Vyleesi Fact Sheet

What is bremelanotide (Vyleesi)?  Bremelanotide (brand name: Vyleesi) is a drug approved by the FDA to treat a lack of sexual desire (hypoactive sexual desire disorder) in premenopausal women. Overview  Bremelanotide is designed to be used on an “as-needed” basis about 45 minutes before sexual activity is expected.  It has to be injected, and an … Continued

FDA General and Plastic Surgery Devices Panel meeting on Breast Implant Safety

By Tessa Ruff On March 26 and 27, the FDA convened a meeting of the General and Plastic Surgery Devices Panel to investigate the safety of breast implants following a reported link between textured implants and lymphoma, as well as a range of reported systemic autoimmune symptoms following implantation, collectively known as breast implant illness … Continued

The NWHN Testifies for the Use of Better Evidence at the FDA

By Tessa Ruff In 2016, the FDA reclassified transvaginal mesh used to repair pelvic organ prolapse (POP) as a Class III device—the highest risk category—in response to over 20,000 adverse event reports during a three-year period alone. The NWHN actively fought for the change, which also should have required manufacturers to submit thorough, randomized safety … Continued

Smartphone Contraception: Policy Issues

In August 2018, Natural Cycles became the first smartphone application (“app”) for contraception cleared by the FDA. Natural Cycles is a high-tech version of the classic rhythm method (also called natural family planning or the fertility awareness method) in which users track their ovulation cycles in order to avoid pregnancy. It is one of several … Continued

Natural Cycles Fertility Awareness App: Health Information

What is it? Natural Cycles is the first smartphone application (“app”) for contraception cleared by the FDA. Visit our advocacy fact sheet to learn more about its expedited clearance process and potential privacy concerns. Natural Cycles is a high-tech version of the classic rhythm method (also called natural family planning or the fertility awareness method) … Continued

Addyi Health Fact Sheet

  What is Flibanserin (Addyi)? Flibanserin (brand name: Addyi) is the first drug approved by the U.S. Food and Drug Administration (FDA) to treat lack of sexual desire (Hypoactive Sexual Desire Disorder) in premenopausal women.  Although the drug is ineffective and potentially dangerous, the agency approved it in 2015 over the objections of the NWHN and … Continued

Fibroids Medications

Although research shows that around a third of women develop fibroids at some point in their lives, there are few non-surgical options available to patients. Recently, however, there has been a surge in development of new uterine fibroid medications designed to help patients manage and treat the condition. What is Esmya? Ulipristal acetate, brand name … Continued

FDA Meeting – Risk Benefit Assessment

Testimony Delivered at the FDA Public Meeting on Benefit-Risk Assessments in Drug Regulatory Decision-Making September 18, 2017 [FDA Docket No. FDA-2017-N-4076]   My name is Caila Brander and I am the Policy Coordinator at The National Women’s Health Network, a nonprofit advocacy organization that works to improve the health of all women. We are supported … Continued

FDA Approvals: On a Fast-Track to Disaster

By Caila Brander, NWHN Policy Fellow Most of us want to be confident when we start a newly prescribed treatment that the medication we take will improve the ailment we seek to treat. We believe that our drugs have been tested and proven effective. We assume that the U.S. Food and Drug Administration (FDA) verifies … Continued