The move, regulators said, was made independent of a recent federal district judge's ruling that called for the emergency contraceptive to be made available over-the-counter to women of all ages without restriction.
NPR: FDA OKs Prescription-Free Plan B Pill For Women 15 And Up
In an effort to find a compromise for a politically fraught issue, the Food and Drug Administration has approved a proposal to make the emergency contraceptive pill Plan B more available to some younger teens without a prescription and to older women by moving the medication out from behind the pharmacy counter (Rovner, 4/30).
Los Angeles Times: Plan B Can Be Sold To 15-Year-Olds Without Prescription, FDA Says
The action comes roughly three weeks after a federal magistrate harshly criticized government regulators for their handling of the drug's approval process, calling their actions "politically motivated and scientifically unjustified." FDA officials said Tuesday that their decision was based on a pending, amended application submitted by the drug's manufacturer, Teva Womens' Health Inc. (Morin, 4/30).
Reuters: FDA Approves Plan B For Girls As Young As 15
The U.S. Food and Drug Administration on Tuesday said it would allow the Plan B One-Step contraceptive to be sold without a prescription to girls as young as 15 years of age. The announcement partially reverses a December 2011 decision that prevented the sale of the emergency contraceptive to all females of reproductive age, which was also overturned by a U.S. district judge in New York on April 5. The FDA said its approval was not related to the judge's ruling (4/30).
CQ HealthBeat: FDA Allows Sale Of Morning-After Pill To Women 15 And Older
The Food and Drug Administration announced late Tuesday that it has approved an application from Teva Women's Health to allow women 15 and older to buy without a prescription the Plan B One-Step morning-after pill the company manufactures. FDA officials said in a statement that their decision on the Teva application was made "independent" of an April 5 federal court order that Plan B be made available to women and teens of all ages without restrictions, as an over-the-counter drug (Norman, 4/30).
Medpage Today: FDA Lowers Age For OTC Plan B
The FDA has approved over-the-counter sale of the emergency contraceptive Plan B One-Step (levonorgestrel) to women and girls as young as 15. The agency announced late Tuesday that the approval was based on actual use studies and label-comprehension data showing that girls and women 15 and older understood that the product was not for routine use and wouldn't prevent sexually transmitted diseases. On April 5, a federal judge in the U.S. District Court's Eastern District of New York reversed a decision from the Department of Health and Human Services that restricted OTC access to levonorgestrel-containing emergency contraceptives Plan B and Plan B One-Step to women and girls 17 and older (Pittman, 4/30).