OTC drug Internet promos jurisdiction will not be ceded by FDA, APCO's Pines predicts.
This article was originally published in The Rose Sheet
Executive Summary
OTC DRUG INTERNET PROMOTIONS JURISDICTION probably will not be given up by FDA, APCO Healthcare President Wayne Pines said at the Drug Information Association's June annual meeting in Montreal. Noting that "some companies favor declaring all Internet materials as `advertising' because advertising for over-the-counter drugs is regulated" by FTC, Pines said "it is not likely that FDA will relinquish to the Federal Trade Commission jurisdiction over OTC drug promotion on the Internet."
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OTC DRUG INTERNET PROMOTIONS JURISDICTION probably will not be given up by FDA, APCO Healthcare President Wayne Pines said at the Drug Information Association's June annual meeting in Montreal. Noting that "some companies favor declaring all Internet materials as `advertising' because advertising for over-the-counter drugs is regulated" by FTC, Pines said "it is not likely that FDA will relinquish to the Federal Trade Commission jurisdiction over OTC drug promotion on the Internet." Enumerating a "few statements of principle" he believes "would adequately address the issues about which FDA is concerned" on the Internet, Pines highlighted labeling. "All product-specific information placed by regulated companies on the Internet is regarded as `labeling' and must include fair balance within the materials themselves and ready access to a full package insert," he noted. Companies should be "fully responsible" for chat rooms they sponsor and the information disseminated "must be within approved labeling," Pines said. "A chat room independently sponsored by someone else is not a company's responsibility, nor is it a company's responsibility to correct misinformation on the Internet, just as it does not have to correct misinformation disseminated by others in other media." Pines emphasized that FDA should keep the Internet policy simple. "To make the policy more complex would create unnecessary complications from a regulatory standpoint and put barriers in the way of full development of the Internet by" OTC drug and prescription companies. Financial information, Pines suggested, should be regulated by FDA "just as if it were issued in writing." Information for a financial audience "must clearly be that, it may not over-promote or prematurely promote a product and must describe clearly a product's regulatory status," he noted. U.S. companies should not be able to use unapproved information from foreign affiliates on their Web sites, Pines said. "Information issued by an overseas subsidiary or home office...that is outside the information permitted in the U.S. may not be promoted." |