FDA Cites Most DTC Drug Spots

More than half of the 30 TV spots for prescription drugs that have aired since the U.S. Food and Drug Administration issued new rules in 1997 violate those guidelines, government officials disclosed last week. The FDA cited 18 pharmaceutical companies for ads which were unfairly balanced or failed to disclose a drug’s side effects.
In all 18 cases, the spots were taken off the air. Some were edited and re-aired. The FDA, which evaluates all pharmaceutical ads, has the power to take a company to court if it objects to the content of its advertising.
“We scrutinize the ads very carefully and we object to risk information being omitted or minimized,” said Nancy M. Ostrove, chief of marketing practices for the FDA’s Center for Drug Evaluation and Research.
Among those cited:
Novartis for its cholesterol reduction drug Lescol. The company failed to send copies of the ad to the FDA. “We had every intention of doing it, but regrettably it did not happen,” said a company representative, noting an internal inquiry on the matter had begun.
Knoll Pharmaceutical for weight-loss drug Meridia. The ad did not display potential side-effects prominently. Foote, Cone & Belding’s Meridia work broke Oct. 22. The ad was pulled, altered and rebroadcast within 24 hours. “We were able to make the corrections immediately,” said a Knoll representative.
Warning letters were also sent to Glaxo Wellcome for Zyban, Schering for Claritan and Pharmacia & Upjohn for Depo-Provera. Some $1.2 billion was spent last year on DTC prescription drug ads.
The American Association of Advertising Agencies cautioned against
zealotry: “I am concerned if the FDA [says] all information about a drug must be in the ad. That’s impossible,” said the 4A’s Hal Shoup. –with Sloane Lucas