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HEALTH NEWS

FDA Puts Off Approval of OTC Morning-After Pill

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Contributed by Jai A. Dennison|  22 January, 2005  22:18 GMT

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Because it is more effective when taken in the first 24 hours after intercourse, many health professionals believe that women should have faster, easier access to the Plan B emergency contraceptive.
The manufacturer of the prescription-only morning after contraceptive called "Plan B" says the Food and Drug Administration (FDA) has not completed the necessary review prior to approving it for over-the-counter sale.Barr Pharmaceuticals, Inc. says the FDA is committed to completing its review of its Supplemental New Drug Application for Plan B (levonorgestrel) emergency contraceptive Over-The-Counter (OTC) in the near future. The company remains optimistic that approval will be given.

15 and Under Would Still Need Rx

Barr has requested permission to sell Plan B over the counter to women 16 years of age and older. Women 15 years and younger still would have to get a prescription from a doctor.

Plan B has been shown to reduce the risk of pregnancy by 89 percent after a single act of unprotected sex if taken within 72 hours of unprotected intercourse, according to Barr. Effectiveness declines as the interval between intercourse and the start of treatment increases, the company notes.

More Effective in First 24 Hours

Plan B was approved by the FDA in 1999 as a safe and effective prescription-only emergency contraceptive for women. Because it is more effective when taken in the first 24 hours after intercourse, many health professionals believe that women should have faster, easier access to it.

Emergency contraception is currently available in some pharmacies without an advance prescription from a physician or healthcare provider in six U.S. states: Alaska, California, Hawaii, Maine, New Mexico and Washington. Thirty-three of the 101 countries in which emergency contraception is available do not require a prescription.

 
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