Judge approves FDA plan to drop limits on morning after pill

NEW YORK Wed Jun 12, 2013 9:45pm EDT

A Plan B One-Step emergency contraceptive box is seen in New York, April 5, 2013. REUTERS/Shannon Stapleton

A Plan B One-Step emergency contraceptive box is seen in New York, April 5, 2013.

Credit: Reuters/Shannon Stapleton

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NEW YORK (Reuters) - A U.S. district court judge on Wednesday approved a U.S. Food and Drug Administration plan to allow unrestricted sales of Plan B One-Step, a one-pill version of the emergency contraception drug.

Judge Edward Korman of the U.S. District Court in Brooklyn, New York, said the FDA proposal was "sufficient" to comply with his order to make emergency contraception widely available.

The Obama administration said on Monday that it would allow unrestricted sales of Plan B One-Step, the one-pill version of the drug made by Teva Pharmaceutical Industries.

The move followed an April 5 order by Korman for the FDA to make emergency contraception available without age or point-of-sale restrictions after finding it had been "arbitrary, capricious and unreasonable" in rejecting a citizen petition to do so.

Korman also said the FDA could lift restrictions on only the one-pill version if it believed there was a "significant difference" between that and an older two-pill version.

In a letter to Korman earlier Wednesday, Andrea Costello, a lawyer in the case, said the FDA had failed to comply with the order by not lifting restrictions on a two-pill version of the drug.

The morning-after pill has been the subject of a lengthy legal fight in the United States. Until recently, it was only available without a prescription to women 17 and older who presented proof of age at a pharmacist's counter.

Nancy Northup, president of the Center for Reproductive Rights, which helped bring the lawsuit, called the judge's decision a "historic victory" that will "bring emergency contraception out from behind the pharmacy counter for millions of women."

FDA spokeswoman Erica Jefferson declined to comment.

(Reporting By Karen Freifeld and Bernard Vaughan. Additional reporting by Jessica Dye; Editing by David Brunnstrom)

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Comments (7)
I love the colors on the packaging… They’re so feminine, aren’t they??? They soft purple (almost violet!) and the citrus green… Who wouldn’t want to abort a baby after seeing such packaging???

Jun 12, 2013 10:06pm EDT  --  Report as abuse
Gigimoderate wrote:
A win for women all over the United States. This will help prevent abortions and unwanted pregnancies.
Not to mention a big help for women in all those states Restricting abortions even for rape victims….here that you white Republican men!

Jun 12, 2013 10:47pm EDT  --  Report as abuse
Jake987 wrote:
OK ….now let’s see if we can get Pfizer to help lower the age for free Viagra to 9 or 10

Jun 12, 2013 11:35pm EDT  --  Report as abuse
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