Message from the Office
Greetings from the Office of Minority Health (OMH)
At the FDA Office of Minority Health, our vision is to create a world where health equity is a reality for everyone. One way we improve health equity is by encouraging minority representation in different facets of FDA outreach.
At the FDA Office of Minority Health, our vision is to create a world where health equity is a reality for everyone. One way we improve health equity is by encouraging minority representation in different facets of FDA outreach.
This is important in clinical trials because demographic subgroups--racial and ethnic minorities, women, and the elderly--may respond differently to some medical products.
Minority representation is important in risk communication campaigns, in stakeholder calls that develop FDA policies, as well as in the research space, where we aim to shed light on diseases that disproportionately affect minorities.
Read below to find out more information about what's happening at OMH and our efforts to improve health equity.
In this Issue:
- Upcoming Workshop: Assessing Safety and Efficacy for Diverse Populations
- Fresh Empire is FDA's First Tobacco Prevention Campaign Targeting Multicultural Youth
- Join Monthly Calls to Reauthorize PDUFA
- #Natives4Heart Twitter Chat 11/18
- Now Available: Get to Know ClinicalTrials.gov!
- Now Available: Chagas Disease Fact Sheet
- Recap: Reversal and Prevention of Organ Damage to Improve Mortality in Patients with Sickle Cell Disease
- Recap: @FDAOMH Hosts First Twitter Chat for National Latino AIDS Awareness Day
UPCOMING WORKSHOP: Assessing Safety and Efficacy for Diverse Populations
FDA and Johns Hopkins University Center for Excellence in Regulatory Science Innovation (CERSI) will host a one-day clinical trials workshop: "Assessing Safety and Efficacy for a Diverse Population."
This workshop will utilize a multi-disciplinary approach to examine how various population-based tools can inform pre-market clinical trials as well as post-marketing studies. It will also include a discussion of other innovative strategies that address meaningful use of subgroup data.
Date: Wednesday, December 2, 2015
Time: 8:00 AM - 5:00 PM
Location: FDA White Oak, BLDG 31, The Great Room
Fresh Empire is FDA's First Tobacco Prevention Campaign Targeting Multicultural Youth
FDA recently launched Fresh Empire, the agency's first public education campaign that promotes a tobacco-free lifestyle among multi-cultural youth who identify with the hip hop crowd.
The campaign is part of FDA's ongoing efforts to combat tobacco use among youth. It complements the general market at-risk youth education campaign, "The Real Cost," which launched in February 2014.
Assistant Commissioner for Minority Health, Dr. Jonca Bull is a spokesperson and supporter of the campaign. She gave the opening remarks at the launch and authored a FDA Voice Blog on the campaign.
Join Monthly Calls to Reauthorize PDUFA
You or a representative of your organization can join monthly calls to renew PDUFA, which is the Prescription Drug User Fee Act. This law authorizes FDA to collect user fees from regulated industry for the process of reviewing human drugs. These fees help speed certain activities within the new drug approval process.
FDA needs organizations that represent diverse communities to participate in order to make sure that the renewal includes a broad range of health care provider, patient, and consumer perpectives.
Make your voice heard. Email PDUFAReauthorization@fda.hhs.
#Natives4Heart Twitter Chat - 11/18
@FDAOMH (OMH's twitter channel) will join The American Heart Association, American Stroke Association, and distinguished American Indian organizations for a twitter chat on Weds. 11/18 from 2-3 PM CDT (1-2 PM EST). Use the hashtag #Natives4Heart.
NOW AVAILABLE: Get to Know ClinicalTrials.gov! Webinar
In this webinar, Rebecca Williams, Pharm. D., MPH, and Assistant Director of ClinicalTrials.gov, helped raise awareness about how to navigate ClinicalTrials.gov and how to find information about clinical trials that may interest you.
Demographic subgroups, e.g. racial and ethnic minorities, women, and the elderly, are not well represented in clinical trials. It is important to have diverse patients participate because some patients may respond differently to some medical products. This is a critical gap in achieving health equity.
If you missed the webinar, access the archive here:
NOW AVAILABLE: Chagas Disease Fact Sheet
Chagas Disease is an emerging public health concern. It is a devastating parasitic infection that can cause serious heart problems or problems with the gastrointestinal track. The disease primarily affects people in rural parts of Latin America, but there are approximately 300,000 people in the U.S. living with Chagas Disease as well.
RECAP: OMH Lecture: Reversal and Prevention of Organ Damage to Improve Mortality in Patients with Sickle Cell Disease
To commemorate sickle cell disease awareness month, Courtney Fitzhugh, M.D., gave a lecture at FDA about her current research. She discussed how she explores new avenues of hematopoietic stem cell (HSC) transplantation for sickle cell disease (SCD), while also studying the currently underexplored cardiovascular complications arising due to this genetic blood disorder. Dr. Fitzhugh is an Assistant Clinical Investigator at the Laboratory of Sickle Mortality Prevention, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH).
RECAP: @FDAOMH Hosts First Twitter Chat for National Latino AIDS Awareness Day
@FDAOMH (OMH's twitter channel) hosted its first Twitter chat on October 15th to commemorate Latino AIDS Awareness Day. We partnered with CDC, AIDS.gov, and the Latino Commission on AIDS and garnered over 16 million impressions during the chat.
Find information from this chat on Twitter in English and Spanish with #LatinosDefeatAIDS.
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