What Outcomes Beyond A1c Should the FDA Consider When Approving Diabetes Drugs?
By Kelly Close
Public workshop scheduled at FDA for August 29, 2016. Get involved!
Currently, the FDA mainly approves drugs based on safety and their impact on A1c. But for many people with diabetes, A1c does not nearly capture the day-to-day story of living with diabetes – hypoglycemia, time “in” and “out” of zone (this is also known as glucose variability), fear, burden, and more. We have been working hard with other organizations to provide the FDA with new patient perspectives on outcomes, and we’re pleased to announce a public meeting has been scheduled for August 29, 2016. Here are the details!
The FDA’s Center for Drug Evaluation and Research (CDER) is sponsoring the public workshop “Diabetes Outcome Measures Beyond Hemoglobin A1c” on August 29, 2016 in Silver Spring, MD. RSVP here to attend live or attend via webcast! The diaTribe Foundation is working hard to make sure that patient voices are well-represented at the meeting and will even be funding a small group of patients to attend, thanks to generous donations we receive from our readers and supporters. Let us know if you have a statement you'd be interested in sharing with the FDA!
Additionally, The diaTribe Foundation will be creating a video compilation with submissions from patient advocates to make sure the voices of people with diabetes and their loved ones are heard (like this one from November 2014). Stay tuned for more details on how you can participate and help change the regulatory system to better meet the needs of people with diabetes! -NK/KC