FDA to Consider Controversial Female Sexual Dysfunction Drug for the Third Time

Over the last five years the National Women’s Health Network has, on numerous occasions, weighed in on the Food and Drug Administration’s (FDA) review of flibanserin, a drug intended to treat female sexual dysfunction. Responding to our serious safety and efficacy concerns with the drug, the FDA has rejected the drug twice; however, now the drug sponsor has re-submitted the same drug for FDA approval for the third and, hopefully, final time. The Network is committed to fighting against the approval of unsafe and ineffective drugs marketed to and used by women. We remain concerned about flibanserin, as prior research has shown that the drug is only minimally effective, has significant side effects, and has not been evaluated for long-term use.

Advocacy

Sign On Letter to Congress

June 2015 | Letter to Members of Congress outlining our concerns about the pending third application for FDA approval of flibanserin.

Testimony at FDA Public Meeting

October 2014 |  NWHN Program Director Coco Jervis at the FDA Patient-Focused Drug Development Public Meeting on Female Sexual Dysfunction.

Letter to FDA Director

September 2013 | Letter to Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research addressing the Network’s concerns with the second application for FDA approval of flibanserin.

Statement at FDA Commiteee Meeting

June 2010 | Former NWHN Program Director Amy Allina at the FDA’s Reproductive Health Drugs Advisory Committee Meeting during the flibanserin’s first application for FDA approval.

In the News

Quote in USA Today

August 2015 | Cindy Pearson is quoted talking about the FDA being swayed by marketing and not science.

NWHN Mention in The Guardian

August 2015 | Our role leading a coalition of organization’s against approval in a letter to the FDA is mentioned.

Quoted by Think Progress

August 2015 | Cindy Pearson told Think Progress  that “Even The Score is full of lies, knowing willful lies.”

Quoted in the Philadelphia Inquirer

August 2015 | Article quotes Cindy Pearson and the fact that women don’t have the information they need about this drug.

Op-Ed in Washington Post

June 2015 | NWHN Executive Director, Cindy Pearson states “I’m a pro-sex feminist, but I believe that advocating for women’s health means finding solutions for women’s sexual problems that are safe and effective. That hasn’t happened.”

Wall Street Journal Quote

June 2015 |  Cindy Pearson,  discussing the FDA Advisory Committee’s vote

HuffPost Live Discussion

June 2015 | Cindy Pearson,  discussing why the Network strongly encourages the FDA to vote against the approval of Flibanserin

Network Newsletter

April 2015 | Coco Jervis writes about the Network’s position on flibanserin for a Network Newsletter article

Huffington Post Live Debate

February 2015 | Cindy Pearson, raised concerns about the rush for a pharmaceutical fix for women’s sexual problems.

National Public Radio Interview

February 2015 | Cindy Pearson interviewed in “Female Libido Pill Fires Up Debate About Women And Sex.”

British Medical Journal Interview

October 2014 | Ray Moynihan, Author of Selling Sickness, interviews Cindy Pearson in “Evening the Score on Sex Drugs: Feminist Movement or Marketing Masquerade?”

Article in the Hoopla

October 2014 | Cindy Pearson, in “The Sex Pill for Frigid Feminists.”

Quoted in Slate.com Article

April 2014 | Amy Allina discusses the flibanserin controversy in “How to Handle FDA Rejection.”