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Plan B Appeal: Order 'Undermines' FDA

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By Aditi Mukherji, JD on May 06, 2013 12:54 PM

In a move that has disappointed reproductive rights advocates, the Justice Department is challenging a federal judge's order requiring the government to make the "Plan B" emergency birth-control pill available over the counter to women of all ages.

The Justice Department's decision came just hours after the Food and Drug Administration last week approved over-the-counter sales of Plan B to women 15 and older. The FDA's approval was unrelated to the judge's order.

The Justice Department's Plan B appeal doesn't target the FDA. Rather, it takes aim at the federal judge's decision.

The Politics of 'Plan B'

Since its arrival in 1999, Plan B has been surrounded by controversy. In 2011, Health and Human Secretary Kathleen Sebelius rejected a request to let anyone under 17 buy Plan B over-the-counter. She overruled the FDA when the agency was ready to approve making the pills available to all women with no minimum age requirement.

Then last month, a federal judge made a splash by throwing Sebelius' rejection in her face. In an April 5 ruling, Judge Edward Korman gave the FDA 30 days to do away with any age and point-of-sale restrictions that prevent women from having easy access to emergency contraception. Korman argued that Plan B is completely safe for all women. He also argued that Sebelius' decision was arbitrary and politically driven.

Separate from the judge's order, the FDA last week approved a request by Plan B's maker, Teva, to sell Plan B over the counter to customers 15 and older. Teva had applied for the change long before Judge Korman's ruling.

What's Going on Now?

Legally speaking, the gloves are off. Because Judge Koman's order was a federal district court decision, it can be appealed; the Obama administration is doing just that.

First, they're asking a court to stay the judge's order (because the judge's order was supposed to take effect today). In federal court documents, the Justice Department argued that the judge overstepped his authority and "undermine[d]" the FDA when he ordered the agency to make emergency contraceptives available to all women over the counter.

It's important to keep in mind that the Justice Department's appeal of the federal judge's ruling doesn't affect the FDA's Plan B decision. The new Plan B rules became effective as soon as they were issued.

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