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Plan B drug maker: FDA approved pill without restrictions

- The Washington Times - Friday, June 21, 2013

The drug maker at the heart of a legal fight over access to emergency contraception said Friday it got the green light to offer its one-pill product to customers of all ages, who will not need a prescription or identification to purchase it.

Teva Women's Health of North Wales, Pa., said the Food and Drug Administration approved its request to sell Plan B One-Step without restrictions, after a roller-coaster court battle that had dogged the Obama administration since early April.

"This landmark decision represents the continuation of improving access to emergency contraception to all who need it, when they need it," the company said in a news release.

It is unclear how long it will take for the drug to be freely available on store shelves.

An FDA spokeswoman said Teva will have to ship their newly labeled product to retailers, but referred additional questions to the company.

A company spokeswoman, Denise Bradley, said the pills should be available on shelves by Aug. 1.

The Obama administration initially appealed an April 5 order by U.S. District Judge Edward Korman of New York that made the morning-after pill available without restrictions.

But after an adverse ruling in the appellate court, the Justice Department decided this month to drop its appeal and make the drug as easy to purchase as aspirin.

Conservatives, concerned about the drug's implications for sexual activity among young teens, found themselves aligned with Mr. Obama on the issue, even if their camaraderie was short-lived.

White House spokesman Jay Carney said this month that President Obama still has reservations about selling the drug to young teenage girls.

He said the administration dropped its fight, as a practical matter, after the 2nd U.S. Circuit Court of Appeals ordered it to make a generic, two-pill version of the drug available to all ages while the panel mulled the merits of restricting the one-pill version.

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