Tuesday, December 6, 2011
HHS Overrules FDA Decision to Allow Younger Teens Access to Emergency Contraceptive Over the Counter
The New York Times: Plan to Widen Availability of Morning-After Pill Is Rejected, by Gardiner Harris:
For the first time ever, the Health and Human Services secretary publicly overruled the Food and Drug Administration, refusing Wednesday to allow emergency contraceptives to be sold over the counter, including to young teenagers. The decision avoided what could have been a bruising political battle over parental control and contraception during a presidential election season.
The contraceptive pill, called Plan B One-Step, has been available without a prescription to women 17 and older, but those 16 and younger have needed a prescription — and they still will because of the decision by the health secretary, Kathleen Sibelius. If taken soon after unprotected sex, the pill halves the chances of a pregnancy. . . .
The Los Angeles Times - Booster Shots blog: Doctors groups blast decision on Plan B contraception, by Shari Roan:
Several major medical groups reacted swiftly Wednesday to denounce the federal government's decision to limit over-the-counter access to emergency contraceptives for younger teens. . . .
The American Academy of Pediatrics, American College of Obstetricians and Gynecologists, Society of Adolescent Health and Medicine and American Society for Reproductive Medicine said Sebelius made the wrong call. . . .
Center for Reproductive Rights press release:
. . . Since 2009, the FDA has continually ignored a federal judge's order to reconsider and rule on the Citizen Petition filed by the Center in 2001 to make all brands of levonorgestrel-based emergency contraception available over-the-counter and to all ages-and the Center will be back in federal court on Tuesday, December 13 arguing the agency is in contempt of court for failing to do so.
The Center initially filed a Citizen Petition with the FDA in 2001 on behalf of over 70 medical and public health organizations, asking the agency to grant emergency contraception over-the-counter status to the original two-pill version of Plan B. When the FDA refused to rule on the petition, the Center filed a lawsuit in 2005 in federal court.
In 2009, the federal court ordered the FDA to reconsider its decision to limit over-the-counter access to Plan B for women over 16 after it was discovered the agency's decision was based on politics rather than science. The Center filed a motion for contempt against the FDA in November 2010 for continually failing to follow that order.
In February 2011, Teva filed a supplemental new drug application for Plan B One-Step asking the FDA to allow unrestricted over-the-counter distribution of the product. According to the FDA, the agency was poised to approve Plan B One-Step for over-the-counter, unrestricted use based on a "body of scientific findings, input from external scientific advisory committees, and data contained in the application that included studies designed to specifically address the regulatory standards for nonprescription drugs."
But today, Secretary Sebelius has blocked that approval, citing the data submitted by Teva "do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age." . . .