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Judge refuses to delay ruling on Plan B

A federal judge who's been battling the Obama administration over “Plan B” emergency contraception took another swipe at the federal government on Friday, denying a request to delay his ruling ordering the government to make the pills available to everyone, without restrictions.

Uncredited / AP

Plan B One-Step is designed to make pregnancy unlikely if taken within three days of unprotected sex.

Judge Edward Korman also accused the Food and Drug Administration of cooking up “a sweetheart deal” with drug maker Teva Pharmaceuticals.

Korman said he would put his original ruling on hold until Monday as a courtesy to the Court of Appeals and to allow the government to appeal the ruling. He didn’t mince words in expressing his opinion of the government’s legal attempts, calling them “frivolous” and saying they were done “in bad faith."

“The motion for a stay pending the appeal is denied. Indeed, in my view, the defendants’ appeal is frivolous and is taken for the purpose of delay,” Korman wrote in the ruling issued on Friday.

In 2011, the FDA approved emergency contraception, also known as the "morning-after" pill or "Plan B", for women of all ages. But the administration stepped in immediately. “The FDA was reversed by the Secretary of Health and Human Services on the same day in a decision that was politically motivated and that, even without regard to the Secretary’s motives, was so unpersuasive as to call into question her good faith,” Korman wrote in Friday’s decision.

Health and Human Services Secretary Kathleen Sebelius said at the time she didn’t want girls “as young as 11” buying contraceptives on their own. She limited over-the-counter sales to women 17 and older.

Women’s health groups filed suit and on April 5, Korman ordered the FDA to lift age restrictions on all levonorgestrel-based emergency contraception.

“I did so because the Secretary’s action was politically motivated, scientifically unjustified, and contrary to agency precedent,” Korman says.

 Just a few weeks later, the FDA approved an application by Teva Pharmaceutical Industries Ltd that would allow girls as young as 15 to buy Teva’s particular product without a prescription. It required that emergency contraception be labeled as not for sale to those younger than 15 and required pharmacies to demand proof of age.

Korman called this a “sweetheart deal’ for TEVA. “Teva’s proposal would enable it to have its product, and its product alone, displayed on the shelves in the family planning area of stores with an on-site pharmacy. Thus, a consumer looking for an emergency contraceptive would only find Plan B One-Step on the shelves, and if she came in after the pharmacy counter was closed, her only option would be Plan B One-Step,” he wrote.

“If she were under the age of 15, she would have no option, because she could only obtain levonorgestrel-based emergency contraceptives with a prescription.” Plus, Teva would get to sell its product to 15- and 16-year-olds for three years exclusively.

“The pharmaceutical companies that sell “brand X” versions of Plan B One-Step as well as the two-pill package of the drug could not display their products on the shelf because the old marketing regime remains in effect for them, and their products can only be sold from behind the pharmacy counter. Anyone under the age of 17 needs a prescription to obtain these products, and anyone over the age of 17 can only obtain them from the pharmacy by showing proof-of-age identification,” Korman wrote.

The government had asked for a stay of Korman’s April 5 ruling, saying it and the public would suffer “irreparable harm." Korman called this “silly” and said the appeal was “taken solely to vindicate the improper conduct of the Secretary”.

Korman also noted that the FDA originally protested Sebelius's decision. FDA commissioner Dr. Margaret Hamburg wrote a scathing blog post, calling it government interference. Yet FDA was now joining the government's lawsuit "in something out of an alternate reality," Korman wrote.

Plan B One-Step is designed to make pregnancy unlikely if taken within three days of unprotected intercourse. The single pill contains a high dose of the same hormone used in birth control pills to prevent or delay ovulation, prevent fertilization or, in some cases, prevent implantation of a fertilized egg in the uterus. Plan B One-Step will not end a pregnancy if a woman is already pregnant and there is no medical evidence it harms a developing fetus, FDA officials have said.

Plan B, available from generic manufacturers, uses two doses of levonorgestrel. Another emergency contraceptive, ella, or ulipristal, is a prescription-only product that prevents pregnancy when taken within five days of unprotected intercourse.

The FDA has said that all the drugs are extraordinarily safe.

Women’s health groups note that girls of all ages can buy far more dangerous products over the counter now, from aspirin to cold medicines, and that they also have access to condoms without a prescription or parental permission.

Related:

Judge criticizes FDA's move on Plan B

FDA approves on Plan B product for girls 15 and older

Plan B available to 15-year-olds - with ID