FDA Panel Considers Toll-Free Number for TV Drug Ads

By Steven Reinberg

HealthDay Reporter

May 16, 2008

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.

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.

Foley said it's important that consumers 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," she said. "That's when the real test happens."

For example, the potentially deadly cardiovascular side effects of the arthritis drug Vioxx weren't discovered until the drug had been on the market for several years.

The FDA does have a method for consumers to report adverse side effects from drugs. However, according to a Consumer Reports survey, most people who report serious side effects report them to their doctor; only 7 percent report them to the FDA, Foley said.

Direct-to-consumer advertising generates billions of dollars in sales for both drug companies and the television industry. In 1997, the federal government eased the rules on advertising on TV and radio, allowing drug companies to shorten the warnings on side effects in commercials. Since that time, drug companies have spent an estimated $14 billion advertising prescription medications on broadcast and cable TV, according to the Dow Jones Newswires.

Some recent direct-to-consumer drug ads have come under fire from consumer advocates. The drug makers Merck and Schering-Plough were criticized for promoting the cholesterol drug Vytorin, while not disclosing studies that questioned the drug's effectiveness. And Pfizer was criticized for ads promoting its cholesterol-lowering drug Lipitor that featured Dr. Robert Jarvik, who is not a practicing medical doctor, Dow Jones reported.

Source: www.medicinenet.com

Comment: Very recently pharmaceutical giant Merck has agreed to pay a $58 million to settle the allegations that it downplayed the potential cardiovascular risks of Vioxx in direct-to-consumer advertising. Vioxx was generating $2.5 billion per year while it was on the market. It was taken off the market in 2004, however Merck executives were aware of the associated heart risks much before that, and intentionally did not disclose it. It is possible that if people had known of the fact that there is an easy way to contact the FDA through a toll-free number, Vioxx heart risks would have been apparent much earlier. The Consumers Union wants the FDA to require a toll-free number and a Web site address on all TV drug ads. Such information is already mandatory for print ads. Yet, the FDA spokesperson — while highlighting bureaucratic steps at FDA — said that it would not be before two years that such regulation can be in effect for TV drug ads. It is surprising that providing such vital information was not already mandatory when the TV ads initially started. On the contrary the federal government relaxed the rules on TV ads in 1997, allowing drug companies to shorten the warnings on side effects in commercials. They were also considering about reducing the number of side effects to be mentioned on a TV ad to three, so as not to overwhelm the layperson with technical information! Since 1997, drug companies have spent on average $14 billion on direct-to-consumer media advertisement. Obviously, such advertisements bring billions of dollars for the television industry and exponentially increase the drug industry profits, but the slow processing at the FDA once again questions the intentions of our regulators. The FDA mission statement states that the agency is responsible for protecting public health by assuring safety and efficacy of various medications, medical devices, veterinary drugs, biological products and the nation’s food supply. In that case any change that would positively affect enhancing public health and safety and should promptly be adopted. However, in reality, the estimated time for adding just a phone number to the drug ad is going to take at least couple of years!

Dr. Rath has been actively involved in bringing such discrepancies to public attention. You can get more information on Dr. Rath's battle and join his health alliance at www.drrathhealthalliance.com