Drug firms getting less scrutiny of advertising

Regulators are issuing fewer citations to drug companies for false and misleading advertisements and are taking longer to do it, a congressional report says.

With annual spending on direct-to-consumer drug advertisements at $4.2 billion and growing, the government has limits on its ability to curb distribution of ads that violate federal rules, according to the report being released today.

From 2002 through 2005, the Food and Drug Administration took four months on average to draft, approve and send warning letters and other correspondence to companies that were in violation of the rules, government auditors said.

But from 1997 to 2001, before FDA lawyers began reviewing the letters as a matter of policy, it took just two weeks on average to issue the letters. The number of letters fell off by about half between the two time periods.

The Government Accountability Office also said the FDA lacked an effective way to screen the more than 10,000 ads and websites brought to the agency’s attention each year. The amount has doubled in just four years.

The Health and Human Services Department, the FDA’s parent agency, acknowledges that the FDA’s six reviewers cannot scrutinize everything, so they focus on ads with the greatest potential to affect public health.

The department said the lengthy legal reviews gave the FDA more teeth because the letters that were sent rested on a more solid legal foundation.

“As a result, companies take our letters more seriously and quickly react to the problems identified therein,” the department said in written comments to the GAO, the investigative arm of Congress.

The report said companies complied with the letters, albeit slowly sometimes, when asked to produce follow-up ads that set the record straight.