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OTC LABEL 'FLEXIBILITY" POLICY EXTENDED TO NDAed/ANDAed PRODUCTS

This article was originally published in The Tan Sheet

Executive Summary

OTC LABEL 'FLEXIBILITY" POLICY EXTENDED TO NDAed/ANDAed PRODUCTS under a proposal published by FDA in the Nov. 9 Federal Register. The "flexibility" policy, also known as the alternative labeling policy, currently applies only to over-the-counter drugs marketed under an approved monograph. The proposal would extend the policy to OTCs marketed under approved NDAs or ANDAs in order to "make the labeling of OTC drug products consistent," the agency said. Comments on the proposal are due by Jan. 10. In a May 1986 final rule, FDA established three alternatives for the "indications" portion of OTC drug product labeling: (1) listing indications as spelled out by the applicable monograph under an "APPROVED USES" heading within a boxed area or including additional information under an "APPROVED INFORMATION" heading; (2) using "other truthful and nonmisleading statements describing indications for use" instead of the monograph language but without the "APPROVED USES"/"APPROVED INFORMATION" boxes; and (3) offering monograph language in the boxed area and other information outside the boxed area. During the development of the 1986 final rule, FDA noted that it received several comments requesting that the alternative labeling be permitted for OTCs marketed under approved applications. FDA said it "agreed in principle" that alternative labeling should be extended to NDAed/ANDAed OTCs. However, because the alternative labeling policy was contained in a part of the FD&C Act that applied only to OTC drugs covered by a monograph, FDA noted that a separate regulation was required to address products subject to an application. Under the Nov. 9 proposal, the labeling of OTCs approved under an application "would be permitted to contain in a prominent and conspicuous location either: (1) the designation 'APPROVED USES,' together with the specific wording on indications for use established under an approved application, all of which must appear in a boxed area; or (2) the designation 'APPROVED INFORMATION,' together with the specific wording on indications for use and other applicable labeling . . . established under an approved application, all of which must appear within a boxed area." The boxed area may be modified to read "FDA APPROVED USES" or "FDA APPROVED INFORMATION" or other similar wording. FDA pointed out that "all labeling for new drugs, including alternative language relating to indications for use, requires preclearance by FDA. FDA may approve alternate labeling language for describing indications for use during the process of approving applications for new OTC drugs." In addition, if the "APPROVED USES"/"APPROVED INFORMATION" boxed area concept is the only change being made in the application's approved labeling, manufacturers would not be required to submit a supplemental application but could inform the agency when this change occurred by including this information in the annual report for that application. In the same way that OTCs marketed under monographs cannot use the "APPROVED USES" designation until the final OTC drug monograph has been issued for that category of drugs, drugs marketed under an application also cannot use the designation without a finalized monograph, FDA said. "Thereafter, the "APPROVED USES" boxed area concept would be implemented at the same time for all drug products in that category, whether marketed under an OTC drug monograph or an application," the agency noted, adding that it "believes that this approach would promote consistency in the labeling of OTC drugs and reduce consumer confusion." Regarding ANDAS, FDA noted that the FD&C Act requires that labeling for a new drug approved under an ANDA be the same as the labeling approved for the listed drug. Although this provision could be applied to the alternative labeling policy to mean that an ANDAed OTC "could not use the 'APPROVED USES' or 'APPROVED INFORMATION' language in its product's labeling unless the manufacturer of the listed drug were to do so first," FDA emphasized that it "does not find this to be an equitable situation." The agency said that it "does not see any inequities" if a new drug approved under an ANDA and a listed drug do not have the same labeling, adding that it does "not believe that consumers would be misled by such a difference in product labeling, when the product is marketed pursuant to an approved application or an OTC drug monograph." Therefore, "FDA proposes that manufacturer of new drugs approved" under an ANDA "be allowed to use this limited alternative labeling." In a separate Nov. 9 Federal Register notice, FDA proposed technical amendments to enable the application of the alternative labeling policy to NDAed/ANDAed OTCs.
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