Groups say FDA's Plan B decision falls short of court order

NEW YORK Wed May 1, 2013 2:50pm 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) - Reproductive-rights groups that sued the Food and Drug Administration over access to the "morning-after" pill will ask a judge to hold the agency in contempt if it fails to comply with a court order directing it to make emergency contraception available to women of all ages.

The FDA said on Tuesday it will allow girls as young as 15 years old to buy without a prescription the Plan B One-Step emergency contraceptive, made by a unit of Teva Pharmaceutical Industries Ltd.

The groups, which include the Center for Reproductive Rights and the Partnership for Civil Justice Fund, said the FDA must remove all age limits and point-of-sale restrictions on emergency contraception, also known as the "morning-after" pill, by Monday.

If not, they said they would ask a federal judge in Brooklyn to hold the agency in contempt of an April 5 order giving the FDA 30 days to make emergency contraception available over-the-counter to girls of all ages.

The FDA could also seek to temporarily stop the court order from taking effect if it files an appeal. It has not done so yet, and the FDA said on Tuesday that the Department of Justice was considering its options.

The ruling from District Judge Edward Korman came in response to a lawsuit originally filed in 2005 by the reproductive-rights groups.

A spokeswoman for the FDA declined to comment Wednesday.

The dispute is the latest twist in a long legal battle over the morning-after pill that has sparked both political and religious debates. If taken up to 120 hours after unprotected sex, it is designed to prevent pregnancy.

The FDA said Tuesday's decision was made in response by an administrative petition from Teva Women's Health, a unit of the Israeli, drug-maker Teva, and was unrelated to Korman's ruling.

The agency said its decision to lower the age limit for Plan B One-Step was based on scientific data submitted by Teva that showed girls as young as 15 could safely use the drug without the intervention of a healthcare provider. Cashiers will still have to verify the customer's age before selling it, the FDA said.

Nancy Northup, president of the Center for Reproductive Rights, said in a statement, that the FDA's decision "does nothing to address the significant barriers that far too many women of all ages will still find if they arrive at the drugstore without identification or after the pharmacy gates have been closed for the night or weekend."

(Reporting by Jessica Dye; editing by Noeleen Walder and Leslie Gevirtz)

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Comments (1)
sean1969 wrote:
If the Judge threaens to throw the Head of the FDA in jail on May 6th & issues a bench warrent I bet the FDA will suddenly file thier appeal on May 5th midnight trying to foot drag further

May 01, 2013 6:23pm EDT  --  Report as abuse
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