In a 59-page decision, US District Judge Edward Korman of New York criticized the Obama administration for making an “obviously political” decision to keep teens under age 17 from purchasing Plan B One-Step without a prescription even though it’s currently “among the safest drugs sold over-the-counter.”
If the federal government opts not to appeal the decision, the US Food and Drug Administration must within 30 days allow pharmacies to stock the products on their shelves—rather than behind the counter—and to sell it without verifying the buyer’s age with an ID check.
The Department of Justice has not yet responded to a request for comment on whether the Obama administration plans to file an appeal.
Women’s health organizations cheered the decision, calling it an “enormous victory” and one that’s been “too long” in coming. “We’ve been in the court with the FDA for eight years despite mountains of evidence that emergency contraception is safe and effective for all ages,” said Nancy Northup, president of the Center for Reproductive Rights, a non-profit group that was one of the plaintiffs in the court case.
But critics of the decision said that young teens might incorrectly use the morning after pill as a method of birth control and that it might encourage sexual promiscuity. “The decision will give young girls a serious drug,” said Anne Fox, president of the Massachusetts Citizens for Life, an anti-abortion group. “I think it’s very irresponsible.”
Emergency contraception contains high doses of the female hormone progestin and needs to be taken within three days of unprotected sex to prevent pregnancy, but it is most effective if taken within the first 24 hours.
“It’s a very brief window of time, and women need to get access to it within that window,” said Marty Walz, chief executive officer at the Planned Parenthood League of Massachusetts. “Women had to go when the pharmacy was open and in rural areas especially, that’s not always easy.”
While the product can cause mild side effects such as nausea, abdominal pain, and breast tenderness, it hasn’t been found to cause any life-threatening reactions.
“This is one of the safest drugs out there,” said Dr. Susan Wood, an associate professor of health policy at George Washington University School of Public Health. “You can’t overdose on it, unlike children’s bubble gum flavor acetaminophen that can cause severe liver damage if you take too much.”
Wood said safety was not the issue in the FDA’s repeat decisions against making Plan B available over-the-counter without any age barriers. She resigned as the FDA’s assistant commissioner of women’s health in 2005 after the agency initially decided not to allow Plan B to be sold over-the-counter for adult women, rejecting the advice of its scientific advisory committee.
The agency later reversed itself, but still required girls 16 and younger to have a prescription. It finally decided in 2011 to lift all the restrictions, only to be overruled by Health and Human Services Secretary Kathleen Sebelius in an unprecented move.
Korman wrote in his decision that “even with eyes shut to the motivation for the Secretary’s decision, the reasons she provided are so unpersuasive as to call into question her good faith.”
The judge ruled that females of all ages be given unfettered access to the Plan B One-Step product but left it up to the FDA to decide whether to continue to restrict access to two-pill generic products, which require girls to space the pills out 12 hours apart.
The FDA declined to comment on the decision, saying it was an “ongoing legal matter for the agency.” Teva Pharmaceuticals, which manufactures One-Step, said in a statement that company officials “received the Court’s decision and are currently reviewing it.”
While providing easier access to emergency contraception will likely increase its use by women and teens, the cost of the $50 product could still present a barrier for teens and low income women. Insurance plans typically don’t cover over-the-counter products, and the Obama adminstration has indicated that emergency contraception, even by prescription, doesn’t fall into the category of contraception that the federal Affordable Care Act mandates must be covered without any co-payments.
The federal government is expected to release its final rules for coverage of birth control methods such as oral contraception and intrauterine devices within the next few weeks.
“We’re worried that the cost might be too much for those under age 17,” said Dr. Cora Collette Breuner, a University of Washington pediatrician who co-authored the American Academy of Pediatrics 2012 position paper that supported lifting the restrictions on emergency contraception. “We’ve won the battle but we don’t want to lose the war.”