'Morning after' pill: why a judge ordered that even preteens can access it

The judge gave the government 30 days to make the morning-after pill available over the counter, without age restrictions. The order is likely to spark a new round of debate over the drug.

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    This undated image made available by Teva Women's Health shows the packaging for their Plan B One-Step tablet, one of the brands known as the 'morning-after pill.' In a rebuke of the Obama administration, a federal judge ruled Friday that age restrictions on over-the-counter sales of the morning-after pill are 'arbitrary, capricious and unreasonable' and must end within 30 days.
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A federal judge has ordered the Obama administration to allow over-the-counter sales of emergency contraceptive pills without any age restrictions, a move likely to spark a new round of debate over the drug.

Senior US District Judge Edward Korman issued the order late Thursday in a 59-page opinion in which he blasted officials of both the Bush and Obama administrations for allowing political considerations to undercut scientific evidence that would have long ago made the drug, known as Plan B or the morning-after pill, available to American women, teens, and girls as young as 11.

“This case is not about the potential misuse of Plan B by 11-year-olds. These emergency contraceptives would be among the safest drugs sold over-the-counter, [and] the number of 11-year-olds using these drugs is likely to be [minuscule],” Judge Korman said.

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“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 said.

Reproductive-rights groups immediately hailed the decision as long overdue.

“Judge Korman’s ruling is an affirmation that policy can and should be driven by facts and by public health,” Ilyse Hogue, president of NARAL Pro-Choice America, said in a statement. “For years, women have had to jump through hoops because officials in Washington played politics with our health.”

“This ruling is good policy, good science, and good sense,” added Cecile Richards, president of Planned Parenthood Federation of America.

Conservative groups were critical of the opinion and urged an appeal.

“Even [Health and Human Services] Secretary Kathleen Sebelius saw the dangers of this logic. Since when have we placed politics over the health and well-being of our kids,” asked Penny Nance, president of Concerned Women for America.

“This harmful ruling should be appealed, and we are confident it will be overturned,” she said.

“Teen girls need parents, not unfettered access to abortion-inducing drugs,” said Marjorie Dannenfelser, president of the antiabortion group Susan B. Anthony List. “Judge Korman’s decision is reckless and denies girls the protection that comes along with the involvement of parents and doctors.”

Korman, a Reagan nominee, has presided over the Plan B litigation for years. In 2009, he ordered the Food and Drug Administration to expand availability of the drug without prescription to 17-year-olds.

The plaintiffs in the case had long argued that the emergency contraceptive drug was safe and effective according to the FDA’s own studies and should be available without prescription regardless of age.

In an unusually candid admission by a federal judge, Korman said he rejected the plaintiffs’ argument in a 2009 decision, even though he’d concluded that the FDA had “bowed to political pressure emanating from the [Bush] White House and departed from agency policy.”

The judge said he wanted to wait and see what new FDA commissioners, appointed by President Obama, and a new Obama administration would decide on the issue. “This change in leadership suggested that the FDA could be trusted to conduct a fair assessment of the scientific evidence,” the judge said.

He added that in his view, any decision to make Plan B available without a prescription regardless of age should be made by the FDA, not a federal judge.

After three years of study, the FDA agreed that the Plan B emergency drug should be made available for all ages. But the judge said the agency action was short-circuited by Secretary Sebelius.

“The motivation for the Secretary’s action was obviously political,” the judge wrote. “It was an election year decision that many public health experts saw as a politically motivated effort to avoid riling religious groups and others opposed to making birth control available to girls.”

Sebelius’s maneuver prompted the New England Journal of Medicine to write: “In our opinion, the secretary’s decision to retain behind-the-counter status for Plan B One-Step was based on politics rather than science.”

The piece continued: “Any objective review makes clear that Plan B is more dangerous to politicians than to adolescent girls.”

In addition to political interference, Korman said the relevant agencies acted in bad faith on the Plan B issue. “More than twelve years have passed since the Citizen Petition was filed [requesting the change] and eight years since this lawsuit commenced,” he said.

“The FDA has engaged in intolerable delays in processing the petition. Indeed, it could accurately be described as an administrative agency filibuster,” the judge said. “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.”

Korman gave the government 30 days to carry out his order.

What it will mean for many teenagers and some preteens is that they will be able – if confronted with an emergency – to obtain a drug that has been deemed safe and effective by the FDA in helping prevent an unwanted pregnancy.

They will not have to first obtain a prescription from a physician. And they will probably be able to obtain it quickly.

“You won’t have to find an open pharmacy," said Susan Wood, associate professor at the School of Public Health and Health Services, George Washington University. “It should be available in a range of settings, just as other birth control products are available in a range of settings,” she said in a conference call with reporters.

“We no longer have to find on a Sunday morning, or Saturday night, an open pharmacy with a pharmacist on duty," Professor Wood said. “Over the counter,” however, could include a decision by a store to put the pills behind the counter or in a locked case, as they are expensive (about $50).

Some advocates are worried that pharmaceutical companies may now increase the cost of the drug. That could create an additional barrier for teens, they say.

But the high cost would prevent it from being used as a day-to-day contraceptive.

Reproductive-rights experts agree with FDA studies that say that the emergency contraceptive pill is safe and effective, regardless of the age of the consumer.

“There’s no scientific data that it’s harmful to young woman. However it’s important that she have a conversation with a health-care provider,” Dr. Cora Collette Breuner of the American Academy of Pediatrics said as part of the conference call with reporters.

She said a “wonderful” aspect of the court’s decision is that public airwaves will soon be filled with advertisements about the newly available emergency contraception drug.

“This will provide an opportunity to talk to children about sexuality, reproductive health, and safety,” she said.

Linda Feldmann contributed to this report.

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