- Decision keeps two-pill version of drug off over-the-counter market, official says
- The FDA says it will allow over-the-counter sales of one-pill product
- A federal judge in New York had ordered the drug be made available without restrictions
- The Obama administration's appeal of that ruling was rebuffed last week
The Obama administration will allow minors to obtain one form of the emergency contraception known as the "morning-after pill," dropping its appeal of a judge's order requiring it to be sold over the counter.
U.S. District Judge Edward Korman had ruled in April that the government must allow over-the-counter sales, and a federal appeals court rejected the administration's challenge to that ruling last week. The administration had been criticized by some women's rights groups for trying to stop contraception sales to underage females.
In a Monday letter to Korman, Justice Department attorneys said the Food and Drug Administration and the Department of Health and Human Services had agreed to make the single-pill version of the drug available "without age or point-of-sale restrictions."
"It is the government's understanding that this course of action fully complies with the Court's judgment in this action," the letter states. "Once the Court confirms that the government's understanding is correct, the government intends to file with the Circuit Court notice that it is voluntarily withdrawing its appeal in this matter."
The FDA has asked the maker of the single-pill emergency contraceptive known as Plan B One-Step to submit a new request for over-the-counter approval, the letter states. The agency "will approve it without delay" once filed.
But the FDA won't allow girls to obtain a two-pill version of the drug, saying there is less safety data available on the use of the product by younger adolescents.
An Obama administration official told CNN on Tuesday that the latest court ruling meant that a version of the drug would have to be made available over the counter, and if the administration had appealed, it would have been the two-pill version. Facing that reality, officials decided to move forward with the one-pill version rather than letting the two-pill configuration hit the market, the official said.
The key ingredient in Plan B is the synthetic hormone levonorgestrel, which can prevent fertilization or prevent a fertilized egg from embedding in the uterus. Emergency contraceptives are intended for use within 72 hours after sex but are most effective if taken within 24 hours.
The FDA announced two years ago there would be no limits on over-the-counter sales of morning-after pills. But Health and Human Services Secretary Kathleen Sebelius unilaterally ordered the age and prescription restrictions, prompting lawsuits.
Sen. Patty Murray, D-Washington, praised the decision.
"After far too long of a delay, science has prevailed," said Murray, who called emergency contraception "an essential part of women's basic health care."
"Today's move by the administration means the safety and effectiveness of Plan B, not politics, will dictate access," she said.
And the abortion rights group NARAL Pro-Choice America said the decision "ends a nearly decade-long battle over lowering barriers to this important medication."
"Health experts like the American Academy of Pediatrics and many others agree that emergency contraception is safe and effective for women of all ages," Ilyse Hogue, president of the rights group, said in a statement hailing the move. "We're happy to see this long overdue victory for science over politics."
The move is likely to draw criticism from opponents of abortion rights, who had condemned Korman's April ruling.
Korman had criticized what he called "nonsensical" government rules that he said unfairly favored the single-pill version over the cheaper, generic two-pill version. Under current policies, prescriptions are still needed for the generic version for those under age 17.
Supporters of Korman's ruling called it a landmark decision, while opponents raised concerns about safeguards being eliminated.
The FDA said in May that it was changing its regulations, allowing sales by a private pharmaceutical firm, Teva Women's Health, to those 15 and over without a prescription. Only those 17 or older were previously allowed to buy the contraceptive.
Many developed countries require a prescription for oral contraceptives, including Canada and most of Europe. Other countries sell the pill without a prescription.