WebMD Medical News
Louise Chang, MD
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,
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
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
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
SOURCES:Rep. Rosa DeLauro, D-Conn.Rep. Jan Shakowski, D-Ill.Liz Foley, Consumers Union.Jeff Trewhitt, spokesman, Pharmaceutical Research and Manufacturers of
America.Jackevicius, C.A. The New EnglandJournal of Medicine, March 30,
2008.WebMD Medical News:
"Vytorin's Shortcoming a Boon for Statins."
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