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Law Emerging in US for Generic Versions of Biotech Medicine

The US might be a capitalist-friendly land. But there too strident voices are being raised in favor of consumers. As a result legislators are now moving// to ensure availability of lower-cost copies of biotechnology drugs that now cost tens or hundreds of thousands of dollars a year.

Generics are now allowed only for traditional, chemical compounds whose patents have expired. You can't get them for complex biological drugs such as hormones or antibodies used in cancer treatments. Some of the world's most potent and popular medicines fall into this biotech basket, and existing federal laws prevent them from going generic.

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.

A legislation is being hammered to enable the Food and Drug Administration (FDA) to approve of generic version of biotech drugs without trials.

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.

But then the bio-tech drugs are prohibitively expensive. A year's worth of Genzyme's (DNA) Cerezyme, for a rare ailment called Gaucher's disease, can top $200,000. Genentech's cancer drug Avastin costs as much as $100,000 per year. That places a huge burden on companies who cover the treatments in their health plans and on consumers.

Consumer groups, employers and insurers are working in tandem with Democrats who have taken control of the US Congress this year on the issue. That is the only way to hold down health costs, they say.
However, the big 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.

The chief medical officer of the FDA Janet Woodcock told the 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.

But Dr. Jay P. Siegel, a senior scientist at Johnson & Johnson, warned, “I would never take a biologic that had not been tested in humans. The risks are too high.”

Dr. Woodcock countered: “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.”

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

Orrin G. Hatch, a Republican senator who had co-authored a 1984 law legitimizing generic versions, is now trying to work out a compromise acceptable to the pharmaceutical giants.

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.

It is also said that it would take several years after any new bill is passed for the FDA to issue regulations. Then, because of safety concerns, the agency could also require some clinical trials before approving generic competitors, slowing their entry to the market.

Further it's unlikely that the copies will automatically be substituted for brand-name drugs, the way today's generics are. Instead, they will be seen just as another c hoice. Even costwise the reduction would be of the order of ten to fifteen per cent, it is predicted.

Still hundreds of thousands of patients are pathetically pleading, “Start somewhere, please get going. Make the drugs we need affordable for us.”


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