FDA needs to watch drugs ads more closely


FDAThe U.S. Food and Drug Administration needs to more closely regulate direct-to-consumer advertising of prescription drugs, the Government Accountability Office said on Thursday.

It found the agency moved too slowly in reviewing ads on products ranging from impotence remedies to incontinence pills, and too slowly in trying to stop misleading ads.

"We believe that regulatory letters must be issued more quickly," the GAO, the investigatory arm of Congress, said in its report.

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

But the GAO disagreed and said FDA could do more.

"Drug company spending on DTC (direct to consumer) advertising -- such as that on television and in magazines -- of prescription drugs increased twice as fast from 1997 through 2005 as spending on promotion to physicians or on research and development," the report reads.

The GAO found that drug companies spent $4.2 billion on such ads in 2005, compared to $7.2 billion spent promoting products to doctors and $31.4 billion on research and development.

"Evidence suggests that the effect of DTC advertising on consumers can be both positive, such as encouraging them to talk to their doctors, and negative, such as increased use of advertised drugs when alternatives may be more appropriate."

The FDA is supposed to watch such advertisements and step in if companies make exaggerated claims, or fail to warn of side-effects. It is supposed to use clear criteria to identify ads posing the greatest threat to consumers.

"However, FDA has not documented these criteria, does not apply them systematically to all of the materials it receives, and does not track information on its reviews. As a result, the agency cannot ensure that it is identifying or reviewing those materials that it would consider to be the highest priority," the GAO said.

It said the FDA had only limited success in stopping ads that violate guidelines.

"The 19 regulatory letters FDA issued in 2004 and 2005 were issued an average of 8 months after the materials were first disseminated," the GAO report read.

"By the time FDA issued these letters, companies had already discontinued use of more than half of the violative materials."

And even when the FDA issued letters, the drug companies sometimes broke the rules again in advertising the very same drugs later.

Sen. Herb Kohl, a Wisconsin Democratic, said: "Americans are bombarded by DTC ads every day, yet this report makes it clear that the FDA's effort to police those ads is inadequate."

"As the incoming chair of the Appropriations panel that oversees FDA's budget, I will be pressing the agency to establish a system and protect the health of consumers through proper review and regulation of drug advertising."

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