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

Teenagers and Plan B One Step: FDA’s Compliance with a Court Order or Just a Different Decision

Posted in Judicial Review & Remedies, Regulatory Process

The Food and Drug Administration (FDA) approved an application by Teva Women’s Health, Inc. to market Plan B One-Step (levonorgestrel) for use without a prescription by teens 15 years of age and older.  The approval of Teva’s application may or may not comply with the order the United States District Court for the Eastern District of New York in Tummino v. Hamburg II – and may not need to comply in this decision.

FDA’s approval of Teva’s application is separate from the Tummino litigation.  After the Tummino I decision that the Bush Administration politically interfered with FDA’s decision, and after the Obama Administration denied a citizen petition in 2011 (the decision subject of Tummino II).  Teva’s application was pending with the FDA for three years before Tummino II was decided.

Tummino II held that the HHS violated its own delegations and failed to explain its departure from established policy to overrule the FDA, an arbitrary and capricious act.  The approval comes days before the Tummino II deadline for FDA to make Plan B One Step be made available “over the counter” to a person of any age.

Today’s FDA press release (not the Department of Health and Human Services (HHS)) merely announces that the FDA has approved Teva’s application – and that may be all that the Administrative Procedure Act (APA) requires absent a contest of that application.  In response to an inquiry, FDA reiterated the key points:

Teva’s application to market Plan B One-Step for women 15 years of age and older was pending with the agency prior to Judge Korman’s ruling.  FDA’s approval of Teva’s current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge’s ruling.  The Department of Justice is considering next steps in the litigation.

The reasoning for an age of 15 remains to be seen – from FDA or DOJ, but it will be in defense of the new age of 15 if further litigation is pressed.  Given early press reports of dissatisfaction by some advocates, expect a “Tummino III” but that is in DOJ’s court.