The short post-Labor Day week is often quiet, but that understates how quiet last week was indeed. Judicial decisions were relatively sparse, but two cases pose interesting problems of agency press releases, and one case raised mootness in the political tumult. The Office of Management and Budget (OMB) completed review of no significant rules, and Congress comes back this week. Some administrative law small nuggets can be found below.
Lease Withdrawal by Press Release & Memo: In a per curiam decision (with two concurrences and a dissent), the United States Court of Appeals for the Tenth Circuit divided over the value of a press release and memorandum in Impact Energy Resources, LLC v. Salazar. At issue was a Secretary of the Interior February 4, 2009, press release and February 6, 2009, memorandum to a lower official stating that he was directing withdrawal of the leases. That lower official effected the withdrawal in February 12, 2009, letters to the lessee / plaintiffs. The relevant Mineral Leasing Act bars suit 90 days “after the final decision of the Secretary.” Plaintiffs sued on the 90th day after the letters; too late the court found.
♦The concurring opinions differ on reasoning, and together with the dissent, the court has clearly stretched to reach this conclusion. Worth the read, but the decision represents an unfortunate instance where press releases and other informal actions are given more imprimatur than they deserve. The decision poses serious potential problems for Administrative Procedure Act (APA) litigation (and issues unanswered) if applied more broadly, and that is easily done, but, hopefully, this is a unique case.
Drug Compounding and Competition: The United States District Court for the District of Columbia, in K-V Pharmaceutical Co. v. United States FDA, dismissed claims that the FDA was violating the APA and several provisions of the Food, Drug, and Cosmetic Act (FDCA) by failing to take action against pharmacies that compound its product drug and thereby creating a cheaper alternative for doctors to prescribe. The drug, Makena, is an orphan drug prescribed to pregnant women with a history of preterm birth to reduce the risk that they would experience another preterm birth, but is quite expensive. Compounding creates a lower dosage and lower cost. The FDA had announced that it would not pursue enforcement actions in a formal press release and K-V Pharmaceuticals claimed that this action cause it to suffer economic loss to its competitors.
FEC Complaint: In La Botz v. Federal Election Commission, La Botz, the unsuccessful candidate for U.S. Senate of Ohio’s Socialist Party in 2010, alleged that the Federal Elections Commission (FEC) dismissed his administrative complaint “contrary to law” under the APA. La Botz complained that he was unfairly excluded from three televised debates during the election cycle under the Federal Election Campaign Act (FECA). The court found that La Botz alleged sufficient injury capable of repetition, yet evading review, and the court had jurisdiction to adjudicate the merits. Finding that the FEC’s decision was not supported by substantial evidence – a summary affidavit that contained no indicia of the affiant’s personal knowledge and only conclusively stated facts without support – the court denied the FEC’s motion to dismiss and remanded the matter back to the FEC.
Right Whales and Undersea Warfare: The United States District Court for the Southern District of Georgia, in Defenders of Wildlife v. United States Dep’t of the Navy, denied a preliminary injunction and permitted the Navy to install an Undersea Warfare Training Range (USWTR) off the coast of Florida. Environmental groups complained that the USWTR was near a federally-designated critical habitat and adjacent to the only known calving grounds of the endangered North Atlantic right whale. The court was satisfied that the Navy complied fully with National Environmental Policy Act (NEPA), the Endangered Species Act (ESA), and the APA. The right whales have been the subject of much maritime regulation and ESA litigation for advocacy groups, industry, and several different agencies, and now the Navy. The court has not posted the decision, unfortunately, and it appears to be available only through paid subscriptions.
Regulations: Surprisingly little activity at the Office of Information and Regulatory Affairs (OIRA) with little being submitted, but Office of Information and Regulatory Affairs (OIRA) did complete review of the World Trade Center Health Program; Addition of Certain Types of Cancer to the List of WTC-Related Health Conditions final rule (consistent with change, of course). Perhaps OIRA is working on the Spring 2012 Unified Agenda.
Budgets & Cliffs: Congress returns to a very full agenda of FY2013 budget and fiscal cliff issues, but little pressing on the administrative law front. OMB resource management offices appear to be working, as they should, on the FY2014 budget proposal, for whatever that will be worth, due the first Monday in February, by whatever President is in office.
Soon: FDA Food Safety and Modernization Act, pending regulations, and litigation.