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FDA Panel Considers Toll-Free Number for TV Drug Ads

Consumers could report side effects, but critics want agency to act, not wait years

By Steven Reinberg
HealthDay Reporter


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FRIDAY, May 16 (HealthDay News) -- Direct-to-consumer drug ads on television should include a toll-free phone number that would allow consumers to report adverse side effects, U.S. health experts suggested Friday.

The experts serve on a panel that advises the U.S. Food and Drug Administration. Such phone numbers are already mandated by the FDA for print ads. At Friday's meeting, the panel discussed designing a study to determine the most effective way of adding the phone number to TV ads.

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FDA spokeswoman Rita Chappelle said the agency would look at the panel's recommendations and incorporate them into the design of a study to determine the best way to include a toll-free number in TV ads. After the study is done, the next step would be to issue regulations and get Congressional approval before they could take effect, she said.

"It could take some time," Chappelle said. "It could take a couple of years."

Chappelle noted that because television is a different medium from print, the best way to put a toll-free number on television ads needs to be studied. Among the factors that require consideration are the best place to put the number and how long it should stay on the screen, she said.

Congress asked the FDA to evaluate adding toll-free numbers to TV ads to get a better understanding of drugs' adverse effects after being approved.

Friday's actions proved disappointing to some consumer advocates, who would like to see faster action on a toll-free number for TV ads.

"We want to make sure that this information gets into TV ads sooner, not later," said Elizabeth Foley, a policy advocate for Consumers Union, who testified before the panel. "We want to figure out if there is a way for the FDA to shorten the time it takes to do a study on this proposal."

Consumers Union wants the FDA to require a toll-free number and a Web site address on all TV drug ads, Foley said. "It's already required for print ads, let's just expanded it to TV ads," she said.

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Copyright © 2008 ScoutNews, LLC. All rights reserved.
Last updated 5/17/2008

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SOURCES: Rita Chappelle, spokeswoman, U.S. Food and Drug Administration; Elizabeth Foley, policy advocate, Consumers Union; May 16, 2008, Dow Jones


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