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Fewer new drug OKs mean boost for new technology of pharmacogenomics

Street Smarts. By Scott Gottlieb, MD, amednews contributor. Feb. 11, 2002.

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STREET SMARTS

A column looking at the corporate side of health care

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The recent withdrawal of Bayer Corp.'s Baycol, suspected to cause rhabdomyolisis and linked to 31 deaths in the United States, from the market was the 14th such recall since 1997. Each has been the result of safety concerns that cropped up after the drugs were approved.

In response, the Food and Drug Administration is taking longer to OK new drugs, and that is forcing drug makers to reset earnings expectations. That's one reason Nasdaq's Biotechnology Index is down 13% this year, to a close of 788.95 as of Jan. 26.

Biotechnology firms, more so than pharmaceutical giants, are especially vulnerable to these delays because they're usually dependent on a single product. In 2001, new molecular entities, the drugs with ingredients never marketed before in the United States, spent an average of 15.7 months being reviewed by regulators before approval -- past the high end of the old assumption of 12 to 15 months for approval. Drugs on a special "six-month" fast track for critical new medicines now take nine months or more to be approved.

The 24 new drugs approved in 2001 mark the fewest cleared by the FDA since 1994, when 23 passed agency muster. For most of the 1990s, there was a concerted effort by the FDA to increase the number of new drugs approved. The result was a doubling of the average rate of new drugs approved, to 40 a year at the end of the decade from 20 a year at the start.

A rising number of rare side effects were inevitable, as more new drugs with narrow indications are administered to heterogeneous populations far larger and sicker than any reasonable clinical trial can replicate. Even if a drug company could afford to sponsor trials large enough to uncover remote risks, it would not be practical to recruit enough eligible patients. [...]