Bloomberg News

Teva Rebuffed by FDA on Morning-After Pill Age Restrictions

December 08, 2011

Dec. 7 (Bloomberg) -- Teva Pharmaceutical Industries Ltd. failed to win U.S. clearance to offer its emergency contraceptive over-the-counter for females of all ages.

The Food and Drug Administration rejected Petach Tikva, Israel-based Teva’s request to make the product the first morning-after pill available to girls of any age without a prescription, the agency said today in a statement on its website. The pill is kept behind pharmacy counters and can only be sold without prescription to women 17 and older.

The decision follows by two years a federal court ruling that age restrictions on the pill were arbitrary, based more on political pressure than safety. On Dec. 13, the FDA is scheduled to explain today’s decision to the court.

“If the FDA doesn’t do what we think they should be doing, that’s the next step,” said Kirsten Moore, president of the Reproductive Health Technologies project. “Anything less than saying, ‘Age restriction comes off, Plan B One-Step treated like any other OTC drug’ is an extreme disappointment.”

Supporters of wider over-the-counter access said it would have enabled females of all ages to get Plan B One-Step when they need it most, without showing proof of age.

Donna Harrison of the American Association of Pro-Life Obstetricians and Gynecologists, based in Holland, Michigan, said easing the rule would have denied teens access to proper counseling or testing for sexually transmitted diseases.

In 2009, when the FDA lowered the age at which the pill could be bought over the counter to 17 from 18, Republican senators wrote the agency asking for data underlying the decision. The letter also suggested that access to the drug at a young age could end up covering up sexual abuse.

“This is not a health product,” Harrison said.

The Teva product, called Plan B One-Step, reduces pregnancy risk if taken within three days of sex. It 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.

--With assistance from Drew Armstrong in New York. Editors: Chris Staiti, Bruce Rule

To contact the reporters on this story: Sarah Frier in New York at sfrier1@bloomberg.net; Molly Peterson in Washington at mpeterson9@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net


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