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Feds Fight Morning-After Pill Age Ruling in NY

By Pharmaceutical Processing | May 28, 2013

NEW YORK (AP) — Department of Justice lawyers filed court papers Friday again asking a federal appeals court to delay lifting age restrictions and prescription requirements on an emergency contraceptive popularly known as the morning-after pill.

The papers seek to delay implementation of a judge’s April 5 ruling lifting restrictions on the drugs, including the medications sold under the brand name Plan B, setting the stage for another court showdown between President Barack Obama’s administration and women’s health activists over access to the contraceptive.

Currently, only people age 17 or older can buy the contraceptive without a prescription, although the Food and Drug Administration announced in late April that it would begin allowing one newer version of the drug, Plan B One-Step, to be sold over the counter to people as young as 15 as long as they present photo ID.

That accommodation only further agitated U.S. District Court Judge Edward Korman, who in his opinion on April 5 said that U.S. Secretary of Health and Human Services Kathleen Sebelius had wrongly let politics trump science when she overruled an FDA decision in 2011 that emergency contraception based on the hormone levonorgestrel could be sold safely to people of all ages without a prescription.

In a follow-up ruling, the judge said that the contraceptive “would be among the safest drugs available to children and adults on any drugstore shelf.” He called the FDA’s deal to allow some over-the-counter sales of Plan B One-Step a “sweetheart agreement” for the medication’s manufacturer, Teva Pharmaceuticals.

He noted that it would continue to restrict access to cheaper brands of the drug and be a hardship to the many young people who don’t have driver’s licenses.

The 2nd Circuit Court of Appeals, in New York, is scheduled to begin considering on Tuesday whether to allow the judge’s ruling to take effect immediately or delay it while further appeals are pending.

The Department of Justice, in its motion for a stay, argued that the judge overstepped his authority in ordering the drugs to be made available. It also said that maintaining the status quo while the case is on appeal would prevent market confusion over the status of the drugs.

Lawyers for a group of women and parents who have sued to broaden access to the contraceptives said in court papers that any further delay in their availability would harm “countless” women by leaving obstructions in place.

While the case is ostensibly about rules limiting the access of teenagers to the drug, it has a practical impact on older women as well because the age restrictions mean that the contraceptives must be kept behind locked pharmacy counters and therefore aren’t always available in the emergencies for which they are intended.

The drugs can prevent pregnancy if taken within 72 hours of sex, but they are more effective the sooner they are taken.

 

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