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FDA Ruling Raises Health Concern for Girls

05/01/13

On Tuesday, April 30, 2013, the Food and Drug Administration said it was making the morning-after pill, known as Plan B One-Step, available to girls as young as 15 and that the drug could be sold over-the-counter. Previously, the pill was available only to those who could prove they were 17 or older.

In early April, a federal district judge in New York ordered the FDA to lift its age limits on over-the-counter access to Plan B and its generic versions.

The FDA said the judge’s ruling played no part in its decision. In his ruling, Judge Edward R. Korman gave the agency 30 days to make the pill available to all ages without a prescription.

Deirdre McQuade, spokeswoman for the U.S. Conference of Catholic Bishops Secretariat for Pro Life Activities, said following the court ruling, that, “The court has acted irresponsibly by making this powerful drug available without a prescription to minor children.”

She noted, "Plan B does not prevent or treat any disease, but makes young adolescent girls more available to sexual predators. The court's action undermines parents' ability to protect their daughters from such exploitation and from the adverse effects of the drug itself.

"Many studies have shown that wider access to 'emergency contraception' among young people does not reduce pregnancy or abortion rates, but can contribute to higher rates of sexually transmitted disease,” McQuade said. “No public health consideration justifies the unregulated distribution of such drugs to children. This ruling should be appealed and overturned."

The appeal to the decision would have to come from the FDA through the Department of Justice.

On Tuesday, the White House said the Department of Justice was still reviewing Judge Korman’s decision and had not determined whether to appeal the ruling. The Department has until Monday to make that determination. 

Penny Nance, CEO and president of Concerned Women of America, said, “It makes no sense that kids need parental permission to take aspirin at school, but they’re free to buy and administer Plan B.”

"While the FDA is failing here in its responsibility to protect children,” McQuade said, “we continue to hope it will appeal the recent decision by one federal judge insisting that this drug be made readily available without any age limit at all."