'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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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.Skip to next paragraph
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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.