FDA Accused Of Contempt Over Morning-After Pill
3 CommentsBy Ed Silverman // November 17th, 2010 // 12:44 pm
The Center for Reproductive Rights has filed a motion in a federal court charging the FDA is in contempt for failing to make the Plan B morning-after pill available to women of all ages without a prescription (see the motion here).
The move comes more than a year after US District Court Judge Edward Korman ordered the FDA to reconsider its 2006 decision that would allow only women ages 18 and older to buy the pill without a scrip. In his March 2009 ruling, Korman chastised the FDA for being “arbitrary and capricious,” making decisions in “bad faith” and being influenced by “impermissble political and ideological considerations” imposed by the Bush White House.
“The record is clear that the FDA’s course of conduct regarding Plan B departed in significant ways from the agency’s normal procedures regarding similar applications to switch a drug from prescription to non-prescription use,” Korman wrote. He then instructed the FDA to do make Plan B available to 17-year-olds within 30 days and review whether to make the emergency contraceptive available to all ages without a doctor’s order.
One month later, in April 2009, the FDA agreed to permit Plan B to be sold without a prescription to all women 17 and older, but would not allow the pill to become available to younger women unless a request was received from the manufacturer. “The FDA has patently ignored the order and continued its administrative stall on the citizen petition,” according to the motion filed by the group, which also filed the petition.
“For the past one-and-a-half years, the FDA has not taken any steps to comply with the court’s command to reconsider the citizen petition…The FDA’s disregard of the court’s clear and lawful order harms women whose access to Plan B is hindered by substantial obstacles imposed by the FDA, particularly in light of the need to take the medication within 72 hours of sexual intercourse in order for it to be effective,” the non-profit charges.
An FDA spokeswoman tells The Washington Post, which first reported this, that the agency believes “the best way for the agency to comply with the court’s order is to review a supplemental drug application expected to be submitted by” Plan B’s manufacturer.
JaT
Not judging one way or the other, and I realize this is for OTC sales, but as with the HPV vaccine - didn’t someone mention during that conversation some rule or ethical implication for a consumer not being able to understand labeling?
Not that I necessarily believe age determines the ability to understand, it just came to mind. With regular birth control a doctor or nurse or someone is guiding and advising (I think). No idea what the risks are for this product.
JaT
I suppose it still must be received through a pharmacist who can advise. Yes?
industry insider
Many of us have had contempt for the FDA over the years