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Executive Summary

OTC "FLEXIBILITY" POLICY EXTENSION TO STATEMENT OF IDENTITY labeling is urged by the Proprietary Association in April 7 comments to FDA on the tentative final monograph for OTC menstrual products. Although submitted to the menstrual product rulemaking, the association is requesting that FDA extend its flexibility policy to statement of identity labeling for all OTC drug classes. Currently, FDA's flexibility policy, which allows use of truthful and nonmisleading labeling statements that are not specified in the monographs, applies only to label claims. "There is the same need and legal requirement for companies to be able to use truthful and nonmisleading terms other than monograph terms to identify OTC products as there is to describe indications for use, which the agency has expressly acknowledged warrants application of the flexibility principle," the association maintained. Statements of identity, P-A argued, "can be characterized as a 'shorthand' or 'abbreviated' version of indications for use . . . [and] are subject to the same legal and policy principles." P-A asked FDA to either "issue an advisory opinion interpreting the statement of identity regulation . . . to permit flexible labeling" or amend "the OTC review regulations to include a flexibility policy regulation covering statement of identity labeling explicitly." As an illustration of the benefits of extending the flexibility policy, the association cited the menstrual TFM's permitted indications for smooth muscle relaxants. Under the rulemaking, the products may carry indications "for relief of . . . cramps" or "for relief of backache," as well as alternative truthful and nonmisleading indications. "The single statement of identity proposed, however, is 'muscle relaxant,'" P-A noted. "If an exclusive labeling policy is applied to statements of identity, a company would not be permitted to employ a manifestly truthful and nonmisleading statement of identity such as 'menstrual cramps medication' without prior agency approval." The association also argues that "application of the exclusivity policy to statements of identity would prohibit truthful and nonmisleading commercial speech" provided for under the First Amendment. "Application of the exclusivity policy to statements of identity (as for indications) fails the third and fourth parts of the test established by the Supreme Court in Central Hudson Gas and Electric Corp. v. Public Service Commission of New York for determining the constitutionality of governmental restrictions on commercial speech," P-A maintained. "These two parts of the test provide that government cannot regulate speech that poses no danger to its asserted interests . . . and that the government cannot completely prohibit expression where a narrower restriction would serve its interests as well," the association explained. Applying the exclusivity policy to statements of identity, P-A continued,"represents the most restrictive means of assuring such labeling is truthful and nonmisleading and it is therefore constitutionally infirm."

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