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FDA called lax on misleading drug ads

/ Source: The Associated Press

The Food and Drug Administration is letting more misleading drug advertisements air unchallenged, and doing little to stop companies that repeatedly overpromise their medications, a congressman contended Thursday.

The FDA is supposed to ensure that drug promotions — both to doctors and in the $2.8 billion worth of annual direct-to-consumer advertising — are fair and accurate.

But last year, FDA sent just 24 citations to drug makers whose ads were false or misleading, a 75 percent drop from 1999 and 2000, according to a report issued by Rep. Henry Waxman, D-Calif.

The decrease doesn’t mean drug advertising became more believable, Waxman said. FDA reviewed an average of 3,200 drug promotional pieces a month last year — 6 percent more than in 2002 — and complaints to the agency about ads’ truthfulness have remained steady.

FDA cited one ad for every eight complaints, Waxman said, compared with one citation per seven complaints in 2002.

Limited oversight

When FDA cited an ad, it took, on average, almost six months after the promotion began, says the report by Democratic staff of the House Government Reform Committee. Waxman is the ranking Democrat on the committee.

In one case, FDA didn’t tell a company to quit hyping the cancer drug Taxotere until a year after a consumer-targeted ad began running. In another, it took FDA more than three months to tell the maker of the controversial painkiller Oxycontin to pull a medical journal ad that “grossly overstated” the drug’s safety.

Congressional investigators at the General Accounting Office in 2002 called FDA’s oversight of drug ads too limited, and then-incoming FDA Commissioner Mark McClellan pledged to do more.

In August, McClellan sent the industry a signal to shape up: FDA told one company to run expensive corrections of newspaper ads that had given false information about a popular cholesterol medicine. The agency also ordered another company to provide doctors with corrected information after learning that drug salesmen had touted an AIDS medicine as a “miracle drug.”

The number of citations means less than targeting the most egregious violators and “making sure the letters that go out have teeth,” said FDA Associate Commissioner Peter Pitts. He noted that overall, the agency’s actions against rule-breakers, including fines, have increased.

Still, delay in targeting false drug ads “is absolutely a problem,” Pitts acknowledged.

Next month, FDA will give drug manufacturers more explicit guidelines on creating truthful ads.