Top FDA Scientists Criticize Rejection of EC Over the Counter
Top Food and Drug Administration (FDA) scientists wrote an internal memo criticizing FDA leadership for rejecting Barr Laboratories' application for over-the-counter status for its emergency contraceptive Plan B. The internal FDA memo reveals that all staff reviewers agreed that the application met with the agency’s usual standards for over-the-counter status, according to the Washington Post. Two expert FDA advisory panels also voted 23-4 for approval in December.
The FDA rejected Barr Laboratories’ application on May 6, citing concerns that there was not enough information about the effects of EC on women under the age of 16. John Jenkins, director of the FDA Office of New Drugs wrote in the internal memo, “The agency has not [previously] distinguished the safety and efficacy of Plan B and other forms of hormonal contraception among different ages of women of childbearing potential, and I am not aware of any compelling scientific reason for such a distinction in this case,” the Post reports. FDA staff also expressed concern that the decision was also based on non-medical concerns about teenage sexual behavior and moral judgments about propriety, according to another internal memo, the Post reports. As part of their analysis, staff reviewers determined that studies indicated there would be no change in teenage sexual behavior, no additional risk of sexually transmitted diseases, and no basis for concluding that Plan B would be any less safe or effective for teenagers than for older women.
According to the Post, Members of Congress have called for hearings due to the irregularities in the FDA decision, and earlier this week, the Associated Press reported that the American Medical Association voted without any debate on a resolution criticizing the FDA’s decision and voicing support for over-the-counter status for emergency contraception.
The Feminist Majority Foundation leads a national drive on college campuses to increase the availability of EC for young women. Emergency contraception is safe, and most effective if taken within 24 hours after unprotected intercourse, contraceptive failure, or rape.