A federal judge said that he won’t hold the U.S. Food and Drug Administration in contempt for ignoring his 2 1/2-year-old order concerning emergency contraceptive Plan B and that he will review an agency ruling on the drug.
In 2009, U.S. District Judge Edward Korman in Brooklyn, New York, told the FDA to reconsider whether Plan B and related generic drugs should be available without a prescription to girls under age 17. The FDA issued its ruling against such a change yesterday after today’s hearing on a contempt motion was already scheduled.
“I’m not going to hold the FDA in contempt,” Korman said today in denying the motion by the Center for Reproductive Rights, which supports loosening the restrictions. “They’ve complied in the sense that they’ve ruled on it.”
Last year, the Manhattan-based center, which had sued the FDA, said the agency failed to take up the issue and should be found in contempt. Yesterday, the FDA blocked unrestricted access to generic copies of the emergency contraceptive, affirming a move last week requiring girls under age 17 to have a prescription for the brand-name drug.
“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,” Nancy Northup, president of the Center for Reproductive Rights, said in an e-mailed statement. “It has been 10 years of battling to bring emergency contraception out from behind the pharmacy counter.”
Suzanne Novak, senior staff attorney at the center, told Korman that the FDA has “refused to give a fair and scientifically based report.”
Korman told Novak to request that he review whether studies done on the drug support the FDA’s decision yesterday, which she said she would do.
The FDA originally said it would approve brand-name Plan B One-Step as the first over-the-counter emergency contraceptive. U.S. Secretary of Health and Human Services Kathleen Sebelius on Dec. 7 ordered FDA Commissioner Margaret Hamburg to reject the application by Teva Pharmaceutical Industries Ltd. (TEVA) to make the drug available to girls under 17 without a prescription. Sebelius’s intervention was the first time HHS overrode an FDA staff decision.
Today, 14 U.S. senators, led by Washington state Democrat Patty Murray, asked Sebelius to explain the scientific basis of her decision.
In its ruling yesterday, the FDA maintained its policy for two-dose generic versions from makers such as Watson Pharmaceuticals Inc. of Parsippany, New Jersey, and Perrigo Co. (PRGO) of Allegan, Michigan.
“We conclude that FDA needs additional data to support a switch of Plan B for women under 17 years of age,” the agency wrote. “In the absence of such data, FDA declines to initiate a rulemaking to switch Plan B” to an over-the-counter product for those consumers.
Plan B One-Step and the generics are currently kept behind pharmacy counters and are sold without prescription only to women 17 and older. Younger girls may obtain the drug with a doctor’s order. Plan B One-Step reduces pregnancy risk if taken within three days of sex. The original brand-name Plan B at issue in the lawsuit is no longer made.
Korman said today there was no difference between the brand-name and generic drugs except the former requires one pill and the latter requires two.
“The FDA would basically make it available to anyone,” he said. “So now we’re dealing with the secretary, who wouldn’t make it available to anyone under 17” without a prescription.
In his March 2009 ruling, Korman said age restrictions on the pill were arbitrary, based more on political pressure than safety. He ordered it to be made available without a prescription to 17-year-olds. It had been available without a doctor’s order to women over 18.
The judge also ordered the agency to reconsider its policy and decide whether to approve Plan B and generics to be sold on drugstore shelves without any age restrictions.
In November 2010, the Center for Reproductive Rights asked Korman to find the FDA in contempt for its “failure to make any meaningful efforts to comply” with his 2009 order. The center originally petitioned the agency in 2001.
Plan B was cleared in 1999 for U.S. sales with a prescription. Barr Pharmaceutical’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. Teva, based in Petach Tikva, Israel, now owns Barr.
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.
Plan B One-Step is made with levongestrel, an ingredient found in birth control pills, and is linked with side effects that can include nausea, dizziness, changes in menstrual periods and fatigue.
The case is Tummino v. Hamburg, 05-cv-366, U.S. District Court, Eastern District of New York (Brooklyn).
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