By Kurt R. Karst –
The decades-long saga over the withdrawal of approval of certain uses of certain classes of antibiotics in food-producing animals is likely to continue for some time given an August 8, 2012 decision from the U.S. District Court for the Southern District of New York. The decision stems from a 2011 lawsuit filed against FDA by the National Resources Defense Council (“NRDC”) and three other member groups of “Keep Antibiotics Working.”
As we previously reported (here, here, and here) the NRDC et al. sued FDA and initially sought to compel the Agency, by a court-ordered deadline, to withdraw approval of all subtherapeutic uses of penicillin in animal feed and nearly all subtherapeutic uses of tetracyclines (oxytetracycline and chlortetracycline) in animal feed and to issue final responses to two Citizen Petitions relating to hearing notices FDA issued in 1977 on the Agency’s withdrawal proposals. FDA subsequently denied the petitions and took other action, and the Plaintiffs supplemented their lawsuit. In a March 22, 2012 decision, Magistrate Judge Theodore H. Katz granted Plaintiffs’ Motion for Summary Judgment on their first claim for relief – that FDA withheld agency action in violation of both the Administrative Procedure Act (“APA”) and the FDC Act (§ 512(e)) by failing to implement withdrawal proceedings – and requested additional briefing on a schedule under which FDA must act. FDA has appealed that decision to U.S. Court of Appeals for the Second Circuit (Case No. 12-2106). In a June 1, 2012 decision, Magistrate Judge Katz denied FDA’s Motion for Summary Judgment and granted Plaintiffs’ Motion for Summary Judgment on another claim concerning the denial of the aforementioned Citizen Petitions. Magistrate Judge Katz found that FDA violated the APA and the FDC Act when the Agency denied the two petitions. FDA has not appealed that decision.
The August 8th decision from Magistrate Judge James C. Francis IV (who was assigned the case upon the retirement of Magistrate Judge Katz) concerns FDA’s proposed schedule pursuant to the Court’s March 22nd Order, as well as the Agency’s Motion for Stay requesting that the court stay the March 22nd Order pending resolution of the appeal (or impose an interim stay), and Plaintiffs’ Motion to Strike certain documents FDA submitted to the record. The meat of the decision deals with FDA’s proposal and motion, so that’s where we’ll focus as well.
FDA proposed a timeline that would require reissuance of the hearing notices within 11 to 17 months, and an additional period of 41 months to complete the withdrawal process, including administrative appeals, but nevertheless asked the court to refrain from imposing a deadline because doing so would impermissibly re-order the Agency’s priorities. Plaintiffs contended that FDA’s proposed schedule should be given a buzz cut so that the Agency would be required to reissue hearing notices within 125 days of commencement of the process and complete withdrawal proceedings within an additional two years.
In deciding whether there has been unreasonable delay meriting the court’s the imposition of a schedule, Magistrate Judge Francis looked to the six so-called “TRAC” factors from the U.S. Supreme Court’s decision in Telecommunications Research & Action Center v. FCC, 750 F.2d 70 (D.C. Cir. 1984), and that the U.S. Court of Appeals for the District of Columbia Circuit laid out in In re Barr Laboratories, Inc., 930 F.2d 72 (D.C. Cir. 1991). In Barr Laboratories, the Court refused to issue a writ of mandamus compelling FDA to act on ANDAs within the statutory 180-day period because “a judicial order putting [one ANDA sponsor] at the head of the queue simply moves all others back one space and produces no net gain.” In finding that “FDA’s unreasonable delay merits the imposition of a schedule for compliance with the March 22 Order,” Magistrate Judge Francis distinguished the case at hand from the D.C. Circuit’s decision in Barr Laboratories:
In Barr Laboratories, the writ of mandamus would have effectively controlled the agency’s generic drug approval process, benefitting one enterprise at the expense of others, failing to improve the efficiency of the process of approving (or disapproving) generic drugs, and having no effect on human health and welfare. Here, the FDA has utterly failed in its duty to initiate congressionally-mandated withdrawal proceedings. Requiring it to do so promptly is not reordering the FDA’s priorities; it is correcting the agency’s misprision of its duty. In Barr Laboratories, the court found that the contemplated order would have no effect on human health and welfare. Here, in contrast, compelling the FDA to timely fulfill its obligations will speed adjudication on the issue of whether the non-therapeutic use of certain antibiotics in animal feed threatens human health and, if the sponsors or other interested parties cannot demonstrate the drugs’ safety, accelerate their compulsory withdrawal.
Moving on to the schedule for compliance with the March 22nd Order, Magistrate Judge Francis ultimately adopted FDA’s proposed 17-month (hearing reissuance) and 41-month (hearing process) timetable, saying that FDA “is in the best position to analyze the issue and propose a realistic schedule that is not based on unsupported assumptions, but rather on its expertise, and it has done so.”
FDA was not so fortunate, however, with its Motion to Stay the district court’s March 22nd Order pending the Second Circuit’s decision on its appeal (or, in the alternative, a stay pending the Second Circuit’s resolution of FDA’s planned application for a stay in that Court). In denying the motion (for both a stay and an interim stay), Magistrate Judge Francis found that FDA did not show that it will be irreparably harmed if a stay is not granted, and that “given the substantial harm that further delay of withdrawal proceedings could visit on the plaintiffs and the public, the balance of the equities would not ‘weigh heavily in favor’ of a stay even if the Government had shown irreparable harm.”
The NRDC touted the district court decision as good news and commented that “FDA needs to move forward as rapidly as possible with the regulatory proceedings to address this pressing health threat and to rectify its decades-long neglect of this issue.” In other related news, a baker’s dozen of U.S. Senators sent a letter to FDA commending the Agency for releasing a guidance document proposing voluntary reductions in the use of antibiotics in food-producing animals, but urging FDA to further strengthen the guidance.