'Morning after' pill: why a judge ordered that even preteens can access it
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.
鈥淭his 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],鈥� Judge Korman said.
鈥淭he 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,鈥� the judge said.
Reproductive-rights groups immediately hailed the decision as long overdue.
鈥淛udge Korman鈥檚 ruling is an affirmation that policy can and should be driven by facts and by public health,鈥� Ilyse Hogue, president of NARAL Pro-Choice America, said in a statement. 鈥淔or years, women have had to jump through hoops because officials in Washington played politics with our health.鈥�
鈥淭his ruling is good policy, good science, and good sense,鈥� added Cecile Richards, president of Planned Parenthood Federation of America.
Conservative groups were critical of the opinion and urged an appeal.
鈥淓ven [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,鈥� asked Penny Nance, president of Concerned Women for America.
鈥淭his harmful ruling should be appealed, and we are confident it will be overturned,鈥� she said.
鈥淭een girls need parents, not unfettered access to abortion-inducing drugs,鈥� said Marjorie Dannenfelser, president of the antiabortion group Susan B. Anthony List. 鈥淛udge Korman鈥檚 decision is reckless and denies girls the protection that comes along with the involvement of parents and doctors.鈥�
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鈥檚 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鈥� argument in a 2009 decision, even though he鈥檇 concluded that the FDA had 鈥渂owed to political pressure emanating from the [Bush] White House and departed from agency policy.鈥�
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. 鈥淭his change in leadership suggested that the FDA could be trusted to conduct a fair assessment of the scientific evidence,鈥� 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.
鈥淭he motivation for the Secretary鈥檚 action was obviously political,鈥� the judge wrote. 鈥淚t 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.鈥�
Sebelius鈥檚 maneuver prompted the New England Journal of Medicine to write: 鈥淚n our opinion, the secretary鈥檚 decision to retain behind-the-counter status for Plan B One-Step was based on politics rather than science.鈥�
The piece continued: 鈥淎ny objective review makes clear that Plan B is more dangerous to politicians than to adolescent girls.鈥�
In addition to political interference, Korman said the relevant agencies acted in bad faith on the Plan B issue. 鈥淢ore than twelve years have passed since the Citizen Petition was filed [requesting the change] and eight years since this lawsuit commenced,鈥� he said.
鈥淭he FDA has engaged in intolerable delays in processing the petition. Indeed, it could accurately be described as an administrative agency filibuster,鈥� the judge said. 鈥淭he plaintiffs should not be forced to endure, nor should the agency鈥檚 misconduct be rewarded by, an exercise that permits the FDA to engage in further delay and obstruction.鈥�
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 鈥� if confronted with an emergency 鈥� 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.
鈥淵ou won鈥檛 have to find an open pharmacy," said Susan Wood, associate professor at the School of Public Health and Health Services, George Washington University. 鈥淚t should be available in a range of settings, just as other birth control products are available in a range of settings,鈥� she said in a conference call with reporters.
鈥淲e no longer have to find on a Sunday morning, or Saturday night, an open pharmacy with a pharmacist on duty," Professor Wood said. 鈥淥ver the counter,鈥� 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.
鈥淭here鈥檚 no scientific data that it鈥檚 harmful to young woman. However it鈥檚 important that she have a conversation with a health-care provider,鈥� Dr. Cora Collette Breuner of the American Academy of Pediatrics said as part of the conference call with reporters.
She said a 鈥渨onderful鈥� aspect of the court鈥檚 decision is that public airwaves will soon be filled with advertisements about the newly available emergency contraception drug.
鈥淭his will provide an opportunity to talk to children about sexuality, reproductive health, and safety,鈥� she said.
鈥� Linda Feldmann contributed to this report.
