FDA Resumes Consideration of Emergency Contraception Over-The-Counter

The Food and Drug Administration (FDA) announced on Monday that it would resume the process of making emergency contraception over-the-counter for some women. Dr. Andrew von Eschenbach, acting commissioner of the FDA, has said FDA officials would like to meet with Barr Laboratories Inc., the manufacturer of the drug, within the next seven days to discuss Barr’s plan to distribute the drug over the counter only to women ages 16 and older while requiring prescription-only access to those 15 and younger. In a letter to Duramed Research, a subsidiary of Barr, von Eschenbach also indicated that the FDA believes only women ages 18 and older should be able to access the drug over the counter, and recommends that Barr resubmit its application to that effect. The announcement came only 24 hours before the Senate Health, Education, Labor, and Pensions Committee began its hearing on von Eschenbach’s nomination to become FDA commissioner.

Despite overwhelming approval from the FDA’s scientific advisory committees, the FDA denied Barr’s application for over-the-counter status for Plan B, a brand of emergency contraception, in 2004. Barr then resubmitted a petition for Plan B to be approved for over-the-counter use for women ages 16 and older, along with an outline of how the age requirement would be enforced. This petition has yet to be approved or denied.

Democrats in the Senate are skeptical of the timing of the announcement, after experiencing two years of inaction in the approval process. “The FDA’s announcement today really is once again a non-decision. We find ourselves at the same place we did a year ago with the administration saying don’t worry, we’re just asking for some more informationÉtrust us,” said Sen. Patty Murray (D-WA) on Monday, according to the Chicago Tribune. Murray and Senator Hillary Rodham (D-NY) have been blocking the confirmation of von Eschenbach until the FDA reaches a decision on over-the-counter Plan B.


Chicago Tribune 7/31/06; Associated Press 7/31/06; Reuters 7/31/06; Philadelphia Inquirer 8/1/06; FDA letter 7/31/06

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