May 16, 2008
Washington, DC–Consumers Union calls on the U.S. Food and Drug Administration to move forward and require television advertisements for prescription drugs to include a toll-free number and a website address to report serious side effects, in testimony before the agency’s Risk Communication Advisory Committee today.
By law, print advertising for drugs is required to include a toll free number and website address for Medwatch, the FDA’s database that tracks incidents of adverse effects of prescription medications. The FDA has two years to study and issue a recommendation on the appropriateness of including such information in direct-to-consumer television ads.
“Two years is too long to study whether the FDA should expand to television what is already required for print ads. We urge the FDA to complete this study as soon as possible and extend the requirement to TV ads,” said Elizabeth Foley, policy advocate for Consumers Union, nonprofit publisher of Consumer Reports magazine. Expanding the reporting notice to TV would inform a wider audience, allowing the FDA to get a more comprehensive picture of the possible risks of medications and better monitor drug safety.
In February, a Consumers Union poll found that among consumers who had taken a prescription drug, one in six (16 percent) had experienced a serious drug side effect, and only 35 percent were aware that serious side effects can be reported to the FDA. Eight in 10 (81 percent) said they had seen or heard an advertisement for prescription drugs within the past 30 days, but virtually all – 98 percent – had viewed an ad on television. Respondents felt overwhelmingly (87 percent) that TV ads should include information to report adverse reactions to the FDA.
“Considering the risks that may emerge after a drug is approved and comes on the market, we believe it is critical that consumers have a simple and understandable way to report serious side effects they experience,” said Foley. “We urge the FDA to require this information be included in television ads as soon as possible. The more information that is available about potentially harmful drug side effects, the better the FDA will be able to evaluate risks and inform healthcare professionals and consumers so they, in turn, can make better informed healthcare decisions.”
Spending on direct-to-consumer advertising has soared since the FDA relaxed rules on drugs ads in 1997. In 2006 and 2007 alone, spending on prescription advertising topped $10 billion.
For a copy of the complete testimony, click here.