NEW YORK, Dec 14 (Reuters) - A reproductive-rights group may reopen its six-year-old lawsuit over the availability of the morning-after pill, a Brooklyn federal judge has ruled, only days after last week's controversial decision by the Obama administration to prohibit the pill, known as Plan B, from being made available over-the-counter to girls younger than 17.
U.S. District Judge Edward Korman on Tuesday invited the Center for Reproductive Rights to file a motion to reopen its case against the U.S. Food and Drug Administration, which the center had accused of failing to respond to a 2001 petition to remove age restrictions on Plan B and its generic form. The ruling gives renewed significance to the long-standing case, which has taken a backseat to FDA rulemaking until now.
The suit, which was first filed by the center in 2005 and is not connected to Sebelius's decision, consolidated numerous challenges from women's groups and other Plan B supporters from across the country after the FDA did not act on the petition, which it eventually denied in 2006.
In 2009 Korman ruled that the FDA acted "in bad faith" in denying the petition, and that it had based its decision on politics instead of science. He ordered the agency to make the pill available without a prescription to all women over 17, and sent the agency back to take a second look at removing the remaining age restrictions.
When nearly two years passed without an agency decision, the center asked the court to hold the FDA in contempt. Late Monday evening, the agency issued a decision denying the petition, stating that it did not have enough evidence that girls younger than 17 could readily understand the instructions for using the drug. "Neither your petition nor any of the public comments to the docket contain sufficient data to satisfy the statutory requirements for FDA to remove the [prescription] requirements for Plan B for women under the age of 17," the FDA said in Monday's decision.
'CONSPIRACY THEORIES CAN ABOUND'
The agency's decision came less than a week after Health and Human Services Secretary Kathleen Sebelius instructed the FDA to deny a similar petition by the drugmaker Teva Pharmaceutical Industries Ltd to make its one-pill version of Plan B, Plan B One-Step, available over-the-counter to women of all ages.
In doing so, Sebelius overruled the FDA's recommendation to the contrary, saying there was insufficient evidence to show that young girls could properly use the drug.
While Korman said on Tuesday the contempt motion was moot, he questioned whether the FDA had violated his 2009 order in other ways -- particularly, if it had again let politics trump science in turning down the center's request.
During the hearing, Korman asked an attorney for the FDA to provide the scientific evidence used by Sebelius in denying Teva's petition.
"This is the first time in history the HHS has overruled the FDA," Korman said. "It raises the question of whether these decisions were based on politics or science."
Assistant U.S. Attorney Scott Landau, who represented the FDA, denied that the agencies' decisions had been based on anything other than scientific proof.
"Conspiracy theories can abound, but there is nothing to support plaintiff's arguments," Landau said.
In court papers, the FDA said it considered the two-pill version of Plan B to be more complicated to use, because it requires the user to take two pills, 12 hours apart, instead of one.
Both versions of Plan B, if taken no more than 72 hours after unprotected sex, can prevent an unwanted pregnancy.
Plan B One-Step contains the same amount of the active ingredient, levonorgestrel, as the two-dose Plan B, and Korman seemed to scoff Tuesday at the FDA's contention that the agency should treat the two drugs separately.
"It's two pills instead of one," Korman said. "I don't think anyone would have trouble understanding that."
'WE'RE TAKING THEM BACK TO COURT'
Korman also suggested that while evidence may show girls 11 years of age or younger can't safely use the drug, it may be possible to make the drug available over-the-counter for girls as young as 12, if there is evidence that they are better able to understand the labeling instructions.
Suzanne Novak, a senior staff attorney at the center, said her group would decide on next steps over the next few days.
"We're taking them back to court," Novak told reporters after the hearing. She said her group would consider adding Sebelius as a defendant in the lawsuit as well.
The FDA and a representative for the U.S. Attorney's office in Brooklyn declined to comment.
The case is Tummino v. von Eschenbach, in the U.S. District Court for the Eastern District of New York, no. 05-366.
For the plaintiffs: Suzanne Novak and Janet Crepps of the Center for Reproductive Rights; Andrea Costello of the Florida Institutional Legal Services and Natalie Maxwell of Southern Legal Counsel Inc.
For the FDA: Assistant U.S. attorney Scott Landau.
(Reporting by Jessica Dye)
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