Legal News

FDA Approves Plan B "Morning After" Pill for 17-Year-Olds

The emergency contraceptive Plan B "morning after" pill will soon be made available over-the-counter to 17-year-olds, federal health officials announced yesterday.

The announcement from the U.S. Food and Drug Administration (FDA) came one month after a federal court slammed the agency's handling of the approval process for the Plan B "morning after" pill (levonorgestrel), and basically ordered that the drug be made available to 17-year-olds over-the-counter (as it is currently available to women 18 and older).

As Reuters reports, a U.S. district court judge ruled in March that the Bush administration's FDA "had allowed politics to cloud its decision-making process regarding availability of the Plan B drug which had been restricted to those 18 and older."

In accordance with that court order, the FDA declared yesterday that "the government will not appeal this decision... FDA notified the manufacturer of Plan B informing the company that it may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older."

The Plan B "morning after" pill (levonorgestrel) is "is a set of two pills that contain higher doses of progestin than are used in prescription birth control pills," and is manufactured by Barr Pharmaceuticals Inc, (now part of Teva Pharmaceutical Industries Ltd.), according to Reuters. The Plan B pill received FDA approval as a prescription drug in 1999, and was cleared for over-the-counter sales in 2003. The following years saw a great deal of back-and-forth among lawmakers, drug manufacturers, and interest groups on both sides of the contraception debate. See a Timeline of Key Dates in the Morning After Pill Controversy, from Reuters.     

• Updated FDA Action on Plan B (FDA.gov)
• Plan B (0.75mg levonorgestrel) Tablets Information (FDA.gov)
• Reuters: FDA Eases Access to Morning-After Pill
• Reuters: Timeline of Key Dates in the Morning After Pill Controversy
• Judge Tells FDA to Make a Plan B for Teen Use of Morning After Contraceptive Drug (FindLaw's Common Law)
• Patient Rights and Responsibilities (provided by Patton Law Practice) 

Full post as published by FindLaw's Common Law on April 23, 2009 (boomark / email).