Mission Possible: Moving the Needle Forward to Advance Health Equity

By: CAPT Richardae Araojo

Every April our country observes National Minority Health Month to spotlight what we’re doing to eliminate health disparities among minority populations. A health disparity is a particular type of health difference that is closely linked with social and economic disadvantage, discrimination, or exclusion. We strive for what we call health equity―the attainment of the highest level of health for all people―by enlisting a range of approaches to remove the social and economic obstacles to health faced by racial and ethnic groups.

CAPT AraojoAs the Director of FDA’s Office of Minority Health (OMH), I lead cross-agency efforts with my team to protect, promote, and advance the public health of our country’s most vulnerable and underrepresented populations. OMH does this in many ways. For example, we:

  • Conduct and fund research on diseases that disproportionately affect minorities, like HIV/AIDS, diabetes, and heart disease.
  • Work to diversify the public health workforce by training principal investigators and pharmacists from diverse backgrounds, such as African Americans, Hispanics, American Indians/Alaska Natives, and Asian Americans and other Pacific Islanders, who can relate to research volunteers and patients from underserved communities. Research shows that people want their health professionals to look like them, so a workforce that reflects the demographics of the community it serves is vital.
  • Help minorities make better informed health decisions by creating culturally and linguistically tailored health education materials for use across different social media platforms.
  • Engage with minority-serving institutions of higher learning to protect and improve the health of the populations they serve.
  • Serve as a voice for those in need by encouraging all our constituents to participate in the work that we do. One example is the inaugural FDA Rural Health Symposium, a cross-Agency effort among OMH, the Office of Health and Constituent Affairs, and the Center for Tobacco Products, with participation from other FDA product centers. The symposium offered stakeholders from rural and tribal communities a forum to discuss how we can work together to address rural health challenges that range from the opioid crisis and tobacco use among youth to the need for telemedicine.

In the spirit of this year’s theme for National Minority Health Month, Partnering for Health Equity, I’d like to share a couple of other ways we’ve been partnering with private- and public-sector organizations to further equity on all fronts.

Getting culturally sensitive messages out to minority communities

My office conducts robust communications and outreach activities to share research and information on FDA-regulated products and to promote public health. For instance, Asian Americans, African Americans, and Latinos have lower immunization rates for adult vaccinations like herpes zoster, whooping cough, hepatitis B, and influenza. To better understand these disparities, OMH is supporting a study to assess the impact of advertising and promotional labeling as it relates to vaccine health disparities. OMH has message-tested FDA’s communications with consumer panels, among others, and we’re using the information from this research to shape FDA’s health education materials and outreach to minority communities.

Ensuring minority representation in clinical trials

Ensuring minority representation in clinical trials is crucial to improving minority health because we need to understand how different racial and ethnic groups respond to medical products before they are approved for use in the broad population. To that end, FDA developed guidance for industry and FDA staff. This guidance provides recommendations on using a standardized approach for collecting and reporting race and ethnicity data used to support marketing applications for FDA-regulated medical products.

OMH also works collaboratively with organizations whose mission includes encouraging more minorities to participate in clinical trials. We’ve partnered with the Veteran Health Administration’s Office of Health Equity to launch two videos featuring veterans talking about why diverse representation is so important. These veterans will also appear in the first installment of our new podcast series on health equity and disparities to share their experiences as participants in clinical trials.

Another important partnership involves our newly formed memorandum of understanding (MOU) with Yale University. Under this MOU, we’ll be working to advance scientific collaborations, outreach, and educational initiatives. Especially exciting is the cultural ambassador’s program, which will engage community members to get more involved in clinical research.

In sum, to create a world where health equity is a reality for all we must involve all stakeholders in new ways of thinking and working. And that requires the kind of teamwork, partnerships, and collaboration across disciplines, experiences, and sectors that I’ve shared with you here.

Visit www.fda.gov/minorityhealth for more information on FDA’s Office of Minority Health, and follow us on Twitter @FDAOMH for updates.

CAPT Richardae Araojo is FDA’s Associate Commissioner for Minority Health

New CDER Report Highlights Ongoing Drug Safety Initiatives and Priorities

By: Janet Woodcock, M.D.

At FDA’s Center for Drug Evaluation and Research (CDER), drug safety is among our highest priorities. Before we approve a drug, we make every effort to ensure its benefits outweigh its risks. After approval, we keep a careful watch for new safety issues that can arise once new therapies are prescribed for a broad population of patients.

Janet WoodcockIt’s a complex and ever-changing responsibility. As drug therapies become increasingly advanced, so too must our methods to prevent and/or manage risks related to their use. These risks come in many forms – including adverse events (side effects), problems arising from inappropriate or incorrect use, manufacturing issues related to sophisticated new production techniques, criminal tampering or counterfeiting, and the devastating effects of addiction, like that of the opioid epidemic. And, as innovative study methods provide new information, new safety issues can emerge for drugs that have been on the market and widely used for decades. For these reasons, we focus our efforts both on newly approved drug therapies and those already on the market.

Our annual report, Drug Safety Priorities 2017, provides updates on our ongoing initiatives, discusses new work, and highlights last year’s safety-related milestones and achievements.

Protecting the American public from risks associated with medications requires teamwork from many scientific and medical specialists at FDA working together to inform decisive regulatory action. Key efforts include the Safe Use Initiative to reduce preventable harm from medications; the FDA Adverse Event Reporting System (FAERS), which collects vast amounts of data about side effects and medication errors from medical products reported by patients, health care professionals, and manufacturers; and the Sentinel System, our state-of-the-art electronic drug safety surveillance system. We also collaborate with health care professionals, academia, researchers, and other health and science agencies in studying the effects of medications before and after approval to help ensure that the benefits of these therapies outweigh their risks.

Our report describes many ways CDER worked in 2017 to enhance drug safety for the American public. These include:

  • Safety surveillance and oversight of marketed drug products: In 2017, CDER’s Office of Surveillance and Epidemiology (OSE) conducted 7,446 safety reviews. Of those, 2,860 were initiated as a result of ongoing OSE surveillance.
  • The importance of real-world evidence to help advance drug safety science: Although randomized clinical trials (RCTs) are the gold standard for medical and scientific evidence needed to support FDA drug product approval decisions, they are often conducted in specialized and controlled research settings and are time-consuming and costly. And at the end of a drug development program, RCTs can leave critical questions unanswered, particularly about the effects or impacts of a drug after it gets into the “real world,” and is used by hundreds of thousands of people over an extended period. CDER safety scientists are using powerful new scientific computing and data storage technologies to enhance our capabilities of gaining valuable information from “real world evidence.”
  • New tools and new approaches for fighting our Nation’s opioid crisis: Our report emphasizes that in 2016, an estimated 11.5 million people misused prescription opioids — and that each day of that year, an estimated 116 people died from an opioid-related overdose. FDA actions taken in 2017 in response to the opioid epidemic align with our current four key priorities in this area: 1) decreasing exposure and preventing new addiction, 2) safely treating those with opioid addiction, 3) developing safe and effective novel alternative therapies to opioids, and, 4) improving enforcement of safety measures and assessing benefit-risk ratios.
  • Safety oversight for generic drugs: The report explains how we evaluate generic drugs to ensure they meet quality standards and deliver the necessary amount of active ingredient, and how we monitor generic drug use in the marketplace to flag early safety concerns. CDER’s Clinical Safety Surveillance Staff (CSSS) is addressing post-marketing safety concerns related to complex generic drug-device combination products. In 2017 a generic drug had two intravenous (IV) bag ports (rather than a single IV bag port used by the brand name drug). This difference raised concerns for potential confusion, risk of incompatibility issues, and potential adverse events in patients. The CSSS’s collaboration activities led to the development of a new process for managing review of similar IV bags with different port configurations.
  • Efforts to reduce preventable harm from medications: More than a million Americans are injured or killed each year due to preventable medication errors. FDA’s Safe Use Initiative works to reduce preventable medication-related errors, such as medicines dispensed in error, medicines taken for too long or not long enough, or medicines inappropriately mixed with other medicines or with foods that can increase risks of side effects. Among many other efforts, our work through the Safe Use Initiative in 2017 included making recommendations to enhance the safety of fluoroquinolone antibiotics, identifying “high-risk” prescribers (those who write prescriptions for high doses or co-prescribe with medications which increase the risk of adverse events) and educating them about safer prescribing practices, and identifying which diabetic patients may be at high risk of hypoglycemia (low blood sugar).
  • Compounded drugs – continuing regulatory and oversight efforts: FDA has taken many steps to strengthen safety measures for compounded medications since the 2012 outbreak of fungal meningitis associated with contaminated compounded drugs. Among other actions, the agency conducted 140 inspections, sent 55 warning letters, and issued 40 recalls related to compounding.
  • Diverse strategies, tools, and services for communicating drug safety: Effectively communicating what we do is an essential component of our work to protect the public. In 2017, we responded to 57,094 inquiries from the public (39,883 by phone, 16,269 by e-mail, and 942 via written letters), each an opportunity to help a patient ensure they are safely using their medication. Our Drug Safety Podcasts reached an estimated 350,000 listeners each week. These and many other communication efforts, such as our Drug Safety Communications that alert consumers and health care professionals about new or potential safety issues, serve to keep the public informed of important drug safety concerns that may impact them.

The report also details a variety of ways we keep pace with the rapid evolution of technology. For instance, we are evaluating the use of technologies, such as machine learning methods and other advanced computation techniques, to help our analytics systems contribute to more predictive safety and risk data. We are also exploring ways to leverage mobile apps, social media, and electronic prescribing data while ensuring patient privacy. As we pursue a wide-ranging safety agenda, CDER Drug Safety Priorities 2017 offers a deeper dive into FDA’s drug safety research, surveillance, and regulatory activities. We hope this report serves to demonstrate CDER’s ongoing commitment to protect the American public.

Janet Woodcock, M.D., is the Director of FDA’s Center for Drug Evaluation and Research

Ironed Out

By: Vanessa Burrows, Ph.D.

During the early part of the 20th century, the growing scientific knowledge that certain diseases were caused by vitamin and mineral deficiencies sparked public interest in products that touted these substances. But the public had little understanding of this emerging health care field and, as a result, was often easy prey for unscrupulous marketers who used phony claims that their products had therapeutic value.

Vanessa BurrowsOne such charlatan was a man named E. Virgil Neal, whose past schemes included palm-reading and hypnotism performed under the name Xenophon LaMotte Sage; a mail-order health and self-improvement program, which earned him a conviction for mail fraud; and a French cosmetics company that marketed false hair regenerators and bust enhancers.

Operating at the dawn of the modern advertising age, Neal employed a sophisticated and misleading marketing campaign to sell Nuxated Iron pills, which included iron and nux vomica, a derivative of the strychnine tree, which is highly toxic to humans and other animals. Beginning in 1917, Neal’s advertisements used celebrity endorsements that touted the product’s invigorating and strength-building qualities, promising to alleviate “that tired feeling.” However, the pills contained so little iron that their health impact was questionable, and so much strychnine that, in at least one case, they caused the fatal poisoning of a young boy.

Neal’s fraudulence was exposed by the American Medical Association and journalists in the early 1920s, but FDA was unable to prosecute him because the misbranding provisions of the 1906 Pure Food and Drugs Act did not outlaw misleading promotional material of the type that Neal distributed. Neal’s product actually contained some iron, albeit negligible amounts, and only made therapeutic claims in promotional materials. It wasn’t until 1944, after the passage of the 1938 Federal Food, Drug, and Cosmetic Act, when FDA was able to take action against the product on new types of misbranding grounds, which forbid, among other things, misrepresenting the quantity of ingredients contained in the product.

Today, FDA continues to play a critical role in protecting consumers from fraudulent, adulterated, and misbranded products like Nuxated Iron.

We hope you enjoy your visit to the History Vault.

Vanessa Burrows, Ph.D., is an FDA Historian

In Forum and On Farms, FDA and Partners Work to Harvest Agreement on Water Issues

By: Samir Assar, Ph.D.

A two-day summit on the topic of agricultural water, followed by farm tours organized by FDA’s Produce Safety Network (PSN), illustrate FDA’s collaborative approach to implementing provisions of the FDA Food Safety Modernization Act (FSMA).

The Produce Safety Rule under FSMA includes standards for the microbial quality and testing of agricultural water that comes in direct contact with the harvestable portion of produce. In response to stakeholder concerns that these standards may be too complex to understand and implement, FDA is exploring ways to simplify them while still protecting public health.

That exploration recently took shape in two different ways. My team and I attended an agricultural water summit on February 27 and 28 with hundreds of participants in Covington, Kentucky, and 28 satellite locations across the country to discuss ways to simplify the agricultural water standards. And after the summit, a handful of FDA produce safety experts embarked on a different kind of fact-finding mission – an educational tour of two South Florida farms covered by new FDA regulations.

Both the summit and the farm tours included representatives from government agencies, academia, and the produce industry, along with farmers who must implement the produce rule provisions. Many of the participants know each other and have been working together to leverage strengths and trade knowledge as they cross territory that’s new for all of us.

There was a consensus at the summit that it’s time to agree on next steps. Some want the water standards to be redone; others want to stay with the standards as written but with a lot more interpretive guidance on how to meet them. There were frank discussions during breakout sessions about the challenges presented by the current requirements, specific on-farm hazards of concern and how they translate into food safety risks, and alternate water management strategies that could be used to control these hazards. Outcomes from these group discussions will help inform the decisions that FDA makes on these important issues.

I spoke at the summit about our need for more information about on-farm conditions and water systems. Ongoing dialogue with stakeholders will be crucial as we move forward.

We received feedback that additional clarity on how we arrived at the current agricultural water requirements in the final rule would be helpful, as would be increased communications on the research FDA is funding, particularly for projects involving cooperative monitoring programs. There was also a push for FDA to establish partnerships with other federal agencies that have water quality databases and tools that might be used to alleviate some compliance challenges. Throughout this process, we have been engaging with people who have technical expertise on a variety of relevant issues (for example, produce safety, water microbiology, and water systems). During the summit, we were able to establish connections with more technical experts, and we plan to continue engaging with all of these experts as we consider ways to simplify the standards.

Farm photo

Canals bring water from Lake Okeechobee to the Duda fields, where it reaches the crops through seep irrigation.

These conversations continued as my colleagues in FDA’s Division of Produce Safety joined their counterparts in the public and private sectors on the two Palm Beach County farms on March 1 and 2. In addition to the produce team and colleagues from the agency, those on the tours included representatives of the Florida Fruit and Vegetable Association, the University of Florida/Institute of Food and Agricultural Science Extension, and state partners from the Florida Department of Agriculture and Consumer Services and the Florida Department of Health.

FDA has been putting these educational farm tours together for about a year, having done 117 in 2017 alone. Trevor Gilbert, the PSN representative whose region includes Florida, organized tours of the J&J Family of Farms and the Duda Farm Fresh Foods Facility, both of which began as family farms and grew to become national suppliers of produce. Both use a kind of irrigation unique to Florida’s high water table called the seepage method. The growing fields are intersected by canals that supply the water that is pulled up through a below-surface bed of sand to reach the crop roots. And both farms have staff specifically dedicated to food safety.

At J&J, the visitors were taken through fields of peppers and squash, the latter being cleaned and packed right in the field—in equipment invented on this farm—because of the crop’s sturdiness. The peppers are cleaned and packed in an off-farm facility. As the J&J food safety staff outlined the steps taken there to prevent the contamination of their crops, the main concern expressed about FSMA is a desire that the standards provide enough flexibility to allow room for innovative methods to ensure adequate supplies of water.

Farm photo

Perry Yance, Duda’s Farm Manager, talks to visitors from FDA about the farm’s use of water resources.

The next day, the team traveled to the Duda Farms, which started as a celery farm in 1926 and has staff members who have worked there for decades. Duda’s fields are fed by water that flows down from Lake Okeechobee, its fields laced with canals and pumps to control the water levels. The visitors were taken through fields of celery and radishes, marked by the occasional alligator sunning itself on the edge of a canal. As at J&J, some of the crops—celery in this case—are packed in the field using equipment invented by these farmers. The sentiment expressed here by the food safety team was one that I heard from others at the water summit: It’s time to reach agreement on the water standards and move forward.

Both farms follow food safety standards that preceded FSMA, ones shaped by audits required by retailers. The need to harmonize the requirements of such audits with FSMA is another challenge that has surfaced in discussions with the produce industry.

One of the calls for action that came out of the agricultural water summit was a need for more transparency and communications. That call will be answered in multiple ways, including building new connections through more of these educational farm tours. And the PSN’s team members are based all over the country to provide information and technical assistance.

FDA will continue working with dedicated teams of produce experts to find the right path forward, one that, where possible, makes the standards easier to understand and follow while still producing safe fruits and vegetables for consumers across America and throughout the world.

Samir Assar, Ph.D., is the Director of FDA’s Division of Produce Safety