Misleading drug ads

The FDA further weakened the drug-safety system when it relaxed restrictions on direct-to-consumer drug ads in 1997 and opened the floodgates to broadcast ads of newly approved drugs, whose risks may not yet be known.

Consumer Reports’ analysis of regulatory letters that the FDA posted on its Web site from January 1997 through September 2005 reveals that consumer-drug ads have contained a wide range of misleading messages: minimizing the risks, exaggerating the efficacy, misstating or omitting the labeling information, making false superiority claims, and promoting unapproved uses for an approved drug.

Our analysis suggests that the FDA has tried to get stricter with advertisers. Starting in 2004, it sent manufacturers significantly more warning letters, which may order drugmakers to run remedial ads or send corrective letters to doctors.

But the number of less serious “notice of violation” letters dropped sharply, starting in 1999, and has stayed low. There hasn’t been a single letter about misleading press materials since 2001. With only about 40 reviewers to vet nearly 53,000 promotional drug pieces in 2004, the latest year analyzed, the FDA appears to lack the resources to adequately monitor drug ads.

In August 2005 PhRMA announced “guiding principles” for consumer ads, including waiting “an appropriate amount of time” before advertising a newly approved drug. PhRMA would also establish its own “office of accountability” to make complaints and company actions public, receive comments on ads, and forward the information to the appropriate company. “The criticisms were legitimate and they needed to be dealt with,” says Billy Tauzin, PhRMA president and CEO. He conceded that the voluntary plan was “in response to public opinion and the concern that government was talking about getting involved.” As of November, most of the group’s 33 members had signed on to the plan.