CONSUMER GROUP RESPONDS TO FDA'S DRAFT GUIDANCE ON DIRECT-TO-CONSUMER ADVERTISING ON TELEVISION

Statement of
LINDA F. GOLODNER, National Consumers League President
regarding the FDA draft guidance for industry;
consumer-directed broadcast advertisements

WASHINGTON, DC -- Almost every consumer has seen the ads -- ads on television and in newspapers and magazines -- promoting prescription drugs. With the proposed guidance issued by the FDA today, the agency attempts to clarify the rules for advertising on radio and television. The National Consumers League wants consumers to receive risk information as well as promotional, benefit information in advertising.

Consumers receive health care information from a variety of sources -- from the pharmacist, the physician, through the Internet, articles in magazines and newspapers, from health reporters on radio and television, and from books that previously were seen only on the shelf of a physician or in a library.

Some consumers question why drugs are promoted to them, since the doctor ultimately determines what medications are right for the patient and writes a prescription when appropriate. The reason ads are directed to consumers is they are becoming more and more responsible for their own health care decisions -- and are being encouraged to open up a dialogue with their physicians and other health care providers to talk not only about pharmaceuticals but also about alternative therapies and nondrug remedies. They should not only discuss the branded medication, but also discuss whether generic alternatives are right for them.

The FDA recognizes that industry needs to know what the rules are when advertising directly to consumers. It is undertaking a comprehensive review of all advertising. With this guidance FDA is opening up the airwaves so industry can tell consumers about prescription drugs they might want to talk to their physicians about. While the National Consumers League does not oppose direct-to-consumer advertising, we think that responsible rules must be put into place. We recognize that this is a proposed guidance. We expect the FDA to be looking over the shoulder of industry to scrutinize the ads that are surely going to flood the market.

The National Consumers League is specifically concerned about:

1. "Major statement" -- safety and efficacy must be balanced with disclosure of risk and limitation of efficacy. This is called "fair balance." Important potential adverse drug events and significant risk information should be in ads. The industry should not be allowed to simply have a disclosure or risk statement in small type at the bottom of the ad "flashed on the screen." Information about risk and potential adverse events should be in the same size type as benefits of the medication and should be spoken as well as printed in a television ad.
   

2. Receiving approved labeling of product -- while the brief summary is not effective in broadcast advertising and has limited value in its present form in print advertising, the National Consumers League supports access to information to consumers about the medications they want to know more about and for medications they are now taking. The toll-free number that is suggested by the FDA is one way to receive that information. Companies might consider working with an independent organization to provide that information -- such as the American Heart Association for a cardiovascular medication.
   

   We are particularly concerned about protecting the privacy of the individual who calls the number. The company and/or the nonprofit organization should be prohibited from capturing information about the caller, except for the number to send a fax or an address to send labeling information. The company should not be permitted to maintain a database of the callers or to use the information for any other purpose, especially for marketing purposes or to sell lists to a third party.
   

3. The National Consumers League supports additional means for consumers to receive information about prescription drugs, especially through libraries, community organizations, pharmacies, grocery stores, and physician offices. These should be written for general audiences who might have limited reading skills and available in languages other than English, when appropriate. The FDA should also have this information available through its web site and through its regional offices and available to a consumer who calls the FDA.
   

The National Consumers League hopes that direct-to-consumer advertising will in fact encourage consumers to discuss symptoms and medications with health professionals. While advertising is of course meant to sell drugs, we hope that companies will use this opportunity to responsibly provide useful information for consumers about health conditions that will help initiate meaningful dialogue between patients and pharmacists and physicians. We also hope that the FDA keep a vigilant watch on the ads and aggressively enforce the law when it detects misleading and deceptive practices. We would expect the agency to call for immediate discontinuance of the ad in question, and that enforcement is not simply a warning letter or similar advisement to the offending company.