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Law Emerging in US for Generic Versions of Biotech Medicine

r> 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
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