2nd Circuit Lifts Stay On 2-Pill Plan B Contraceptive, Expedites FDA's Appeal

2nd Circuit Lifts Stay On 2-Pill Plan B Contraceptive, Expedites FDA's Appeal

NEW YORK - (Mealey's) The Second Circuit U.S. Court of Appeals on June 5 said the federal government failed to meet the standard to obtain a stay of a lower court order that the Food and Drug Administration immediately make the older, two-pill Plan B emergency contraceptive available without prescription and without age or sales restrictions (Annie Tummino, et al. v. Margaret Hamburg, et al., No. 13-1690, 2nd Cir.). 

(Order available.  Document #28-130620-001R.)


A motion panel of the Second Circuit did grant the government's motion to stay an order by a district court judge to lift all restrictions for Plan B One-Step, the newer, one-pill version of the drug.  But as to the government's motion to stay the lower court order about the two-pill Plan B, the panel said that "a stay is denied because the Appellants have failed to meet the requisite standard" (McCue v. City of N.Y. [In re World Trade Ctr. Disaster Site Litig.], 503 F.3d 167, 170 [2nd Cir. 2007] [enhanced version available to lexis.com subscribers]). 

The panel also ordered that the appeal be heard on an expedited basis.  The clerk then scheduled the government's appeal brief to be filed by July 10 and the appellee's brief filed by Aug. 14. 

District Court Order 

The panel's order as to two-pill Plan B lifts a temporary stay issued by U.S. Judge Edward Korman of the Eastern District of New York that the government provide immediate over-the-counter access to two-pill Plan B.  Currently, that version of the drug is available without prescription at the pharmacy counter by women 17 and older, but a prescription is required for women under 17. 

Individuals and advocacy groups have been attempting for years to get the government to switch Plan B from prescription to nonprescription status.  Plaintiffs who sued the FDA in the Eastern District reopened their case after Health and Human Services Secretary Kathleen Sebelius overruled an FDA staff recommendation and imposed restrictions on two-pill Plan B. 

In the meantime, the FDA this year approved an application by Teva Women's Health Inc. to sell Plan B One-Step over the counter in stores with a pharmacy to women 15 and older with proof of age. 

Bad Faith 

In April, Judge Korman found that the government acted in bad faith in its handling of a citizen's petition and ordered the government to immediately make all emergency contraceptives available without prescription or age or point-of-sale restrictions.   

Judge Korman denied the government's motion to stay his order pending appeal but issued a temporary stay as a courtesy to the Second Circuit.  The government last month asked the appeals court motion panel to issue its own stay. 

The motion panel was composed of Circuit Judges Ralph K. Winter, Peter W. Hall and Gerard E. Lynch. 


The government is represented by Stuart F. Delery, Beth S. Brinkmann, Mark B. Stern and Adam C. Jed of the U.S. Justice Department in Washington, D.C., U.S. Attorney Loretta E. Lynch and Assistant U.S. Attorney F. Franklin Amanat of the U.S. Attorney's Office for the Eastern District of New York and David J. Horowitz, Elizabeth H. Dickinson, Annamarie Kempic and Scott A. Kaplan of the U.S. Department of Health and Human Services in Washington. 

The plaintiffs are represented by Kirsten Clanton of Southern Legal Counsel Inc. in Gainesville, Fla., Andrea Hope Costello and Mara Verheyden-Hilliard of the Partnership for Civil Justice Fund in Washington and Janet L. Crepps of the Center for Reproductive Rights in Simpsonville, S.C. 

Intervenor Teva Women's Health is represented by Michael D. Shumsky of Kirkland & Ellis in Washington.

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