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Executive Summary

FDA should not mandate preclearance of direct-to-consumer advertising of prescription drugs, King & Spalding stated in a June 14 citizen petition to the agency. King & Spalding, an Atlanta law firm with an active D.C. food and drug law practice, petitioned the agency to forestall a pending direct-to-consumer advertising proposal. The law firm said it "requests that the commissioner refrain from adopting or implementing any policy to regulate consumer-oriented prescription drug advertising such as proposed" in an early version of the proposed guidance on direct-to-consumer ads. "If adopted, the proposed policy would mandate routine prior approval of the content of truthful and non-misleading prescription drug advertising." The law firm asked FDA Commissioner Kessler to "recognize that existing FDA regulations in [the Code of Federal Regulations] adequately serve FDA's legitimate interest in protecting consumers from false or misleading advertising, particularly when the advertising promotes only consumer preference characteristics of the drug product." The petition is based on the proposed policy as it was submitted in a July 17, 1990 letter from Center for Drug Evaluation and Research Director Carl Peck to then-Acting Commissioner Benson. Neither the original letter nor subsequent revisions of the policy have been published. Under the proposed policy, King & Spalding noted, direct-to- consumer ads will be classified into three categories: "help- seeking;" "product-mention" or reminder ads; and "product-claim advertisements." For product-claim advertisements, the proposed policy would require that sponsors obtain prior approval. King & Spalding's primary concern centers on ads that focus on consumer preference characteristics, which are included in the product-claim advertisement category and therefore must be pre- approved. King & Spalding argued that "consumer preference characteristics are, like drug prices, intended only to enhance 'informed purchasing decisions after a drug has been prescribed.'" The commissioner should, the law firm argued, "interpret any new prior approval requirement as inapplicable" to such ads. The law firm also maintained that prior approval "constitutes an overbroad prior restraint on constitutionally protected commercial speech." The law firm pointed out that "failure to obtain prior approval, according to the proposed policy, will be grounds for the issuance of regulatory letters and the use of seizures or injunctions to halt distribution of the advertised drug." To get approval of consumer-oriented product claim advertisements under the policy, the petition says, a company "must submit 'evidence' that: 1) the message to the consumer cannot be conveyed by help-seeking or other forms of institutional advertisements, and 2) the proposed PCA presents needed information in a balanced, understandable and otherwise non- misleading manner." The petition adds that "the evidence may consist of medical, public health and other scientific literature as well as methodologically appropriate consumer testing." Before conducting consumer testing, the proposed policy requires that companies submit a proposal of their ads "to obtain an agency determination that the circumstances warrant testing." Only "after such testing has demonstrated, and FDA has agreed, that help-seeking or institutional advertising will not meet informational needs and consumers will properly interpret and comprehend the intended message, may a sponsor's proposed PCA be approved." Lou Morris, head of FDA's marketing practices and communications branch, Division of Marketing, Advertising and Communications, has been on detail at the Federal Trade Commission helping develop consumer perception tests that are used to generate evidence in cases of OTC drug advertising violations. FDA may use its experience with FTC in future regulation of direct-to- consumer advertising of prescription drugs.

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