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February-19-04

FDA Delays Approval of Over-the-Counter Emergency Contraception

The Food and Drug Administration announced on Friday that it would delay its decision on over-the-counter status for the emergency contraceptive Plan B. The deadline on the decision was extended 90 days from the original date of February 20. The FDA says that it needs more time to evaluate the use of Plan B among teenagers.

The decision to delay approval of emergency contraception (EC) over the counter has been seen by many women's health advocates as politically motivated. Right-wing groups and members of Congress have been fighting the drive for over-the-counter EC. A group of 49 members of Congress sent a letter to President Bush urging him to intervene, claiming that making EC more accessible could lead to increased sexual behavior and sexually transmitted infections among teenagers, according to the Philadelphia Inquirer.

"It appears that the FDA is taking the advice of special interests over an expert, scientific panel that has said Plan B is safe and effective," Rep. Carolyn Maloney (D-NY) told the Washington Post "They're letting politics trump science."

Two expert advisory panels convened by the FDA recommended 23-4 to allow Plan B to be sold over the counter in a December meeting. EC can prevent pregnancy for up to 72 hours after unprotected sex, failed contraception, or rape. It is safer than aspirin, meets all of the FDA's requirements for over the counter status, and is up to 95% effective if used within the first 24 hours. EC has the potential to prevent 800,000 abortions in the United States annually.

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Media Resources: Washington Post 2/14/04; Philadelphia Inquirer 2/14/04; Feminist Majority Foundation

   

     

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