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The FDA

GAO calls for stricter FDA oversight of DTC drug ads

Friday, December 15, 2006 by: Jessica Fraser
Tags: the FDA, direct-to-consumer ads, drug advertising


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(NewsTarget) The Government Accountability Office announced today that the U.S. Food and Drug Administration (FDA) is unable to properly regulate direct-to-consumer (DTC) ads for pharmaceuticals in a timely manner.

The GAO report found that the agency was too slow to review and regulate ads on a wide range of drugs, often issuing regulatory letters several months after drug firms run ads on television and in magazines. The report also said pharmaceutical firms were spending advertising dollars on DTC drugs ads twice as fast as they were investing in research and development or physician promotion since a ban on DTC ads was lifted in 1997.

The Health and Human Services Department -- which oversees the FDA -- called the GAO report unrealistic, and claimed meeting the report's recommendations "would require vastly increased staff to essentially review every piece in detail."

However, according to the GAO, the FDA is charged with monitoring drug ads -- both televised and in print -- for exaggerated claims or failure to warn of side effects. The report found that the FDA "has not documented these criteria, does not apply them systematically to review all of the materials it receives, and does not track information on its reviews."

The FDA issued a mere 19 regulatory letters in 2004 and 2005 to companies whose ads violated regulations, but the GAO found those letters "were issued an average of 8 months after the materials were first disseminated. By the time the FDA issued these letters, companies had already discontinued use of more than half of the violative materials."

The report also found that on the few occasions the FDA issued regulatory letters, often the violating drug companies broke the law again later by running ads for the same drugs, without further reprisal.

According to FDA critic Mike Adams, the United States is the only advanced country in the world that still allows DTC drug advertising, which he says should be outlawed.

"The kinds of exaggerations, false claims and promotional hype that occur in DTC drug advertising are an embarrassment to scientific medicine," Adams said. "DTC drug ads have subjected Americans to nearly 10 years of medically useless advertising that serves no legitimate purpose. They do, however, sell lots of overpriced pharmaceuticals to people who either don't need them or will be harmed by them."

Adams says the FDA conspired with Big Pharma companies in 1997 to legalize DTC advertising, opening up yet another source of revenue for cash-rich drug firms. Since the legalization of DTC ads, the FDA and Federal Trade Commission (FTC) have looked the other way, allowing drug companies free reign to advertise their products, he says.

"It's an advertising free-for-all that utterly lacks anything resembling scientific scrutiny," Adams said. "Where is the FTC on all those misleading drug ads? The commission will jump on some small company advertising a vitamin, but when powerful drug corporations make utterly false claims in national advertising campaigns, it looks the other way, just like the FDA.

"There is nothing resembling honest regulation of pharmaceutical advertising in the United States today. The drug companies have become the ultimate snake oil salesmen," he said.

Adams urges concerned consumers to visit www.StopDrugAds.org to learn more about deceptive drug firm marketing tactics, and to ask Congress to outlaw DTC advertising.

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