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Federal Regulations Advisor Insight and Commentary on U.S. Government Regulatory Affairs

Teenagers and Plan B One Step: Appeal and Request for Stay of FDA Compliance with District Court Order

Posted in Agency Authority, Judicial Review & Remedies

UPDATE (May 1, 2013 2015):  In an unsurprising move, the Department of Justice (DOJ) is appealing the district court’s ruling in Tummino v. Hamburg II after the FDA announced yesterday a new approval for the sale of the Plan B One Step (or morning after pill) over the counter with proof of age of at least 15.  Numerous reports (often repeats of the Associated Press report, and with no documentation) indicate that DOJ is appealing to the district court order to the United States Court of Appeals for the Second Circuit and has asked the district court to stay its order pending appeal.  

Politico’s Kathryn Smith reports:

In a court filing, the federal government asked for a stay so that the FDA would not be forced to comply with that decision immediately, and argued that the court didn’t have the authority to control the FDA’s decision.

“This court lacks subject matter jurisdiction to review any aspect of [the manufacturer’s application], including the HHS Secretary’s December 2011 directive to the FDA Commissioner to issue a complete response letter that rejected that SNDA. A district court does not have jurisdiction to review such agency action,” the DOJ states in a court filing.

Expect much more litigation on core authority and administrative law issues.