818 F.2d 879 - Cutler v. Hayes — 818 F.2d 879

¶1 *882William B. Schultz, with whom Katherine A. Meyer and Alan B. Morrison, Washington, D.C., were on the brief, for appellants.

¶2Neil R. Ellis, Atty., Dept, of Justice, with whom William F. Baxter, Asst. Atty. Gen., Dept, of Justice, Robert B. Nicholson, Atty., Dept, of Justice, Washington, D.C., Thomas Scarlett, Chief Counsel, and Kenneth C. Baumgartner, Associate Chief Counsel, Food and Drug Admin., Rockville, Md., and Jeffrey N. Gibbs, Sp. Asst. U.S. Atty., Washington, D.C., were on the brief, for appellees.

¶3Robert A. Altman, with whom J. Griffin Lesher, Bryan Jay Yolles, Daniel F. O’Keefe, Jr., and Gregory M. Fisher, Washington, D.C., were on the brief, for appellee/cross appellant The Proprietary Ass’n, Inc.

¶4Before ROBINSON and SCALIA *, Circuit Judges, and WRIGHT, Senior Circuit Judge.

¶6Opinion for the Court filed by Circuit Judge SPOTTSWOOD W. ROBINSON, III.

¶7SPOTTSWOOD W. ROBINSON, III, Circuit Judge:

¶8This case presents a challenge by consumers of over-the-counter (OTC) drugs to the program undertaken by the Food and Drug Administration (FDA) comprehensively to review these drugs for their safety and effectiveness. The consumers allege (1) that the regulations implementing this program violate the Food, Drug and Cosmetic Act of 1938 (FDC Act),1 as amended by the Drug Amendments of 1962,2 pursuant to which they were promulgated; (2) that FDA’s policy of nonenforcement of the efficacy requirement for marketing over-the-counter drugs in interstate commerce violates the agency’s statutory duty; and (3) that FDA’s lack of progress in completing the review program and the unlikelihood that the review will be completed in the near future infringes the provisions of the Administrative Procedure Act3 disapproving unreasonable agency delay. The District Court granted appellees’ motion for summary judgment on all counts. While we affirm the District Court’s judgment on appellants’ first two claims, we vacate the judgment on the charge of unreasonable delay and remand the case to the District Court for reconsideration in accordance with this opinion.

¶9I. The Statutory Scheme and the OTC Drug Review Program

¶10The FDC Act prohibits the marketing of “new drugs” without premarketing approval by FDA of a new drug application (NDA).4 The FDC Act as originally *883adopted by Congress classified “new drugs” as those not generally recognized by experts as safe for their intended use (GRAS).5 In 1962, Congress amended the definition of “new drugs”6 to include all drugs “not generally recognized among experts ... as safe and effective for use [GRAS/E] under the conditions prescribed, recommended, or suggested in the labeling thereof.”7 Drugs first marketed before 1938 were exempted from both the safety and efficacy requirements of the Act provided that they were not subsequently relabeled.8 Similarly, drugs marketed between 1938 and 1962 as GRAS, and thus without an NDA, were exempted from the newly-imposed efficacy requirement as long as the conditions for use suggested by the labeling remained unchanged.9

¶11The 1962 amendments specified that after a two-year transition period,10 all “new drugs” marketed under an approved NDA would be subject to the effectiveness requirement, and directed the FDA to withdraw approval, after due notice and an opportunity for a hearing, of all NDAs for drugs that failed to satisfy both the safety and efficacy requirements.11 To support a finding of effectiveness, Congress required substantial evidence to demonstrate that a drug actually produces its claimed effect.12 The efficacy requirement became operative immediately for drugs not classified as “new drugs.” 13 For such drugs to be classified as GRAS/E, there must be an “expert consensus ... founded upon ‘substantial evidence’ ” of the drug’s effectiveness 14 and safety.15

¶12In 1966, FDA began its effort to ensure compliance with the new requirements of the FDC Act by initiating its Drug Efficacy Study Implementation (DESI) review to determine whether all “new drugs” — those marketed pursuant to an approved NDA— satisfied the Act’s efficacy requirement.16 The vast majority of the products examined in this study were prescription drugs, sold only under the direction of a physician.17

¶13In 1972, upon completion of this review, 18 FDA turned its attention to phar*884maceuticals marketed under the Act’s GRAS/E exemption, which include primarily over-the-counter drugs,19 readily accessible to all consumers for use without medical supervision. A drug efficacy study undertaken by the National Academy of Science-National Research Council (NAS-NRC) had concluded, after reviewing 420 drugs broadly representative of the OTC market, that only one-fourth of the drugs reviewed were actually effective.20 In response, FDA began a comprehensive review of all OTC drugs to determine whether they were properly marketable under the GRAS/E exemption.21 Instead of evaluating each of the hundreds of thousands of those drugs22 individually, however, FDA classified the medications according to their comparatively few active ingredients,23 and directed the OTC drug review to be conducted in four phases. First, advisory review panels of qualified experts are appointed to analyze existing test data and make recommendations in the form of monographs establishing the conditions under which each OTC drug could be marketed without an NDA.24 In Phase II, FDA reviews these monographs and publishes them in the Federal Register for public comment on the safety and effectiveness of the products under examination.25 The third stage of the program obligates FDA to review comments, to publish a tentative final monograph, and to offer the public the opportunity to object formally, either in writing or at a hearing, to the findings made with respect to individual drugs.26 In the fourth and final part of the OTC review, FDA promulgates a final monograph containing the agency’s conclusive and legally binding determinations on the conditions under which a drug is considered GRAS/E.27

¶14The regulations call upon the agency to categorize products into three groups: Category I, covering drugs recognized as safe and effective and establishing the conditions under which they may be marketed;28 Category II, including all ingredients, labeling claims and other conditions that would result in a drug’s being not generally recognized as safe and effective;29 and Category III, including ingredients for which available data are insufficient to justify classification in either of the other groups.30 As originally promulgated by FDA, the regulations authorized the marketing of any Category III drug after publication of the final monograph provided the manufacturer engaged in additional testing.31 The District Court for the District of Columbia, however, struck down *885this provision, holding that it directly contravened the FDC Act by sanctioning for an indefinite period the marketing of drugs that were unable to satisfy the GRAS/E requirements.32 In response to this decision, FDA amended its regulations to their present form, eliminating the post-final monograph marketing authorization for Category III drugs,33 but adding a twelvemonth period following publication of the tentative final monograph in which the administrative record is kept open for receipt of new information regarding the safety and effectiveness of drugs tentatively placed in Category III.34

¶15The OTC drug review has progressed sluggishly at best since its inception in 1972. The District Court found that FDA had completed Phase I of its OTC review.35 Phase II was scheduled for completion by the end of 1983,36 but because of FDA’s policy requiring completion of each phase before proceeding to the next stage of review,37 the vast majority of the tentative final monographs and final monographs to be produced are yet to be completed38 and are not expected to be forthcoming for some time.39

¶16II. Proceedings Below and Issues on Appeal

¶17Appellants Mimi Cutler and Stephen Annand,40 consumers of over-the-counter drugs, challenge both the legality of the regulations governing the OTC drug review and the progress of that program as implemented.41 They argued unsuccessfully before the District Court and again argue on appeal (1) that FDA’s failure to complete the OTC review more than 10 years after it was initiated, and over 20 years after the efficacy requirement was added to the FDC Act, constitutes agency action unreasonably delayed contrarily to *886Sections 642 and 10(c)43 of the Administrative Procedure Act;44 (2) that FDA’s failure to complete the OTC review, when coupled with its unwillingness to bring enforcement actions against marketers of in-efficacious drugs, violates the FDC Act,45 which imposes upon FDA a duty judicially enforceable;46 and (3) that the regulations implementing the OTC review program are inconsistent with the Act because they create an interim testing period after publication of the tentative final monograph, which, by postponing promulgation of the final monograph, protects drugs not generally recognized as safe and effective.47

¶18The District Court denied the motion of intervenor-defendant The Proprietary Association, Inc. (PA) to dismiss for lack of standing to sue 48 and for failure to exhaust administrative remedies,49 but granted FDA’s motion for summary judgment.50 The court held that the regulations as amended did not violate the FDC Act as interpreted in Cutler v. Kennedy,51 and that FDA had acted neither arbitrarily nor capriciously in adding the 12-month period for submission of additional information after publication of the tentative final monograph.52 The court rejected appellant’s claim that “FDA had adopted (and made known to the industry) a policy of non-enforcement against OTC drugs pending completion of the review which ... amounts to an implied promise of immunity for an indefinite and protracted future,”53 concluding that such a policy did not exist.54 The District Court further found that the 17 enforcement proceedings identified by FDA55 were “a reasonable exercise of the prosecutorial discretion the FDA ... possesses].” 56

¶19Finally, in rejecting appellants’ claim that failure to complete the OTC drug review program in a timely fashion constitutes unreasonable delay by FDA, the District Court relied on McIllwain v. Hayes,57in which this court held that the “ ‘... enormously complicated, uncertain and evolving technology ... ’ of mandatory scientific testing of 23 food color additives for safety alone (being conducted by the industry itself in deference to the FDA’s own finite resources) could lawfully be protracted for 24 years.”58 The District Court stressed the supposed voluntariness of the OTC drug review program, which was undertaken by FDA as one of several ap*887proaches it might have utilized,59 and the complexity of the review.60

¶20We hold that the District Court erred in concluding that McIlwain v. Hayes controls disposition of appellants’ unreasonable-delay claim and vacate the portion of its judgment relating to that issue. On all other grounds, we affirm the judgment of the District Court.

¶21III. Standing

¶22We first address intervenor’s two threshold challenges.61 The PA alleges that appellants Mimi Cutler and Stephen D. Annand lack standing to bring this case, and are merely “sham plaintiffs.” 62 The District Court held that the doctrine of collateral estoppel precluded PA from raising the standing issue63 since this question was conclusively resolved in Cutler v. Kennedy. 64 In that case, in which all parties to the present action participated, the plaintiffs were held to have standing to challenge the legality of a precursor to the present set of OTC regulations, which au*888thorized the sale of Category III drugs after the issuance of final monographs.65

¶23We begin with the observation that “the doctrine of res judicata has application ‘to questions of jurisdiction as well as to other issues’ [and] it ordinarily precludes a subsequent challenge to a finding that jurisdiction does exist.”66 Standing ranks amongst those questions of jurisdiction and justiciability not involving an adjudication on the merits,67 whose disposition will not bar relitigation of the cause of action originally asserted, but may preclude, or collaterally estop,68 relitigation of the precise issues of jurisdiction adjudicated.69 In Montana v. United States,70the Supreme Court set forth a concise statement of the estoppel principle and the policies it promotes:

Under collateral estoppel, once an issue is actually and necessarily determined by a court of competent jurisdiction, that determination is conclusive in subsequent suits based on a different cause of action involving a party to the prior litigation---- To preclude parties from contesting matters that they have had a full and fair opportunity to litigate protects their adversaries from the expense and vexation attending multiple law suits, conserves judicial resources and fosters reliance on judicial action by minimizing the possibility of inconsistent decisions.71

¶24A valid jurisdictional judgment has preclusive effect, we note, even if erroneous.72

¶25 *889Principles of collateral estoppel clearly apply to standing determinations.73 As the District Court correctly determined, Cutler, Annand and PA were all parties to the proceeding in Cutler v. Kennedy;74thus the sole “remaining inquiry is whether the issue presented in the two proceedings is substantially the same.”75 In the Kennedy case, the plaintiffs claimed that FDA’s Category III regulations76 were unlawful to the extent that they authorized marketing of OTC drugs without a prior determination of safety and effectiveness.77 The Kennedy court examined the question whether the plaintiffs had standing to challenge FDA’s Category III regulations, and determined that they did.78 It found that the plaintiffs incurred an increased risk of consuming unsafe or ineffective drugs constituting a cognizable injury for standing purposes,79 one traceable to the FDA Category III regulations they challenged80 and redressable by the relief sought.81 PA never appealed this judgment but, in effect, attempts to attack it in the present action. The District Court held that principles of estoppel barred this renewed challenge to plaintiffs’ standing,82 and its judgment seems to us unquestionably correct.

¶26FDA has eliminated post-final monograph marketing authorization for Category III drugs in accordance with the judgment in Kennedy, but has added a 12-month period following publication of the tentative final monograph in which the administrative record is to remain open for new information on safety and effectiveness before issuance of the final monograph.83 It is this regulation that appellants in the present action challenge as sanctioning, in new regulatory guise, the marketing of drugs not determined to be safe and effective; they claim further that the agency’s alleged policy of nonenforcement against OTC drugs disregards the agency’s statutory mandate and that its delay in completing OTC review ignores the APA.84 As the District Court found, *890the gravamen of appellants’ complaint is in substance the same:85 FDA regulatory and enforcement policy sanctions the continued marketing of Category III OTC drugs not affirmatively shown to have met FDC Act standards, in violation of the agency’s statutory responsibilities.86 No change in “controlling facts or legal principles” 87 is apparent that would qualify this determination.88

¶27IV. Exhaustion of Administrative Remedies

¶28PA next argues that appellants’ failure to exhaust administrative remedies is ground for dismissal.89 The exhaustion requirement is not jurisdictional,90 however, but rather should be applied “flexibly, with an eye toward its underlying purposes.” 91 These purposes include (1) discouraging the “ ‘frequent and deliberate flouting of administrative processes;’ ”92 *891(2) protecting agency autonomy by allowing an agency the first opportunity to apply its expertise, exercise its discretion, and correct its errors; (3) aiding judicial review by promoting the development of facts during the administrative proceeding; and (4) promoting judicial economy by reducing duplication, and perhaps even obviating judicial involvement.93 Since the doctrine is not linked to the power of the court to entertain actions, but instead implicates prudential considerations, the exhaustion requirement may be waived by the agency, or disregarded by the court when applica-, tion of the doctrine would be futile.94

¶29The District Court based its rejection of the PA’s argument primarily on two grounds: that FDA had failed to raise the exhaustion issue and thus had waived it,95 and that resort to agency process in this case would have been futile.96 These two factors, when considered in tandem, clearly suggest that the purposes of the exhaustion doctrine would not be served by withholding our consideration of appellants’ charge of unreasonable delay until FDA had a prior opportunity to reject it. As we stated in Etelson v. Office of Personnel Management,97

[w]hen an agency has committed itself not to change its rule unless judicially compelled to do so, has made known that its general views are contrary to those of the complainant, and has never given an inkling that it would consider a matter afresh, and when the regulations in question have received careful attention within and outside the agency, a complainant need not make a pro forma request that the agency redo its system.98

¶30 *892We therefore affirm the District Court’s denial of intervenor’s motion to dismiss for failure to exhaust administrative remedies.99

¶31V. Nonenforcement of Statutory Mandate

¶32As we understand their argument, appellants assert that FDA has abdicated its statutory duty by (1) postponing enforcement of the Act’s efficacy requirement and substantially limiting enforcement of the safety mandate until the completion of the OTC drug review program, and (2) then delaying completion of the program unreasonably. They urge, citing as authority our en banc decision in Adams v. Richardson,i100 that we direct the agency to enforce both the safety and efficacy requirements of the statute.101

¶33The District Court rejected appellants’ argument, concluding that “FDA has not adopted a policy of total nonenforcement,” and that “such enforcement as has been undertaken indicates a reasonable exercise of the prosecutorial discretion FDA was acknowledged to possess in Cutler v. Kennedy.” 102 The District Court found decisive the evidence submitted by FDA demonstrating that it had taken enforcement action on at least 17 occasions.103

¶34We believe the court’s affirmative finding in this regard is to be qualified by its failure adequately to distinguish between enforcement actions aimed at drugs that are simply ineffective and those directed at the marketing of drugs that are both ineffective and unsafe. FDA’s compliance policy guidelines specify that “[p]rior to the final publication of a proposed monograph, it would not be in the agency’s interest to pursue regulatory action unless failure to do so posed a potential health hazard to the consumer.” 104 FDA has thus made clear that it will not presently take action against an OTC drug that is safe but demonstrably ineffective for its intended use.105 The District Court erred in construing FDA’s policy otherwise.

¶35Nevertheless, Adams v. Richardson does not call for judicial intervention in the case at bar. In Heckler v. Chaney,106a case involving FDA, the Supreme Court held that an agency’s refusal to take enforcement action is presumptively unreviewable.107 The Court did note that an extreme case, amounting to abdication of the agency’s statutory responsibilities, might warrant judicial examination,108 citing Adams v. Richardson in illustration of actionable nonfeasance.109 We find Adams, however, easily distinguishable from the case before us.

¶36In Adams, we directed the Secretary of Health, Education, and Welfare and the Director of the Office of Civil Rights to commence enforcement proceedings against primary and secondary school districts operating racially segregated schools *893while receiving federal funding.110 Title VI of the Civil Rights Act of 1964 111 explicitly directed all federal departments and agencies distributing federal funds to effectuate the provision of the Act prohibiting racial discrimination in programs accepting such funds.112 We held that the consistent failure of the federal defendants to carry out this clear and direct statutory mandate was a “dereliction of duty reviewable in the courts,” 113 and ordered the defendants to institute enforcement proceedings against schools operating in violation of the Act.114

¶37In the case before us, we have been unable to identify any statutory mandate comparable to the provisions of the Civil Rights Act we found dispositive in Adams. The FDC Act imposes no clear duty upon FDA to bring enforcement proceedings to effectuate either the safety or the efficacy requirements of the Act. Without a doubt, FDA has a responsibility under the Act to identify drugs generally recognized as safe and effective and require premarketing clearance for all others.115 But Congress has not given FDA an inflexible mandate to bring enforcement actions116 against all violators of the Act.117 Hence, appellants’ argument that judicial intervention under Adams v. Richardson is warranted to compel agency enforcement of FDC Act requirements is not persuasive.118

¶38Nor does FDA’s policy of postponing enforcement of the efficacy requirement until after publication of final monographs afford a basis for intervention under Heckler v. Chaney.119 Particularly as *894an agency with limited resources, 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.120 More importantly, 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;121 besides, pri- or to promulgation of a final monograph, the agency’s conclusion that an OTC drug is ineffective is subject to reconsideration based on new information122 that may be submitted to FDA.123 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.124 Given these rational justifications for postponing enforcement of the efficacy requirement, we hold that FDA’s policy on that score does not amount to an abuse of discretion.125

¶39VI. Unreasonable Delay of OTC Drug Review

¶40Appellants next argue that the limited progress of the OTC drug review since its inception in 1972 has frustrated achievement of the safety and efficacy goals of the 1962 Amendments, and therefore constitutes unreasonable agency delay remediable under the APA.126 The District Court rejected this claim,127 relying on our decision in McIlwain v. Hayes.128That case involved the scheme of the FDC respecting food-coloring additives, and we approved an additional extension of time for industry submissions of proof of nontoxicity as 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.129 Deeming the OTC drug review a program *895undertaken “voluntarily,”130 the District Court felt that it was comparable to the mode of regulation of food-coloring products:

If the "... enormously complicated, uncertain, and evolving technology ...” of mandatory scientific testing of 23 food color additives for safety alone ... could lawfully be protracted for 24 years ..., it can hardly be said that a voluntary testing program of over 700 active ingredients contained in various combinations in more than 300,000 OTC drug products for effectiveness as well as safety might not reasonably be expected to take at least as long.131

¶41We do not join in the District Court’s characterization of the OTC drug review as a “voluntary” program. Consequently, we cannot agree that Mcllwain supports the court's outcome on the delay claim. The District Court must now reconsider that claim m accordance with acceptable legal standards.

¶42As we have already stated, the 1962 amendments to the FDC Act obligate FDA to review all nonexempt OTC drugs for their therapeutic efficacy132 as well as their safety. Concededly, FDA has broad discretion in deciding how to achieve this objective.133 The District Court erred, however, in equating the agency’s freedom to exercise its discretion with voluntariness.134 Although FDA’s discretion extends to review of OTC drugs by ingredient rather than by product — a choice implicitly approved by the Supreme Court in Bentex Pharmaceuticals135— the agency lacks authority to simply do nothing to effectuate the purpose of the Act.

¶43Once FDA elected to respond to its legislative directive by establishing the OTC drug review program, the APA imposed an obligation to proceed with reasonable dispatch.136 We have often intervened to compel an agency unreasonably delaying to speed up its activities,137 and our authority to do so in appropriate instances is not here in question.138 In rejecting appellants’ delay argument, however, the District Court examined none of the factors that have traditionally guided assessments on the propriety of agency delay;139 rather, the court relied solely on a single precedent — -McIlwain v. Hayes140— which involved a statutory scheme very different from the one before us today. The provisions governing marketing of food-color ad*896ditives contain a transitional mechanism allowing commercially-established additives to be marketed on an interim basis prior to a final determination on safety;141 as this court observed, it authorized FDA to postpone the closing date for submissions “ ‘for such period or periods as ... necessary to carry out the purpose of this section.’ ” 142 Not only do the 1962 amendments of the FDC Act lack an analogous provision,143 but the majority opinion in Mcllwain took pains to distinguish the statutory arrangement in that case from the regime implicated here.144 It should also be noted that in the case at bar, initial research had indicated that a vast number of drugs on the market were ineffective,145 while none of the test data on the food additives at issue in Mcllwain suggested that they were unsafe.146 Given these significant distinctions, McIlwain clearly does not control the disposition of appellants’ contention that there has been unreasonable agency delay.147

¶44Since the District Court relied solely on McIlwain to support its awards of summary judgment, we must remand for reconsideration in accordance with correct legal standards. Resolution of a claim of unreasonable delay obviously may require a number of factual determinations, and may also entail a balancing of competing considerations. It therefore would be inappropriate for us to rule on the question without the benefit of initial consideration by the District Court.148

¶45Any 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.149 An agency has broad discretion to set its agenda and to first apply its limited resources to the regulatory tasks it deems most pressing.150 The agency’s discretion is not unbounded, however, since the consequences of dilatoriness may be great.151 As we have had occasion to state, “[tjhere must be a ‘rule of reason’ to govern the time limit to administrative proceedings. Quite simply, excessive delay saps the public confidence in an agency’s ability to discharge its responsibilities and creates uncertainty for the parties, who must incorporate the potential effect of *897possible agency decisionmaking into future plans.”152 Moreover, unjustifiable delay may undermine the statutory scheme153 and could inflict harm on individuals in need of final action. In some cases, agency delay may collide with the right to judicial review.154

¶46Our cases identify a number of factors that aid in determining whether an agency’s foot-dragging constitutes unreasonable delay.155 First, 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.156 Next, “[t]he reasonableness of the delay must be judged ‘in the context of the statute’ which authorizes the agency’s action.”157 This entails an examination of any legislative mandate in the statute and the degree of discretion given the agency by Congress.158 The court must also estimate the extent to *898which delay may be undermining the statutory scheme, either by frustrating the statutory goal159 or by creating a situation in which the agency is “losing its ability to effectively regulate at all.” 160

¶47Third, and perhaps most critically, the court must examine the consequences of the agency’s delay. The deference traditionally accorded an agency to develop its own schedule is sharply reduced when injury likely will result from avoidable delay. Economic harm is clearly an important consideration and will, in some cases, justify court intervention,161 and “[djelays that might be altogether reasonable in the sphere of economic regulation are less tolerable when human lives are at stake.”162 Lack of alternative means of eliminating or reducing the hazard necessarily adds to unreasonableness of a delay.163

¶48The agency must justify its delay to the court’s satisfaction. If the court determines that the agency delays in bad faith, it should conclude that the delay is unreasonable.164 If the court finds an absence of bad faith, it should then consider the agency’s explanation, such as administrative necessity, insufficient resources, or the complexity of the task confronting the agency. Although complexity bears on avoidance in ascertaining reasonableness, it is not always sufficient to justify lengthy delays.165 And if an agency’s failure to proceed expeditiously will result in harm or substantial nullification of a right conferred by statute, “the courts must act to make certain that what can be done is done.” 166 The court should weigh any plea of administrative error, administrative convenience, practical difficulty in carrying out a legislative mandate, or need to prioritize in the face of limited resources.167 Of course, these justifications become less persuasive as delay progresses, and must always be balanced against the potential for harm.

¶49On remand, then, the District Court should scrutinize FDA’s justifications for delay in completing the OTC drug *899review168 and balance them against the consequences ensuing.169 The court must examine the delay in the context of the FDC Act and in harmony with the principles articulated herein. And it goes without saying that this time the court will bear in mind that the OTC drug review is not a voluntary program for these purposes.170

¶50VII. The Category III Regulatory Scheme

¶51Lastly, appellants attack as inconsistent with the FDC Act and the District Court’s decision in Cutler v. Kennedy,171the amendment to the OTC drug review regulations creating a period for comment on temporary final monographs. This amendment eliminated the marketing period for Category III drugs after formulation of the final monograph,172 but added a twelve-month period following publication of the tentative final monograph for interested persons to present “new data and information to support a condition excluded from the monograph in the tentative order.” 173 Cutler v. Kennedy held that a prior version of the regulations, which permitted marketing of drugs classified by final monograph in Category III to continue during ongoing product-testing,174 contravened congressional intent because Category III drugs by definition were not generally recognized as safe and effective.175

¶52Appellants argue that the newly-added twelve-month period for submitting additional information bearing on tentative final monographs176 serves only to delay implementation of the Act’s safety and efficacy requirements by further postponing publication of final monographs, and, in effect, to sanction the impermissible marketing of Category III drugs at an earlier stage in the process.177 FDA, on the other *900hand, contends that the revised regulations are consistent with the Act since they no longer authorize any marketing of drugs that officially have been labeled not generally recognized as safe and effective.178 FDA also asserts that this provision is unlikely to delay promulgation of final monographs since the twelve-month period will be used concurrently to prepare them.179 Moreover, the agency declares, the regulations will merely hold the administrative record open during these twelve months, and thus avoid the immense drain on resources likely to occur if all who sought to present new information on a drug’s Category III classification were required formally to petition for reopening of the record.180

¶53The District Court held that FDA had complied with Cutler v. Kennedy by removing from its regulations language authorizing marketing of Category III drugs after promulgation of final monographs. The court further concluded that FDA had “proffered a reasonable justification for the interim testing period based on administrative necessity,”181 and approved the new provision. We agree that the regulation as amended is in harmony both with Cutler and with the applicable law.182 We therefore uphold the District Court’s denial of appellants’ request for declaratory relief.

¶54We do not share appellants’ expansive interpretation of Cutler. It is evident that there the first set of OTC regulations were condemned because they permitted continued marketing of Category III drugs after publication of final monographs.183 By eliminating this marketing authorization, however, FDA has overcome the difficulty that was fatal in Cutler.

¶55Nor do we perceive the current regulations as arbitrary, capricious, or otherwise inconsistent with the FDC Act.184 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.185 Moreover, until publication of a final monograph, FDA makes no conclusive determination of a drug’s GRAS/E status; rather, panel recommendations and tentative conclusions remain subject to reconsideration in light of any additional information submitted in timely fashion to the agency.186 Moreover, the agency has presented reasonable justifications for adopting the twelve-month open-record period. FDA designed this procedure to facilitate gathering of supplemental information, including that which is often solicited by the agency from manufacturers. Leaving the record open for this period promotes efficiency since it eliminates the *901need to deal with the expectably large number of individual petitions to reopen the record,187 and allows the agency simultaneously to evaluate the public comments, objections, and requests for hearings tendered after publication of the tentative final monographs.188 We therefore conclude that FDA did not act arbitrarily or otherwise improperly when it amended its regulations on Category III drugs.

¶56VIII. Conclusion

¶57In 1962, Congress ordained that only those drugs generally recognized as safe and effective could be marketed without premarketing clearance. Because, a quarter-century later, this mandate has not yet been fully satisfied, close scrutiny must be paid to appellants’ claim that FDA has unreasonably delayed its completion of the OTC drug review program. For that purpose, we vacate the judgment of the District Court on the question of unreasonable delay and remand the case for reconsideration on that point. We affirm the judgment in all other respects.

¶58So Ordered.

¶76. In American Pub. Health Ass’n v. Veneman, supra note 16, the District Court for the District of Columbia held that FDA regulations which permitted the continued marketing of drugs *884conclusively found to be ineffective, while affording manufacturers an opportunity to provide additional data to FDA on the question of efficacy, violated the clear language of the FDC Act requiring removal of such drugs from the market after the grace period. 349 F.Supp. at 1315-1316, 1317. The court also directed FDA to complete its evaluation of certain over-the-counter drugs marketed under NDAs instead of postponing its consideration of these products until initiation of the over-the-counter drug review program. Id. at 1317. FDA had examined prescription drugs before OTC drugs because of the former’s greater potential for harm to consumers. 37 Fed.Reg. 85 (1972).

¶99. This is actually the second time these litigants have challenged the OTC drug review program. Their first effort culminated in a favorable disposition of their claim that the regulations contravened the FDC Act. See text supra at notes 31-32 and infra at notes 174-175. The complaint in this case, as originally drafted, alleged that FDA had failed to amend its regulations and thus had not conformed to the District Court’s decision in Cutler v. Kennedy, supra note 16. Complaint f 22, Cutler v. Hayes, No. 81-2092 (D.D.C.) (filed Sept. 3, 1981), J.App. 14. When FDA finally promulgated its revised regulations on September 29, 1981, see 46 Fed.Reg. 47730 (1981), appellants amended their complaint to allege that the new provisions continued to violate the FDC Act. Amended Complaint f 22, Cutler v. Hayes, No. 81-2092 (D.D.C.) (filed Jan. 20, 1982), J.App. 21-22.

¶119. Appellees asserted initially that the District Court lacked subject-matter jurisdiction over this case, see Answer to Amended Complaint ff 2, 26, Cutler v. Hayes, No. 81-2092 (D.D.C.) (filed Feb. 9, 1982), J.App. 50, 54, but have not pressed the argument. The District Court apparently acted on the assumption that it had general federal-question jurisdiction, see 28 U.S.C. § 1331 (1982), as appellants had alleged. See Amended Complaint f 2, supra note 42, J.App. 17. Because our subsequent decision in Telecommunications Research & Action Center v. FCC (TRAC), 242 U.S.App.D.C. 222, 750 F.2d 70 (1984), clarified the standard for determining jurisdiction to examine the pace of agency action, we sua sponte consider appellees’ contention anew.

¶120TRAC held that "where a statute commits final agency action to review by the Court of Appeals, the appellate court has exclusive jurisdiction to hear suits seeking relief that might affect its future statutory power of review.” Id. at 224, 750 F.2d at 72. Like the instant case, TRAC involved a claim of unreasonable agency delay, and we ruled that the District Court was without jurisdiction to entertain it. See id. at 249-251, 750 F.2d at 77-79. Essential to our holding, however, were statutory provisions enabling us to review any final FCC order. See id. at 249, 750 F.2d at 77. We now must ascertain whether any of appellants’ claims trigger similar statutory grants of jurisdiction to review final FDA actions.

¶121The FDC Act contains no single, overarching provision governing judicial review. Instead, discrete agency actions are subject to specialized review provisions. See, e.g., 21 U.S.C. § 355(h) (1982) (review by court of appeals of agency’s disapproval of new-drug application); id.§ 360g (review by court of appeals of regulations classifying devices); id.§ 371(f) (review by court of appeals of orders issued pursuant to provisions enumerated in § 371(e)). Agency action taken under sections silent in this respect are directly reviewable in a district court under some appropriate head of its jurisdiction, for courts of appeals have only such jurisdiction as Congress has chosen to confer upon them. Shaw v. United States, 93 U.S.App.D.C. 300, 302, 209 F.2d 811, 813 (1954); Diamond Shamrock Oil & Gas Corp. v. Commissioner, 422 F.2d 532, 534 (8th Cir.1970).

¶122Appellants’ claims in the instant case involve FDA regulations implementing § 355 and the related agency inaction in enforcing them. Section 355(h), however, authorizes review by a court of appeals only in cases challenging disapprovals of new-drug applications, and is therefore inapplicable here. Cf. Weinberger v. Bentex Pharmaceuticals, Inc., supra note 22, 412 U.S. at 651, 93 S.Ct. at 2493, 37 L.Ed.2d at 240-241 (interpreting § 355(h) narrowly and endorsing district-court jurisdiction to hear appeals from orders affecting new-drug status). Similarly, § 371(f) is inapposite because § 355 is not among the provisions listed in § 371(e). We note, too, that the Supreme Court has implicitly approved the exercise of district-court jurisdiction over similar claims pertaining to FDA’s enforcement duties under § 355. See Heckler v. Chaney, 470 U.S. 821, 824-825, 105 S.Ct. 1649, 1652, 84 L.Ed.2d 714, 719-720 (1985). We thus conclude that because in this case no statute commits direct review of FDA new drug regulations to this court, TRAC does not apply, and the District Court properly exercised jurisdiction.

¶128. See Worth v. Seldin, 422 U.S. 490, 500, 95 S.Ct. 2197, 2206, 45 L.E.2d 343, 355 (1975) ("standing in no way depends on the merits of the plaintiffs contention that particular conduct is illegal"); Continental Cas. Co. v. Canadian Universal Ins., 605 F.2d 1340, 1342-1343 (5th Cir.1979), cert. denied, 445 U.S. 929, 100 S.Ct. 1317, 63 L.Ed.2d 762 (1980) (dismissal "for want of a judicial controversy between live litigants” is not a judgment on the merits, but on jurisdiction); McCarney v. Ford Motor Co., 657 F.2d 230, 232-234 (8th Cir.1981) (standing determination does not reach merits but involves questions of justiciability and is quasi-jurisdictional in nature); Sherman v. British Leyland Motors, Ltd., 601 F.2d 429, 439-440 (9th Cir.1979) (standing question is "akin to that of jurisdiction”).

¶130. See Dozier v. Ford Motor Co., supra note 66, 227 U.S. App.D.C. at 14-15, 702 F.2d at 1192-1193 (amount in controversy for diversity jurisdiction); Carr v. District of Columbia, 207 U.S. App.D.C. 264, 272-273, 646 F.2d 599, 607-608 (1980) (subject-matter jurisdiction); Estevez v. Nabers, 219 F.2d 321 (5th Cir.1955) (lack of justiciable controversy); Oglala Sioux Tribe v. Homestake Mining Co., 722 F.2d 1407, 1411— 1413 (8th Cir.1983) (subject-matter jurisdiction); see also Segal v. American Tel. & Tel. Co., 606 F.2d 842, 844-845 (9th Cir.1979) (dismissal for lack of jurisdiction results in issue preclusion, which unlike bar, forecloses litigation only of those issues of fact or law that were actually litigated and necessarily decided by a valid and final judgment between the parties); see generally IB J. Moore, J. Lucas & T. Currier, Moore’s Federal Practice fi 0.405[5] (2d ed. 1984) (discussing preclusive effect of jurisdictional judgments). For cases applying collateral estoppel principles to standing questions, see noté 73 infra.

¶133. See Underwriters Nat'l Assurance Co. v. North Carolina Life & Accident &; Health Ins. Guar. Ass’n, 455 U.S. 691, 706-707, 709 n. 16, 102 S.Ct. 1357, 1366-1367, 1368 n. 16, 71 L.Ed.2d 558, 571-572, 573 n. 16 (1982) (principles of res judicata apply to jurisdictional judgments where "the second court’s inquiry discloses that those questions have been fully and fairly litigated and finally decided in the court which renders the original judgment”); Stoll v. Gottlieb, 305 U.S. 165, 172, 59 S.Ct. 134, 138, 83 L.Ed. 104, 109 (1938) ("[a]fter a party has his day in court, with opportunity to present his evidence and his view of the law, a collateral attack upon the decision as to jurisdiction there rendered merely retries the issue previously determined. There is no reason to expect that the second *889decision will be more satisfactory than the first"); IB J. Moore, J. Lucas & T. Currier, supra note 69, f 0.405[5], at 227, 229-230 (‘‘[w]here the issue of jurisdiction is raised and is determined in favor of jurisdiction and the case then proceeds to a judgment on the merits, on wellsettled principles the judgment is not later open to collateral attack on the jurisdictional issue, whether or not the determination thereon was erroneous”) (footnote omitted); see also 13A C. Wright, A. Miller & E. Cooper, Federal Practice and Procedure: Jurisdiction § 3531.15, at 106 (2d ed. 1984) (“[o]rdinarily [collateral] attacks [for want of standing] should be rejected, even if the Article III requirements of standing were not met”) (footnote omitted).

¶134. Cutler v. Hayes, supra note 24, 549 F.Supp. at 1343 (applying doctrine to standing) (policies furthered by collateral estoppel doctrine "are equally served when the doctrine is applied to jurisdictional questions as to the merits”). For authorities applying principles of collateral estoppel to questions of standing, see, e.g., Safir v. Dole, 231 U.S.App.D.C. 63, 69 n. 4, 718 F.2d 475, 481 n. 4 (1983), cert. denied, 467 U.S. 1206, 104 S.Ct. 2389, 81 L.Ed.2d 347 (1984); Mrazek v. Suffolk County Bd. of Educ., 630 F.2d 890, 896 n. 10 (2d Cir.1980); Planned Parenthood Ass’n v. Kempiners, 700 F.2d 1115, 1138 (7th Cir.1983) (concurring opinion); McCarney v. Ford Motor Co., supra note 67; California Chamber of Commerce v. Simpson, 601 F.Supp. 104, 106-107 (C.D.Cal.1985); City Communications, Inc. v. City of Detroit, 650 F.Supp. 1570, 1580 (E.D. Mich.1987).

¶149. The District Court found that PA had “not introduced any evidence to refute the essential factual predicate underlying the standing decision in Cutler v. Kennedy, viz, that the individual plaintiffs consume OTC drugs and would be exposed to an increased health risk by the marketing of products which may not be safe or effective____” Cutler v. Hayes, supra note 24, 549 F.Supp. at 1343-1344 n. 3. In so ruling, the District Court correctly determined that any new evidence PA might have produced in support of its contention that the individual appellants are merely “sham plaintiffs,” see Brief for Intervenor-Appellee at 14-15, was immaterial to the legal basis on which the Kennedy court's ultimate findings on standing rested, see Cutler v. Kennedy, supra note 17, 475 F.Supp. at 850 n. 34 (holding PA’s “sham-plaintiff" contention "without legal merit"), and so could not demonstrate a change in controlling facts sufficient to justify an exception to collateral estoppel principles. See Cutler v. Hayes, supra note 24, 549 F.Supp. at 1343 n. 3 (citing Montana v. United States, supra note 70, 440 U.S. at 155, 99 S.Ct. at 974, 59 L.Ed.2d at 218). Neither has there been any change in the legal principles governing the constitutional standing inquiry that would warrant excepting the Kennedy court’s determination of standing from the normal estoppel rule. Compare Cutler v. Kennedy, supra note 17, 475 F.Supp. at 847-850 (three-part inquiry into constitutional elements of standing) with American Legal Found. v. FCC, 257 U.S.App.D.C. 189, 193, 808 F.2d 84, 88 (1987) (”[t]he Supreme Court has in recent years distilled the constitutional requirement of standing into a three-part inquiry: 'A plaintiff must allege [1] personal injury [2] fairly traceable to the defendant's allegedly unlawful conduct and [3] likely to be redressed by the requested relief ”) (quoting Allen v. Wright, 468 U.S. 737, 751, 104 S.Ct. 3315, 3324, 82 L.Ed.2d 556, 569 (1984) and citing Valley Forge Christian College v. Americans United for Separation of Church & State, Inc., 454 U.S. 464, 472, 102 S.Ct. 752, 758, 70 L.Ed.2d 700, 709 (1982)).

¶156. Cutler v. Hayes, supra note 24, 549 F.Supp. at 1344. PA alleges that this conclusion is erroneous since FDA’s Memorandum of Points and Authorities in Support of Federal Defendants’ Motion to Dismiss or in the Alternative for Summary Judgment and in Opposition to Plaintiffs’ Motion for Summary Judgment, at 20-21, Record (R.) 52, included the claim that administrative remedies had not been exhausted. Brief for Intervenor at 18. FDA has not appealed from the District Court’s ruling, however, and does not argue before this court that appellants did not exhaust their administrative remedies. If an agency makes only a token effort to sustain a claim alleging failure to exhaust, a court may well conclude that the claim has been waived, particularly when futility is an issue. See, e.g., Mathews v. Diaz, supra note 94, 426 U.S. at 76-77, 96 S.Ct. at 1889-1890, 48 L.Ed.2d at 487-488; Etelson v. Office of Personnel Management, supra note 91, 221 U.S.App.D.C. at 401, 684 F.2d at 923 (claim of failure to exhaust administrative remedies made by OPM in “perfunctory and oblique manner"). Because this question involves an element of judgment by the District Court, and especially because the agency itself does not press the exhaustion issue before us, we will not overturn the District Court’s determination that this claim has been waived.

¶159. Etelson v. Office of Personnel Management, supra note 91, 221 U.S.App.D.C. at 403, 684 F.2d at 925 (footnotes omitted). Although we were wary of possible misuse of the futility exception in Etelson, and thus based our holding in that case on several factors rather than on apparent futility alone, we recognized that the potential for abuse stems primarily from efforts to "‘deliberately] flout ... administrative processes.’" Id. at 403-404, 684 F.2d at 925-926 (quoting McKart v. United States, supra note 91, 395 U.S. at 195, 89 S.Ct. at 1663, 23 L.Ed.2d at 204). In the case at bar, the fact that FDA does not press the argument that appellants have failed to exhaust administrative remedies supports the premise that an appeal to FDA would have been futile. See Etelson v. Office of Personnel Management, supra note 91, 221 U.S.App.D.C. at 401, 684 F.2d at 923 (OPM’s failure to assert that plaintiff did not exhaust administrative remedies “strongly suggests that OPM considered itself to have rejected finally all of [plaintiff’s] contentions, and it counsels us against a contrary determination”). It also seems clear that appellants have made no effort deliberately to bypass a firmly established agency procedure for resolving this controversy.

115

¶176. In Weinberger v. Hynson, Westcott & Dunning, supra note 14, the Supreme Court described the 1962 amendments to the FDC Act as a "statutory mandate to review all marketed drugs for their therapeutic efficacy, whether or not previously approved." 412 U.S. at 614, 93 S.Ct. at 2475, 37 L.Ed.2d at 214; see also H.R. Rep. No. 2464, 87th Cong., 2d Sess. 3 (1962); 37 Fed.Reg. 9,464-9,465 (1972) ("[t]here can be no question, however, that the Food and Drug Administration is obligated to review all OTC drugs to assure that all those found in the marketplace are safe and effective and not misbranded”). In addition, it is clear that the efficacy requirement for the full range of OTC drugs took effect within two years of passage of the Drug Amendments of 1962. See text supra at notes 10-13. Hence, we disagree with the District Court’s characterization of the OTC drug review program as "voluntary.” See Cutler v. Hayes, supra note 24, 549 F.Supp. at 1348.

117

¶178. The FDC Act’s enforcement provisions remain almost identical to those first enacted in 1938. See 21 U.S.C. §§ 335-337 (1982). The Secretary of the Health and Human Services refers violations of the Act to the appropriate United States Attorney, who may launch either a criminal prosecution or a civil action in the name of the United States. Id.§§ 335, 337 (1982). But Congress made clear that the Secretary would have no obligation to “report for prosecution, or for the institution of libel or injunction proceedings, minor violations of this chapter whenever he believes that the public interest will be adequately served by a suitable written notice or warning.” Id.§ 336. FDA has authority to promulgate regulations for the "efficient enforcement” of the safety and efficacy requirements. Id.§ 371(a).

124

¶185. For a drug to be generally recognized as effective, there must be "expert consensus ... founded upon 'substantial evidence.'" Weinberger v. Hynson, Westcott & Dunning, supra note 14, 412 U.S. at 632, 93 S.Ct. at 2484, 37 L.Ed.2d at 224; accord. United States v. Rutherford, supra note 8, 442 U.S. at 549-550 n. 7, 555, 99 S.Ct. at 2474 n. 7, 2477, 61 L.Ed.2d at 75 n. 7, 78. For the definition of substantial evidence, see supra note 12. "In the absence of any evidence of adequate and well-controlled investigation supporting ... efficacy .... [a drug] would be a ‘new drug’ subject to the provisions of the [FDC] Act.” Weinberger v. Hynson, Westcott & Dunning, supra note 14, 412 U.S. at 629-630, 93 S.Ct. at 2483, 37 L.Ed.2d at 223. Thus, the additional information would have to be significant enough to change the view of those experts who previously rejected classification of the drug as effective.

154

¶215; See, e.g., Sierra Club v. Gorsuch, supra note ' 149, 230 U.S.App.D.C. at 185, 715 F.2d at 659 ("judicial review of decisions not to regulate must not be frustrated by blind acceptance of an agency’s claim that a decision is still under study”) (emphasis in original); Environmental Defense Fund, Inc. v. Hardin, 138 U.S.App.D.C. 391, 397, 428 F.2d 1093, 1099 (1970) (“when administrative inaction has precisely the same impact on the rights of the parties as denial of relief, an agency cannot preclude judicial review by casting its decision in the form of inaction rather than in the form of an order denying relief'); American Broadcasting Co. v. FCC, 89 U.S.App.D.C. 298, 307, 191 F.2d 492, 501 (1951) (“[t]he Commission cannot, by its delay, substantially nullify rights which the Act confers, though it preserves them in form”).

158

¶219. In Heckler v. Day, 467 U.S. 104, 104 S.Ct. 2249, 81 L.Ed.2d 88 (1984), the Supreme Court held invalid an injunction, issued on behalf of a statewide class, requiring all future social security disability claims to be adjudicated according to judicially-established deadlines. In doing so, the Court was persuaded by extensive legislative history rejecting mandatory deadlines for resolution of disputed disability claims. Id. at 111-116, 104 S.Ct. at 2254-2256, 81 L.Ed.2d at 96-100. In the face of such a strong showing of congressional intent, the Court declined to sanction use of the traditional equity power to impose deadlines to prevent future delays. Id. at 119, 104 S.Ct. at 2258, 81 L.Ed.2d at 101. That, the Court believed, would be "an unwarranted judicial intrusion into this pervasively regulated area.” Id.

¶220Since the injunction in Heckler v. Day was predicated on the District Court’s view that the Department of Health and Human Services had infringed the claimant’s statutory rights under 42 U.S.C. § 405(b) (1982), 467 U.S. at 108, 104 S.Ct. at 2252, 81 L.Ed.2d at 94, neither that court nor the Supreme Court reached the question whether the agency’s action constituted unreasonable delay under the APA. See id. at 110 n. 13, 104 S.Ct. at 2253, n. 13, 81 L.Ed.2d at 95 n. 13. Yet the Supreme’s Court’s stern counsel against judicial imposition of mandatory deadlines, where legislative history strongly indicates congressional repudiation of them, clearly applies to delay claims under the APA. We note, however, that the legislative history of the FDC Act contains no discussion of the OTC drug review since this program was wholly devised and implemented by FDA. See notes 20-21 supra and accompanying text. Given this fact, we must, in divining congressional intent regarding deadlines for enforcing the FDC Act’s GRAS/E requirements, seek guidance from the scheme and purposes of the Act. See note 115 supra and accompanying text.

169

¶231. Should, on remand, 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. Two factors are relevant to this determination: how much work the agency has yet to do, and how long it should take for the work to be done. The District Court may find it appropriate, after hearing all parties, to impose a binding timetable upon FDA for completion of the program. Cf. MCI Telecommunications v. FCC, supra note 137, 200 U.S.App.D.C. at 292, 627 F.2d at 345; American Pub. Health Ass’n v. Veneman, supra note 16, 349 F.Supp. at 1317. See also Oil, Chem., & Atomic Workers Int'l v. Zegeer, supra note 138, 248 U.S.App.D.C. at 55, 768 F.2d at 1488.

177

¶239. Brief for Appellants at 50-51 (comparing regulation here challenged with scheme prohibited in Cutler v. Kennedy, supra note 17). Appellants also charge that the twelve-month open-record period serves no legitimate purpose, and in reality constitutes a vehicle for violations of the Act, since it will be used only to accept the results of new tests on efficacy and safety. Brief for Appellants at 53. This is clearly prohibited, since " ‘the Act is designed so that drugs on the market ... will have mustered the requisite scientifically reliable evidence of effectiveness long before they are in a position to drop out of active regulation by ceasing to be a "new drug.’”” Weinberger v, Hynson, Westcott & Dunning, supra note 14, 412 U.S. at 631, 93 S.Ct. at 2484, 37 L.Ed.2d at 224 (quoting Solicitor General). Accord, Cutler v. Kennedy, supra note 17, 475 F.Supp. at 852-853 n. 36.

¶240FDA has insisted that this criticism of the open-record period misconstrues its purpose. Responding to the same argument, made in a public comment opposing the proposed amended regulation, FDA elucidated:

The comment incorrectly assumes that the 12-month period following the tentative final monograph is for the sole purpose of giving manufacturers additional time for testing to upgrade a condition to Category I status. Rather, that period is the fixed time during *900which persons may submit data to the agency without petitioning to reopen the administrative record. These data may consist of additional data and information that FDA, either from informal meetings with manufacturers to discuss testing requirements or after a review of previously submitted data, has determined are necessary to upgrade a condition to Category I. In addition, manufacturers may submit new data from tests previously conducted.

¶24146 Fed.Reg. 47,734 (1981). We find this explanation adequate, and therefore reject appellants’ argument on this point.

188

¶252. See id. at 31,424 (‘‘[biased on the agency’s experience with comments filed to Panel Reports and with the tentative final and final monographs published to date, the evaluation of the comments, objections, and requests for hearings will take at least as long as the fixed time period established for the submission of new data”). Appellants argue that the period for completing the OTC drug review will be further prolonged because the revised regulations provide for a sixty-day comment period to enable the public to respond to material submitted while the administrative record remained open. 21 C.F.R. § 330.10(a)(7)(iv) (1986); see Reply Brief for Appellants at 15. Given the unavoidable long-term nature of the OTC drug review in its entirety and the benefit derived from keeping the record open, we regard any slight delay created by the public comment period as de minimis and well within the bounds of reasonableness.

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