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Executive Summary

FDA expects to publish five OTC final monographs and 10 tentative final monographs (TFMs) in the next eight months, FDA told the D.C. District Court in a Sept. 22 document detailing the agency's progress with the OTC monograph process. "During the remainder of 1987 and the first part of 1988, FDA expects to issue some five final monographs . . . [and] some 10 TFMs," the agency reported. The status report was submitted in response to an Aug. 6 order from the district court. The district court is reviewing FDA's timeliness in completing the OTC review in connection with a 1981 suit brought against FDA by consumers representing the Health Research Group. The district court had ruled in favor of FDA; however, the D.C. Circuit Court, in a May 7 ruling, remanded the district court to review the "unreasonable delay" charges because the district court erred in using a color additive decision as precedent ("The Pink Sheet" May 11, p. 3). The five final monographs expected before the end of April 1988, FDA said, are: antibiotic first aid, expectorant, nighttime sleep-aid, ophthalmic, and skin bleaching. Of the upcoming final monographs, nighttime sleep-aid has been pending for the longest time -- since 1978 when the TFM was published. TFMs for antibiotic, expectorant, and skin bleaching products were released in 1982, and the TFM for ophthalmics came out in 1983. "During the same [eight month] period," the court document adds, "the agency expects to issue . . . 10 TFMs: antifungal, cough/cold combination products, internal analgesic, menstrual, oral health care, anorectal, digestive aid, first aid antiseptic (revised), and health care antiseptic (revised)." The upcoming monographs are detailed in a draft agenda scheduled to appear in the Federal Register this October. The agency noted that first aid antiseptic and health care antiseptic were recently separated out as two monographs. The external antiseptic products were originally being reviewed as one class. The regulatory agenda for the remainder of 1988 includes the final monograph for alertness aids and three TFMs. "Tentative plans, which will be confirmed in the publication of the April 1988 regulatory agenda, now also call for publication in 1988 of the final monograph for alertness aids, and amendments to the final monograph for cholecystokinetic," the court filing states. "Also scheduled for publication in 1988 are the TFMs for topical hormone, pediculicide, and boil treatment." FDA predicts that all TFMs will be published before the end of 1990 and that all final monographs will be out before the close of 1993 -- 20 years after the beginning of the OTC Review. The agency's 1989-1993 agenda for OTC regulation looks like this: 1989 -- "Publication of most of the remaining TFMs, some 15 documents, and at least one additional final monograph." 1990 -- "Publication of the last of the TFMs and some 12 final monographs, including several for major OTC drug categories. (Major OTC during categories include both those that are widely marketed and those intended for significant indications. Examples include antitussive, internal analgesic, and external analgesic.)" 1991 -- "Publication of some 13 final monographs, including most of the remaining major drug categories." 1992 -- "Publication of some 18 final monographs, including all but two or three covering the remaining major drug categories." 1993 -- "Publication of the remaining final monographs, presently estimated to involve some 15 OTC drug categories." In remanding the "unreasonable delay" review to the district court, the appeals court had stated that a court-imposed timetable for completing the OTC review might be appropriate if the court finds that FDA has unreasonably delayed the review process. FDA's filing responds: "This report and the total record in this case show conclusively that there has been no unreasonable delay in requiring judicial intervention and that there is no basis for the imposition of a judicially imposed timetable." The filing maintains that "significant accomplishments have been made since the filing of the law suit" in 1981. "For example," FDA stated, "in the nearly nine years from the date of the OTC drug review began until the suit was filed (during the panel phase of the review), some 62 monograph documents were published including 47 panel reports/proposed monographs, 8 TFMs, and seven final rules. Following completion of the panels' work, in the six years since 1981, some 91 monograph documents have been published, including 36 panel reports/proposed monographs, 40 TFMs, amended TMFs, and 12 final rules." The appeals court had directed the district court to review "'FDA's practice of generally postponing publications of final monographs on OTC drugs until all temporary final monographs are completed'" as part of its review on the reasonableness of any delays. FDA responded to that direction stating that "the record does not support the [appeals] court's concern." The agency explained that "several final monographs have been issued while TFM's were pending for other categories." For example, FDA stated, "important final monographs have been issued in the cough/cold area for anticholinergic, antitussive, and bronchodilator while very closely related TFMs (e.g., antihistamine, and cough/cold combination drugs) were still being developed." FDA pointed out that "the plaintiffs would have had the FDA complete all four phases for a drug category before turning to the next, a procedure that the FDA rejected as an inefficient use of resources." Concluding, FDA noted that "even though the particular phases of the review remain for some drug categories, there has been considerable adjustment in the market through reformulation and relabeling. Moreover, the agency has simultaneously undertaken several programs to ensure that OTC drugs in the U.S. are safe and effective." Chart omitted.

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