Federal judge denies FDA effort to block contraceptive access

McClatchy NewspapersMay 10, 2013 

Morning After Pill

Plan B One-Step (levonorgestrel) tablet from Teva Women's Health


— A New York federal judge on Friday denied a request by the Obama administration to delay his April 5 court order that allows emergency contraceptives to be sold without age limits or a prescription.

In a sharply-worded decision, U.S. District Judge Edward Korman of Brooklyn said the U.S. Food and Drug Administration’s attempt to stay his order pending an appeal was “frivolous” and “taken for the purpose of delay.”

He gave the agency until Monday at noon to file another stay motion, this time with the 2nd U.S. District Court of Appeals in order to delay compliance with his order yet again.

Robert Nardoza, a spokesman for the U.S. Attorney’s Office for the Eastern District of New York, would only say that government attorneys are “considering options” in the case.

In his 17-page ruling, Korman said the effort to make emergency contraceptives available without prescription has gone on for 12 years “even though they would be among the safest drugs available to children and adults on any drugstore shelf.”

“The FDA, responding to unjustified political interference, delayed as long as it possibly could before it took even one incremental step in the process,” he said. The FDA declined a request to comment on the judge’s ruling.

Womens’ rights supporters hailed the judge’s decision and accused the Obama administration of trying to score points with conservatives, who oppose emergency contraceptives, known as “morning-after” pills.

“It is as plain as day that the Obama administration has used deception and distraction as a tactic to avoid complying with the court order to make the morning-after pill available without age restriction or identification barriers,” said Mara Verheyden-Hilliard, executive director of the Partnership for Civil Justice Fund.

Korman’s ruling is the latest move in a tit-for-tat legal battle over the sale and marketing of emergency contraceptives that contain the active ingredient levonorgestrel. These products include Plan B and its single-dose version, Plan B One-Step.

In December 2011, the FDA recommended that Plan B One-Step could be sold over the counter without prescription or age restriction. But Health and Human Services Secretary Kathleen Sebelius overruled the recommendation, and the FDA later rejected a petition calling for unrestricted over-the-counter sales of the drug. Korman said the Sebelius’ action was “politically motivated, scientifically unjustified, and contrary to agency precedent.”

After several organizations challenged Sebelius’ decision, the judge directed the FDA on April 5, 2013, to grant a 2001 citizens’ petition that would make Plan B and/or Plan B One-Step available without age restriction or prescription.

But a separate application to market Plan B One-Step for girls ages 15 and older was already pending before the judge’s decision. Last month, the FDA lowered the minimum purchase age from 17 to 15.

Email: tpugh@mcclatchydc.com; Twitter: @TonyPughDC

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