TV ads for prescription drugs are already required to list potential side effects, but Consumers Union says that mandate doesn't go quite far enough. It wants the ads to also include a toll-free number and a website address where consumers can report serious side effects.
CU says it's not an unreasonable request. By law, print ads for drugs are 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 same requirement, the group argues, should apply to drug ads on TV.
The FDA has two years to study and issue a recommendation on the appropriateness of including such information in direct-to-consumer television spots.
"Two years is too long to study whether the FDA should expand to television what is already required for print ads," said Elizabeth Foley, policy advocate for Consumers Union. "We urge the FDA to complete this study as soon as possible and extend the requirement to TV ads."
Expanding the reporting notice to TV would inform a wider audience, according to CU, 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 could be reported to the FDA.
Eight in 10 (81 percent) said they had seen or heard an ad 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 health care 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.
