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FDA "EXCLUSIVITY RULE" FOR NDAed OTC DRUG LABELING

Executive Summary

FDA "EXCLUSIVITY RULE" FOR NDAed OTC DRUG LABELING will be amended "in the near future" to conform to flexible OTC monograph label regulations, FDA's OTC Drug Evaluation Division Director William Gilbertson, PharmD, told a Food and Drug Law Institute seminar Jan. 26 in Washington. "Right now, if you have an NDA for an OTC drug you would have to get that labeling precleared to include the box [on the product's packaging or labeling]," Gilbertson declared. "But we will be publishing, in the near future, a regulation which will allow you to do that without having to come to the FDA." For OTCs approved under a final monograph, FDA's current labeling requirements establish three ways for a manufacturer to state indications in OTC drug labeling, according to Gilbertson. First, indications for use that have been established in an applicable final monograph can appear within a boxed area designated, "Approved Uses." Other labeling information could also be included at the manufacturer's discretion; however, the boxed area would be designated, "Approved Information." Secondly, "other truthful and nonmisleading language" describing those indications can be prominently displayed, but a box cannot be used. Finally, in addition to the wording required in the boxed area, the labeling can contain, outside the box, alternative wording describing indications for use. Using the example of American Home's Advil, Gilbertson acknowledged some of the "dilemmas" that might result from the agency's as yet complete OTC review. "Technically, [American Home] should be able to get the 'FDA Approved' [statement] because they are approved," the FDAer remarked. "However, we have an ongoing rulemaking with all the other products that are in the monograph system -- the Anacins, the Bufferins, and such -- which cannot get a box until we have gone through the rulemaking and come out with the final rule. It will be interesting to see how the FDA deals with that."
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