FDA Hearing on flibanserin

On June 18, 2010, the FDA Reproductive Health Advisory Committee convened for the second time in its history to consider a drug for "female sexual dysfunction" (the first drug, Intrinsa, failed in 2004). This time it was a neurotransmitter, "flibanserin," manufactured by German pharmaceutical giant Boehringer-Ingelheim. The New View Campaign opposed the approval of flibanserin, and prepared materials, testimony, and petitions. In combination with the materials we prepared in 2004 for the Intrinsa hearing, these resources offer a rich analysis of the medicalization of sexuality.

As with Intrinsa, the FDA Advisory committee voted unanimously against flibanserin.

Here is the New View Campaign's Post Hearing Statement

New View Resources*

Here is our first resource document, a juicy bibliography of 27 counter-narratives to the narrow and unenlightened (not to mention inaccurate and self-serving) view of women's sexuality and sexual problems offered by the pharmaceutical industry.

A Bibliography of 27 Counter-Narrative Sources

Here are six FACT SHEETS about different aspects of flibanserin that we have developed to provide the full story of this new drug, its marketing and its clinical trials. These fact sheets were written and researched by a hard-working team of Rachel Liebert, Karen Hicks, Michelle Leve, Annemarie Jutel, Amber Hui, Liz Canner, Thea Cacchioni, and Leonore Tiefer, and formatted by Dan Ward and Tash Wong.

Fact Sheet on Clinical Trials
Fact Sheet on ADRs (Adverse Drug Reactions or Side Effects)
Fact Sheet on HSDD (Hypoactive Sexual Desire Disorder)
Fact Sheet on Gender and Choice
Fact Sheet on Distress
FactSheet on Marketing

We solicited a lot of letters to the FDA challenging the flibanserin application. Read them for a variety of arguments from a variety of sources.

Letters Sent By New View Supporters to FDA

The New View flibanserin planning team decided to create a petition against flibanserin to show public support for our position. We first collected 113 signatures at the Manhattan premiere of Orgasm, Inc on May 27, 2010. We mailed those in to the FDA Reproductive Health Advisory Committee. Then we designed an online petition that generated 650 signatures in 2 weeks, from 22 countries and 47 states. You can see those signatures here.

*The New View documents on this page are PDF files and must be opened with Adobe Acrobat. For a free download, click here.