Lawmakers Ask FDA for Drug Ad Changes

April 2, 2008 -- Members of Congress called on the FDA Wednesday to move faster in forcing drug companies to include safety-reporting information in their television and radio ads.

The lawmakers want "direct-to-consumer" advertisements crowding the airwaves during nightly news and other broadcasts to include information telling consumers how to report potential side effects to the FDA.

The agency tracks so-called "adverse events" and uses reports from doctors and patients to tip them off to potential safety problems with drugs on the market. The system is voluntary, and agency scientists complain that it misses the vast majority of drug reactions that occur.

"When only a fraction of adverse drug reactions are reported to the FDA, that means the system is failing," says Rep. Rosa DeLauro, D-Conn., who chairs the House subcommittee controlling FDA's budget.

"Consumer reporting is an alarm system," says Rep. Jan Shakowski, D-Ill.

FDA and Ad Requirements

A law enacted in September 2007 requires print drug ads to state, "You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088." There's no requirement that broadcast ads carry the statement, though the law required the FDA to begin studying the issue by January 2008.

The study has not yet been completed, and in late December the Consumers Union petitioned the FDA to require the statement on TV and radio drug ads.

"We know drug ads are everywhere, so at the very least giving people an opportunity to report drug side effects should be available," says Liz Foley, who leads drug advertising efforts at Consumers Union.?

FDA spokeswoman Rita Chappelle said the agency is reviewing the group's petition. "All of this is in process right now, so it is not accurate to say this isn't going on."

Chappelle would not confirm whether the agency had begun studying the issue.

Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry's main lobbying group, says the group will not comment until the FDA has completed its study.

"We want them to finish their study on the feasibility of adding this information and we want to see what they recommend," Trewhitt says.

Direct-to-consumer advertising is credited with driving billions in U.S. sales, though it is impossible to pinpoint the ads direct impact on prescription numbers. DeLauro cited a New England Journal of Medicine article published last month detailing a $200 million advertising campaign for the cholesterol drug Vytorin. The article credited the campaign with helping drive total sales to $5 billion in 2007.

Findings from a recently published study show that Vytorin, which combines the unique cholesterol drug Zetia with the older, cheaper statin drug Zocor, was no better than Zocor alone at slowing plaque buildup in high-risk patients.