Nine women were arrested Friday as they participated in a protest of the Food and Drug Administration’s (FDA) holding up the over-the-counter-use of Emergency Contraception (EC). Part of a group of some 40 protesters, the nine women, mostly from New York and Florida, were charged with disorderly conduct as they were arrested by Homeland Security officers for blocking the entrance to FDA headquarters in Rockville, MD.
The protestors said that they wanted to meet with Steve Galson, Acting Director of the FDA Center for Drug Evaluation who issued a “not approvable” letter in May 2004 in response to the initial application from Barr Pharmaceuticals, Inc., but were told he was unavailable. Two FDA advisory panels voted in December 2003 to recommend approval of the sale of Plan B without a prescription, but Galson said that he made the May 2004 decision on his own and did not follow these recommendations.
The American College of Obstetricians and Gynecologists (ACOG) just released a statement urging the FDA to approve a new Barr application for over-the-counter EC. ACOG said in its release that “greater access to emergency contraceptives could cut the U.S. unintended pregnancy and the abortion rate in half.”
The FDA is expected to rule later this month on a second application by Barr to make Plan B Emergency Contraceptive more accessible. This second proposal employs a novel packaging requirement called the “dual label,” which, if approved, would allow the drug to be sold to females older than 16 without a prescription but would require a doctor’s order for those younger than 16.
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