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Message from the FDA Office of Minority Health
This quarter we want to formally recognize our new Commissioner, Dr. Robert Califf. He is a champion for clinical trials inclusion and declared 2016 the "year of clinical trials diversity." We're really excited for our new Commissioner and looking forward to the road ahead under his leadership.
In this issue you will find ways to get involved in minority health issues, new materials you can use to spread the word about special health topics, an overview of our recent events, and what's new on our website.
Special update on Zika:
Get Involved for Minority Health
Twitter Chats
Join our twitter chats on minority health with the FDA Office of Minority Health and our partners: FDA Office of Women's Health (@FDAWomen), the Health and Human Services Office of Minority Health (@MinorityHealth), and the NIH National Institute of Minority Health and Health Disparities (@NIMHD).
What we're talking about:
4/19 Ways for minority women to improve and maintain their health with the Black Women's Health Imperative (@BlkWomensHealth), Million Hearts (@MillionHeartsUS) and the National Heart Lung & Blood Institute (@NIH_NHLBI). Follow the conversation using #FDAHealthChat.
4/27 How to empower research communities to engage minorities in clinical research with @NIMHD. Use #MinorityResearch to join the conversation.
We will send more information about the chats through the listserv once it is available. You can also find more information on our twitter account, @FDAOMH.
Comment to the Docket about Minorities in Clinical Trials by 4/29
Alert! Please send in your comments to the FDA docket by April 29, 2016: Request for comments on progress of FDASIA 907. This is an important means to make your concerns known about diversity in clinical trials.
In 2014, FDA issued an action plan on demographic subgroups (sex, age, race, and ethnicity) in clinical trials (FDASIA 907). Specifically it aimed to:
1) Improve quality and quantity of data derived from under-represented groups in clinical trials;
2) Increase their participation in clinical trials; and
3) Make data from clinical trials publicly available.
FDA seeks comments to (1) discuss how stakeholders have been affected by the changes implemented in the Action Plan, and (2) make recommendations for improvement.
Voice of the Patient: Patient-Focused Drug Development Meeting
Neuropathic Pain Associated with Peripheral Neuropathy
Neuropathic Pain Associated with Peripheral Neuropathy
Patients have the opportunity to tell FDA and industry what symptoms impact you the most and the pros and cons of current treatment options. This meeting is an exciting opportunity to bring your voice to FDA and the drug development process. Neuropathic pain frequently occurs in patients with diabetes.
Learn more and register to attend the meeting in-person or via webcast by visiting www.
Date: June 10, 2016
Time: 1 PM to 5 PM
Location: FDA White Oak Campus
10903 New Hampshire Ave.
Building 31, Great Room
Silver Spring, MD 20993
Building 31, Great Room
Silver Spring, MD 20993
New Health Education Materials You Can Use
Beware of Health Fraud Scams that Target Ethnic Communities
Watch and share videos from the FDA Office of Minority Health's new campaign. Videos spread awareness of health fraud scams in ethnic or international stores, flea markets, swap meets, and online.
Health Information on Colorectal Cancer
Below are two articles and two infographics that will help you better understand colorectal cancer: what it is, if you need to be screened, and your options if you have the disease. We promoted these materials in March, or colorectal cancer awareness month.
Recent FDA Meeting on Clinical Trials
FDASIA 907 Public Meeting: Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data
FDA hosted a public meeting on 2/29/2016 to solicit feedback and recommendations on the progress of FDASIA 907: the Action Plan to Improve Clinical Trials Data for Minorities, Women, and Other Demographic Subgroups.
Why do we need minorities in clinical trials?
In clinical trials, research participants should represent the patients who will use the medical product. This article will help you understand the importance of having diverse groups, such as minorities, participate in clinical trials. You will also learn what FDA is doing to promote minority representation in clinical trials.
Minority Health Resources
FDA offers many easy-to-read, culturally appropriate resources on minority health. Check out our new web page, a one-stop-shop where you can find blogs, consumer updates, articles, videos, infographics, and more. They are organized by health topic.
Resources in Foreign Languages
FDA offers easy-to-read publications in Spanish and other languages that you can access online or print and share. Find resources in other languages and learn about our Language Access Plan: an evolving blueprint to provide people with limited English proficiency easy access to health information in a language and manner that they can understand.
Visit the Office of Minority Health website or follow us @FDAOMH
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