FDA Insight: Episode 15 – Transcript
>> Anand Shah: Welcome back to another episode of FDA Insight. I'm Dr. Anand Shah, the Deputy Commissioner for Medical and Scientific Affairs here at the FDA. Thank you for joining us for another great episode. This week, we'll be discussing women's health with our guest, Dr. Kaveeta Vasisht, Associate Commissioner for Women's Health here at FDA. Dr. Vasisht, welcome to FDA Insight.
>> Kaveeta Vasisht: Thank you for having me. It's great to be here.
>> Anand Shah: Well, let's start with an overview of the Office of Women's Health. What should listeners know about OWH?
>> Kaveeta Vasisht: Sure, FDA's Office of Women's Health was established by congressional mandate in 1994 as part of the Office of the Commissioner. And this was in response to advocacy and appeals to address and focus on women's health, including the participation of women in clinical trials. So, since we were established, we have been committed to protecting and advancing the health of women through policy, science, education, and outreach, as well as promoting the inclusion of women in clinical trials and for the evaluation of sex differences, recognizing the importance of sex as a biological variable.
In our role as a principal advisor to the Commissioner, we also provide leadership and policy direction for the agency regarding the issues of women's health. And we achieve this by identifying and monitoring the progress of cross-cutting multi-disciplinary women's health initiatives. This includes changing the areas that require study and new challenges to the health of women as they relate to our mission here at FDA.
>> Anand Shah: Scientific research is a large part of the Office of Women's Health portfolio. Can you give us a few examples of how OWH-funded and -conducted research has helped advance women's health?
>> Kaveeta Vasisht: Absolutely. Findings from OWH-funded research have informed product labeling, contributed to safety information, and informed guidance for industry. For example, OWH-supported research provided valuable insight into the diagnosis and treatment of heart disease in women. Since our inception, we've worked across several FDA centers to support studies on topics ranging from identifying sex differences in cardiac intervention to understanding the mechanisms of sex differences in drug-induced Q.T. prolongation, which can result in life-threatening arrhythmias. The results of these completed studies have led to a better understanding of heart disease in women and contributed to the development of guidance.
Another area is mammography. Mammography quality standards have also been directly influenced by the research findings from studies supported by OWH. We also conduct our own research, such as our decadal review evaluating the participation of women in cardiovascular clinical trials that were submitted to FDA in support of several therapeutic marketing applications. And this research and the subsequent publication of the findings has helped to expand our collective understanding of women's participation in these trials.
So, to answer your question, OWH has advanced the health of women by supporting and conducting research initiatives that aim to support FDA regulatory decision-making by expanding our understanding of sex differences, increasing our knowledge of health conditions unique to women and those that may disproportionately impact women.
>> Anand Shah: What new research and scientific initiatives is FDA promoting this year and in 2021, with respect to women's health?
>> Kaveeta Vasisht: Great question. So, as the science has evolved, so have we. In recent years, we've funded more research using innovative technologies in hopes of filling knowledge gaps in women's health. This year, we funded research at FDA that uses artificial intelligence to help predict the risk of developing cancer in response to hormone therapy for endometrial hypoplasia. This may enable more personalized care and better inform choices for women with this condition. We also recently funded a study to better understand how a patient's sex and genetic traits impact their likelihood to develop cardiotoxicity in response to certain breast cancer drugs. This project utilizes innovative tools like next-generation DNA and RNA sequencing to predict treatment risks and outcomes.
Filling knowledge gaps in pregnancy and laxation has also been a major focus of our office. Last year, we funded research to develop a virtual pregnant woman, an artificially intelligent model to predict how drugs or vaccines might act in pregnant women, who have often been excluded from clinical trials. In addition, this year, we funded research utilizing a mobile app to cure pregnancy treatment repository application, captures the experiences of the clinicians around the globe when they find novel ways of using FDA-approved drugs for infectious disease and cancer. And this is to expand our knowledge about their effects and population. So, in 2021, we expect to see more research proposals incorporating novel and innovative technologies to advance personalized medicine and generally improve health outcomes.
>> Anand Shah: Can you tell us about the most popular outreach and communications materials that the Office of Women's Health has produced, as well as any recent projects you're particularly excited about?
>> Kaveeta Vasisht: Sure. Our top -- most-accessed print publications for this fiscal year are our "Mammograms and Menopause" fact sheet and our "My Medicines" brochure. As of earlier this month, over one million OWH publications have been ordered and distributed this fiscal year, even during the pandemic. We're also very excited about our Knowledge and Views on Women's Health Initiative, also referred to as our KNOWH campaign. This was launched in February of 2020, and this campaign is designed to educate and share important women's health information.
So, for American Heart Month, we've released the "Getting a Beat on What Women Know About Hearth Health" video. And this was to raise awareness in women about heart disease, risk factors, prevention tips, and signs and symptoms that may present differently in women. And this video has achieved over 700,000 views so far. We also created the Knowledge and Views on Women blog, which was launched this past May to coincide with National Women's Health Week. Our first topic focused on women prioritizing our physical and mental health while navigating the challenges presented by the COVID-19 pandemic.
For Thyroid Awareness Month, our blog helped shed light on uterine fibroids and highlighted FDA's recent approval of the first medical treatment option, an oral medication specifically for reducing heavy menstrual bleeding caused by uterine fibroids, which is a condition that many women often suffer from, silently.
>> Anand Shah: Dr. Vasisht, a lot of great work coming out of the Office of Women's Health. How has your office adapted its programs to COVID-19?
>> Kaveeta Vasisht: Well, logistically, we have successfully transitioned to remote work and converted all our in-person events to webinars and virtual conferences. We've also refocused many of our programmatic efforts towards COVID-19. Our most recent scientific speaker seminar discussed COVID-19 and pregnancy, and our next seminar will explore COVID-19 and sex differences. And these seminars are -- strive to bring in world-renowned experts to discuss cross-cutting topics to inform FDA staff and our federal partners on important sex and gender considerations to enhance the regulatory process.
We've also incorporated COVID-19 information in our Office of Women's Health monthly newsletter and social media for our stakeholders and continue to look for opportunities to support research to advance knowledge gaps in this area.
>> Anand Shah: Can you give us a sneak peek into new women's health programming that's in the pipeline at FDA?
>> Kaveeta Vasisht: Yes, we're very excited about our upcoming scientific seminar on CBD and other cannabinoids, which will explore sex and gender differences in use and responses. This meeting really highlights our commitment to considering sex and gender in emerging public health issues to promote improved health and safety for both women and men. This year, also in partnership with NIH's Office of Research on Women's Health, we launched the “Bed-to-Bedside: Integrating Sex and Gender to Improve Human Health” webinar series.
These self-paid webinars aim to help researchers and clinicians learn about sex and gender differences that impact health. Topics already released include immunology, pulmonary disease, cardiovascular disease, and neurology, with endocrinology and mental health webinars coming soon. And what is also great is that the course is free, and C.E. is available. We're also planning to expand educational materials under our Knowledge and Views on Women's Health Initiative.
>> Anand Shah: Dr. Vasisht, as many of our listeners know, women have historically been underrepresented in clinical trials. What initiatives is the Office of Women's Health just -- and the agency, more broadly -- supporting to create a more diverse pool of clinical trial participants?
>> Kaveeta Vasisht: Well, a few years ago, our office launched the Diverse Women in Clinical Trials Awareness campaign. This campaign was developed in collaboration with NIH's Office of Research on Women's Health to raise awareness about the importance of diverse women of different ages, races, ethnic backgrounds, and health conditions participating in clinical trials and to share best practices about clinical research design, recruitment, and population analyses. Recently, data from the 2019 Drug Trial Snapshots Report from the FDA's Center for Drug Evaluation and Research saw several novel drugs approved for conditions specific to women, such as post-menopausal osteoporosis, postpartum depression, and Hypoactive Female Sexual Desire Disorder, which is great.
Moreover, women were well-represented in the trials supporting the 40 novel drugs FDA approved in 2019 for conditions generally affecting both women and men, with women comprising an average of 63 percent of trial participants. So, we have made progress in women's participation in clinical trials in many areas. However, to continue this momentum, our office recently put out a federal register notice seeking input from our stakeholders on ways to further direct outreach to diverse groups of women to encourage participation in clinical trials, to promote access to relevant information about FDA-regulated products, and to maintain dialogue about critical women's health topics.
>> Anand Shah: The Office of Women's Health has led efforts in maternal health for the FDA. Can you tell us a bit about that?
>> Kaveeta Vasisht: Yes. Maternal health is very important -- focused area for our office. We are proud to represent FDA on the task force on research specific to pregnant and lactating women, also known as PRGLAC. The 21st Century Cures Act established this task force really to focus on gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women.
In 2018, the task force developed 15 recommendations, and we've been meeting over the past year to develop implementation recommendations. So, in addition to serving on the PRGLAC task force, our office maintains a website that lists pregnancy exposure registries. And these are studies that collect health information from women who take prescription medicines or vaccines when they are pregnant. We maintain this website to serve to as a resource to inform pregnant women and their healthcare providers of potential opportunities to enroll in research because enrolling in a pregnancy exposure registry can help inform safety information for medicines used during pregnancy and be can used to update medication labeling.
So, in addition to this and the research we fund, we also have valuable resources for pregnant women on our pregnancy resources webpage. And this includes a medicine and pregnancy fact sheet and a pregnancy social media toolkit. Also, last year, we co-hosted an expert meeting about asthma medication safety in pregnancy and lactation. So, an important area for us.
>> Anand Shah: Definitely. Just to pivot here, the Office of Women's Health celebrated its 25th anniversary last year and has a long legacy of supporting women's health. What are some of the more recent milestones for the Office of Women's Health?
>> Kaveeta Vasisht: Well, we're very proud of our KNOWH Initiative, which I mentioned earlier, that highlights important women's health topics, such as our cardiovascular disease video and our new blog. A few years ago, our office published the women's health research roadmap, a first of its kind. The roadmap incorporated cross-agency input to create strategic direction by outlining priority areas to maximize the impact of research initiatives that ultimately promote optimal health for women.
We're also very proud of our educational programming such as our scientific speaker series, which focuses on the importance of sex and gender consideration and potential intersection with the regulatory work that we do. In addition, we have over 40 fact sheets, brochures, and medicine booklets on a wide range of health topics. This includes safe medication use, information about heart disease, HIV, to information about tattoos and menopause and birth control, and -- some of which are available in multiple languages.
>> Anand Shah: You've shared a ton of timely and helpful information during our conversation. How can our listeners engage with the Office of Women's Health at FDA?
>> Kaveeta Vasisht: Well, thank you for asking. Our stakeholders are critical to the success of our office, and we are very grateful for their support over the years. There are several ways to engage with us: attending our public scientific meetings, such as our upcoming CBD meeting in November. Registration is currently open for that. Become a partner and collaborator, subscribe to our newsletter, and engage with us on social media.
>> Anand Shah: Again, you have shared a lot of great insight on today's podcast. Dr. Vasisht, I want to thank you for all that you do for the Office of Women's Health and for the agency. Thanks a lot for taking the time to join us this week on FDA Insight.
>> Kaveeta Vasisht: Thank you again for having me on the show. I really appreciate it.
>> Anand Shah: And thank you to our listeners. As always, we'll be providing you insight in plain language to help you understand the products that we regulate, the issues that we face, and the processes that we follow. We hope you enjoyed this episode of FDA Insight. Please subscribe on your favorite podcast app, such as Apple Podcast, Google Podcast, and others. Thanks for listening.
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