Drug regulators must make the morning-after pill available over the counter to girls as young as age 17, a federal judge in New York ruled yesterday, suggesting that the Food and Drug Administration (FDA) consider making the medication accessible to younger girls, as well.
U.S. District Judge Edward Korman said the FDA has 30 days to comply with his decision. He said that delays in approving the drug, Barr Pharmaceuticals’ Plan B, for non-prescription sale were “repeated and unreasonable,” and that the agency's decisions about the drug, including limiting it to women 18 and older, were “arbitrary and capricious.”
The FDA approved the over-the-counter sale of Plan B in 2006 after years of political haggling and the resignation of its director of women’s health, Susan Wood, who quit in protest over what she said was the politicization of the issue.
The Center for Reproductive Rights in New York sued the FDA in 2005 for allegedly holding the drug to a different safety standard than other meds. Its president, Nancy Northrup, said yesterday in a statement that the ruling “is a tremendous victory for all Americans who expect the government to safeguard their health, not undermine it. The court recognized that the FDA favored politics over science, ideology over women’s health, and violated the law in the process.”
But conservative groups slammed the ruling. “An activist judge has ordered that minor girls have access to this drug without medical oversight or parental knowledge,” Wendy Wright, president of the right-leaning policy group Concerned Women for America, said in a statement. “Minor girls need permission to go on a field trip, get a piercing, or in some states use a tanning booth. But now, by one judge’s order, girls will be encouraged to rely on an ineffective drug without medical oversight or parental involvement.”
Plan B is a high dose of birth-control pills that, if taken within 72 hours of unprotected sex, can prevent a fertilized egg from implanting in the uterus. Korman noted in his decision that the medication is available without a prescription or age restrictions throughout much of the world, “including virtually all industrialized countries.”
FDA spokesperson Rita Chappelle said this afternoon that the agency is reviewing the decision.
Updated at 4:45 p.m. March 24 with FDA comment.
Image © iStockphoto/Emiliano Rodriguez