Using Social Media to Teach Consumers About Heart Health

By: Jonca Bull, M.D.

Jonca BullFebruary is American Heart Month. Heart disease remains a significant problem in the United States – it’s the leading cause of death, disproportionately affecting minorities. In particular, minorities have higher rates of hypertension, diabetes, and smoking, which are risk factors that can cause heart disease. This month, we’ll be working with the Centers for Disease Control and Prevention and the National Institutes of Health to help raise awareness.

Our social media platforms will be key to engaging the multicultural population. And they have a proven reach: 65% of Hispanics and 56% of African Americans use social media. In 2014, on average 40% of all cell phone owners used a social media site, with blacks and Hispanics leading the trend at 48% and 49%, respectively.

So, how will FDA’s Office of Minority Health use social media to reach key populations? Here are just a few things we have in store for February:

  • Sharing culturally relevant messages for Twitter and Facebook. We want to stimulate dialogue on two key areas: (1) knowing your risk factors and (2) using our resources to help manage them. This month, our outreach will provide information and resources on the following:
    • Heart Disease: Who does it affect and what are the risk factors?
    • Smoking: Smoking is a risk factor for developing heart disease. FDA has resources to help you quit.
    • Healthy Eating and Living: FDA has materials to help consumers make heart healthy decisions (e.g. how to read the food label), manage their risk factors through FDA-approved medications, and tips for preparing healthy meals.
  • Working with stakeholders to use social media as an engagement tool. We have developed a social media toolkit to guide stakeholders in communicating with their members. The toolkit will contain drafted social media messages, infographics, and links for consumers on heart disease and risk factor management. Email omh@fda.hhs.gov to receive the toolkit.
  • Hosting a bilingual Twitter chat with our partner, @SaludToday on Tuesday, Feb. 16th from 1 p.m. – 2 p.m., EST. We’ll chat about risk factors for heart disease and provide tips to lead a heart healthy lifestyle. We hope you can join us and provide your insights on this important topic.
  • Spearheading an #ILoveMyHeart social media campaign with our partners @SaludToday and @ABCardio1 asking you to show us how much you love your heart! Participants will upload pictures with the #ILoveMyHeart hashtag describing their heart healthy activities. Be sure to post your picture and tag @FDAOMH!

We know that social media is becoming a valuable health education tool to reach minorities. And, we will continue to use it to engage with our audience. Please follow us and share heart-healthy messages all month.

For more information about FDA’s OMH visit us at: www.fda.gov/minorityhealth

Follow us on Twitter @FDAOMH

Jonca Bull, M.D., is FDA’s Assistant Commissioner for Minority Health

Making Progress in Protecting Consumers from Unsafe Supplements

By: Stephen Ostroff, M.D.

An estimated 200 million Americans take dietary supplements to maintain or improve their health. Protecting consumers from unsafe or contaminated dietary supplements is extremely important to FDA.

Acting FDA Commissioner, Stephen Ostroff, M.D.We’ve recently taken a number of important steps to prevent illnesses and deaths from unsafe supplements, and, while our current authority over supplements is arguably limited, we are doing what we can to strengthen our existing oversight. I’d like to give you a picture of the challenges, achievements and opportunities regarding the regulation of these products, beginning with the challenges.

One challenge is sheer volume. The dietary supplements industry is one of the fastest-growing in the world. When the Dietary Supplement Health and Education Act (DSHEA) was passed by Congress in 1994, annual sales of dietary supplements totaled about $5.8 billion. Since then, sales have risen six-fold to about $35 billion annually. Large volumes of supplements are also now sold on the Internet. The significant growth in the dietary supplements industry, and the various ways supplements reach consumers, outpace FDA’s resources to regulate this industry.

Moreover, tracing these products can be difficult because supply chains are often fragmented, with a single product sometimes passing through numerous suppliers, manufacturers and distributors of all kinds, sizes, and locations (including those overseas). Ultimately, when proper quality control and recordkeeping procedures are not followed across the supply chain, it can be difficult to guarantee what ingredients in what amounts are in the final product, and whether the ingredients are safe or even qualify as dietary supplements.

Under DSHEA, FDA does not have the authority to approve dietary supplements before they are marketed to consumers. However, we do have the authority to take enforcement actions after a product is on the market – only when we can establish that the dietary supplement is adulterated (e.g., unsafe); misbranded (e.g., misrepresentations are made on the product labeling); or cannot be marketed as a dietary supplement (e.g., an unapproved new drug). We monitor the marketplace through market surveys, undercover buys, label reviews, a review of reports of illness or deaths, and product testing. When necessary, we take actions to protect public health, including issuing public warnings, taking legal action, and working with the company to recall the product. But all this must be done based on evidence and within the bounds of our legal authority and limited resources.

Despite these constraints, our actions have produced important results over the past year. Here are just a few key accomplishments:

  • At the request of FDA, this month U.S. Marshals seized almost 90,000 bottles of dietary supplements labeled as containing kratom. Kratom has been indicated to have both narcotic and stimulant-like effects.
  • Use of pure powdered caffeine products has already resulted in the deaths of two teenagers. We took action to help prevent harm, including deaths, from the use of these products, by issuing warning letters to five distributors of these potentially dangerous products.
  • In 2015, FDA identified products containing BMPEA, DMBA and picamilon that are unlawfully marketed and issued a series of warning letters to 24 companies that marketed dietary supplements containing these ingredients. The companies that received the warning letters market products that are either misbranded for falsely declaring the ingredients as dietary ingredients or marketing products containing new dietary ingredients without the required pre-market notification.
  • We worked closely with our government partners, including the Department of Justice, the Federal Trade Commission and the U.S. Postal Inspection Service, on a year-long sweep to identify potentially unsafe products and/or products containing undeclared ingredients. In November 2015, that sweep culminated in civil injunctions and criminal actions against 117 manufacturers and/or distributors of dietary supplements and tainted products.
  • We issued more than 100 consumer alerts warning about products falsely marketed as dietary supplements that were found to contain active pharmaceutical ingredients.
  • We conducted more than 600 inspections of dietary supplement firms in the U.S. and other countries. We also worked with companies on voluntary compliance actions, such as removing illegal claims, destroying inventory and ceasing distribution.

I am excited about the opportunities that await us in this area, and the plans we’re making for the future. For example, within FDA, we have established the new Office of Dietary Supplement Programs and are working on increasing the visibility, capacity and staffing for that new office. This will include hiring permanent leadership to sharpen our focus on potential safety problems and to support regulatory actions.

We want to expand our use of criminal investigation and enforcement tools to address serious safety-related violations and cases of intentional fraud; and further build strategic investigatory and enforcement collaborations with the Federal Trade Commission, Department of Justice, and state governments, including state health departments and attorneys general.

Ultimately our top priority is to protect the consumers who want to improve, not damage, their health and have a right to expect that dietary supplements will be safe for them and their families.

Stephen Ostroff, M.D., is Acting Commissioner of the U.S. Food and Drug Administration

Advancing Women’s Health Research

By: Pamela E. Scott, Ph.D.

Career inspiration can come from many sources. My inspiration came from a broken ankle.

Pamela ScottIn the winter of 1999, I broke several bones and had three surgeries to repair my ankle. While working with my doctors on my treatment plan, I had to make some serious decisions about the proposed medical devices that would be used in my care.

I had more information at my fingertips than the average person. I was an FDA insider who had worked on medical devices. I had worked as a statistical reviewer, and I was in the process of completing my PhD in epidemiology and clinical trials methodology. But despite my background and access to information, I still had questions about how well the devices work for women like me.

My experience motivated me to make sure that women have the data and information they need to make informed choices about their medical care. When I returned to FDA, I dedicated my efforts to promoting women’s health research. Years later, I continue this work in my current role as Deputy Director and Director of Research and Development for the FDA Office of Women’s Health (OWH).

Throughout its history, FDA has conducted research to help inform its regulatory and policy decisions. OWH and FDA Centers have supported research that has developed new methods and tools that can help predict the safety and efficacy of FDA-regulated products, identify sex differences, and guide product labeling.

Since its establishment in 1994, the OWH Research and Development Program has played an integral role in promoting sound policies and regulations by supporting research projects, workshops, and training to help FDA answer regulatory questions related to women’s health. OWH has funded more than 300 research projects that have expanded our understanding of the science of women’s health.

New Women’s Health Research Roadmap

To build upon these projects, OWH recently released a Women’s Health Research Roadmap that outlines seven broad areas where new or enhanced regulatory science research would be beneficial to women’s health. Future OWH-funded research will seek to:

  1. Advance Safety and Efficacy
  2. Improve Clinical Study Design and Analyses
  3. Identify Novel Modeling and Simulation Approaches
  4. Advance Biomarker Science
  5. Expand Postmarket Data Sources and Analysis
  6. Improve Health Communications
  7. Identify Sex Differences related to Emerging Technologies.

OWH will work with FDA Centers to increase collaboration and communication on research endeavors related to women’s health. By promoting collaborative research in mission critical areas, the Roadmap will better position FDA to foster the advancement of innovative products that promote and protect the health of all Americans.

While I may never be able to run a marathon, my injury helped guide my career at FDA and my work to strengthen FDA’s commitment to advancing women’s health research. And with the new Roadmap, we are well positioned to continue the progress that has been made in women’s health.

Pamela E. Scott, Ph.D., is Deputy Director and Director of Research and Development, FDA Office of Women’s Health.

Progress and Collaboration on Clinical Trials

By: Barbara D. Buch, M.D.

There are few responsibilities at FDA more important than reviewing the design and outcomes of clinical trials. Understanding the science behind the trials — and the individuals included in them — helps us to ensure that the medical products we approve are safe and effective.

Dr. Barbara BuchLast year, FDA took important steps to support the inclusion of diverse populations in clinical trials. Following Congress’s directive in Section 907 of the Food and Drug Administration Safety and Innovation Act, FDA is looking more closely at the sex, age, and race/ethnicity data that are collected in clinical trials.

In August, FDA published an Action Plan designed to address three specific priorities: improving the quality and comprehensiveness of demographic subgroup data collection, reporting and analysis; identifying and eliminating barriers for increased participation in clinical trials; and improving the transparency of subgroup data.

We’ve come far in achieving this plan. As we begin 2016, I want to outline our progress in preparation for the next important milestone: a public meeting on this topic on February 29.

Priority 1 – Quality

  • FDA updated and/or finalized relevant guidance on demographic subgroup data, as illustrated by these two examples of FDA staff training and/or outreach to external stakeholders:
  • The Office of Minority Health (OMH) developed a plan that supports specific research projects and leads to better understanding of medical product clinical outcomes in racial/ethnic demographic subgroups.
  • The Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) modified their clinical review templates:
    • CDER developed a review process that encourages reviewers to watch for inappropriate clinical trial exclusion and inclusion criteria; accompanying training emphasizes the need to include broad population diversity in clinical trials.
    • CDRH and CBER modified statistical reviewer templates to include analysis of demographic subgroup information.
  • CBER and CDER incorporated discussions on diverse inclusion and subgroup participation and analysis into pre-application submission meetings with industry.
  • FDA updated its MedWatch forms to standardize collection of demographic information on possible adverse events that occur after medical products are broadly available on the U.S. market.
  • And a few days ago, the Office of Women’s Health (OWH) posted their Research Roadmap and its strategic plan for women’s health research. OWH also funded two research projects:
    • Methods to improve data quality in demographic subgroups
    • Examination of sex-specific outcomes with cardiac resynchronization therapy.

Priority 2 – Participation

  • FDA is making demographic information from clinical trials more easily available to consumers through its easy-to-read online Drug Trials Snapshots webpage and a corresponding article for consumers.
  • The Office of Minority Health and the Institute of Medicine convened a Public Meeting to discuss minority health disparities and clinically meaningful differences.
  • FDA and The Johns Hopkins University co-sponsored a clinical trials workshop, Assessing Safety and Efficacy for a Diverse Population.

Priority 3 — Transparency

  • FDA established a Language Access Plan Working Group designed to implement communication strategies sensitive to the needs of under-represented subpopulations, focusing on language access and health literacy.
  • CBER launched a transparency pilot program to make demographic information available to physicians and the public for original Biologics License Applications.
  • CDRH modified templates for certain documents that are posted to the FDA website upon approval of certain medical devices to ensure that demographic information is consistently included.

We’ve certainly made progress, and will continue the forward momentum in the years to come. And we will need the continued investment of our stakeholders and partners.

We look forward to continuing this important and productive conversation with you next month at the public meeting.

Barbara D. Buch, M.D., is the Chair of the 907 Steering committee and the Associate Director for Medicine in FDA’s Center for Biologics Evaluation and Research

FDA 2015: A Look Back (and Ahead) – Part 2: Medical Product Safety and Oversight

By: Stephen M. Ostroff, M.D.

In my first look back on FDA’s 2015 accomplishments, I focused on our achievements in medical product innovation and our constant drive to make safe, effective and innovative products available. Because FDA’s responsibility covers the entire life cycle of products, in this second year-end blog post, I will review FDA’s impact on medical product safety and oversight.

Acting FDA Commissioner, Stephen Ostroff, M.D.Responding to Ebola

In a world where disease knows no borders FDA’s response to the Ebola epidemic in West Africa demonstrates how we use our scientific expertise and regulatory authorities to the fullest extent possible to address a tragic public health crisis of global impact. Our response involved collaborating with partners across government, pharmaceutical and diagnostic companies, international organizations like the World Health Organization, and our international regulatory counterparts. We played a key role in expediting the availability of diagnostic tests and investigational therapeutics and vaccines, as well as investigating fraudulent products marketed to diagnose, prevent and treat Ebola. And many FDA commissioned corps officers of the U.S. Public Health Service served on the front lines, deployed in a humanitarian mission to provide care to patients at the Monrovia Medical Unit in Liberia, one of the West African nations that were hard hit by the outbreak.

Addressing Transmission of Infections from Duodenoscopes

This year we took steps to help protect the public from the risk of transmitted infections, including antibiotic-resistant infections, from duodenoscopes. Duodenoscopes are complex devices used during endoscopic retrograde cholangiopancreatography (ERCP), a potentially life-saving procedure to diagnose and treat blockages in the pancreas and bile ducts. In the United States, duodenoscopes are used in more than 500,000 ERCP procedures each year.

Last February, the FDA issued a safety communication to raise awareness about the risk of transmitted infections from duodenoscopes, after it determined that the design of these devices may impede effective reprocessing, even when the manufacturer’s reprocessing instructions are followed correctly. Reports also indicated that some healthcare facilities may not have adequately followed the manufacturer’s reprocessing instructions. To address these concerns, the FDA has been working with the device manufacturers to ensure that the reprocessing instructions for their duodenoscopes are put through the most rigorous testing. The Agency held a public advisory committee meeting in May to discuss the scientific challenges, and it incorporated recommendations for enhancing the safety margin of reprocessing duodenoscopes into a safety communication in August. Also in August, FDA issued Warning Letters to all three duodenoscope manufacturers citing violations found during recent inspections. In October, the FDA ordered the manufacturers to develop postmarket surveillance studies of how the devices are reprocessed in real-world clinical settings.

Our foremost concern is protecting patients, and we are committed to taking steps to assure that duodenoscopes – and all reprocessed medical devices — are safe to use.

Compounding

We continue to respond effectively to the 2012 outbreak of fungal meningitis linked to contaminated compounded drugs. We are implementing the Drug Quality and Security Act and continuing our inspection and enforcement efforts at compounding facilities nationwide. To that end we have issued numerous policy documents regarding compounding and related activities to provide guidance to industry as we implement the new law. We’ve also held meetings with stakeholders, including pharmacy, physician, and consumer groups, and we have continued our active and successful collaborations with state governments.

Addressing the Opioid Abuse Crisis

Over the last year, we’ve been very focused on the growing epidemic of opioid abuse and addiction and its devastating impact on public health. This focus has required us to strike a delicate balance: ensuring medical treatments are available for patients who are in pain, while addressing the often tragic consequences of abuse and misuse, which all too often overwhelm individuals, families, friends and communities. Our approach is multi-pronged, from encouraging scientific investigation to improving the training of practitioners who prescribe these powerful medicines.

We believe it is vitally important to encourage the development of abuse-deterrent formulations of opioids and to support options for medication-assisted treatment of opioid-dependence. Final guidance for industry regarding the development of abuse-deterrent formulations was issued in April and several abuse-deterrent products have been approved. We are also making strides to treat the consequences of overdoses. In November, FDA approved the first nasal spray version of naloxone hydrochloride, to provide a route of delivery in addition to injection for this life-saving medication that can stop or reverse an opioid overdose. And we are working with our federal partners to improve access to naloxone.

While we cannot solve this complex problem alone, we remain committed to making the best use of our regulatory authorities and working with our partners both in and outside government to reduce the risks associated with opioids. To continue to achieve that, we have been engaging in a comprehensive review of our many current activities related to opioids and identifying which measures can and should be strengthened and what further measures are needed to address this crisis during 2016.

Ensuring the safety of the medical products we regulate requires us to manage a wide-range of issues across multiple scientific disciplines; and to employ scientists with the knowledge to solve today’s complex regulatory challenges. The last year brought many challenges, and just as many solutions.

In my final post, I will address some of our accomplishments in the area of food, tobacco product regulation, and antimicrobial resistance.

Stephen M. Ostroff, M.D., is Acting Commissioner of Food and Drugs

What We Mean When We Talk About Data

By: Robert M. Califf, M.D. and Rachel Sherman, M.D., M.P.H.

Robert Califf

Robert M. Califf, M.D., FDA’s Deputy Commissioner for Medical Products and Tobacco

Medical care and biomedical research are in the midst of a data revolution. Networked systems, electronic health records, electronic insurance claims databases, social media, patient registries, and smartphones and other personal devices together comprise an immense new set of sources for data about health and healthcare. In addition, these “real-world” sources can provide data about patients in the setting of their environments—whether at home or at work—and in the social context of their lives. Many researchers are eager to tap into these streams in order to provide more accurate and nuanced answers to questions about patient health and the safety and effectiveness of medical products—and to do so quickly, efficiently, and at a lower cost than has previously been possible.

But before we can realize the dramatic potential of the healthcare data revolution, a number of practical, logistical, and scientific challenges must be overcome. And one of the first that must be tackled is the issue of terminology.

Defining Terms

Although “data,” “information,” and “evidence” are often used as if they were interchangeable terms, they are not. Data are best understood as raw measurements of some thing or process. By themselves they are meaningless; only when we add critical context about what is being measured and how do they become information. That information can then be analyzed and combined to yield evidence, which in turn, can be used to guide decision-making. In other words, it’s not enough merely to have data, even very large amounts of it. What we need, ultimately, is evidence that can be applied to answering scientific and clinical questions.

So far, so good. But what do we mean when we talk about “real-world data” or “real-world evidence”?

Rachel Sherman

Rachel Sherman, M.D., M.P.H., FDA’s Associate Deputy Commissioner for Medical Products and Tobacco.

Clinical research often takes place in highly controlled settings that may not reflect the day-to-day realities of typical patient care or the life of a patient outside of the medical care system. Further, those who enroll in clinical trials are carefully selected according to criteria that may exclude many patients, especially those who have other diseases, are taking other drugs, or cannot travel to the investigation site. In other words, the data gathered from such studies may not actually depict the “real world” that many patients and care providers will experience—and this could lead to important limitations in our understanding of the effectiveness and safety of medical treatments. Clinicians and patients must be able to relate the results of clinical trials—studies that are done in controlled environments with certain patient populations excluded and which may therefore be challenging to generalize—to their own professional and personal experiences. It seems straightforward, then, to think that studies including a much fuller and more diverse range of individuals and clinical circumstances could ultimately lead to better scientific evidence for application to decisions about use of medical products and healthcare decisions.

But “real-world evidence” has its own issues that must be understood and dealt with carefully. First of all, the vague term “real-world” may imply a closer relationship with the truth—that the real-world measurement is preferable to one taken in a controlled environment. For example, is “real-world” blood pressure data gathered from an individual’s personal device or health app better (e.g., more reliable and accurate) than a blood pressure measurement from a doctor’s office? It could be, because a patient’s blood pressure might be uncharacteristically elevated during a visit to the physician. But at the same time, do we know enough about the data gathered from the patient’s personal device—how accurate is it? Is the patient taking their own blood pressure correctly? What other factors might be affecting it?—to use it for generating evidence? Already we are being reminded of the complexities of potentially relying on data that were gathered for purposes other than the ones for which they were originally intended.

In most cases “real-world evidence” is thought of as reflecting data already collected, i.e., epidemiologic or cohort data that researchers review and analyze retrospectively. Also of interest is whether randomized trials can be conducted in these “real-world” environments. In considering comparisons of treatments, one must always consider the possibility that the treatments were not assigned randomly, but reflected some relevant patient characteristic. This is, of course, the reason for doing randomized clinical trials.

Better Terms for Complex Subjects

There is little doubt that the new sources of data now being opened to researchers, clinicians, and patients hold enormous potential for improving the quality, safety, and efficiency of medical care. But as we work to understand both the promise and pitfalls of far-reaching technological changes, we need a more functional vocabulary for talking about these complex subjects, one that allows us to think about data, information, and evidence in ways that capture multiple dimensions of quality and fitness for purpose (e.g., for appropriate use in regulatory decision making). The incorporation of “real-world evidence”—that is, evidence derived from data gathered from actual patient experiences, in all their diversity— in many ways represents an important step toward a fundamentally better understanding of states of disease and health. As we begin to adapt “real-world data” into our processes for creating scientific evidence, and as we begin to recognize and effectively address their challenges, we are likely to find that the quality of the answers we receive will depend in large part on whether we can frame the questions in a meaningful way.

Robert M. Califf, M.D., is FDA’s Deputy Commissioner for Medical Products and Tobacco.

Rachel Sherman, M.D., M.P.H., is FDA’s Associate Deputy Commissioner for Medical Products and Tobacco.

Want to Help the FDA? Become a Consumer Representative on an FDA Advisory Committee

By: CAPT Dornette Spell-LeSane, M.S.N., M.H.A., A.N.P.-B.C.

Have you ever wanted to be part of the food and drug regulatory process? Do you have a history of public interest or a passion for consumer advocacy? Do you have experience analyzing scientific data?

Dornette Spell-LeSaneIf you answered “Yes,” here’s your opportunity to become an advocate for consumers! The Food and Drug Administration continually seeks input from consumers on scientific and medical issues by including Consumer Representatives on Agency advisory committees.

Participation as a Consumer Representative requires a modest time commitment. Travel expenses are paid and representatives receive reasonable compensation.

Consumer Representatives serve as Special Government Employees on a committee for up to a four-year term. Committees meet 1-3 times annually for 1-2 days. All meetings are held in the Washington, D.C. area. Members receive per-diem and travel expenses and are paid at a GS-15/10 hourly rate for the days attending a meeting.

Consumer Representatives provide the perspective of consumers to advisory committees and do not represent their own personal expertise. Their role is to:

  • Represent the consumer perspective on issues and actions before the advisory committee;
  • Serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and,
  • Facilitate dialogue with the advisory committees on scientific issues that affect consumers.

To apply you must:

(1) Be an active participant in independent consumer- or community-based organizations or have a history of advocating for the public’s interest; and

(2) Demonstrate an ability to analyze scientific data and critique research design.

FDA’s Consumer Representatives are grass-roots advocates, organizers, policy makers, or leaders of organizations with an interest in a specific subject matter. We encourage all meeting the criteria to apply.

Individuals applying to be a Consumer Representative may nominate themselves or be nominated by an organization. Applications for membership are reviewed and individuals are selected for final nomination by their peers. The Consumer Nominating Organizations, called CNOs, whose objectives are to promote, encourage, and contribute to the advancement of consumer education and to the resolution of consumer problems, receive ballots and rank the nominated candidates. The individual with the highest number of votes is forwarded for final nomination and generally will be the consumer representative for the committee.

FDA utilizes a total of 50 advisory committees and panels to provide independent advice to the agency on a range of complex scientific and policy issues, and they are an important part of the agency’s decision-making processes.

Here is a list of our current and upcoming vacancies on FDA advisory committees:

Medical Device Panels:

Anesthesiology and Respiratory Therapy

Circulatory System

Molecular and Clinical Genetics

Dental Products

Hematology & Pathology

General and Plastic Surgery

Neurological

General Hospital and Personal Use

Ophthalmic

Drugs Products Advisory Committees:

Dermatologic and Ophthalmic

Pharmaceutical Science & Clinical Pharmacology

Biological Products Advisory Committees:

Vaccines & Related Biological Products

Other:

Science Advisory Board to the Food and Drug Administration

Science Advisory Board to National Center for Toxicological Research (NCTR)

CAPT Dornette Spell-LeSane, M.S.N., M.H.A., A.N.P.-B.C., is Deputy Director of FDA’s Advisory Committee Oversight and Management Staff

FDA Invests in Innovative Ways to Communicate to Hispanics

By: Gloria Sánchez-Contreras, M.A.

En Español

National Hispanic Heritage Month–celebrated annually from September 15 to October 15—gives Americans a great opportunity to celebrate the histories, cultures, and contributions of Hispanic Americans whose roots are in Spain, Mexico, the Caribbean, and Central and South America.

Gloria Sanchez-ContrerasAt FDA, we join in this celebration as we continue to use innovative ways to reach Hispanics as part of our mission to protect the public health. To achieve this goal, FDA uses media strategies that are culturally and linguistically tailored to Hispanics, who, according to research, are avid users of online and social media.

There are 54 million people of Hispanic origin in the United States, making them the nation’s largest ethnic or racial minority group, with 17 percent of the nation’s total population, according to the U.S. Census Bureau. The United States has the second-largest population of Spanish-speaking residents in the world, ahead of Colombia and Spain, and second to Mexico, a recent study by the Instituto Cervantes shows.

These statistics cannot go unnoticed. FDA recognizes the importance of connecting with this growing and diverse segment of our population. Consequently, we have increased our online consumer information in Spanish and developed a variety of bilingual communications strategies to reach and engage all Hispanics.

One of the most important strategies we use is to make sure that messages created for Hispanics speak to them effectively. We consider Hispanics’ informational needs, lifestyles, and cultural health beliefs both when creating new messaging and when translating messaging from English to Spanish.

For example, we know Hispanics respond better when communications are in their primary language – which can be English or Spanish – and when communications use images that relate to them. We do this by employing a bilingual and bicultural team that reviews messaging for cultural competence and adapts translations to ensure they are culturally sensitive and in plain language.

In addition to our English-language communications, we have developed strategies to reach out to Spanish-speaking Hispanics online. Our Consumer Updates and drug safety communications are regularly translated into Spanish. We share Spanish-language information through our social media channels, including Twitter, Facebook, Pinterest, and YouTube.

In addition, we also have a complete Web section in Spanish for consumers (www.FDA.gov/ArticulosConsumidor), a press room (“Comunicados de Prensa”), and a central page (www.FDA.gov/Espanol) that links to a variety of Spanish-language content developed across the Agency’s product centers and offices.

These are exciting times, and it is a privilege to lead some of these efforts for our agency. The Office of External Affairs works diligently across FDA to share important and timely public health news with Latino consumers, stakeholders, media, and community organizations. And during Hispanic Heritage Month—and all the months of the year–we want Hispanics to know that FDA is a trusted source of consumer information.

Gloria Sanchez-Contreras, M.A., is a Bilingual Public Affairs Specialist and the Spanish-Language Communications Lead in FDA’s Office of Media Affairs.

National Preparedness Month: FDA and Access to Medical Countermeasures During Public Health Emergencies

By: Brooke Courtney, J.D., M.P.H.

Just weeks after witnessing the fall of the World Trade Center on Sept. 11, 2001, I was a student volunteer in a New York City hospital emergency department when several people arrived saying they had been exposed to anthrax.

Brooke CourtneyOne had even brought a small plastic bag holding white powder. Around this time, the media was reporting on letters mailed that were laced with white powder confirmed to be Bacillus anthracis, which causes anthrax.

At the hospital, we wondered whether we might become exposed to anthrax and how it could be prevented or treated. We quickly escorted the patients who had been exposed to white powder safely away from others to be examined by physicians.

Fortunately, our patients hadn’t been exposed to anthrax. But the letters contaminated with the agent tragically led to five deaths, and 17 more people became ill. Many others were treated with antibiotics as a precaution.

That year, 2001, was a turning point in our nation’s readiness for public health emergencies, including those that result from deliberate attacks or from natural causes like a disease outbreak. In particular, the U.S. government has invested substantially in medical products required for diagnosis, prevention or treatment of a wide range of threats, including anthrax. FDA is part of that national preparedness.

At FDA, we work to help ensure the availability of safe and effective medical countermeasures (MCMs). These are the medical products, including drugs, vaccines, and in vitro diagnostics (IVDs), to counter chemical, biological, radiological and nuclear (CBRN) threats, including emerging infectious diseases like Ebola.

In 2010, FDA launched an agency-wide effort, the Medical Countermeasures Initiative (MCMi), to advance and coordinate the challenging, ongoing MCM development and emergency use work that was occurring in FDA’s product centers and other offices and with other federal partners. Our most recent program update details many of FDA’s MCM achievements since that time, including important, exciting product approvals and regulatory science advances.

At the foundation of FDA’s MCM efforts is a legal and regulatory framework strengthened by Congress after 2001 with the enactment of several MCM-related laws. For example, FDA now has the authority:

  • When the Secretary of HHS declares that the circumstances justify such an authorization, to authorize the use of unapproved MCMs and unapproved uses of approved MCMs under Emergency Use Authorizations (EUAs) during or in preparation for an emergency, and,
  • For approved MCMs, to authorize emergency dispensing by stakeholders, waive certain manufacturing requirements, and extend the useful life of product held in state and local stockpiles.

As an example of our legal authorities in action, we’ve issued multiple EUAs to facilitate access to uncleared IVDs to support disease detection and diagnosis during the H1N1 influenza pandemic and for H7N9 influenza, Middle East Respiratory Syndrome coronavirus (MERS-CoV), and Ebola virus that emerged in West Africa in 2014.

Today, our nation is far more prepared than at the time of the anthrax attacks with flexible emergency legal authorities, critical MCMs stockpiled or under development, and enhanced knowledge about how to prevent or treat threats. But, as the recent Ebola epidemic and MERS outbreak show, threats both known and unknown continue to evolve or emerge and require our constant attention and vigilance.

September is National Preparedness Month. And while FDA and other agencies work hard every day to help prepare the nation for potential threats, everyone can be involved in disaster readiness. As we approach the end of Preparedness Month, here are a few things you can do now:

  • Become familiar with disasters that might occur where you live; plans for your community, workplace or school; and what HHS is doing. You can also download a variety of free disaster apps.
  • Make and test a family plan (e.g., communicating during an emergency).
  • Make an emergency kit of supplies, including medical products, you’ll need for at least three days.

Brooke Courtney, J.D., M.P.H., is Senior Regulatory Counsel in FDA’s Office of Counterterrorism and Emerging Threats.

Advancing precision medicine by enabling a collaborative informatics community

By: Taha A. Kass-Hout, M.D., M.S., and David Litwack, Ph.D.

FDA plays an integral role in President Obama’s Precision Medicine Initiative, which foresees the day when an individual’s medical care will be tailored in part based on their unique characteristics and genetic make-up. Yet while more than 80 million genetic variants have been found in the human genome, we don’t understand the role that most of these variants play in health or disease. Achieving the President’s vision requires working collaboratively to ensure the accuracy of genetic tests in detecting and interpreting genetic variants. We are working towards that goal by developing an informatics community and supporting platform we call precisionFDA.

Taha Kass-Hout

Taha A. Kass-Hout, M.D., M.S., FDA’s Chief Health Informatics Officer and Director of FDA’s Office of Health Informatics.

Sophisticated, relatively inexpensive technology known as next generation sequencing (NGS) already exists to sequence a person’s genome quickly. Developers and users of NGS tests must then comb these sequences to look for segments that suggest potentially meaningful differences and determine whether those differences provide useful and actionable information about the state of a person’s health, and their future risk of disease, behavior, or treatment choices.

Special features of this technology pose novel regulatory issues for FDA. Most diagnostic tests follow a one test-one disease paradigm that readily fits FDA’s current device review approaches for evaluating a test’s accuracy and clinical interpretation. Because NGS tests may be used in many ways in the clinic and can produce an unprecedented amount of data about a patient, we are working to evaluate whether a better option might simply be requiring each NGS test developer to show that the test meets certain standards for quality. Similarly, to demonstrate a test’s clinical value, we are assessing whether it may be more efficient for developers to refer to evidence in well-curated, validated, and shared databases of mutations instead of independently generating data to support a mutation-disease association.

David Litwack

David Litwack, Ph.D., Policy Advisor, Office of In Vitro Diagnostics and Radiological Health, at FDA’s Center for Devices and Radiological Health.

To begin to realize this new vision, precisionFDA is designed as a crowd-sourced, cloud-based platform to advance the science needed to develop the necessary standards. PrecisionFDA will supply an environment where the community can test, pilot, and validate new approaches. For example, NGS test developers, researchers, and other members of the community can share and cross-validate their tests or results against crowd-sourced reference material in precisionFDA.

Planned for beta release (work in progress) in December 2015, precisionFDA will offer community members access to secure and independent work areas where, at their discretion, their software code or data can either be kept private, or shared with the owner’s choice of collaborators, FDA, or the public. Initially, precisionFDA’s public space will offer a wiki and a set of open source or open access reference genomic data models and analysis tools developed and vetted by standards bodies, such as the National Institute of Standards and Technology (e.g., Genome in a Bottle). We believe precisionFDA will help us advance the science around the accuracy and reproducibility of NGS-based tests, and in doing so, will advance consumer safety. We look forward to continuing to update the community on the development of these new tools.

Taha A. Kass-Hout, M.D., M.S., is FDA’s Chief Health Informatics Officer and Director of FDA’s Office of Health Informatics.

David Litwack, Ph.D., is Policy Advisor, Office of In Vitro Diagnostics and Radiological Health, at FDA’s Center for Devices and Radiological Health.