Federal Judge Orders FDA to Remove Age Restriction on Over the Counter 'Morning After Pill'

The “morning after pill” must be made available to people of all ages without restriction, federal judge says.


U.S. District Judge Edward Korman argued that Plan B "would be among the safest drugs sold over-the-counter" and the FDA's argument that young people could misuse the drug was very "unpersuasive."

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A federal judge ruled Friday that the Food and Drug Administration must remove all restrictions on the "morning after pill," opening the door for people below the age of 16 to buy it over the counter.

[AP: NY Judge Makes Morning-After Pill Available to All]

Commonly known as Plan B, the pill was originally approved by the FDA on a prescription-only basis in 1999—in 2006, they allowed the pill to be sold over the counter to women over the age of 18. Friday's ruling, issued by Edward Korman, a U.S. District Judge for New York's Eastern District, would further loosen regulations on the emergency contraception pill.

According to the 2006 announcement by the FDA that made the pill available over the counter, "when used as directed, Plan B effectively and safely prevents pregnancy." At the time, the agency said it would "monitor the effectiveness of the age restriction and safe distribution of [over the counter] Plan B" before making a decision on whether to offer it over the counter to minors. In 2009, the agency was ordered by Korman to sell the pill over the counter to 17-year-olds.

The lead plaintiff in the case, Annie Tummino of the group National Women's Liberation, argued that age restricting Plan B was "arbitrary and capricious."

[CDC: Emergency Contraception Use Rising]

"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," she said in a statement Friday. "Women and girls should have the absolute right to control our bodies without having to ask a doctor or a pharmacist for permission."

In his decision, Korman agreed and said he had hoped the FDA would make the pill available without age restriction after his 2009 decision.

"It was my view that the decision whether to make Plan B available without a prescription regardless of age was one that should be made by the FDA … not by a federal district judge," he said in his decision.

In 2011, President Barack Obama said that he supported the FDA's decision to not make the pill available to people of all ages.

[ALSO: More People Than Ever Living Together Before Marriage]

"[The FDA] could not be confident that a 10-year-old or an 11-year-old [that goes] into a drugstore, should be able—alongside bubble gum or batteries—to buy a medication that potentially, if not used properly, could end up having an adverse effect," he said. "The question is can we have the confidence that [adolescents] would potentially use Plan B properly."

Korman argued that Plan B "would be among the safest drugs sold over-the-counter" and the FDA's argument that young people could misuse the drug was very "unpersuasive." He said he believed the FDA was under pressure from the George W. Bush administration to keep the drug age-restricted and that the case "has proven to be particularly controversial because it involves access to emergency contraception for adolescents who should not be engaging in conduct that necessitates the use of such drugs."

He said that, legally, the argument is invalid.

"The standards are the same for aspirin and for contraceptives," he said. "The standard for determining whether contraceptives or any other drug should be available over-the-counter turns solely on the ability of the consumer to understand how to use the particular drug 'safely and correctly.'"

The FDA said that it would not comment on the decision because it is an ongoing legal issue.

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