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Lawmakers Press for Changes to Drug Advertising

Apr 3, 2008 | Parker Waichman LLP On Wednesday, members of Congress asked the Food and Drug Administration (FDA) to move faster in forcing drug companies to include safety-reporting information in their television and radio ads.  The lawmakers are looking for those "direct-to-consumer" advertisements that appear during nightly news and other broadcasts to include information advising consumers how to report potential drug side effects to the FDA.  The agency tracks drugs’ adverse events and uses reports from doctors and patients to be alerted to potential safety problems with drugs currently on the market.  Because the system is voluntary, FDA scientists are concerned it misses most adverse drug reactions.  "When only a fraction of adverse drug reactions are reported to the FDA, that means the system is failing," says Representative Rosa DeLauro, Democrat-Connecticut, who chairs the House sub-committee controlling the FDA's budget.  "Consumer reporting is an alarm system," says Representative Jan Shakowski, Democrat-Illinois.

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, or call 1-800-FDA-1088."  Currently, broadcast ads have no requirements carry the statement, though the law required the FDA to begin reviewing this issue by this January; the study is not yet completed.  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 looking at 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 drives billions of dollars in US sales and studies find most television prescription drug ads minimize risk information.  Prescription drug ads began being run on the air just over a decade ago, but a recent University of Georgia study finds most do not present a fair balance of information, especially when it comes to drugs’ side effects.

The 1997 FDA guidelines that allowed drug companies to greatly expand the scope of their direct-to-consumer advertising required that the companies present a fair balance between information about effectiveness and information about risk; however, fair balance is not defined by the FDA.  Proponents of direct-to-consumer ads argue that they help raise awareness of various medical conditions and treatments while critics argue that the ads drive up health care costs by steering consumers to purchase costly drugs that they might otherwise not need.

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