In the latest volley over the contraceptive Plan B, a federal judge reversed the Department of Health and Human Services decision to restrict over-the-counter availability of the morning after pill to those 17 years or older .
Judge Edward Korman of the District Court of Eastern New York overturned Health and Human Services (HHS) Secretary Kathleen Sebelius’ decision to add an age limit to obtaining Plan B without a prescription; citing concerns over the safety of the emergency contraceptive, which is effective about 50% of the time in preventing pregnancy before the fertilized egg implants in the uterus, being taken by girls as young as 11 years old, Sebelius required anyone under 17 to provide a prescription in order to purchase Plan B, while allowing those 17 and older to buy the contraceptive over-the-counter.
It’s the latest development in a contentious regulatory battle that dates to 2009, when Plan B’s manufacturer, Teva Pharmaceuticals, filed an application with the Food and Drug Administration to change the drug’s status from a prescription medication to an over-the-counter one. At the time, only women 17 years or older could obtain Plan B without a prescription, and the company wanted to remove the restriction and expand over-the-counter access to women of all ages. After reviewing the application and available studies on the pill, the FDA‘s Center for Drug Evaluation and Research (CDER) determined that Plan B was safe and effective for adolescents, and concluded that younger girls were capable of correctly using and understanding the risks of Plan B without doctor intervention.
Based on the CDER conclusions, FDA commissioner Margaret Hamburg recommended that the contraceptive be sold without a prescription for “all females of child-bearing potential.”
In an unprecedented move, however, Sebelius invoked her authority as Secretary of HHS, which oversees the FDA, and overruled the recommendation, noting that the company failed to provide research showing that young girls could use the drug safely. Her decision was backed by President Obama, who said, “As I understand it, the reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old going into a drugstore should be able — alongside bubble gum or batteries — be able to buy a medication that potentially, if not used properly, could end up having an adverse effect. And I think most parents would probably feel the same way,” according to the New York Times.
Critics of her decision argued the motives were politically-driven, and that the labeling change was long overdue given the rates of unprotected sex and teen pregnancy. They argued that more access to contraceptives would lead to fewer unintended pregnancies and abortions, and pointed to data supporting the drug’s safety. Those who supported the restrictions made the opposite argument, maintaining that freer access to contraceptives could lead to more unprotected sex and abortions.
In reversing Sebelius’ decision, Judge Korman said that the ruling was made in “bad faith and improper political influence,” writing in his decision, “it is hardly clear that the Secretary had the power to issue the order, and if she did have that authority, her decision was arbitrary, capricious, and unreasonable.”
The age restriction means that while women over age 17 can get Plan B without a prescription, the medication is kept behind the pharmacy counter, which has made getting the drug more difficult when pharmacies are closed and pharmacists are not on duty.
“This is really great news for women. It is great news that the evidence is really going to be put into practice. We have known for a long time that it is safe enough to be put on the shelf, and it was really a political decision not to,” says Dr. Daniel Grossman, the vice president of research at Ibis Reproductive Health. “I thought [Sebelius' decision] was very surprising, because the evidence was really quite clear. It was unprecedented to do something like this. I hope that HHS will comply with the ruling and it will be on shelves soon.”
Grossman is also hopeful the judge’s ruling will increase access to all modes of contraceptives, including an eventual over-the-counter availability for daily birth control. “The evidence will show that that is also safe for women of all ages and should be on the shelves as well. There is a lot of work trying to move daily birth control over-the-counter. We are still not there yet, but one thing holding pharmaceutical companies back was this age restriction on emergency contraception and the lack of clarity about what would happen to regular birth control pills that was also approved for over-the-counter sale by the FDA,” he says.
In an email response to requests for comment, Allison Price, a spokesperson at the Department of Justice, said “The Department of Justice is reviewing the appellate options and expects to act promptly” while an HHS spokesperson said in an email that HHS’ concern “always has been and remains the health of young women nationwide.”