Federal judge strikes down age restrictions on over-the-counter emergency contraception
A federal judge in the Eastern District of New York ruled Friday morning that emergency contraception, more commonly known as the “morning after pill” or “Plan B,” should be made available to women of all ages over the counter, according to the New York Times. The judge blasted Secretary of Health and Human Services Kathleen Sebelius’ argument against doing so as overtly political.
Judge Edward R. Korman, in the case of birth control activist Annie Tummino vs. Food and Drug Administration Commissioner Margaret Hamburg, ruled in a highly critical 59-page opinion, “This case has proven to be particularly controversial because it involves access to emergency contraception for adolescents who should not be engaging in conduct that necessitates the use of such drugs and because of the scientifically unsupported speculation that the drug could interfere with implantation of fertilized eggs. Nevertheless, the issue in this case involves the interpretation of a general statutory and regulatory scheme relating to the approval of drugs for over-the-counter sale. The standards are the same for aspirin and for contraceptives. While the FDA properly recognizes that cognitive and behavioral differences undermine ‘the ability of adolescents to make reasoned decisions about engaging in sexual intercourse,’ the standard for determining whether contraceptives or any other drug should be available over-the-counter turns solely on the ability of the consumer to understand how to use the particular drug ‘safely and effectively.'”
The FDA originally approved emergency contraception for women ages 18 and older for over-the-counter use in 2006. Emergency contraception, which comes in a two-pill form and a one-dose form, administers the hormone progesterone to women, does not have any long-term side effects, and short-term side effects are minor, including nausea, headache and fatigue. The pill is designed to prevent or delay ovulation from occurring, thereby acting as a form of contraception.
The religious right, however, often confuses the science, conflating emergency contraception with RU-486, a medication that causes abortion or miscarriage.
Korman originally ruled on the case in 2009, when activists challenged the FDA’s determination that the medication only be available over the counter to women 18 and older. At that time, Korman expanded availability to women at age 17, saying, “the same evidence relied on by the agency to support over-the-counter access to the drug by 18-year-olds applied equally to 17-year-olds.”
Though Korman said he agreed with the plaintiffs that emergency contraception shouldn’t have an age restriction, he said, “the FDA bowed to political pressure emanating from the White House and departed from agency policy.” But Korman at the time didn’t expand the use to all ages because he believed the Obama administration would make this call on its own.
Instead, Sebelius, “invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions” in 2011, determined that the pill should not be accessible over the counter to younger women because “it is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age.”
Obama endorsed Sebelius’ decision, saying she couldn’t be confident “a 10-year-old or an 11-year-old go 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.”
Korman clearly didn’t understand this reasoning, especially since emergency contraception pills were still available to those under the age of 17 with a prescription. “These emergency contraceptives would be among the safest drugs sold over-the-counter, the number of 11-year-olds using these drugs is likely to be miniscule, the FDA permits drugs that it has found to be unsafe for the pediatric population to be sold over-the-counter subject only to labeling restrictions, and its point-of-sale restriction on this safe drug is likewise inconsistent with its policy and the Food, Drug, and Cosmetic Act as it has been construed,” he said. “Instead, the invocation of the adverse effect of Plan B on 11-year-olds is an excuse to deprive the overwhelming majority of women of their right to obtain contraceptives without unjustified and burdensome restrictions.”
He blasted Sebelius’ decision as blatantly political, saying, “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” and that “she has failed to offer a coherent justification for denying the over-the-counter sale of levonorgestrel-based emergency contraceptives to the overwhelming majority of women of all ages who may have need for those drugs and who are capable of understanding their correct use.”
He goes on to dissect factual inaccuracies in her argument, sentence by sentence, and criticized the FDA’s delay in addressing the plaintiff’s petition. “The plaintiffs should not be forced to endure, nor should the agency’s misconduct be rewarded by, an exercise that permits the FDA to engage in further delay and obstruction.”
Susannah Baruch, Interim President & CEO of the Reproductive Health Technologies Project, praised the decision in a press release. “Today we celebrate a long overdue victory for all women. Our decade long struggle is finally over. Emergency contraception will now sit on store shelves allowing timely access to this important product used to prevent unintended pregnancy. We urge Secretary Sebelius and the FDA to move swiftly to put emergency contraception on store shelves and into the hands of women and couples who need it.”
Update, 6:24 p.m. EST: Think Progress reported that White House press secretary Jay Carney said in a press briefing that Obama had not changed his position on the issue despite the ruling.
“He believes it was the right, common sense approach to this issue,” Carney said on the president, adding that the administration felt there was not enough evidence to show that “all those who could use this medicine, Plan B, can understand the label and use the product appropriately.”
Photo: Secretary of Health and Human Services Kathleen Sebelius (Flickr)
[Editor’s note: This story has been updated to more accurately reflect Obama’s quote.]