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FDA faulted over unapproved uses of medications
http://news.yahoo.com/s/ap/20080727/ap_on_go_co/fda_off_label_drugs

The review that Grassley requested by the investigative arm of Congress found that the FDA is ill-equipped to catch even blatant marketing abuses by drug companies. The agency does not have any staff exclusively assigned to monitor whether companies are following the rule against marketing drugs for unapproved uses.

The FDA “isn’t keeping track of how drugs are marketed for off-label use, even though marketing for off-label use is illegal and it’s the FDA’s job to enforce that law,” Grassley said in a statement. “As a result, drug makers aren’t being held accountable for promoting unapproved use of medicine and patient safety is diminished.”

Instead, the job is handled by the office that oversees all drug advertising, including television commercials and magazine ads. That office has 44 full-time employees assigned to review ads. Last year, they had to dissect the fine print on some 68,000 advertisements.

The office tries to set priorities, by focusing first on misrepresentations that could have a damaging impact on human health. But the report found that the FDA lacks a system for tracking all the material it receives.

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