FDA Approves Sale of Plan B One-Step to Minors Without Prescription

By:  Raven Clabough
05/01/2013
       
FDA Approves Sale of Plan B One-Step to Minors Without Prescription

The United States Food and Drug Administration (FDA) announced that it would allow the Plan B One-Step contraceptive to be sold without prescription to females as young as 15.

On Tuesday, the United States Food and Drug Administration (FDA) announced that it would allow the Plan B One-Step contraceptive to be sold without prescription to females as young as 15. The announcement amends a December 2011 decision that prohibited the sale of emergency contraceptives to all females of reproductive age without restriction, which had been overturned by U.S. District Judge Edward Korman on April 5. According to the FDA, its latest announcement was not prompted by the judge’s ruling, but is based on a study released by the company that makes the Plan B drug.

Reuters writes, “The FDA initially approved sale of the drug to all reproductive age females, but was ordered to bar girls under 17 by U.S. Health and Human Services Secretary Kathleen Sebellius.” President Obama agreed with Sebellius’ decision.

When the FDA did not approve an application from Teva Women’s Health Inc. — a unit of Plan B maker Teva Pharmaceuticals Ltd — that would have made Plan B One-Step available over-the-counter for all females of reproductive age, the company amended its application and resubmitted it. The application was amended so as to change the company’s bid to sell the product to those 15 and older.

Meanwhile, on April 5, 2013, Judge Korman ordered the FDA to grant a 2001 citizen’s petition to the agency that sought to allow over-the-counter access to Plan B for women of all ages without restrictions. At the time of Judge Korman’s ruling, Teva’s amended application was still pending.

Still, the FDA’s approval of Teva’s application is independent of the pending litigation and the Department of Justice is in the process of working on the next steps in the litigation.

The Wall Street Journal observes that Plan B has been “controversial” since 1999, and that the move for the product to be sold without a prescription has been “the subject of litigation for years.”

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