Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA'S OTC FLEXIBILITY POLICY GIVES MFRS. OPTION OF ALTERNATIVE LABEL CLAIMS; INCENTIVE TO USE FDA'S SPECIFIED CLAIMS IS AN IMPLIED FDA 'SEAL OF APPROVAL'

Executive Summary

FDA's proposed policy for OTC label claims would allow mfrs. to substitute alternative wording for the label indications specified in the agency's OTC mongraphs. The agency's plan for revising the current approved labeling indications policy appears in the April 22 Federal Register. Rather than requiring mfrs. to use exact, FDA-approved language, the agency will permit mfrs. to choose "other truthful and nonmisleading language describing those indications for use that have been developed under a relevant monograph." The April 22 proposed reg states a "flexibility" policy for OTC label claims and represents a major change in regulatory philosophy by the agency. A whole generation of execs in the OTC industry has grown up describing FDA's approach to OTC claims from a diametrically opposite point of view, expressed in the common Washington catch-phrase, the OTC "exclusivity" rule. In the preamble to the April 22 proposal, FDA declares: "The agency now believes that the goal of ensuring truthful, nonmisleading labeling without inhibiting effective consumer communication does not require the enforcement of a rigid exclusivity policy." "Recourse" Without Consuming Valuable "Resource" Is HHS' Poetic Way Of Describing Reg "Recognizing that, within limits, there can be various ways of accurately stating the same thing, some of which may even be more meaningful to potential purchasers of OTC drug products," FDA explains, "the agency has concluded that it can meet its responsibilities by providing greater flexibility for the use of alternative truthful statements without recourse to the time and resource-consuming monograph amendment process." The proposal gives manufacturers three options for presenting labeling claims: [1] exact FDA terminology within a boxed area designated "approved uses," "FDA-approved use," or a similar term; [2] a manufacturer's own, synonymous terms in an unboxed area; or [3] a combination of boxed, approved terms and unboxed alternative language. If the boxed information includes FDA-mandated statements about the products in addition to claims, then the reg says that the box could be designated by a term such as "FDA-approved information" instead of approved uses. The agency indicates that monograph language will be used as a "regulatory benchmark" to define the boundaries of appropriate terms. Acknowledging that "other wording may be developed that would also" accurately describe a drug's "properties," the agency says, "the specific wording established in the monograph would provide a standard for measuring the accuracy of synonymous terminology. The standard could be used both by the agency in determining appropriate enforcement actions and by the courts in evaluating the merits of such actions." In a number of recent tentative final monographs, FDA has included lists of indications to supplement approved claims. The agency says that these lists will be treated as examples of "other truthful and nonmisleading" labeling claims. The lists will not be included, however, in final monographs. The agency states the limits of alternative language by asserting that manufacturer synonyms cannot be "inconsistent" with language in a "relevant final monograph." Further, manufacturer language cannot "imply or indicate a use that is not established under a relevant monograph." Alternative language that is inconsistent with final monograph statements "would render the drug product a 'new drug,'" FDA says. FDA suggests in the preamble the advantages of using agency-specified language. "The agency anticipates," the notice says, "that consumers will look for the approved labeling when purchasing OTC drugs, thereby providing an incentive for mfrs. to use this alternative." The relaxation of the exclusivity policy, FDA says, applies only "to the indications for use tht are established in the final monograph." The agency cautions that "all other required OTC drug labeling would continue to be subject to the existing exclusivity standard." While modifying the rules for OTC labeling on "policy" grounds, the agency addresses the legal justification in the Federal Register notice. "FDA specifically rejects the assertions in the submitted comments that the present policy is legally deficient on constitutional grounds, is in violation of the Administrative Proceedure Act, or contrary to the Federal FD&C Act." The flexibility policy apparently will shift the burden of reviewing labeling claims from the OTC Drug Evaluation Division to the OTC compliance group and could speed up the issuance of the remaining final monographs. It also could free the OTC Drug Evaluation Division for more work on Rx-to-OTC switches. The resolution of the labeling claims issue was previewed to Proprietary Assn. board members in late March in a presentation by HHS Secty. Heckler. Heckler told P-A at that time that the proposed regulation is "a step in the direction of achieving a better partnership with the private sector." She emphasized that "the partnership is very much dependent upon the conduct and responsiveness of each party to the deal." The HHS Secty. noted that the Reye Syndrome information campaign is test of "voluntary partnership." She told P-A: "I point to this whole Reye Syndrome question as really a test case on the more significant issue of the ability of our government, especially in terms of health policy, to actually effect a policy of regulation [in which] it doesn't respond to every crisis with the regulatory reflex as the first answer." The flexibility rule was also previewed two-and-a-half years ago prior to the FDA open hearing on the subject. At that time, FDA noted that one of its options for the labeling policy would be to allow two sets of terms, FDA-specified or mfr. synonyms. The final proposal additionally allows the combination of [approved terms and synonyms] and the use of graphics to highlight the FDA-approved status.
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS008193

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel