>From: dsinc!jabber!cpp!jdavids@intercon.intercon.com >Date: Wed, 10 Aug 1994 22:49:45 -0500 (EST) Women are the fastest growing group of people with AIDS in 1994, but the FDA is not helping women get access to potentially lifesaving experimental treatments. The Food and Drug Administration (FDA) is killing women. Change the guidelines that can save women's lives! The ACT UP Women's Network invites you to: Z A P T H E F D A ........... A U G U S T 1 5 -- 1 9 phone: 301-443-2410 _ _ _ _ _ _ _ _ FAX: 301-443-3100 Guidelines aren't binding. Regulations are. The FDA has issued guidelines for private and public drug developers about including women in clinical trials. Using guidelines instead of regulations means that the FDA is only suggesting women be included, not requiring that women are included in trials. ZAP FDA COMMISSIONER KESSLER THIS WEEK: DEMAND JUSTICE FOR WOMEN We are also planning a massive demonstration at the FDA on September 20th. For more information on this campaign, call Julie Davids in Philadelphia: 215-731-1844, box 8; Honora Gibbons & Laura Sheets in NYC: 718-599-1315; or Mary Lucey in LA: 310-822-1198. Women are the fastest growing group of people with AIDS in 1994, but the FDA restricts women's access to potentially lifesaving experimental treatments. - - - - CLIP 'N' FAX - - - 8/15 TO 8/19 - - - CLIP 'N' FAX - - - _________________________________________________________________ COMMISSIONER KESSLER: WE DEMAND JUSTICE FOR ALL WOMEN. We demand: 1. A meeting on or by September 20, 1994, with Commissioner David Kessler to discuss FDA regulations! Women with HIV/AIDS and other life-threatening illnesses and their advocates must be able to attend. 2. The FDA must adopt the regulations put forth by the ACT UP Women's Network regarding women's access to clinical trials. 3. The FDA must take responsibility for overseeing local Institutional Review Boards and their decisions regarding changes in protocols which may affect the enrollment of women. 4. The FDA must require a warning label in English and Spanish on _all_ over-the-counter vaginal anti-fungal creams, such as: WARNING: Recurrent, or persistent vaginal yeast infections may be a sign of HIV infection. Please consider getting counseling regarding HIV/AIDS. For a test site near you, call 800-342-2437. COMMISSIONER KESSLER, WHAT DO YOU INTEND TO DO ABOUT OUR DEMANDS? FAX BACK YOUR RESPONSE IMMEDIATELY TO: __________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ \\\ cut out 'n' fax to 301-443-3100 every day: 8/15 - 8/19 ///