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FDA TIMETABLE FOR COMPLETING OTC MONOGRAPHS COULD BE CONSIDERED BY DISTRICT COURT IF AGENCY PROGRESS IS DEEMED "UNREASONABLY DELAYED," D.C. CIRCUIT COURT RULES

Executive Summary

The wrap-up of FDA's OTC Review could be bound by a court imposed timetable if the D.C. District Court rules that FDA has unreasonably delayed monograph review, D.C. Circuit Court Judge Robinson indicated in a May 5 ruling. Robinson told the District Court to review the "reasonableness" of FDA's progress in the OTC monograph review. "Should . . . the District Court conclude that FDA, by failing to make adequate progress in completing the OTC drug review, has delayed unreasonably, the court must determine whether a remedy can be fashioned to effectively redress appellants' concerns," Robinson said. The appellate judge suggested that "the District court may find it appropriate, after hearing all parties, to impose a binding timetable upon FDA for completion of the program." Judge Robinson stated that the District Court, if it rules that FDA has shown unreasonable delay, should consider two factors in recommending a course of action: "How much work the agency has yet to do, and how long it should take for the work to be done." The appellate court's decision comes at a time when FDA appears ready to pick up the pace again on the release of monographs. The agency released one final monograph, the antiemetic product monograph, on April 30. The agency also recently published a regulatory agenda with plans for four final monographs (expectorant, ophthalmic, altertness aids, and nighttime sleep aids) and three tentative final monographs (nonantimicrobial oral health care, internal analgesics, and menstrual products) by the end of the summer. The practical effect of the appellate court decision is to support efforts by FDA's OTC evaluation staff to finish the OTC Review. The appellate court's instructions to the district court could draw attention to the review wrap-up from FDA topside and the higher levels of regulatory review in HHS and the Office of Management & Budget. Robinson's decision supports the conclusion of the 15-year review and but does not openly fault FDA for the length of the review or criticize the tenets behind it. Robinson also identified three issues the District court should consider in determining whether the length of the OTC review constitutes an unreasonable delay. "First," Robinson stated, "the court should ascertain the length of time that has elapsed since the agency came under a duty to act, and should evaluate any prospect of early completion." Next, "the reasonableness of the delay must be judged in the context of the statute which authorizes the agency's action. This entails an examination of any legislative mandate in the statute and the degree of discretion given the agency by Congress." Third, Robinson continued, "and perhaps most critically, the court must examine the consequences of the agency's delay." The judge explained that "the deference traditionally accorded an agency to develop its own schedule is sharply reduced when injury likely will result from avoidable delay." Economic harm, he added, "is clearly an important consideration." Robinson asserted his view of the agency's right to set its own pace. He noted that "any discussion of the standards relevant to the issue of delay must begin with recognition that an administrative agency is entitled to considerable deference in establishing a timetable for completing its proceedings. An agency has broad discretion to set its agenda and to first apply its limited resources to the regulatory tasks it deems most pressing." At one point in the decision, Robinson distinguished between the timeliness demands of health requlation and economic regulation. "As an agency with limited resources," Robinson noted, "FDA reasonably may assign enforcement of a statutory requirement designed to prevent unnecessary consumer expense to a lower priority than that accorded one concerned with identifying and eliminating threats to human life." Given "these rational justifications for postponing enforcement of the efficacy requirement," the appeals judge concluded, "we hold that FDA's policy on that score does not amount to an abuse of discretion." The appeals court remand stems from a 1982 suit brought against FDA by two consumers representing the Health Research Group. The suit, and the subsequent 1983 appeals filing, also alleged that FDA's OTC monograph procedures violate the FD&C Act and the agency's statutory mandate by postponing enforcement of its efficacy charge until completion of the monographs. Robinson upheld the District Court's ruling in favor of FDA with regard to all allegations except the "unreasonable delay" complaint. In ruling for the "unreasonable delay" remand, the appeals court explained that the District Court ruled in favor of FDA based on a prior appeals court ruling regarding color additives. In that case, the appeals court ruled that FDA's allowance of additional time for sponsor submission establishing lack of toxicity was "a reasonable exercise of FDA's discretion despite the fact that the additives had been marketed provisionally for more than 20 years after enactment of the statute," Robinson said. The District court equated the two cases, maintaining that a voluntary testing of OTC ingredients could be expected to take at least as long as the color additive review. The District Court "erred . . . in equating the agency's freedom to exercise its discretion with voluntariness," Robinson said. "Although FDA's discretion [in deciding how to achieve an efficacy review] extends to review of OTC drugs by ingredient rather than by product . . . the agency lacks authority to simply do nothing to effectuate the purpose of the [Administrative Procedures] Act." Since the District Court "relied solely" on the color additive ruling to "support its awards of summary judgment," Robinson explained, "we must remand for reconsideration in accordance with correct legal standards." Addressing the allegation that "FDA has abdicated its statutory duty by postponing enforcement of the Act's efficacy requirement and substantially limiting enforcement of the safety mandate until completion of the OTC drug review program," Robinson observed that "the FD&C Act imposes no clear duty upon FDA to bring enforcement proceedings to effectuate either the safety or the efficacy requirements of the Act." Robinson noted that "without a doubt, FDA has a responsibility under the Act to identify drugs generally recognized as safe and effective and requires premarketing clearance for all others." However, the appeals court judge said, "Congress has not given FDA an inflexible mandate to bring enforcement actions against all violators of the Act. Hence, appellants' argument that judical intervention . . . is warranted to compel agency enforcement of FD&C Act requirements is not persuasive." Robinson also observed that the FDA has not made a "conclusive" determination on efficacy until the final monograph is issued, and therefore, enforcement action at the TFM stage would be "futile" if the products proved to be effective. "Until FDA issues a final monograph, the agency has yet to make a substantiated and conclusive determination that a drug is not generally recognized as effective; besides, prior to promulgation of a final monograph, the agency's conclusion that an OTC drug is ineffective is subject to reconsideration based on new information that may be submitted to FDA," Robinson observed. "It would be a futile act, as well as one financially disastrous for manufacturers of pharmaceuticals, were the agency to require removal of a potentially ineffective drug from interstate commerce only to find, on the basis of later unfolding information, that the drug should have been classified as generally recognized as effective." Robinson also ruled that FDA's provision for a twelve-month open record period after publication of a TFM is consistent with current law. "We [do not] perceive the current regulations as arbitrary, capricious, or otherwise inconsistent with the FD&C Act," Robinson said. "The OTC review program in its present form does not sanction the marketing of OTC drugs during the twelve-month period for which the administrative record remains open." Moreover, Robinson added, "the agency has presented reasonable justifications for adopting the twelve-month open-record period. . . Leaving the record open for this period promotes efficiency since it eliminates the need to deal with the expectedly large number of individual petitions to reopen the record, and allows the agency simultaneously to evaluate the public comments, objections, and requests for hearings tendered after publication of the TFMs."
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