2017 | Q3 Newsletter | Q & A with Health Advisory Council Member
Associate Commissioner for Women’s Health, U.S. Food and Drug Administration
Q. Please discuss your work and how it relates to FDA’s overarching mission.
A. I lead the FDA’s Office of Women’s Health (OWH) which works to protect and advance the health of women through scientific, educational, and outreach initiatives on issues impacting women across their lifespan. Our research helps the agency to better understand sex differences as they relate to product safety and effectiveness, and advance knowledge towards the diagnosis and treatment of health conditions that disproportionately impact women. In addition to our research efforts, OWH supports FDA’s public health mission through educational and outreach initiatives for health professionals so that they can make informed decisions about the safe use of the products FDA regulates. Our efforts support the Commissioner’s and FDA Center priorities…just using a sex and gender lens.
Q. How long have you been at FDA/OWH, and what do you love most about your job?
A. I have been working at FDA for 20 years. All of that time has been at the Office of Women’s Health. I have stayed at the Agency so long because I enjoy working with brilliant scientists and health professionals from a variety of disciplines who have dedicated their lives to improving the public health. I love the fact that FDA’s work touches almost every facet of women’s daily lives from life-saving medicines and vaccines to microwaves to foods and cosmetics. The importance of ensuring their safety and effectiveness cannot be understated. Whenever I travel abroad, I have great comfort knowing that the quality of our products is second to none and that FDA has set the gold standard for the world.
Q. What are the biggest challenges and opportunities facing FDA/OWH today?
A. The fast pace of scientific advancement is our biggest challenge and our biggest opportunity. The science of women’s health and medical innovation is rapidly evolving — from gene therapies and in-silico clinical trials to biosimilars and miniaturization. This scientific innovation offers hope for new treatments and medical products to improve the health of women. But these advancements also mean that FDA must find new ways to evaluate the safety and effectiveness of the products it regulates. Over the years, the Office of Women’s Health has sponsored many innovative scientific programs. We offer staff expertise and reviewer training Agency-wide to make sure that the unique needs of women are considered in regulatory decision making, and also our knowledge to assist with rapidly changing technologies or emerging health issues such as the Zika virus and the opioids epidemic. As an agency we’ve made significant progress, and the FDA Office of Women’s Health has been there every step of the way to make sure that this progress benefits women. And as new scientific findings emerge, with new legislative demands, we will be a voice for the unique needs of women.
Q. What FDA/OWH initiatives would you like to share with the Council?
A. A major focus for our Office is supporting research and educational outreach on chronic diseases affecting women in areas such as heart disease, diabetes, Alzheimer’s disease, HIV, and depression. OWH’s Diverse Women in Clinical Trials Initiative works to raise awareness and share best practices to promote women’s participation in clinical trials for these diseases and others. Our Take Time to Care outreach program conducts national campaigns and disseminates digital and print resources to promote safe medication use and support chronic disease management. We also work to improve the health of special populations of women such as pregnant women, minority women, caregivers, and women with disabilities. And our Women’s Health Research Roadmap will assure that 21st Century Cures will address sex as a biologic variable across the Agency to promote optimal health for women.
Q. What does FDA/OWH value about membership in NCL’s Health Advisory Council?
A. Membership in NCL’s Health Advisory Council affords FDA/OWH the opportunity to meet and collaborate with public and private groups focused on helping consumers make informed healthcare decisions. The Council helps to share and cross promote messaging and resources for the general public and health influencers. It offers us the ability to continuously cultivate strong mutually supportive relationships to address key consumer health issues. Ultimately, our collective efforts will advance the health of all women and their families.