Ms. magazine  -- more than a magazine a movement

SIGN UP FOR MS. DIGEST, JOBS, NEWS AND ALERTS

FEMINIST WIRE NEWSBRIEFS

ABOUT
SEE CURRENT ISSUE
SHOP MS. STORE
MS. IN THE CLASSROOM
FEMINIST DAILY WIRE
FEMINIST RESOURCES
PRESS
JOBS AT MS.
READ BACK ISSUES
CONTACT
RSS (XML)
 
feminist wire | daily newsbriefs

June-18-04

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.

TAKE ACTION Urge the FDA to Stop Playing Politics With Women’s Lives

DONATE to FMF and support our campaign for over the counter status of emergency contraception

Media Resources: Associated Press 6/15/04; Washington Post 6/18/04; Feminist Daily News Wire


© Feminist Majority Foundation, publisher of Ms. magazine

If you liked this story, consider making a tax-deductible donation to support Ms. magazine.

 

 

Send to a Friend
Their
Your
Comments
(optional)


More Feminist News

7/29/2015 An Extreme Abortion Ban is Now Law in Wisconsin - Wisconsin Governor Scott Walker signed an extreme 20 week abortion ban into law last week. The law, which bans abortions performed past 20 weeks, has no exception whatsoever for rape, incest, or fatal fetal anomalies. . . .
 
7/29/2015 Jen Welter Just Made NFL History - Jen Welter was hired as a coach for the Arizona Cardinals this week, becoming the first woman ever to be a National Football League coach. . . .
 
7/27/2015 Senate Majority Leader Mitch McConnell Blocked Efforts to Defund Planned Parenthood - An attempt in the Senate to defund Planned Parenthood by Mike Lee (R-UT) was blocked this weekend by Senate Majority Leader Mitch McConnell (R-KY). Lee tried to attach the elimination of federal funds for Planned Parenthood to a vote for highway legislation, a move which was rejected by McConnell as out of order. Republican legislators have redoubled their efforts to block funding for Planned Parenthood since the release of two heavily edited clandestine videos of different PPFA employees taken without their knowledge. . . .