March 23 (Bloomberg) -- The U.S. Food and Drug Administration can’t deny women under 18 years of age access to Barr Pharmaceutical Inc.’s over-the-counter contraceptive known as Plan B, a New York judge said.

Plan B, also known as the “morning-after-pill,” can be sold without a prescription only to women who are 18 or older under the current FDA policy. U.S. District Judge Edward Korman, in Brooklyn, New York, today ruled that within 30 days Barr should be allowed to make the drug available without a prescription to 17-year-olds.

“The FDA’s justification for this age restriction, that pharmacists would be unable to enforce the prescription requirement if the cutoff were age 17, rather than 18, lacks all credibility,” Korman said. “No useful purpose would be served by continuing to deprive 17-year-olds access to Plan B without a prescription.”

Korman ordered the agency to reconsider its policy and decide whether to approve Plan B for over-the-counter sales without any age restrictions. He said the decision should be based on scientific evidence alone, adding the restrictions put in place under the administration of President George W. Bush were politically influenced.

“Today’s ruling is a tremendous victory for all Americans who expect the government to safeguard their health, not undermine it,” Nancy Northup, president of the Center for Reproductive Rights, said in an e-mail. “The court recognized that the FDA favored politics over science, ideology over women’s health, and violated the law in the process.”

Rita Chappelle, a spokeswoman at the FDA, said the agency is reviewing the ruling and declined to comment further.

Three-Year Debate

Plan B, which prevents pregnancy if taken within 72 hours of sexual intercourse, was cleared in 1999 for U.S. sales with a prescription. Barr’s application to sell the pills over the counter in 2003 ignited a three-year debate among people who wanted more timely access to the drug and those who argued that it might promote sexual promiscuity among teenagers.

The Center for Reproductive Rights sued the FDA in January 2005 over its failure to act on the request for over-the-counter sales. In 2006, the FDA granted Barr permission to sell the pill without a prescription only to women 18 years of age or older.

Korman said the evidence shows FDA officials and staff agree that 17-year-olds can use the drug safely without a prescription.

Unreasonable Delay

“The FDA repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons,” Korman wrote.

Korman said FDA’s upper management and Commissioner Andrew von Eschenbach “wrested control over the decision-making on Plan B from staff that normally would issue the final decision on an over-the-counter” application. “The Commissioner, at the behest of political actors, decided to deny non-prescription access to women 16 years and younger before FDA scientific review staff had completed their reviews.”

The case is Annie Tummino, et al, v. Frank M. Torti, Acting Commissioner of the Food and Drug Administration, 05-CV-366, U,S, District Court, Eastern District of New York (Brooklyn).

To contact the reporter on this story: Patricia Hurtado in New York federal court at pathurtado@bloomberg.net.

Last Updated: March 23, 2009 16:26 EDT