The “morning after” pill can be made available nationwide to women of all ages and without a prescription, a federal judge ruled, dealing a blow to U.S. restrictions on access to the contraceptive.
U.S. District Judge Edward Korman in Brooklyn, New York, excoriated the Food and Drug Administration yesterday for what he called a 12-year delay in making the emergency contraceptive, Teva Pharmaceutical Industries Ltd. (TEVA)’s Plan B, available over the counter. The case isn’t about “the potential misuse of Plan B by 11-year-olds,” the judge said, while acknowledging that easier access to contraception may encourage sexual conduct by minors.
“These emergency contraceptives would be among the safest drugs sold over the counter,” Korman wrote, and “the number of 11-year-olds using these drugs is likely to be minuscule.”
“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,” the judge wrote.
Korman ordered the FDA to make the drug available nationwide without limits in 30 days. His ruling followed a reproductive-rights group’s request to reopen a lawsuit over access to the contraceptive, claiming the FDA acted in bad faith when it placed restrictions on the drug.
“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,” said Korman, 70, a former federal prosecutor appointed to the bench in 1985 by President Ronald Reagan, a Republican.
Erica Jefferson, a spokeswoman for the FDA, declined to comment on the ruling or the possibility of an appeal to the U.S. Court of Appeals in New York.
Korman’s ruling expands on a 2009 decision in which he ordered the pill made available without a prescription to women as young as 17. The judge said then that the age restrictions were arbitrary and based more on political pressure than safety.
The pill and generic versions of it are now kept behind pharmacy counters and sold without prescription only to women 17 and older. The contraceptives, which contain a larger dose of the hormone levonorgestrel than found in other birth control pills, prevents pregnancy by inhibiting fertilization. The drugs are most effective when taken within 24 hours of intercourse.
Advocacy groups heralded Korman’s decision, calling it a step forward for women’s health.
“Today science has finally prevailed over politics,” Nancy Northup, president of the Center for Reproductive Rights, which represented plaintiffs, said in a statement. “This landmark court decision has struck a huge blow to the deep- seated discrimination that has for too long denied women access to a full range of safe and effective birth control methods.”
The ruling is “good policy, good science and good sense,” Planned Parenthood said in a statement.
Women no longer will face the “disrespect” of having to produce ID or talk to a pharmacist to get access to the drug, Terry O’Neill, president of the National Organization for Women, which has Florida affiliates as plaintiffs in the case.
“Now that goes away,” she said. “It’s right there next to the condoms. You don’t have to deal with anyone’s disapproval.”
The 2005 case was reopened after Northup’s group petitioned Korman in February 2012, claiming it was the most efficient way for the organization to overturn the FDA’s age restraints on the drug.
Lawyers for the group accused the FDA of treating emergency contraception differently from other medicines.
The group previously supported Teva, based in Petach Tikva, Israel, in a failed bid to make the emergency contraceptive, Plan B One-Step, available in stores to all ages.
Kathleen Sebelius, the U.S. secretary of health and human services, ordered the FDA to reject Teva’s application in December 2011 because of the “cognitive and behavioral” differences in girls of the youngest reproductive age. The reproductive-rights group asked to add Sebelius as a defendant in the case.
Korman denied a request by Teva to join the case, ruling the company’s inclusion would be pointless. Teva sought to intervene to defend its right to exclusively market Plan B One- Step.
Denise Bradley, a U.S. spokeswoman for Teva, didn’t immediately respond to a call seeking comment.
Teva’s American depositary receipts, each representing one ordinary share, fell 15 cents to $39.22 at 4:21 p.m. in New York Stock Exchange trading.
FDA rules for approving drugs for over-the-counter sale are the same for aspirin as they are for contraceptives, Korman said. The standard for determining whether any drug should be made available over the counter turns solely on the buyer’s ability to understand how to use it safely and effectively, the judge said.
He rejected the FDA’s request that he send the case to the agency for further rulemaking. The agency has engaged in “intolerable” delays since a citizen petition was first filed more than 12 years ago, Korman said.
The government may appeal the judge’s decision or try to limit it in other states, Marcia Greenberger, co-president of the National Women’s Law Center in Washington, said in an interview. Its impact on the rest of the country depends to some degree on what the government does, she said.
“It’s a decision that can and does effect the whole country,” Greenberger said. “It’s a sad commentary that there’s so much controversy over contraception. A vocal minority can’t be allowed to stand in the way of women’s health.”
Allison Price, a spokeswoman for the Justice Department, said in an e-mailed statement that the agency “is reviewing the appellate options and expects to act promptly.”
Anti-abortion groups, which have alleged that the pill can kill embryos by preventing implantation, criticized the decision and said that widespread access to Plan B could be harmful for young girls.
Donna Harrison of the American Association of Pro-Life Obstetricians & Gynecologists said in a statement that girls may forgo counseling or other treatment for abuse or sexually- transmitted diseases if they are able to obtain emergency contraception without a prescription.
“You’re taking girls at highest risk of STD and isolating them from medical care,” Harrison said.
Charmaine Yoest of Americans United for Life called the pill “a potent and potentially life-ending drug” that young girls should need medical supervision to take.
“This decision allows the abortion industry to gamble with young girls’ health in distributing a life-ending drug, with no real understanding of the long-term implications on their bodies,” she said in a statement.
In his ruling today, Korman said the pill has “not been shown to cause a post-fertilization event -- a change in the uterus that could interfere with implantation of a fertilized egg.” He described suggestions otherwise as “scientifically unsupported speculation.”
The case is Tummino v. von Eschenbach, 05-cv-366, U.S. District Court, Eastern District of New York (Brooklyn).
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