Message from the Director
Dear Women’s Health Colleagues,
As you know, FDA makes review decisions looking at a variety of factors. Key among them -- Sex as a Biological Variable (SABV). It is important that drug approvals ensure safety and efficacy for the populations most likely to utilize the products. It is data that support our approval decisions, with the percentages of women vs men included in the clinical trial one of many considerations. We have been quoted as saying – “we need enough” data to make the regulatory decision. So the Great Debate explored the question – “What is Enough?” – to ensure safe and effective cardiovascular medications for both women and men.
When it comes to data, FDA’s is not just focused on clinical trial participation. Our goal is to be able to make a reasonable assessment of trial results in order to ensure efficacy and safety for the public.
We perform our work in a regulatory framework and approaches to and sources of data which inform our decisions are diverse and varied. Our primary data source is in the drug application; however additional sources may be used to inform our decisions at all phases of the pre-market and post-market processes. FDA’s data analysis and approach is broader than the conventional academic model. This must be the case given the complexity of public health decision-making, drug law and balancing risks vs. benefits.
I will close by saying that even in the heat of debate, FDA must remain committed to sharing what we know and do not know with others including scientists, clinicians, patients and consumers to get the best possible products – to the people who need them – fast!
Thank you, Dr. Redberg and Dr. Unger for your thoughtful presentations, and to our own Director of Medical Initiatives and Scientific Engagement, Dr. Marjorie Jenkins, for moderating this event. In addition, let’s all congratulate Dr. Jenkins for receiving the “Linda Joy Pollin Women’s Heart Health Leadership Award” from the Barbra Streisand Women’s Heart Center and the “Award for Public Policy & Advocacy in Women's Health" from the Women's Health Congress 2018 Conference.
Marsha Henderson, Associate Commissioner for Women's Health