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U.S. judge strikes age rules for 'morning-after' pill

Source: Thomson Reuters Foundation - Fri, 5 Apr 2013 19:00 GMT
Author: Reuters
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* Says FDA rules 'arbitrary, capricious and unreasonable'

* Pediatricians had recommended access for younger girls

* Appeal considered unlikely

By Jessica Dye

NEW YORK, April 5 (Reuters) - A federal judge on Friday ordered the U.S. Food and Drug Administration to make "morning-after" emergency contraception pills available without a prescription to all girls of reproductive age and criticized the Obama administration for interfering with the process for political purposes.

The ruling in a Brooklyn court is the latest step in the years-long legal saga over the pill known as "Plan B," a drug that has also sparked political and religious battles. Reproductive-rights groups cheered the decision as overdue, while anti-abortion and religious groups condemned it.

The order reverses a December 2011 decision by U.S. Health and Human Services Secretary Kathleen Sebelius to limit the pill without prescription to women age 17 or older, a surprise move that countered an FDA recommendation for access at all ages and that President Barack Obama supported by invoking his daughters.

In his ruling, U.S. District Judge Edward Korman said the FDA's rejection of requests to remove age restrictions was "arbitrary, capricious and unreasonable."

"The motivation for the secretary's action was obviously political," Korman wrote.

One expert in administrative and medical law said the judge may have actually done the Obama administration a favor, though, giving it cover to back down on restricting the controversial drug without having to make a politically unpopular decision.

"This may be a free pass for them. You can say, 'our hands were tied, we were forced to cave in.' They may appreciate what (Judge) Korman did," said Lars Noah, a professor at the University of Florida College of Law.

"Whatever the political calculus is, I'd be shocked if they appealed this. They are probably just going to walk away from this one, and maybe thank their lucky stars this is how they got to the right outcome."

White House press secretary Jay Carney said on Friday that Obama maintains his backing for the Sebelius decision.

"The president supported that decision after she made it," Carney told reporters, adding, "and he supports that decision today. He believes it was the right common sense approach to this issue."

FDA spokeswoman Erica Jefferson declined to comment on the ruling, saying it was an ongoing legal matter. The Justice Department said it was reviewing the judge's opinion.

'ARBITRARY DELAYS'

The Center for Reproductive Rights and other groups had petitioned the FDA to strike down age and access limits, saying there was no scientific proof that girls younger than 17 could not safely use the drug without supervision.

Nancy Northup, president of the Center for Reproductive Rights, hailed the ruling. "Women all over the country will no longer face arbitrary delays and barriers just to get emergency contraception," she said.

The ruling is also likely to be well received by medical groups like the American Academy of Pediatrics, which recommended last year that pediatricians write advance prescriptions for patients under 17.

But opponents of abortion decried the ruling and warned that the pill's widespread availability could spur criminal activity.

"When these are right out there with the bubble gum, they're going to be part of the date rape cocktail," said Karen Brauer, president of Pharmacists for Life.

Some pharmacists across the United States have refused to dispense emergency contraceptives because it violates their religious faith. Making the pills available over the counter removes the pharmacist's role in dispensing the drug, which Brauer welcomed.

POLITICAL CONTROVERSY

In 1999, Teva Pharmaceuticals Ltd's Plan B became the first emergency contraceptive available for prescription use in the United States. The company also markets Plan B One-Step, a one-pill version of Plan B. Actavis Inc also markets a generic version of the drug; its shares rose nearly 1 percent Friday on what was otherwise a broadly lower day for stocks.

"Teva has received the Court's decision and we are currently reviewing it," said company spokeswoman Denise Bradley. "We have no additional comment at this time."

As of February, Plan B U.S. sales over the past 12 months were about ${esc.dollar}79 million, according to data compiled by IMS Health, which tracks pharmaceutical sales. That is a relatively small amount by pharmaceutical industry standards, but one that also understates the importance of the drug to young women.

Emergency contraceptives generally sell for ${esc.dollar}10 to ${esc.dollar}80. Although they can work as long as 120 hours after unprotected sex, they are most effective in the first 24 hours.

In 2005, the FDA declined to approve over-the-counter sales of the drug overruling its panel of outside experts as well as its own scientists.

In December 2011, the FDA reversed that stance and moved to approve over-the-counter sales with no age limits. But Sebelius overruled it, ordering that girls under 17 could only get the pills with a prescription.

As a result of that policy, women well beyond their teens are often asked to present proof of age to show that they are old enough to purchase the pills without a prescription.

'QUESTION HER GOOD FAITH'

In his ruling on Friday, Korman said Sebelius' actions were clearly political.

"Nevertheless, 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," he wrote.

One FDA veteran praised the decision.

"This has been a 10-year saga during which the FDA was not allowed to do its role properly, not allowed to make science-based decisions," said Susan Wood.

Wood resigned from the FDA as assistant commissioner for women's health in 2005 over its decision not to approve over-the-counter sales of emergency contraception. She is now director of the Jacobs Institute of Women's Health at George Washington University in Washington.

"This decision gives the FDA the chance to reclaim its ability to make decisions based on science, medicine and evidence," Wood said, "not politics."

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