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Executive Summary

OTCs APPROVED THROUGH NDA PROCESS SHOULD BE ALLOWED SAME FLEXIBILITY in labeling as ingredients contained in monographs, the Proprietary Assn. (P-A) recommended in July 22 comments to the agency. The assn. submitted the comments in response to FDA's proposed changes in its "exclusivity" policy to allow use of alternative, truthful wording for approved label claims. The FDA proposal should be clarified, P-A said, because NDAed OTCs could "arguably" be precluded, under current FDA policy, from stating FDA APPROVED USES or APPROVED USES on a product label. FDA regs bar representations of agency approval from labeling of drugs approved under the new drug provisions (Sec. 505) of the FD&C Act. The proposed "flexibility" rule allows mfrs. to use exact FDA terminology within a boxed area designated FDA APPROVED USES or APPROVED USES. The assn. declared: "There is no supportable foundation in the record of this proceeding, nor in general regulatory policy, for permitting GRAS/E [generally recognized as safe and effective] OTCs to utilize one or more of the alternatives in describing indications for use approved under the OTC Drug Review, yet denying NDAed OTCs that same flexibility with respect to indications approved under applicable NDAs." P-A further argued that the regs governing statements of NDA approval on labeling apply only to approvals meeting statutory criteria for "new drugs." The flexibility proposal, P-A said, "addresses only the listing on labels or in labeling of 'APPROVED USES,' that is, 'indications' which have been approved by the FDA in a final OTC monograph. It can reasonably be argued that such labeling neither represents nor suggests that the drug is being marketed pursuant to an approved NDA and therefore is an FDA-approved new drug. It merely states that 'uses' for the drug are approved." In the comments, submitted by P-A President James Cope, the assn. praised the agency's general proposal. However, Cope reiterated the group's position that the exclusivity policy is "fundamentally defective on constitutional grounds, illegal under the Administrative Procedure Act, and in contravention of the FD&C Act." Noting the agency said it proposed the flexibility rule for "policy" reasons, Cope said the assn. "reserves the right to challenge" the final regs on legal grounds, should they "reintroduce a greater degree of 'exclusivity.' " P-A also urges that the proposal be clarified to specifically allow mfrs. to combine the alternatives for a single product. For example, Cope said, "there may be situations in which a mfr. may wish to utilize the first alternative by listing 'APPROVED USES' or 'FDA APPROVED USES' in a boxed area on the outside container, and then employ the third alternative by presenting on the principal display panel inside the package the same FDA-approved indications," boxed along with "alternative truthful and nonmisleading terminology outside the boxed area."

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