Federal Judge Rules that Plan B Must Be Made Available to 17-Year-Olds Without Prescriptions; Labels FDA’s Actions Political

On March 23, 2009, U.S. Federal District Judge Edward Korman, writing for the U.S. District Court of the Eastern District of New York, ordered the Food and Drug Administration (the FDA) to permit Barr Pharmaceuticals, the manufacturer of Plan B, to make Plan B available to 17-year-olds without a prescription in the same manner as the drug is currently available to women age 18 and over.  (For the full opinion, click here)

The Court ruled that the FDA’s denial of nonprescription status was a political one that went against the recommendations of a panel of medical and scientific experts the FDA had appointed.  According to Judge Korman, under the Bush administration, the FDA had “repeatedly and unreasonably” delayed issuing a decision on the nonprescription status. 

The Court remanded to the FDA final determination on age and prescription requirements, but mandated that the drug be made available to 17-year-olds without prescription in light of the evidence that was presented at trial:

[T]he matter is remanded to the FDA for reconsideration of whether to approve Plan B for over-the-counter status without age or point-of-sale restrictions.  While the FDA is free, on remand, to exercise its expertise and discretion regarding the proper disposition of the Citizen Petition, no useful purpose would be served by continuing to deprive 17 year olds access to Plan B without a prescription.  Indeed, the record shows that FDA officials and staff both agreed that 17 years olds can use Plan B safely without a prescription.  The FDA’s justification for this age restriction, that pharmacists would be unable to enforce the prescription requirement if the cutoff were age 17, rather than 18, lacks all credibility.

The lawsuit was filed in 2005 by the Center for Reproductive Rights and others after the FDA denied a petition asking it to make Plan B available without a prescription to women of all ages. 

“Today’s ruling is a tremendous victory for all Americans who expect the government to safeguard public health,” said Nancy Northup, president of the center.

Plan B reduces the chance of pregnancy if taken within three days after sex. It works by preventing ovulation or fertilization and interfering with implantation of a fertilized egg, which some people consider the equivalent of abortion.