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Judge OKs fed's Plan B One-Step offer, cautions against exclusivity deals

A federal judge has approved the Obama administration's concession to make the Plan B One-Step "morning after" pill available to all girls and women without prescriptions or restrictions on where it can be sold. 

U.S. District Court Judge Edward Korman's ruling applies only to the brand-name, one-pill version of the emergency contraception product, not to the cheaper, two-pill versions. 

But he said the government's reversal on its position in a decade-long fight over the pills that prevent unintended pregnancy should be approved due to the efforts of the women's groups who fought so hard to achieve it. 

"It is they, and the women who benefited from their efforts, who deserve to be rewarded," Korman wrote in his six-page ruling. 

Korman also cautioned the government against granting drugmaker Teva Pharmaceutical Industries Ltd. exclusivity in the market, which would delay availability of more cost-effective pills for women. 

"Market exclusivity means that no other manufacturer will be permitted to market its products over-the-counter for three years," Korman wrote. "This confers a near-monopoly that will only result in making a one-pill emergency contraceptive more expensive and thus less accessible to many poor women."

Women's rights groups had objected to the government's plan, saying failed to expand access to the to the currently available two-pill product and because they didn't say how soon they would comply. But they cheered Korman's ruling just the same.  

"We are tremendously gratified that this lawsuit has resulted in an historic victory to bring emergency contraception out from behind the pharmacy counter for millions of women across the United States," said Nancy Northup, president and chief executive at the Center for Reproductive Rights, which vigorously pursued the lawsuit. 

However, it still will take time for the pills to show up on store shelves because Teva needs time to re-apply for approval and re-package the drugs in a way appropriate for the new sales venues. Lawyers involved in the legal case say Plan B One-Step could be available without restriction in mid-July. 

The pills now are only available with ID to girls aged either 15 or 17, depending on the product, with ID. Anyone younger or without ID needs a doctor’s prescription.

The Justice Department notified Korman on Monday that it would submit a plan for compliance and drop its appeal of his April 5 ruling directing the federal Food and Drug Administration to make all emergency contraception pills that contain levonorgestrel available without prescription or so-called "point of sale" restrictions. 

According to the department's letter, the FDA has told Teva to submit a new drug application for the Plan B One-Step products. The FDA "intends to approve it promptly," the letter said. 

In his ruling, Korman said that the government misinterpreted his April order in several ways, but added that the concerns were not sufficient to prevent him from delaying any effort to make emergency contraception widely available. 

"The effort to convert these levonorgestrel-based contraceptives from prescription to over-the-counter status has gone on for over twelve years, even though they would be among the safest drugs available to children and adults on any drugstore shelf," said Korman, who excoriated the government for "unjustified political interference." 

The FDA itself thinks women and girls of all ages should be able to get the pills freely. Many medical studies have shown they are safe -- safer than aspirin, for example -- and effective in preventing conception when used early enough after unprotected sex.

But FDA was overruled by Health and Human Services Secretary Kathleen Sebelius in 2011 and, after an initial angry outburst by FDA administrator Dr. Margaret Hamburg, has complied.

 

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