Judge dismisses legal challenge to Plan B, may review FDA decision

December 13, 2011

A federal judge Tuesday rejected a request to hold the Food and Drug Administration in contempt of court over its policy on the emergency contraceptive Plan B but said he would consider reviewing the government’s refusal to make it easier for girls and women to get the drug.

U.S. District Judge Edward R. Korman in Brooklyn agreed with the government that the request to hold the FDA in contempt was “moot” because the agency had reviewed a petition by family planning groups to make Plan B available without a prescription and had concluded Monday that there was insufficient evidence to do so.

But Korman said he was willing to hear arguments over whether the agency should have allowed the sale of the morning-after pill to girls younger than 17 without a prescription, and he instructed advocacy groups to file the appropriate legal motions. Korman specifically suggested adding Health and Human Services Secretary Kathleen Sebelius to the lawsuit.

The Center for Reproductive Rights, which is leading the court challenge, said it would comply with the judge’s request.

“This fight is far from over. We intend to take every legal step necessary to hold the FDA and this administration accountable for its extraordinary actions to block women from safe, effective emergency contraception,” said Nancy Northup, the center’s president and chief executive.

When asked about the judge’s decision, FDA spokeswoman Erica Jefferson said, “This matter remains under consideration by Judge Korman, therefore FDA has no comment.”

The legal maneuvering was the latest development in the long, contentious battle over Plan B. The Obama administration stunned many women’s health advocates last week by rejecting a request to allow anyone to buy the newer Plan B One-Step directly off the store shelves without a prescription. Currently, only those 17 and older are able to buy Plan B One-Step or the generic forms of Plan B without a prescription and must show proof of age.

Also on Tuesday, 14 Democratic senators, led by Sen. Patty Murray (D-Wash.), called on Sebelius to explain the rationale behind her decision, which had infuriated many members of Congress and women’s health advocates.

The court challenge involved a petition filed in 2001 and a lawsuit filed in 2005 by the center and more than 60 family-planning and health organizations in response to the initial delays in relaxing restrictions on the original two-pill Plan B.

Plan B contains a higher dose of a synthetic form of the hormone progesterone found in many standard birth-control pills. Taken within 72 hours of unprotected intercourse, the pill has been shown to be 89 percent effective at safely preventing pregnancy. It was approved in 1999 but only for women who had a doctor’s prescription.

Plan B works primarily by preventing an egg from being fertilized. But some critics focus on the chance that it might prevent a very early embryo from implanting in the womb, an action they consider equivalent to an abortion. Conservative lawmakers and advocacy groups also question the drug’s safety and argue that wider availability could encourage sexual activity and make it easier for men to sexually abuse underage girls.

In 2003, Plan B’s manufacturer asked the FDA to allow the contraceptive to be sold without a prescription so that women would be able to get the drug more quickly. The FDA delayed a decision on that request for three years despite recommendations by outside advisers, internal reviewers and leading medical authorities. It approved nonprescription sales in 2006 but only to women 18 and older.

In 2009, the agency allowed the sale of Plan B One-Step, a new version that works with one pill instead of the original two, to 17-year-olds without a prescription. But the decision came only after Korman ordered the change in response to the lawsuit.

In that decision, Korman criticized the FDA’s handling of the issue, agreeing with allegations that the decision to keep the restrictions was “arbitrary and capricious” and influenced by “political and ideological” considerations.

In February, Teva Pharmaceutical Industries asked the FDA to drop the remaining restriction on Plan B One-Step, citing two new studies that it said showed that girls as young as 11 could use the product properly and safely. FDA Commissioner Margaret A. Hamburg agreed. But in an unprecedented decision, Sebelius overruled Hamburg. The HHS secretary said that the evidence on the drug’s use by girls was insufficient, a decision endorsed the next day by President Obama.

Tuesday’s hearing involved the two-pill contraceptive Plan B, which is now sold in two generic versions as Next Choice and Levonorgestrel Tablets, 0.75 mg.

In rejecting the center’s petition, Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, argued that the only evidence that Plan B can be used safely by young girls comes from studies of Plan B One-Step.

“Plan B and Plan B One-Step are not the same product; they differ in their dose and directions for use,” Woodcock wrote in the letter released late Monday. “We conclude that FDA needs additional data to support a switch of Plan B for women younger than 17 years of age.”

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