Women's Health Update - April/May 2018

Message from the Director Advocating for the participation of women in clinical trials and sex, gender, and subpopulation analysis continues to be a core value of OWH’s mission. National Women’s Health Week is May 13-16, 2018. One of the major OWH events of this week is “The Great Debate. What is Enough … Women in Clinical Trials?” on May 16, 2018, from 1:00 – 2:00 pm EST. Featuring two cardiologists, Dr. Ellis F. Unger, from FDA’s Center for Drug Evaluation and Research (CDER), and Dr. Rita F. Redberg, from the University of California San Francisco Medical School and Chief Editor of JAMA Internal Medicine, the debate will center on cardiovascular disease clinical trials and the challenges and complexity of the question “What is enough?” when determining participation of women in these trials. This will be a robust discussion centering on this complex question that has been discussed and debated among academia, federal, and non-government and consumer organizations for more than a quarter century. We are also honored to have FDA Commissioner, Dr. Scott Gottlieb, as the Keynote speaker for this event. I encourage you and your networks to join us via webcast for this important discussion. This is an event that you will not want to miss!   Marsha Henderson, Associate Commissioner for Women's Health

Save The Date – March 16, 2018 – The Great Debate! On May 16, 2018 from 1:00 pm - 2:30 pm, join the FDA Office of Women’s Health for The Great Debate! The debate centers on cardiovascular disease clinical trials and the challenges and complexity of the question “What is enough?” when determining participation of women in these trials. FDA Commissioner Scott Gottlieb, M.D. will provide the Keynote in celebration of National Women’s Health Week. View the meeting webpage. New Journal Article: Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs FDA’s Office of Women’s Health conducts studies to assess the participation of women in clinical trials in support of FDA product applications and collaborates with FDA centers and external partners to understand the impact of sex differences on response to therapy. In support of these efforts, FDA staff authored a new publication titled, “Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs.” This study, published in the Journal of the American College of Cardiology, examined clinical trial inclusion/exclusion criteria, women’s participation, and the reported safety and efficacy by gender for pivotal cardiovascular disease (CVD) trials submitted to the U.S. Food and Drug Administration (FDA) supporting marketing applications over one decade (2005-2015).  Read “Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs.” Learn more about FDA research on heart disease in women. National Women’s Health Week Resources  On May 13 – 17th, we celebrate National Women’s Health Week (NWHW). Throughout the week, use these resources to help women take steps to make informed decisions about their health. Follow @FDAWomen on Twitter and other social media platforms for tips for women of every age. Use our free women’s health resources for your events and outreach. FDA Issues Draft Guidance on Including Pregnant Women in Clinical Trials FDA announced the availability of a draft guidance for industry entitled, “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.” This draft guidance discusses the ethical and scientific issues when considering the inclusion of pregnant women in clinical trials of drugs and biological products. This draft guidance is intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection regulations.   Read the draft guidance, "Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials." Read the federal register notice. FDA Takes New Steps to Advance the Development of Innovative Products for Treating Opioid Use Disorder  FDA announced the latest action to encourage and support the development of treatment options for people with opioid use disorder (OUD). The agency has released the first of two new draft guidanceintended to aid industry in developing new medications for use in medication-assisted treatment (MAT) for opioid dependence. Read the news release. Read the draft guidance, “Opioid Dependence: Developing Buprenorphine Depot Products for Treatment,”  Read the statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to encourage more widespread innovation and development of new treatments for opioid use disorder. FDA Takes Step to Protect Consumers Against Dietary Supplements Containing Dangerously High Levels of Extremely Concentrated or Pure Caffeine FDA took an important step to better protect consumers from the dangers of highly concentrated and pure caffeine products. These products present a significant public health threat because of the high risk that they will be erroneously used at excessive, potentially dangerous doses. Highly concentrated and pure caffeine, often sold in bulk packages, have been linked to at least two deaths in otherwise healthy individuals. Read the news release.

Celebrate Minority Women’s Health Join the FDA in honoring minority women by helping diverse women in your community learn about a range of topics that affect their health. Share these resources to help teach women ways to protect their health. Download and order free fact sheets and medicine booklets in English, Spanish and 17 other languages. Encourage women to learn about topics ranging from safe medication use to mammography with resources from our Pink Ribbon Sunday Program, ¡Nunca Más! Novela Health Series!, and our Hispanic Women’s Health webpage. Visit FDA’s Office of Minority Health and FDA en Español webpages for more minority women’s health information. 5 Things to Know About Breast Implants  FDA offers online tools to help people who are seeking information, as well as advice, when making decisions about breast implants. Learn the facts about risks and consider these 5 tips. Read the consumer update. FDA Grand Rounds Tune in to FDA’s Grand Rounds on Thursday, May 10 from 12-1p.m. EST. Dr. Suzanne Fitzpatrick of FDA’s Center for Food Safety and Nutrition (CFSAN) will present, “FDA's Predictive Toxicology Roadmap: Implications and Opportunities for Stakeholders.” View the Meeting Webpage FDA Seeks Public Comment on a Potential Product Standard to Lower Nicotine in Cigarettes to a Minimally or Non-Addictive Level FDA issued Tobacco Product Standard for Nicotine Level of Combusted Cigarettes, an advance notice of proposed rulemaking (ANPRM) seeking public comment for consideration in developing a potential nicotine product standard. Lowering nicotine to a minimally or non-addictive level could potentially save millions of lives, both in the near and long-terms. Submit scientific data and research through June 14. Learn more.

Participate in Upcoming FDA Meetings

Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) The 21st Century Cures Act established PRGLAC to advise the Secretary of Health and Human Services regarding gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women. PRGLAC is tasked with identifying these gaps and will report its findings back to the Secretary. May 14 -15, 2018 National Institutes of Health, Bethesda, MD Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting May 22, 2018, 8:00 am to 4:30 pm College Park Marriott Hotel and Conference Center, Hyattsville, MD Public Workshop: 2018 Clinical Outcome Assessments in Cancer Clinical Trials June 22, 2018, 8:15 am to 5:00 pm FDA White Oak Campus, Silver Spring, MD Visit an OWH exhibit booth or presentation at these upcoming conferences: Women’s Health Congress May 4-6, 2018, Washington, DC American Academy of Physician Assistants March 16 – 19, 2018, Nashville, TN Society for Clinical Trials May 20 – 23, 2018, Portland, OR American College Health Association May 29 – June 2, 2018, Washington, DC Learn more about OWH staff presentations at national and international meetings and conferences.