A federal judge Tuesday said that a last-minute Food and Drug Administration response to a citizen petition seeking to relax FDA rules regarding a birth-control product rendered moot a complaint to hold the agency in contempt of court.
But the legal battle over FDA regulations on products like Plan B One-Step is far from over.
He invited the Center for Reproductive Rights (CRR), which brought the lawsuit, to file appropriate legal motions in the case, and said Health and Human Services Secretary Kathleen Sebelius could be added as a defendant.
“This fight is far from over,” Nancy Northup, CRR president, said after the court hearing. “It has been 10 years of battling to bring emergency contraception out from behind the pharmacy counter. The FDA cannot simply continue moving the goal posts down the field for women’s reproductive health care.”
Emergency contraception refers to one or two specially designed birth-control pills that women can take to prevent pregnancy after unprotected sexual intercourse. The pills must be taken within 72 hours of the sex act to be effective.
CRR and dozens of reproductive rights and medical groups want emergency contraception available to teens and women without a prescription. The morning-after pills are safe and effective and will reduce unintended pregnancies, they argue.
The FDA was widely expected to give over-the-counter status to Teva Pharmaceutical Industries Inc.’s Plan B One-Step on Dec. 7. However, Mrs. Sebelius overruled FDA Commissioner Margaret Hamburg and blocked the change.
Mrs. Sebelius, supported by President Obama, said there wasn’t enough data with young teens to ensure that these products were safe for over-the-counter status.
On Tuesday, 14 U.S. senators sent a letter to Mrs. Sebelius, asking for her “specific rationale” on her decision.
CRR and its allies noted that in the FDA’s Dec. 12 response to their citizen petition, the agency again denied over-the-counter status to the pills. CRR said that these products were being illegally held to a different and nonscientific standard than other drugs and that “political calculations” were still in play.
Morning-after pills, which have been used for years to treat rape victims, cannot affect an established pregnancy. However, pro-life groups oppose them because it could prevent implantation of a fertilized egg, thus acting as an abortifacient. They also oppose the idea of selling any birth-control pills over the counter because of the risks for health problems such as blood clots.