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Greetings from the FDA Office of Minority Health (OMH)
2015 was a great year and 2016 is shaping up to be even better. The OMH communications team grew--we added 5 wonderful new specialists who completely enhance our outreach efforts. We made real strides in making FDA more accessible to people like you through webinars, workshops, and public meetings, and we expanded our social media presence.
In 2016 we are working harder to make your voices heard. That's why throughout this issue you will find opportunities to attend public meetings, comment on open dockets, and even apply to a fellowship at FDA.
These are important opportunities to make a difference in minority health--health disparities are too numerous for FDA alone to identify and impact. Your suggestions help us close the health equity gap and ensure that medical products and devices are safe and effective for everyone.
In this issue:
- FDASIA 907 PUBLIC MEETING: Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data
- CONSUMER UPDATE: Who's In Clinical Trials?
- Join the New Diverse Women in Clinical Trials Campaign
- #ILoveMyHeart
- American Heart Month Twitter Chat
- FR NOTICE: Patient and Medical Professional Perspectives on the Return of Genetic Test Results and Interpretations; Public Workshop; Request for Comments
- Tobacco Fellowship Application
- CONSUMER UPDATE: Some Imported Dietary Supplements and Nonprescription Drug Products May Harm You
- Get Email Updates on Safety Alerts and Recalls
- WORKSHOP RECAP: Assessing Safety and Efficacy for Diverse Populations
FDASIA 907 PUBLIC MEETING: Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data
FDA will host 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.
Date: February 29, 2016
Time: 9 AM - 4 PM
Location: The Great Room at FDA White Oak
10903 New Hampshire Ave
Silver Spring, MD
10903 New Hampshire Ave
Silver Spring, MD
More Information
FDA Voice Blog: 2016: The Year of Diversity in Clinical Trials
FDA Voice Blog: Progress and Collaboration on Clinical Trials
About FDASIA Section 907: Inclusion of Demographic Subgroups in Clinical Trials
The Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data
FDA Voice Blog: Progress and Collaboration on Clinical Trials
About FDASIA Section 907: Inclusion of Demographic Subgroups in Clinical Trials
The Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data
CONSUMER UPDATE: Who's in Clinical Trials?
Have you ever wondered if someone like you participated in the clinical trials for a new drug? If you have, you're not alone.
That's why FDA is making demographic information from clinical trials--such as the inclusion of women and minority groups--easily available to consumers through its online Drug Trials Snapshots database.
Join the New Diverse Women in Clinical Trials Campaign
Clinical trials help to show whether a test or treatment is safe and works well. Because medical products can affect men and women differently, it is important for women to participate in clinical trials.
Last month, the FDA Office of Women's Health launched a new Diverse Women in Clinical Trials awareness campaign to educate women of all ages, racial and ethnic groups, and women with disabilities or chronic health conditions about clinical trials. The national campaign encourages diverse women to ask their healthcare providers whether a clinical trial is right for them.
Visit FDA's Women in Clinical Trials website for tips and resources to help you talk to your family, friends and health care provider about clinical trials.
Join the #ILoveMyHeart campaign by the FDA Office of Minority Health (@FDAOMH), Salud Today (@SaludToday) and the Association of Black Cardiologists (@ABCardio1) and show us how much you love your heart!
In honor of American Heart Month this February, take a picture with a dry erase board or poster describing how you keep your heart healthy. You can also share pictures preparing healthy meals, engaging in a physical activity, taking your medication or doing any other activities that keep your heart healthy. Share your photos on Twitter with the #ILoveMyHeart hashtag and @FDAOMH Twitter handle. Every Monday we will pick the best three photos and post them on FDA's Facebook page.
American Heart Month Twitter Chat
OMH (@FDAOMH) will participate in a Twitter chat sponsored by Million Hearts (@MillionHeartsUS) and Men's Health Network (@MensHlthNetwork) in order to raise awareness of heart health among African American Men.
Date: February 17, 2016
Time: 3:00 PM EST
FR NOTICE: Patient and Medical Professional Perspectives on the Return of Genetic Test Results and Interpretations; Public Workshop; Request for Comments
FDA will host a public meeting to solicit patient and provider perspectives on receiving medically relevant genetic test results. Specifically, FDA wants to know what information about the tests patients and providers want to know the most, the information patients need in order to understand what their results mean, and how patients and providers want to receive their results.
Date: March 2, 2016
Time: 8 AM - 4 PM
Location: The Great Room at FDA White Oak
10903 New Hampshire Ave
Silver Spring, MD
10903 New Hampshire Ave
Silver Spring, MD
FDA Tobacco Fellowship Applications Open Now Through March 1st
FDA is offering mid-career professionals the opportunity to spend a year as a Tobacco Regulatory Science Fellow in the Center for Tobacco Products (CTP). This is a collaborative program between CTP and the National Academy of Medicine.
Fellows will have the chance to help develop science-based public health strategies, serve as leads for defined projects, and meet with policy leaders. Opportunities are available in the following areas within CTP: Compliance and Enforcement, Health Communication and Education, Management, Regulations, Policy, and Science.
Tobacco use heavily impacts minority consumers, so this is an important opportunitiy for mid-level professionals to help reduce health disparities in tobacco use.
CONSUMER UPDATE: Some Imported Dietary Supplements and Nonprescription Drug Products May Harm You
If you buy imported products marketed as "dietary supplements" and nonprescription drug products from ethnic or international stores, flea markets, swap meets or online, watch out. Health fraud scams abound.
According to Cariny Nunez, M.P.H., a Public Health Advisor in the Office of Minority Health at the Food and Drug Administration (FDA), "health scammers often target advertising to people who prefer to shop at nontraditional places, especially those who have limited English proficiency and limited access to health care services and information."
EMAIL UPDATES: Get Email Updates on Safety Alerts and Recalls
MedWatch Safety Alerts - Human medical product safety alerts, Class I recalls, market withdrawals, and public health advisories.
FDA MedWatch is a gateway to find information about and report serious adverse events with human medical products.
Recalls, Market Withdrawals, and Safety Alerts - FDA press releases, industry press releases on FDA-related products and safety alerts concerning significant (primarily Class I) product recalls/actions.
Medical Device Recalls - Notices about Class I medical device recalls and some Class II and III recalls of interest to consumers.
WORKSHOP RECAP: Assessing Safety and Efficacy for Diverse Populations
FDA and Johns Hopkins Center for Excellence in Regulatory Science Innovation (CERSI) hosted a one-day clinical trials workshop: "Assessing Safety and Efficacy for a Diverse Population" on December 2, 2015. This workshop utilized a multi-disciplinary approach to examine how various population-based tools can inform pre-market clinical trials as well as post-market clinical trials as well as post-marketing studies. It also included a discussion of other innovative strategies that address meaningful use of subgroup data.
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