FDA Relaxes TV Ad Policy; Print Ads Still Burdened

By Richard E. Kaplar
The FDA, long known for keeping a curmudgeonly grip on drug information, is trying something decidedly unorthodox: a lighter touch on television ads for prescription drugs.

The agency surprised many observers in early August by issuing proposed guidance on TV and radio drug ads that dropped the requirement to broadcast detailed product information. The move is intended to heighten consumer awareness and has already sparked a vastly expanded category of prescription drug advertising.

The FDA is now evaluating four months of actual broadcast experience and reviewing comments filed during a 60-day period that ended in early October. "By and large most advertisers seem to be in full compliance, although it is too early to gauge the effect on consumers and physicians," said FDA press spokesman Brad Stone.

Previously, stating both a drug's name and its purpose triggered a requirement to air voluminous data of interest mainly to physicians. This so-called "brief summary" information was virtually impossible to accommodate in a short commercial.

As a practical matter, only two types of drug commercials that escaped the disclosure rule were aired: ads that mentioned a product by name but didn't discuss its intended use; or ads that described a medical condition without mentioning a specific product. These so-called "reminder ads" urged viewers to consult their physicians, but often left consumers understandably confused.

Under the new policy, prescription drug ads must include information about major risks and must tell consumers how to obtain more information about a drug's uses and risks. Consumers are to be referred to sources of information that include:

  • a toll-free telephone number to request information by mail, fax, or phone;
  • ads running concurrently in newspapers or magazines that contain the "brief summary" information;
  • brochures, if widely available in places like doctors' offices, libraries, and stores;
  • a statement in the television ad that pharmacists and/or physicians (or veterinarians) may provide additional information.
  • an Internet web page with product labeling information.
Ads for prescription antihistamines and allergy medicines were among the first to hit the airwaves, although one drug maker, Schering Plough, quickly ran afoul of the FDA for its Claritin ads. The agency said the risk statement and directions to other information sources were unclear, but those problems have since been corrected, said the FDA's Stone.

Paul J. Boyle, director of government affairs for the Newspaper Association of America (NAA), called the new policy "a step in the right direction," but said it created a double standard because print ads must still carry the extensive "brief summary" information.

NAA and the Magazine Publishers Association filed joint comments with the FDA urging the agency to develop a clearer and shorter "brief summary" for prescription drug advertising, written in "consumer-friendly" language.

Daniel L. Jaffe, executive vice president of the Association of National Advertisers, agreed the new television ad policy was an "important step forward" but said the print requirement "turns consumers off and buries important information under a sea of data." The FDA plans to monitor the proposed guidance for two years before making it final, according to Stone.