget proposals, the Obama administration recently called for a new regulatory pathway to “accelerate” access to affordable generic biologic drugs. Support for the bill has been growing.

AARP, the Consumers Union and a number of businesses as well as the AFL-CIO are among the broad-based backers of the bill.

Biologic drugs treat complex, chronic conditions such as cancer, rheumatoid arthritis and multiple sclerosis that affect millions of older Americans. The drugs command prices 10 to 100 times higher than those of other prescription medications because patients have few alternatives and there are usually no competing medications. Multiple sclerosis drugs Avonex and Betaseron, for example, run about $24,000 a year while the arthritis drug Humira is $22,000. Those high prices are prompting more insurance plans to charge higher copayments, and even people on Medicare may face devastating bills for the drugs.  

An AARP study released Monday on biologics reports that a patient on Medicare Part D with a total drug bill of $25,000 a year would face out-of-pocket expenses of about $5,000.

While biologic drugs can help cure and calm diseases, “for too many people, these life-saving medicines are simply out of reach because of their overwhelming price tags,” says Nancy LeaMond, AARP executive vice president. She says the new legislation will help bring “safe, less expensive generic versions” of biologics to market and help control the “skyrocketing” costs of health care in America.

The industry group PhRMA (the Pharmaceutical Research and Manufacturers of America) released a statement charging that the Waxman bill would “impede medical progress … and chill investment in the biotechnology sector.”

While maintaining that PhRMA supports the creation of a regulatory pathway for generic biologics, Ken Johnson, senior vice president of the group, says such a pathway “must maintain meaningful protection of incentives for innovation,” by protecting a biologic drug for a minimum of 14 years before a generic could be marketed.

The Waxman bill proposes following the current system for prescription drugs, which allows five years of exclusivity for a drug and up to three more years of exclusivity if that drug is improved or modified.  

Barbara Basler is a senior editor with the AARP Bulletin.

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