The OTC Morning After Pill

Plan-B Contraception | The Maher Law FirmThe OTC (Over The Counter) morning after pill is no longer restricted by age

A federal judge rules that Plan B and Next Choice should be available to all, including minors.

Plan B was first approved for use in 1999 by prescription only; the FDA granted over-the-counter access to the pill for women 18 and older while maintaining the prescription requirement for younger females in 2006.

The Department of Health and Human Services (HHS) secretary Kathleen Sebelius made a decision in 2011 that prevented the FDA from expanding over-the-counter access to the pills without age restrictions as the agency had planned.

Judge Korman reversed the decision by the HHS saying, “Make lovonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within 30 days. There is no serious health risk associated with the use of Plan B as prescribed and intended, much less one that would make restrictions on distribution necessary for its safe use.”

Nancy Northup, president and CEO of the Center for Reproductive Rights said the message is clear “Women’s reproductive health and access to reproductive healthcare must never be held hostage by politics.” The ruling “has swept away all the FDA’s stalling, all the interfering, and all the political gamesmanship. Women all over the country will no longer face arbitrary delays and barriers just to get emergency contraception.”

Michael Halpern, program manager at the Center for Science and Democracy at the Union of Concerned Scientists said, “A federal judge has accomplished what two administrations failed to do: make a decision about access to a drug based on medical evidence.”

Judge Korman did, however, leave open the possibility of further action from the FDA, “On remand, the FDA may determine whether any new labeling is reasonably necessary. Moreover, if the FDA actually believes there is any significant difference between the one-and two-pill products, it may limit its over-the-counter approval to the one-pill product.”

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