Healthy Skepticism Library item: 9350

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Publication type: news

Pear R.
Congress Seeks Compromise on Generic Drugs
New York Times 2007 Apr 7
http://www.nytimes.com/2007/04/08/washington/08drug.html?_r=1&em&ex=1176177600&en=dc6671ca66f46bbd&ei=5087%0A&oref=slogin

Full text:

WASHINGTON, April 7 – 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.

Biotech 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 biotech 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.

Biotech 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 already 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 Dr. 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 biotech 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.

Biotech 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, Representative Henry A. Waxman, Democrat of California, is pushing a bill that would authorize the Food and Drug Administration to approve safe, lower-cost versions of biotechnology drugs.

Senators Charles E. Schumer and Hillary Rodham Clinton of New York, both Democrats, have introduced an identical bill, with support from several Republicans, including Senators Susan Collins of Maine and David Vitter of Louisiana.

The chief lobby for makers of biotech drugs, the Biotechnology Industry Organization, strongly opposes the bill, saying it would endanger patients and kill incentives for research and innovation.

But 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, Senator Orrin G. Hatch, Republican of Utah, predicted that Congress would pass legislation on the issue this year.

Mr. Hatch is trying to work out a compromise, more acceptable to brand-name drug makers, in negotiations with Mrs. Clinton and Senators Edward M. Kennedy, Democrat of Massachusetts, and Michael B. Enzi, Republican of Wyoming.

Mr. Kennedy represents a state with scores of biotech companies and is chairman of the Senate committee with authority over the issue. Mr. Enzi is the senior Republican on that panel.

They are seeking a balance like the one struck in the 1984 law, which fostered a booming generic drug industry while protecting the patent rights of brand-name drug makers – a crucial incentive for research on new drugs.

The manufacture of biotech drugs is more complex and costly than the production of conventional medicines. But economists cite another reason for the high prices: biotech medicines generally face no competition from copycat drugs.

When the first generic copy of a conventional drug becomes available, it may cost 15 percent less than the brand-name product. If several competing generic versions are available, the price often falls by 60 percent or more.

Prof. Henry G. Grabowski, a health economist at Duke University, said prices would decline less for biotechnology drugs.

But Scott McKibbin, an aide to Gov. Rod R. Blagojevich of Illinois, said biotech drugs were so expensive that discounts of just 10 percent to 20 percent would save tens of millions of dollars for the state’s Medicaid program and the state employees’ health plan.

The debate over biotech drugs is filled with paradoxes. Brand-name drug companies, which have for years criticized the regulation of drug prices in Europe, now point to Europe’s strict regulation of “follow-on biologics” as a possible model for the United States. Democrats, who have often criticized the F.D.A. as lax in enforcing drug safety laws, now say they trust the agency to decide whether copies of biotech drugs are safe and effective, without the full range of tests required for new products.