By Kurt R. Karst –
Magistrate Judge Theodore H. Katz of the U.S. District Court for the Southern District of New York has dealt FDA another loss in litigation over the withdrawal of approval of certain uses of certain classes of antibiotics in food-producing animals. In a June 1st decision on cross-motions for summary judgment, Magistrate Judge Katz denied FDA’s Motion for Summary Judgment and granted a Motion for Summary Judgment filed by the National Resources Defense Council (“NRDC”) and three other member groups of “Keep Antibiotics Working” – the Center for Science in the Public Interest, the Food Animal Concerns Trust, and the Union of Concerned Scientists – and found that FDA violated the Administrative Procedure Act (“APA”) and the FDC Act (§ 512(e)) when the Agency denied two Citizen Petitions requesting that FDA withdraw approval of subtherapeutic uses of penicillin and tetracyclines in animal feed because of a threat to human health.
The June 1st decision follows a March 22, 2012 decision in which Magistrate Judge Katz granted Plaintiffs’ Motion for Summary Judgment on their first claim for relief – that FDA withheld agency action in violation of both the APA and the FDC Act (§ 512(e)) by failing to implement withdrawal proceedings (see our previous posts here and here). FDA recently appealed that decision to U.S. Court of Appeals for the Second Circuit (Case No. 12-2106). Representative Louise Slaughter (D-NY), who is the author of legislation (the Preservation of Antibiotics for Medical Treatment Act) that would, among other things, phase out the non-therapeutic use in livestock of medically important antibiotics, promptly criticized FDA’s decision to appeal the March 22nd ruling as “a dereliction of duty.” FDA will presumably appeal Magistrate Judge Katz’s June 1st decision as well.
Magistrate Judge Katz’s June 1st decision stems from a Supplemental Complaint the Plaintiffs in the case filed after FDA denied (here and here) two Citizen Petitions submitted to the Agency – one on March 9, 1999 (Docket No. FDA-1999-P-1286) and another on April 7, 2005 (Docket No. FDA-2005-P-0007) – relating to Notices of an Opportunity for Hearing FDA issued in 1977 on proposals 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. In both petition denials, FDA commented that formal withdrawal proceedings “can consume extensive periods of time and Agency resources,” and that instead of instituting formal withdrawal proceedings, the Agency is instead “currently pursuing other alternatives to address the issue of antimicrobial resistance related to the production use of antimicrobials in animal agriculture.” Those “other alternatives” include a final guidance FDA issued in April 2012, titled “Guidance for Industry No. 209: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals,” and a a draft guidance issued at the same time, titled “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with [Guidance for Industry No. 209].”
FDA argued that the court lacks subject matter jurisdiction over the Agency’s denial of the 1999 and 2005 petitions, because FDA’s petition denials are actions outside the scope of judicial review pursuant to APA in that they are enforcement actions “committed to agency discretion by law.” Magistrate Judge Katz disagreed, and wrote that “initiating the withdrawal of approval of a new animal drug is not an enforcement action.” And even if such withdrawal is an enforcement action, the FDC Act “provides sufficient guidelines for the agency to follow in exercising its enforcement powers to rebut the presumption of unreviewability” (internal quote omitted), wrote Magistrate Judge Katz.
Finding that the petition denials are subject to judicial review, the court moved on to the Plaintiffs’ APA claim and found that FDA’s petition denials were both arbitrary and capricious. In doing so, Magistrate Judge Katz harshly criticized FDA:
For over thirty years, the Agency has been confronted with evidence of the human health risks associated with the widespread subtherapeutic use of antibiotics in food-producing animals, and, despite a statutory mandate to ensure the safety of animal drugs, the Agency has done shockingly little to address these risks. Now, in responding to this litigation and two Petitions that have been pending for years, requesting that the Agency comply with its statutory mandate, the Agency has refused to make any findings and instead intends to adopt a voluntary program that is outside the statutory regulatory scheme. The adoption of voluntary measures does not excuse the Agency from its duty to review the Citizen Petitions on their merits. The Agency must evaluate the safety risks of the petitioned drugs and either make a finding that the drugs are not shown to be safe or provide a reasoned explanation as to why the Agency is refusing to make such a finding.
The FDA failed to offer a reasoned explanation, grounded in the statute, for its refusal to initiate withdrawal proceedings, and, therefore, its action was arbitrary and capricious and otherwise not in accordance with law.
The June 1st decision is the latest in a string of losses for FDA in court in non-Hatch-Waxman cases. Earlier this year, the U.S. District Court for the Northern District of Connecticut ruled that FDA’s qualified health claim regarding the relationship between green tea and the risk of breast and prostate cancer violates the First Amendment (see our previous post here). FDA also lost cases in the U.S. District Court for the District of Columbia involving death row inmates and unapproved thiopental sodium, and the Agency’s regulation requiring the display on cigarette packages of graphic warnings (see our previous posts here and here). FDA has appealed both of those decisions to the U.S. Court of Appeals for the District of Columbia Circuit.