Federal Judge Rules FDA Must Lift Restrictions on Plan B
U.S. must make 'morning-after' pill available over-the-counter for all without prescription
FRIDAY, April 5 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) must lift any age and sale restrictions on Plan B One-Step and its generic versions within 30 days, a federal judge ruled today.
The ruling counteracts a 2011 decision made by the Obama administration's Health and Human Services secretary, Kathleen Sebelius, who had then overruled an earlier FDA recommendation to make the pill available for all ages without a prescription.
Since December 2011, Plan B, the so-called "morning-after" birth control pill, has not been available without a prescription to young women under the age of 17. That surprise decision came the same day that the FDA was expected to make the controversial drug available to all females without a prescription.
Following Sebelius' announcement, FDA Commissioner Dr. Margaret Hamburg issued a statement saying her agency had found "there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential."
More Information (http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm109775.htm )