Judge orders FDA to eliminate age restrictions on over-the-counter morning-after pill

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Women under the age of 17 may purchase the morning-after pill without a prescription, a federal district court judge ruled Friday, overturning an FDA age restriction on the oral contraceptive.

Calling Secretary of Health and Human Services Kathleen Sebelius’ decision to keep age restrictions on purchase of the contraceptive without a prescription “arbitrary, capricious, and unreasonable,” U.S. District Judge Edward Korman in New York directed the FDA to “make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within thirty days.”

Korman’s ruling reversed the HHS decision to limit over-the-counter sales to women ages 17 and up, saying that HHS’ reasoning, based on the possibility 11 year olds would not know how to use the drug appropriately, was ill founded.

“This case is not about the potential misuse of Plan B by 11-year-olds,” Korman wrote in his ruling. “These emergency contraceptives would be among the safest drugs sold over-the-counter, the number of 11-year-olds using these drugs is likely to be miniscule, the FDA permits drugs that it has found to be unsafe for the pediatric population to be sold over-the-counter subject only to labeling restrictions, and its point-of-sale restriction on this safe drug is likewise inconsistent with its policy and the Food, Drug, and Cosmetic Act as it has been construed.”

The lawsuit was originally filed in 2005 by the Center for Reproductive Rights in response to a Bush-era decision to prevent over the counter sales of the morning-after pill, according to the NY Daily News. The FDA later made it available over the counter to women 18 and older and, in 2009, Korman ordered the pill be available without a prescription to 17 year olds.

In 2011, the FDA decided to allow purchase of the pill without a prescription to women of all ages a decision that HHS subsequently overruled. Friday’s ruling reversed the HHS’s earlier decision.

“This decision is a welcome advance and affirms what feminists have been fighting for all along – the Morning-After Pill should be available to females of all ages, on the shelf at any convenience store, just like aspirin or condoms” Annie Tummino, the lead plaintiff in the suit and Coordinator of National Women’s Liberation said in a statement.

The socially conservative Concerned Women for America condemned the ruling.

“The morning-after pill contains 40 times the dosage of Levonorgestrel, the same drug used in other forms of birth control,” CWA president and CEO Penny Nance said in a statement. “Yes, 40 times the dose. Our young girls do not need to be part of this ‘social experiment’ on their bodies in the name of politics. It makes no sense that kids need parental permission to take aspirin at school but they’re free to take and buy Plan B. We call on the FDA to appeal the ruling and we are confident it will be overturned.”

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Caroline May