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

7/31/2014 Massachusetts Enacts New Law to Protect Access to Reproductive Health Facilities - Massachusetts Governor Deval Patrick (D) signed into law yesterday a bill to help protect access to reproductive health care facilities in the state. The law, entitled An Act to Promote Public Safety and Protect Access to Reproductive Health Care Facilities, enables a law enforcement official to order the "immediate dispersal of a gathering that substantially impedes access to or departure from an entrance or a driveway to a reproductive health care facility." The order would "remain in place for 8 hours or until the close of business of the reproductive health facility, whichever is earlier," and make noncompliance punishable with a fine or jail time. . . .
 
7/31/2014 First World Day Against Human Trafficking Encourages International Action - The first World Day against Trafficking in Persons took place Wednesday in an effort by the United Nations to bring attention to the continuing need for international support to help trafficking victims and end impunity for perpetrators. Millions of people are still trafficked every year, sold to work in brothels, fields, and sweatshops. . . .
 
7/30/2014 Fifth Circuit Court Rules In Favor Of Mississippi's Last Clinic - Mississippi's last remaining abortion clinic will remain open after a the US Court of Appeals for the Fifth Circuit upheld a preliminary injunction against HB 1390, the Mississippi TRAP (Targeted Regulation of Abortion Providers) law requiring abortion providers to obtain admitting privileges at area hospitals. Had the court not upheld the lower federal's court's injunction, HB 1390 would have shuttered Jackson Women's Health Organization (JWHO), the state's only comprehensive reproductive health center. . . .