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FDA "PRIOR APPROVAL" OF Rx ADS WILL BE CONFIRMED

Executive Summary

FDA "PRIOR APPROVAL" OF Rx ADS WILL BE CONFIRMED by a written response from the agency, according to a new guidance policy from FDA's prescription ad review group. The just-released policy statement notes that FDA's Division of Drug Advertising & Labeling will distinguish between a "superficial" review and "prior approval" of prescription drug ads. The agency's ad review group says that it "considers the results of the two types of review quite differently." The guidance, dated March 1988, is described by FDA as its "best judgment" on ad preclearance policies "at this time." The outcome of a "superficial review," FDA stated, "without a written response by the [ad] division, does not constitute a review for 'prior approval' and will not be considered as such." The guidance notes that members of the pharmaceutical or medical advertising community "occasionally . . . request a review of basic ideas and concepts or a superficial review of materials for obvious errors." The ad division says it "generally encourages these meetings because they usually occur early in the development of promotional campaigns when FDA advice can be efficiently incorporated without necessitating major revisions." FDA pointed out that the result of this type of superficial review is usually in the form of verbal advice and, consequently, the ad division does not keep written materials from such meetings in its files. However, the results of a "thorough review, with results of the review reported in writing to the requesting firm, constitutes in our view a review for 'prior approval' of the specific materials," the guidance explains. Agency staffers say that the guidance was not prepared in response to any specific situation. There have been several highly visible incidents, such as the Tavist-1 ad campaign, that have created uncertainty about the meaning of FDA preclearance of advertising. By linking "prior approval" to a written response from FDA, the ad division is making it more difficult for firms to feel that they have carte blanche for an Rx ad campaign. The agency's natural reluctance to put any decisions in writing will act as a restraint on the number and frequency of letters to manufacturers pre-approving Rx ads. FDA DRUG AD DIV. POLICY GUIDE ON PRE-PUBLICATION APPROVAL OF PROMOTIONS This is a reproduction of the drug ad policy guidance prepared by FDA and dated March 1988. The first paragraph is a disclaimer on the policy guidance explaining its "informal" standing in the scope of FDA regulatory statements. THIS STATEMENT IS AN INFORMAL COMMUNICATION UNDER 21 CFR 10.90(b)(9) THAT REPRESENTS THE BEST JUDGMENT OF THE DIVISION OF DRUG ADVERTISING AND LABELING/DRUG ADVERTISING REGULATION BRANCH AT THIS TIME. THIS STATEMENT, HOWEVER, DOES NOT REPRESENT THE FORMAL POSITION OF THE FOOD AND DRUG ADMINISTRATION/CENTER FOR DRUG EVALUATION & REVIEW, AND DOES NOT BIND OR OTHERWISE OBLIGATE THE FOOD AND DRUG ADMINISTRATION TO THE VIEWS EXPRESSED. Policy Guidance: Pre-Publication Review of Promotional Materials 21 CFR 202.1(j)(4) states: "Any advertisement may be submitted to the Food and Drug Administration prior to publication for comment. If the advertiser is notified that the submitted advertisement is not in violation and, at some subsequent time, the Food and Drug Administration changes its opinion, the advertiser will be so notified and will be given a reasonable time for correction before any regulatory action is taken under this section. Notification to the advertiser that a proposed advertisement is or is not considered to be in violation shall be in written form." FDA follows the same procedures for promotional labeling. On the other hand, occasionally members of the pharmaceutical or medical advertising community request a review of basic ideas and concepts or a superficial review of materials for obvious errors. FDA generally encourages these meetings because they usually occur early in the development of promotional campaigns when FDA advice can be efficiently incorporated without necessitating major revisions. Results of these superficial reviews are in the form of verbal advice and FDA usually does not maintain materials in its files. The Division of Drug Advertising & Labeling considers the results of these two types of review quite differently. The results of a thorough review, with results of the review reported in writing to the requesting firm, constitutes in our view a review for 'prior approval' of the specific materials. The results of a superficial review, without a written response by the Division, does not constitute a review for 'prior approval' and will not be considered as such.
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