U.S. health experts suggested Friday that direct-to-consumer television drug ads include a toll-free phone number to enable consumers to report adverse side effects. This follows last month’s request by Congress that the Food and Drug Administration (FDA) speed its efforts in forcing drug companies to include safety-reporting information in television and radio ads. Such information is currently FDA-mandated for print ads. Congressional Democrats have long been increasing pressure on the drug industry following mounting problems over the marketing of several popular drugs, including Vytorin, Lipitor, and Procrit.The experts involved serve on a panel that advises the FDA and at Friday’s meeting, discussed designing a study to determine the best way to add the phone number to TV ads. FDA spokeswoman Rita Chappelle said the FDA would look at the panel’s recommendations and incorporate them into the design of a study. Once complete, the next step would be to issue regulations and obtain Congressional approval, she said. No quick fix, “It could take some time,” Chappelle said. “It could take a couple of years.”
This was a disappointment to some consumer advocates looking for a quicker response. “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.”
Chappelle added that because television is a different medium, study is needed, such as the best location and length for the number. Congress asked the FDA to evaluate adding these numbers to TV ads for a better understanding of drugs’ adverse effects following approval. Consumers Union wants the FDA to require a toll-free number and a Web site address on all TV drug ads. “It’s already required for print ads, let’s just expand it to TV ads,” Foley said, adding that consumers should have a way to report adverse side effects. “Most of the time, drugs are only tested on a very small number of people and it’s not until the drug is on the market that we start to see serious side effects. That’s when the real test happens,” Foley argued. The FDA does have a method for consumers to report a drug’s adverse side effects, according to a Consumer Reports survey; however, most people report side effects to their doctor; only seven percent report them to the FDA.
Direct-to-consumer drug marketing nets billions in sales for drug makers and television. In 1997, the government relaxed TV and radio ads rules, allowing drug makers to shorten warnings on side effects in commercials. Now, some recent ads have come under fire. Merck & Co. and Schering-Plough have been harshly criticized for promoting cholesterol drug Vytorin and not disclosing a study questioning Vytorin’s effectiveness. Pfizer Inc. featured Robert Jarvik, inventor of the artificial heart in commercials in which “he appears to be giving medical advice”; Jarvik in neither a cardiologist nor a practicing physician. Side effects of the potentially deadly cardiovascular arthritis drug Vioxx were not discovered until Vioxx was on the market for years.
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