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OTC IBUPROFEN APPROVAL RECOMMENDATION BY ADVISORY CMTE. REFLECTS "ACTUAL"

Executive Summary

OTC IBUPROFEN APPROVAL RECOMMENDATION BY ADVISORY CMTE. REFLECTS "ACTUAL" safety and efficacy, but not general recognition of safety and efficacy of the product, D.C. District Court Judge Thomas Flannery said in a May 10 opinion. The ruling upheld FDA's decision in May 1984 to reject Chattem's petition requesting that 200 mg OTC ibuprofen be approved through OTC monograph procedures rather than through NDA proceedings. In the lawsuit filed in June 1984, Chattem asked the D.C. Federal Court to overturn FDA's decision and to order the agency to reconsider the product's status. Noting that Chattem "has relied entirely on the findings" of FDA's Arthritis Advisory Cmte. as the basis for asserting OTC ibuprofen was generally safe and effective, Flannery declared: "While the Arthritis Advisory Cmte. concluded that OTC ibuprofen was actually safe and effective, the transcript of the cmte.'s hearing does not indicate that it ever considered whether or not the scientific community would, as a general matter, agree with that conclusion." Judge Flannery noted that FDA regarded the advisory cmte.'s recommendation not as acknowledgement of ibuprofen's "generally recognized" safety and effectiveness, as Chattem argued, but rather as a consideration of the actual safety and effectiveness of the drug. Siding with FDA, Flannery stated: "The fact that such a panel finds a drug to be actually safe and effective does not necessarily mean, however, that either members of the panel or the scientific community as a whole would agree that safety and effectiveness are 'generally recognized.' " Flannery added that "if Chattem's approach were adopted, new drugs would achieve GRASE [generally recognized as safe and effective] status whenever an advisory panel recommends approval of an NDA, so long as that approval is based, at least in part, on published and available data." "Further undercutting" Chattem's claim for GRASE status of OTC ibuprofen at the 200 mg dosage is the fact that the company's argument is based on experience with 400 mg Rx ibuprofen, Flannery said. "Although the FDA was willing to extrapolate from the data on 400 mg Rx ibuprofen to find that 200 mg OTC ibuprofen is safe and effective for purposes of approving the NDA's, FDA's refusal to accept experience with the 400 mg Rx dosage as evidence of general recognition for the 200 mg dosage as could hardly be deemed unreasonable," the district court Judge continued. In its lawsuit, Chattem argued that FDA should have considered GRASE of 400 mg OTC ibuprofen apart from its consideration of GRASE of 200 mg OTC ibuprofen. Judge Flannery concluded that, because of the wording of the petition ("one or two 200 mg tabs every four hours, with a maximum 1200 mg total dose"), FDA's denial was warranted: "Clearly the conclusion that the low end of the proposed OTC dosage regimen was not GRASE precluded FDA from granting plaintiff's citizen petition." However, Flannery noted, if the petition had specifically requested GRASE status for either a 200 mg dosage or a 400 mg dosage, not exceeding the 1200 mg per day limit, then FDA would have been compelled to address the issue of GRASE for 200 mg and for 400 mg OTC ibuprofen individually. While the judge concurred with FDA that the low end of the proposed dosage regimen of ibuprofen is not GRASE, he intimated that this may not be the case for the higher dosage of 400 mg. "Because significant evidence of safety and effectiveness of 400 mg ibuprofen was adduced by the Arthritis Advisory Cmte., and because there is extensive experience with that dosage on a prescription basis, it could be concluded that the argument for recognizing 400 mg ibuprofen as GRASE is considerably stronger than the evidence supporting the general recognition of 200 mg ibuprofen," Flannery suggested.

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