Report on FDA Review of Drug Ads

Article in the New York Times — Group Wants FDA to Review More Drug Ads, by the Associated Press:

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 limited ability to curb distribution of ads that violate federal rules, according to the report being released Thursday.

From 2002 through 2005, it took the Food and Drug Administration 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.

Between 1997 and 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.

BGS