FDA Voice: Thank you for blogging with FDA Voice today. Can you tell us about the Cardiovascular and Endocrine Liaison Program in FDA’s Office of Special Health Issues?
To help fight the spread of these conditions, Janelle Derbis, PharmD, and I established the Cardiovascular and Endocrine Liaison Program (CELP) in 2011. We facilitate interactions among patients, health professionals, and the FDA Centers that regulate the medical products that are used to treat diabetes, hypertension and heart disease.
I was an optometrist for 21 years before joining FDA. Treating diabetes and hypertension is near and dear to my heart because many of my patients were affected by these conditions. And Janelle brings her background as a pharmacist to this work.
Patients with these conditions and the health professionals who treat them want an effective, consistent way to interact with FDA and to become part of FDA’s decision-making processes.
FDA Voice: What is the public impact of these two medical conditions?
Clayton-Jeter: Heart disease and stroke are the first and third leading causes of death, respectively, for both men and women in the United States, accounting for more than one-third of all deaths, according to the Centers for Disease Control and Prevention. An estimated 23.6 million people in the U.S.—approximately 7.8% of the population—have diabetes. This chronic illness is the number one cause of blindness in the U.S and one of the leading causes of disability. Complications associated with these conditions can result in significant costs to patients and to the health care system.
FDA Voice: Can you describe some of the CELP tools and activities?
Clayton-Jeter: We recently launched two new web pages, one for diabetes and one for CVD. Both include information on product safety, new drug and device approvals and clearances, prevention and wellness information, and opportunities for public comment.
We also launched two e-mail lists: FDA DiabetesMonitor and FDA CardioBeat. These e-mail lists deliver FDA updates on safety and regulatory issues related to diabetes and CVD, including product approvals, safety warnings, notices of upcoming public meetings, and notices of draft regulatory guidances.
CELP takes advantage of our office’s existing communication tools to facilitate and moderate stakeholder calls on new product approvals. These calls help patient and health professional groups better explain the issues to their constituents because their representatives get the information first-hand.
We are working with Medscape—part of WebMD’s health professional network— to provide information about new topics within FDA. Working with Medscape, we have developed two articles on drug-eluting stents — a medical device and a drug used to treat blocked arteries – and risks posed when taking high dose simvastatin – a cholesterol-lowering drug.
FDA Voice: What do you have coming up on the horizon for CELP?
Clayton-Jeter: We plan to introduce more web-based training programs on CVD and diabetes issues. We will also be speaking at patient advocacy and health professional conferences, such as the Second Annual Health Professional Organization Conference scheduled for October 4, 2012 at FDA’s White Oak Campus.
We encourage you to visit the web pages and sign up for the e-mail lists to stay current on FDA announcements in the areas of CVD and diabetes.
Helene Clayton-Jeter, O.D., co-manages the Cardiovascular and Endocrine Liaison Program (CELP), at FDA’s Office of Special Health Issues.