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Drug lag -- precaution or pipelines?

According to a CNN Money article, a report released yesterday shows that the FDA has been cracking down on new drug approvals. Pharmaceutical companies this year through July had only 38 new drugs approved, down from 55 for the same period last year. The report was from James Kumpel, health care analyst for Friedman, Billings, Ramsey.

Though some say that's occurring because the pharmaceutical companies' pipelines are drying up, others attribute the slowing down of approvals on the FDA's fear of approving drugs with some side effects, after recent highly publicized concerns with drugs on the market:

But Fran Hawthorne, author of "Inside the FDA," argues that there's nothing new about Big Pharma's lack of innovation. She said the drug approval slowdown is "far more [a result of the FDA's] paranoia than the pipelines." "It's true that the pipelines are pretty dry at the drug companies, but the pipelines were dry five years ago when the FDA was approving more," said Hawthorne. Hawthorne said that the regulatory policy "cycle always turns," and that the FDA will eventually lower the bar again, as patient advocacy groups complain that the sluggish review process keeps people from getting the drugs they need. "If we don't get another scandal -- another Vioxx, another drug with horrible side effects -- then the pressure will be on the FDA to speed things up," said Hawthorne.

Precautionary approaches to drug approval and their negative effects on patients have long been a focus of CEI's work. As CEI's statement releasing one of its on-going surveys of physicians pointed out, there is a real risk on the other side in delaying new or improved drug therapies:

Any attempt to make FDA's approval process more stringent will add to its length and expense, making the development of new therapies even more difficult. In the view of many analysts, impeding the availability of new therapies creates a far greater risk to public health than that posed by the handful of drugs and devices that may have been erroneously approved.