Medical Device Link.

Originally Published MDDI March 2002

NEWS & ANALYSIS

Flora Nguyen

According to Janet M. Richardson, partner in the law firm of Morris, Polich & Purdy, the rules and regulations governing medical product promotion and advertising are changing—and medical device manufacturers should be changing their advertising strategies to keep pace.

Richardson presented on the topic of avoiding liability and compliance issues in product promotion and advertising in the device industry at the Medical Design & Manufacturing West Conference and Exhibition, held in Anaheim, CA, in February.

"Many medical device companies now use their Web sites for direct-to-consumer advertising," Richardson said, "and in order to protect the public from potential dubious and overstated claims, the legal and regulatory climate for medical product advertising has also changed to keep up with the new kinds of media available."

FDA and the Federal Trade Commission (FTC) share oversight of device manufacturers' advertising and promotional activities. The FTC regulates all forms of advertising in any medium, while FDA is only concerned with the marketing and promotion of regulated pharmaceutical and medical device products. FDA requires predistribution submission and clearance of labeling for regulated products. "The agency defines 'labeling' as all labels and other written, printed, or graphic materials appearing upon or accompanying any regulated product," she said.

If a company decides to copy an ad and disseminate it, however, Richardson said "the ad then becomes a label." She suggested that manufacturers be especially aware when materials are deemed labels by FDA and to incorporate such awareness into their advertising strategies.

Until both agencies issue guidelines, said Richardson, medical device manufacturers will do best to make sure their Web content mirrors the language of all FTC-cleared advertising and FDA-approved labeling. "In this case," concluded Richardson, "it is better to be safe than sorry, as product-liability litigation can be a very expensive and time-consuming process for medical device companies."

Copyright ©2002 Medical Device & Diagnostic Industry