U.S. District Judge Edward Korman in New York on Monday ordered FDA to reconsider allowing 17-year-old girls access to the morning-after pill Plan B without a prescription within the next 30 days and consider allowing access to the pill for women of all ages (Stein, Washington Post, 3/24).
An FDA advisory panel in December 2003 recommended that Plan B, manufactured by Barr Pharmaceuticals, be sold over-the-counter. The agency in August 2006 ruled that only women older than age 18 could acquire the drug without a prescription (Rubin, USA Today, 3/24).
The ruling was the result of a lawsuit filed in 2005 by the Center for Reproductive Rights and other parties after FDA denied a petition seeking to make Plan B available without a prescription to women of all ages (AP/Arizona Daily Star, 3/23). FDA said that there was not enough safety data to approve the drug for teenagers younger than age 18 and that pharmacists would not be able to enforce the age cutoff. According to the Post, FDA's ruling meant women must show proof of their age when acquiring Plan B, making it more difficult to obtain for certain women, such as undocumented immigrants.
According to the Post, Korman in his written decision repeatedly criticized FDA's handling of Plan B, agreeing with the lawsuit allegations that the agency's decisions were "arbitrary and capricious" and swayed by "political and ideological" considerations imposed by the administration of former President George W. Bush. He wrote that there is "evidence of a lack of good faith and reasoned agency decision-making." Korman cited interferences by "political actors" in FDA's handling of the drug, including the delay in approving it and a decision to act only after some senators attempted to apply pressure by blocking confirmation of acting FDA commissioners. He wrote that the agency's final decision on Plan B "lacks all credibility" and the agency's conduct "departed in significant ways from the agency's normal procedures regarding similar applications to switch a drug from prescription to non-prescription use" (Washington Post, 3/24).
Korman wrote, "The record shows that FDA officials and staff both agreed that 17-year-olds can use Plan B safely without a prescription" (Marzulli, New York Daily News, 3/24). He added that "[b]arriers like a prescription requirement, which delays access to Plan B, may needlessly increase the chances that 17-year-olds will suffer unwanted pregnancies" because the drug is most effective within the first 24 hours after unprotected sex (Cornell, New York Post, 3/24). FDA spokesperson Rita Chappelle said the agency is reviewing the ruling (Washington Post, 3/24).