published Thursday, December 8th, 2011

A short-sighted ruling

U.S. Health and Human Services Secretary Kathleen Sebelius ruled Wednesday that young girls should not be allowed to buy the Plan B morning-after pill over the counter without a prescription. The ruling was a shock, particularly since the decision overruled a recommendation from the Food and Drug Administration to lift age limits on the purchase of the emergency contraceptive.

Current rules, which allow women age 17 and older to purchase the drug without prescription, will remain in place. Sebelius’ decision does not mean that women under 17 will not have access to the drug. They still can purchase it, but only with a prescription. That requirement, some reasonably have argued, is a disservice to young women.

A number of medical, public health and advocacy groups believe that removing the age limitation and making the drug — generally agreed to be both safe and effective — more widely available would help the ongoing effort to lower the high number of unplanned pregnancies in the United States. The FDA decision to lift the age limit supported that belief.

Sebelius’ ruling is not the first time Plan B has been embroiled in controversy. Indeed, the medication taken after unprotected sex to prevent pregnancy initially made it to pharmacies only after long debate.

For several years the drug unfortunately was caught up in a political war that pitted scientists, women’s health and pro-choice groups and many physicians against conservatives and pro-life activists. The latter successfully pushed the George W. Bush administration to oppose all sales of Plan B. It was a short-term triumph. Courts and common sense eventually convinced regulators to approve the medication for sale with age restrictions.

Removing those restrictions and making the drug available to all women without a prescription was a logical next step after FDA scientists carefully studied the issue and recommended making Plan B available for purchase by individuals of any age without a prescription. The recommendation was not made lightly.

“There is adequate and reasonable, well-supported and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential,” FDA Commissioner Dr. Margaret Hamburg wrote. Sebelius disagreed.

She said Wednesday that “I have concluded that the data ... do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.” Sebelius clearly was concerned that some girls as young as 11 or 12 might become pregnant and might seek to use the drug. Those girls, Sebelius added, can have significant cognitive and behavioral differences from older girls and might not be able to understand how to use the drug without adult supervision That’s reason enough, she suggested, to maintain current age limits.

That’s a reasonable concern, but overlooks one important point. Young girls have the same need for a safe alternative to unwanted pregnancy as their older peers. Sebelius’ ruling could deny them that option if the youngsters have no responsible adult to help them obtain the necessary prescription. Besides, the question of age-related safety was adequately addressed by FDA drug safety experts. They concluded that Plan B’s age limit should be lifted.

The secretary’s ruling, which will be honored by the FDA, should be revisited. Sebelius and HHS should make it easier not more difficult for young girls to avoid unwanted pregnancy.

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