FDA Loosens Restrictions on Drug Ads on TV, Radio
WASHINGTON — In a move expected to spark an avalanche of commercials for prescription drugs, the Food and Drug Administration on Friday announced a policy giving pharmaceutical companies more leeway to promote their products on television and radio.
The revised FDA restrictions mean companies may spell out their product’s explicit purpose on commercials without including a long list of side effects and potential problems associated with the drug. That requirement had caused manufacturers to either shy away from using television and radio or to air commercials notable for their vagueness.
Now the companies can directly tout the benefits of their wares, along with the main risks. If the consumer wants to know more, a toll-free phone number or Internet address is required to be included in the ad.
“This will allow the consumer to get a more direct message,” said Don McLearn, a spokesman for the FDA. “The ad agencies will like this, the drug producer will like this and the consumer will like this.”
But some consumer groups criticized the change, warning it will result in misleading drug ads and incomplete information, which in turn could prove harmful to the public.
Companies raced to take advantage of the policy: Glaxo Wellcome planned to immediately begin airing a TV commercial that tells herpes sufferers the new drug Valtrex can treat the sexually transmitted disease. And early next week, those ads featuring a wind-surfer in a wheat field telling people to “Ask your doctor about Allegra” will double to 60 seconds as Hoechst Marion Roussel adds the information that the drug treats allergies.
The new policy does not affect guidelines for print ads. In fact, many of the new TV campaigns for prescription drugs are expected to direct consumers to read magazines that carry fuller ads, complete with FDA-approved warning information.
FDA officials, however, said they intend to review the rules for print ads to determine whether they should be eased as well.
Drug advertising already had been growing rapidly, and some experts expected Friday’s FDA announcement to fuel a boom. Pharmaceutical companies spent $595.5 million on ads last year, a 90% increase over the $313.2 million spent in 1995, according to Competitive Media Reporting, with the bulk of the money going to magazines.
“This has been one of the fastest growing areas of advertising despite the hurdles, and as you lower those hurdles the advertising will only increase,’ said Daniel Jaffe, executive vice president of the Assn. of National Advertising. “I will be shocked if there is not going to be a very substantial increase in advertising.”
Michael Marino, president of a New York ad agency specializing in health care, called the FDA policy change “great, great news for us.”
“We’re very excited for our clients that now have huge opportunities to talk to their constituents,” Marino said.
But Sidney Wolfe, a physician associated with the Public Citizen consumer organization, said: “There is little doubt that these ad campaigns will work, but in the process they will do more harm than good.”
Wolfe said he doubted most consumers would call a toll-free number or go to an Internet site to get more information on a drug. And if they do, Wolfe said, he is worried that in some cases inaccurate or misleading information will be given.
The new guidelines went into effect immediately, but the FDA will accept public comment on the rules for 60 days, after which they could be modified. Responding to concerns about the policy change, FDA spokesman Brad Stone said: “If any data comes out showing negative effects, we would be very interested in looking at it.”
The FDA also plans to reexamine the policy every two years, in part to ensure drug companies are not airing misleading commercials.
