FDA Will Approve Plan B Without a Prescription for 17-Year Olds

April 22, 2009

By Christine P. Bump – 

On April 22, 2009, FDA announced that it sent a letter to the manufacturer of Plan B stating that the Agency would, “upon submission and approval of an appropriate application,” permit the sale of Plan B without a prescription to women 17 years of age and older.  Plan B is manufactured by Duramed Research, Inc., a subsidiary of Barr Pharmaceuticals. 

FDA’s announcement was in response to the scathing 52-page opinion issued by the United States District Court for the Eastern District of New York.  As we previously reported, the decision vacated FDA’s denial of a Citizen Petition which requested that the Agency make Plan B (and all emergency contraceptives like it) available without a prescription to women of all ages, and ordered FDA to permit Barr Pharmaceuticals to make Plan B available without a prescription to 17-year old women.   FDA’s statement yesterday specified that its letter to Duramed Research, Inc. was in accordance with the court’s order, and that it was “consistent with the scientific findings since 2005 by the Center for Drug Evaluation and Research.”  The government is not going to appeal the decision of the United States District Court for the Eastern District of New York.

Plan B, often referred to as the morning after pill, is an emergency contraceptive that can be used to reduce the risk of unwanted pregnancy if taken within 72 hours of unprotected sex or the failure of contraception.  It contains one of the same active ingredients used in prescription birth control pills (levonorgestrel), but at a much higher dose, and is not for routine use. 

Plan B has been available by prescription since 1999.  On August 24, 2006, FDA approved non-prescription use of Plan B for women 18 years and older.  Women 17 years and younger, however, still needed a prescription to obtain the drug.  FDA described its August 2006 decision as a conclusion reached through an “extensive process” of obtaining expert advice and public comment.  The Agency stated that the non-prescription use of Plan B presented novel issues, and that FDA was committed to “a careful and rigorous scientific process,”  although an advisory panel convened by FDA had recommended by a vote of 23-4 that Plan B be available over-the-counter without any age restrictions.   Note that the effect of both the District Court's decision and FDA's notice would still require a prescription for girls under the age of 17, although the District Court remanded the matter back to FDA for the Agency to “reconsider its decisions regarding the Plan B switch to OTC use.”

Categories: Drug Development