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Morning-after drug must be sold over counter to all, judge orders

Plan B, the “morning after pill,” will be available to anyone.

Joe Raedle/Getty Images

Plan B, the “morning after pill,” will be available to anyone.

Consumers may soon find Plan B emergency contraception on supermarket and drugstore shelves next to condoms, tampons, and pregnancy tests after a federal judge ruled Friday that the product must be made available for purchase over the counter, without any age restrictions.

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 age 16 and under from purchasing the product without a prescription even though it’s currently “among the safest drugs sold over-the-counter.”

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If the federal government chooses not to appeal the decision, the US Food and Drug Administration must, within 30 days, allow pharmacies to stock Plan B One-Step 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 did not respond to a request for comment on whether the Obama administration plans to file an appeal.

JUDGE KORMAN’S OFFICE

Judge Edward Korman criticized the Obama administration for what he called an “obviously political decision.”

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 nonprofit group that was one of the plaintiffs in the court case.

But critics of the decision said that young teens might indiscriminately 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 antiabortion group. “I think it’s very irresponsible.”

The Family Research Council, a conservative Christian group based in Washington, argued that the decision could lead to more sexually transmitted diseases or leave teens vulnerable to pressure to take Plan B even if they don’t want to. “The involvement of parents and medical professionals act as a safeguard for these young girls,” said the group in a statement.

President Obama has argued in the past that Plan B should continue to have an age restriction, since a 10-year-old or an 11-year-old should not be able to go into a drugstore and, “alongside bubble gum or batteries, be able to buy a medication that potentially, if not used properly, could end up having an adverse effect.” His press secretary indicated on Friday that the president still holds this view.

Emergency contraception contains high doses of the female hormone progestin. Research suggests it works by preventing the fertilization of an egg by sperm, though some religious opponents contend there’s a possibility that fertilized eggs could be expelled from the uterus, making it a form of abortion.

The pill 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.’’

Wood said safety was not the issue in the FDA’s repeated 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 to adult women, rejecting the advice of its scientific advisory committee.

The agency reversed itself a year later, and then allowed 17-year-olds to have over-the-counter access in 2009 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.

White House press secretary Jay Carney told reporters on Friday that Obama still “supports that decision today,” adding that the President considered it a “common-sense approach.”

Korman wrote 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 take the pills 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, One-Step’s $50 price could still present a barrier for teens and low-income women. Insurance plans typically don’t cover over-the-counter products, and the Obama administration 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 an 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.”

Deborah Kotz can be reached at dkotz@globe.com. Follow her on Twitter @debkotz2.
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