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FDA OTC MARKETING STATUS WILL BE GIVEN ONLY TO DRUGS WHICH CAN BE LABELED FOR USE WITHOUT MD SUPERVISION, FDA SAYS IN DENYING NARD "THIRD CLASS" PETITION

Executive Summary

FDA will approve a drug product for OTC marketing only if it can "be adequately labeled for safe and effective use by lay persons without supervision of a physician," the agency said in a letter rejecting the Natl. Assn. of Retail Druggists (NARD) petition for a third class of drugs. In a Dec. 3 letter to the assn., FDA Com. Young noted that the agency has considered the issue of limiting certain drugs to sale-by-pharmacist only several times since 1974. In each case, Young said, "the agency has continued to conclude that limiting certain drugs to sale-by-pharmacist only is unnecessary because a public health need for such a limitation has not been demonstrated." NARD's January 1984 citizen petition specifically requested that FDA consider sale-by-pharmacist only for drug ingredients under consideration for Rx-to-OTC switches, new entity OTC drug ingredients approved through the NDA process and ingredients moved from Rx to OTC status since Jan. 1, 1981. The petition also asked that FDA limit OTC availability of ibuprofen for a specified transitional period to sale-by-pharmacist only. FDA declared that "under the federal Food, Drug & Cosmetic Act there is no provision for an intermediate class of drugs between OTC and Rx products. The statutory requirement that a drug either be limited to Rx dispensing or available OTC with adequate directions for use seems to preclude the agency from establishing a class of drugs whose labeling would need to be supplemented by a pharmacist's instructions." In its petition NARD cited and FDA statement indicating the agency was authorized to restrict the channels of distribution for a drug. The statement "must be viewed in light of the decision in the methadone case," FDA remarked. "The statement preceded the decision in that case, and that decision did establish that certain kinds of restrictions on the channels of distribution of an Rx drug are not permitted under the [FD&C] act." In the methadone case, an FDA effort to restrict distribution of methadone was successfully challenged by the American Pharmaceutical Assn. With respect to ibuprofen, Young stated that FDA's approval of ibuprofen for OTC use "reflects the agency's determination that adequate labeling for lay use can be prepared for ibuprofen and that sale-by-pharmacist only is not necessary for its safe use." NARD's petition, FDA noted, "does not present any new evidence that would support such a limitation with respect to ibuprofen or to a drug switched from Rx use." Young added: "Certainly, if the agency were to find that the labeling for a particular OTC drug product did not provide sufficient information for a lay person to use that product safely, it would take appropriate action." Responding to NARD's request that switched ingredients be limited to pharmacies only, FDA said it reassessed all switches that occurred since 1976 and reaffirmed its position that "labeling of those drug products is adequate for public health protection." FDA also denied a similar petition submitted by the American College of Apothecaries in June. In its petition, the college cited the Proprietary Assn.'s consumer self-medication study released in March, contending that the survey supports a need for a class of non-Rx drugs for sale-by-pharmacist only. "We have reviewed the results of the Proprietary Assn. study to which you refer, and disagree that it points out a need for establishing such a class of products," Young stated in a letter to the group. "While the study indicates that a large number of American consumers turn to non-Rx drugs to treat various ailments, and provides evidence that these consumers find OTC medicines useful, it does not demonstrate that the public health would be enhanced through the availability of Rx drugs through sale-by-pharmacist only."

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