April 5, 2013

Federal judge makes morning-after pill available to all

Larry Neumeister and Lauran Neergaard / The Associated Press

WASHINGTON

— In a scathing 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.

The ruling by U.S. District Judge Edward Korman of New York means consumers of any age could buy emergency contraception without a prescription – instead of women first having to prove they're 17 or older, as they do today. And it could allow Plan B One-Step to move out from behind pharmacy counters to the store counters.

The Justice Department didn't immediately say whether it would appeal the ruling.

"We are reviewing the decision and evaluating the government's options," said F. Franklin Amanat, a lawyer for the government.

It's the latest twist in a decade-long push for easier access to emergency contraception, which can prevent pregnancy if taken soon enough after unprotected sex.

The Food and Drug Administration actually was preparing to lift all age limits on Plan B One-Step in late 2011 when Health and Human Services Secretary Kathleen Sebelius, in an unprecedented move, overruled her own scientists. Sebelius said some girls as young as 11 are physically capable of bearing children but shouldn't be able to buy the pregnancy-preventing pill on their own.

President Barack Obama said at the time that he supported Sebelius' decision, also citing concern for young girls. On Friday, White House spokesman Jay Carney said the president's position hasn't changed.

"He believes it was the right common-sense approach to this issue," Carney told reporters.

The 2011 move shocked women's groups — and in his ruling, Korman blasted Sebelius for what he called an "obviously political" decision.

"This case is not about the potential misuse of Plan B by 11-year-olds," Korman wrote, saying the number of young girls using such drugs "is likely to be minuscule."

Yet the sales restrictions are making it hard for women of all ages to buy the pills, especially young and low-income ones, he said.

Moreover, Korman noted that numerous over-the-counter drugs are dangerous for children, but are still sold nevertheless without age requirements, while "these emergency contraceptives would be among the safest drugs sold over-the-counter."

"It has been clear for a long time that the medical and scientific community think this should be fully over the counter and is safe for women of all ages to use," said Dr. Susan Wood, who resigned as FDA's women's health chief in 2005 to protest Bush administration foot-dragging over Plan B.

"Having worked on this for many years, the judge really wanted to make it clear that FDA had come to a scientific determination and was once again overruled, and that is not acceptable," she added.

The Center for Reproductive Rights, which filed suit against the age restriction, and other groups have argued that contraceptives are being held to a different and non-scientific standard than other drugs and that politics has played a role in decision-making.

"I think this is a landmark decision in terms of providing women and girls in the United States access to a safe and effective form of birth control," said attorney Andrea Costello with the Partnership for Civil Justice Fund.

Social conservatives criticized the ruling.

"This ruling places the health of young girls at risk," said Anna Higgins of the Family Research Council. "There is a real danger that Plan B may be given to young girls, under coercion or without their consent. The involvement of parents and medical professionals act as a safeguard for these young girls. However, today's ruling removes these commonsense protections."

The judge said the FDA decided after 11 months, 47,000 public comments and hundreds of thousands, if not millions, of dollars spent, that it did not need rulemaking on the subject.

(Continued on page 2)

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