WASHINGTON — WASHINGTON -- Senior members of Congress from both parties are working feverishly on legislation that could give consumers access to lower-cost copies of biotechnology drugs that now cost tens or hundreds of thousands of dollars a year.
Prospects for the legislation have increased since Democrats took control of Congress this year. Consumer groups, employers and insurers are lobbying for the bill, which they see as a way to hold down health costs.
The proposal faces formidable scientific and political obstacles. Brand-name pharmaceutical companies contend that biotechnology products, made from cells and living organisms, are so complex that a copy will never be identical to the original and therefore cannot be certified as safe without testing in humans.
Biotechnology medicines are the fastest-growing category of health spending, with sales of $40 billion last year, up 20 percent from 2005, according to IMS Health, a market research company. More than 400 biotechnology products are in the pipeline, for more than 100 diseases, including cancer, AIDS, diabetes and Alzheimer's.
Conventional drugs are synthesized by putting atoms together from basic chemicals and are often in pill form.
Biotechnology drugs, also known as biologic products, are typically proteins made by modifying the DNA of bacteria, yeast or mammal cells, and they are often given by injection or infusion.
Supporters of the legislation received an unexpected boost when the chief medical officer of the Food and Drug Administration, Dr. Janet Woodcock, told Congress last month that the agency had the expertise and experience to decide what types of human and laboratory tests were needed to ensure that copies of a biotechnology drug worked as well as the original.
Brand-name drug manufacturers have urged Congress to require human trials before allowing the sale of any products billed as comparable or equivalent to biotechnology medicines on the market.
"Some level of clinical testing should be required in all cases," said Dr. Susan D. Desmond-Hellmann, president for product development at Genentech.
Dr. Jay P. Siegel, a senior scientist at Johnson & Johnson, said: "I would never take a biologic that had not been tested in humans. The risks are too high."
But Woodcock said: "Where trials are not needed, it is of questionable ethics to repeat them. The use of human subjects for trials that are not needed is not desirable."
Many biotechnology drugs are effective but expensive. Avastin, a cancer treatment made by Genentech, can cost $4,400 to $8,800 a month, with a maximum cost of $55,000 a year for people who qualify for the company's patient assistance program.
Cerezyme, a drug made by Genzyme for Gaucher disease, costs $200,000 a year. Enbrel, made by Amgen for rheumatoid arthritis and psoriasis, costs an average of $16,000 a year.
Biotechnology treatments for multiple sclerosis range in price from $16,000 to $25,000 a year. "Many patients are denied access to these important drugs because even the co-payments can reach thousands of dollars a year," said Arney Rosenblat, a spokeswoman for the National Multiple Sclerosis Society.
Consumers save billions of dollars a year by using low-cost generic versions of conventional drugs, which are approved by the government under a 1984 law.
One author of the 1984 law, Rep. Henry A. Waxman, a California Democrat, is pushing a bill that would authorize the Food and Drug Administration to approve safe, lower-cost versions of biotechnology drugs.
Sens. Charles E. Schumer and Hillary Rodham Clinton, both New York Democrats, have introduced an identical bill, with support from several Republicans, including Sens. Susan M. Collins of Maine and David Vitter of Louisiana.
The chief lobby for makers of biotechnology drugs, the Biotechnology Industry Organization, strongly opposes the bill, saying it would endanger patients and kill incentives for research and innovation.
But the AARP, the lobby for older Americans, has joined the Consumers Union, Aetna, the Blue Cross and Blue Shield Association, Caterpillar, General Motors, Kaiser Permanente, and Walgreens and other chain drugstores in a coalition supporting the legislation.
The bill reflects the initial negotiating position of the generic drug industry and its allies as Congress begins serious negotiations to reach a compromise.
A co-author of the 1984 law, Sen. Orrin G. Hatch, a Utah Republican, predicted that Congress would pass legislation on the issue this year.