Stroke Awareness Month: What’s New in Stroke Therapies?

By: Jovonni R. Spinner, M.P.H., C.H.E.S.

Stroke is the leading cause of severe disability, and the fifth leading cause of death for all Americans. The burden is worse in minority communities; minorities have higher stroke risks, strokes at an earlier age, and more severe strokes. For example, African-Americans are twice as likely to die from a stroke compared to Whites.

Jovonni SpinnerOften this is because people do not know the warning signs (e.g., sudden numbness, confusion, or loss of balance), or the risk factors that lead to stroke, like high blood pressure, diabetes, and an irregular heart rhythm (atrial fibrillation, or AF). Some minority groups also suffer disproportionately because of cultural and language barriers- which can lead to a delay in treatment or not seeking treatment at all.

Aspirin Therapy: Who should use it?

Although there is broad agreement about the benefits of aspirin in secondary prevention of stroke, (the use of aspirin in people who have already had a stroke) there has been debate in the scientific community about the benefits and risk of using aspirin for primary stroke prevention, i.e., in people without a prior stroke. The Food and Drug Administration has not recommended that use.

To help dispel myths and provide accurate information, we have issued consumer and provider friendly guidance on the appropriate use of aspirin therapy.

Here is the latest evidence on who should and should not use aspirin for stroke prevention.

Primary prevention: In patients who have never had a stroke, aspirin therapy can increase their risk for bleeding in the stomach and brain and a reduction in strokes with aspirin has not been established.

Secondary Prevention: In patients who have already had an ischemic stroke, which happens when a blood vessel that supplies blood to the brain becomes blocked by a blood clot; aspirin therapy has been shown to decrease the risk of having a subsequent event. In general, the benefits may outweigh the risks for these patients.

Aspirin is, of course, readily available in drug stores and grocery stores. Before using it, however, patients should discuss with their healthcare providers whether aspirin therapy is the right course of action for stroke prevention.

Drug Trials Snapshot: Savaysa

On another note, In January 2015, FDA approved Savaysa, a drug used to reduce the risk of stroke in patients with AF, a type of abnormal heart rhythm. This is a blood thinning medication similar to several other recently approved anti-coagulants and an older drug, warfarin. All of these drugs reduce the chance of stroke in patients with this condition by more than 50%. But note, that for patients with kidneys that work really well, Savaysa did not work as well as warfarin.

More than 21,000 people with AF participated in the Savaysa clinical trial.  Clinical trial data, which are made available from the “Drug Trials Snapshot”, showed a large stroke reduction and no meaningful differences by sex, race (Whites versus Asians), or age (greater than 75 years) for the drug’s performance or side effects (e.g., major bleeding), a finding that is also true for the other anti-coagulants. Other minority groups were under-represented in this trial, so data are not available for those groups.

The Drug Snapshot is part of FDA’s transparency initiative that displays the clinical trial data analyzed by subgroup (e.g., sex, race, and age). This is an important initiative because it provides information on clinical trial participation among varying groups.

Here at FDA, we strive to make data transparent and easily accessible to our stakeholders. The Office of Minority Health is leading FDA’s efforts to encourage diversity of participants in clinical trials and assess possible differences in effects among varying groups. We know that demographic subgroups (e.g., minorities, women) can respond differently to medications and clinical trial participants should reflect the populations that will most likely use these products.

Visit our website or follow us on Twitter to find out more information about our research programs, outreach, and communications.

www.fda.gov/minorityhealth

@FDAOMH

 Jovonni R. Spinner, M.O.H., C.H.E.S. is a Public Health Advisor in FDA’s Office of Minority Health

FDA Teams With National Forum to Reduce Deaths from Heart Disease: Program is first of its kind

By: Heidi C. Marchand, Pharm.D.

In the U.S., only about 1 in every 4 prescriptions is taken as directed by a health care provider – a problem that costs our nation more than 125,000 lives a year. Millions of Americans with heart disease – the nation’s No. 1 killer – are especially vulnerable.

Heidi MarchandTo stem that tide, FDA has teamed with the nonprofit National Forum for Heart Disease and Stroke Prevention to advance the cause of a heart-healthy and stroke-free society.

FDA’s Office of Health and Constituent Affairs has signed a Memorandum of Understanding with the National Forum to promote and increase the use of health knowledge, skills and practices by the public in their daily lives. The five-year agreement is a first-of-its-kind cooperative public education program to reduce the burdens of heart disease and stroke.

Heart disease, which kills 1 in 4 Americans, can be managed. To prevent heart attacks, transient ischemic attacks and other cardiac events, doctors prescribe medications and lifestyle therapies (e.g. heart-healthy diets). Because medication is not readily adhered to – and neither are lifestyle treatments – millions of people suffer from preventable cardiac episodes. As a nation, lack of medication adherence (which can be as simple as not getting a prescription filled or refilled) costs more than $100 billion annually in excess hospitalizations.

To confront this problem, FDA is taking the lead in support of Million Hearts®, a national initiative of the Department of Health and Human Services to prevent 1 million heart attacks and strokes by 2017. A key partner in that mission is the National Forum, whose members include more than 80 U.S. and international organizations representing public, private, health care, advocacy, academic, policy and community sectors.

Together we will:

  • Explore, demonstrate and evaluate innovative health promotion concepts.
  • Exchange information on nutrition, heart disease, and ways to increase the number of patients who take their medication and/or therapy.
  • Identify and systematize best practices in behavior modification education.
  • Develop concepts for community-based interventions.

Our goals are clear: create recommendations to improve compliance with prescribed medical therapies and implement the recommendations to improve the lives of patients living with heart disease.

FDA’s Dr. Helene Clayton-Jeter and Dr. Fortunato “Fred” Senatore are leading a diverse team in identifying strategies to help patients take their medicines as directed and follow the advice of their doctors.

Concurrently, the National Forum will recruit a Therapy Adherence Steering Committee, made up of experts and stakeholders from physician and nursing groups, pharmacy (retail/system), behavioral health, consumer/patient groups and others invested in complying with medical therapy.

We’ll then jointly develop action plans for high-probability, high-yield strategies to promote heart health by helping ensure that patients take their medicines and adopt healthier lifestyles. Our plan is to complete all steps in the next several years.

We cannot fix this problem overnight. But by addressing it strategically, we can move forward and improve the odds of preventing and surviving heart disease and stroke among Americans.

Heidi Marchand, PharmD, is Assistant Commissioner in FDA’s Office of Health and Constituent Affairs

FDA Celebrates 30 Years of Advancing Health Equity

By: Jonca Bull, M.D.

April is Minority Health Month! I am proud to say that FDA’s Office of Minority Health (OMH), in collaboration with  the Department of Health and Human Service’s Office of Minority Health, is celebrating this year’s theme: “30 Years of Advancing Health Equity, The Heckler Report: A Force for Ending Health Disparities in America.” For us at FDA, this year also marks the 5th anniversary of OMH, which serves as the principal advisor to the Commissioner on minority health and health disparities.

Jonca BullThe Heckler Report was a major, ground breaking document that transformed HHS’s views and actions on minority health. For the first time in history, representatives from each agency convened to talk about minority health and, more importantly, put forth recommendations to achieve health equity. Findings illustrated huge disparities between African Americans and other minorities compared to the population at large for key health indicators, such as life expectancy and infant mortality. Key recommendations relevant to FDA’s mission centered around health information and education, cooperative efforts (inside and outside of the government), health professions development, data development, and developing a research agenda.

Let’s stroll down memory lane and recap FDA’s activities that resulted from the Heckler report.

Health Information and Education 

FDA has developed numerous outreach activities to improve consumer education and access to health information by utilizing the best cultural and linguistic practices to reach diverse minority populations. Hosting symposiums and webinars, participating in conferences, exhibiting in health fairs, and creating consumer educational materials are just some of the activities FDA has carried out to raise awareness and educate the public. Most recently, OMH has created a social media presence on Twitter and Pinterest, and maintains an active listserve with a quarterly newsletter. One of our most successful outreach campaigns has been the “Heart Health Toolkit” for American Heart Month, which reached over 6,000 people in February.

Our most recent consumer outreach occurred on March 25th via a webinar on how the public can respond to requests for comments on regulatory proposals and public health issues by using FDA dockets.

Cooperative Efforts/Health Professions Development

OMH embraces the notion that protecting the public’s health cannot be done in isolation. We have focused on four areas to improve stakeholder relations:

  • Work with Industry to increase diversity in clinical trials;
  • Work with minority serving institutions and organizations to implement strategies and programs to improve regulatory science (specific to minorities);
  • Provide platforms for stakeholders to become informed and involved about our work; and,
  • Host and promote mentoring programs to encourage minorities to stay in scientific and academic careers.

Data Development and Research Agenda

We have a robust research agenda that focuses on advancing regulatory science related to eliminating health disparities. The agenda consists of various intramural and extramural grant programs, giving preference to minority-serving institutions. FDA also promotes and funds research that aims to increase the quantity, and improve the quality, of data on minorities, and to make these efforts transparent to the public.

In short: FDA has been and will continue to be committed to narrowing the health disparities gap. OMH will continue our legacy of creating culturally and linguistically tailored tools, materials, and resources for minority communities to increase their awareness and understanding of FDA’s mission and of the products that FDA regulates, increase their participation in clinical trials, and increase diversity in the workforce. This ensures better representation in the workforce, and most importantly: better health for all minorities!

More information about specific programs can be found on our website.

The Heckler Report can be found at: http://collections.nlm.nih.gov/catalog/nlm:nlmuid-8602912-mvset.

Jonca Bull, M.D., is Director of FDA’s Office of Minority Health

Turning the Tide on Ebola

By: Calvin W. Edwards, CAPT, U.S. Public Health Service Commissioned Corps

Before accepting their agreements to work in Liberia in a mobile hospital for Ebola patients, I emailed each of the 68 Commissioned Corps officers of the U.S. Public Health Service that they would face danger, needed to accept certain risks, and that they would have to perform under extremely austere conditions.

Capt. Edwards

Calvin W. Edwards, CAPT, U.S. Public Health Service Commissioned Corps

Turns out, if anything, I may have underestimated the hardship.

Initially we lived 12 to a room in two-bedroom cabanas that were intended for four people and had ”septic” issues (sewage backups and overflowing toilets) to boot. We ate MRE’s (Meals Ready to Eat) intended for troops in combat. Six weeks into the two-month deployment, we were moved into tents next to the mobile hospital, about 20 officers per tent.

We worked 12-hour shifts in 90 degree heat and 90 percent humidity, often wearing head-to-toe heavy layers of plastic gear that left us soaked in sweat within minutes. A single slip in protocol could expose us to a deadly virus as we worked with vomiting patients who could defecate up to three gallons of diarrhea a day and could quickly dehydrate.

The Payoff

But when the first patient emerged with a clean bill of health, the hardships were forgotten.

A Liberian physician’s assistant, a man in his 30s, was the first to walk out with a certificate documenting that two tests showed him to be virus-free.

Ebola Survivor

U.S. Public Health Service officers celebrate as a Liberian man adds his handprint to a “survivors wall.” Each patient who overcame Ebola after treatment at the USPHS mobile hospital outside Monrovia was given a set of clothes and essentials and invited to mark their recovery with a handprint.

His family arrived like a chorus, singing, praising God, thanking America, jubilantly crying, and shouting, “He lived!”

This ex-patient became the first person to dip his hand in yellow paint and make an imprint on our “survivors’ wall.” Although total numbers have not yet been released, there were more handprints to come, and more patients survived than died.

Each patient who walked out confirmed that we were correct deciding to cross an ocean to help stop the spread of Ebola. To see a once desperately sick person recover and go home, knowing we had a part in that, was more satisfying than I can describe.

We were the first group of Public Health Service officers to move to the tents that were set up as a hospital in Liberia. Our group, which I commanded, included 24 women and 45 men. I had three weeks’ notice before flying out; some in our group had as little as five days to decide and be deployed.

Since our return, two more groups of Public Health Service officers have been deployed to the hospital built in a remote area about 1.5 hours from downtown Monrovia. The final group is still there.

The Mission

Our mission was to treat health care workers who contracted the Ebola virus. Before our arrival health care workers were leaving in droves, and the volunteer pool was drying up. The creation of our treatment facility helped turn the tide.

Liberia Compound

An aerial photo shows the mobile medical compound where Public Health Service Officers treat health care workers who contract Ebola.

The Liberian Ministry of Health told us that some health care workers were waiting until we had set up the facility before agreeing to come to Liberia. The fact we had a small part in increasing the pool of workers treating desperate patients was awesome. How often in our lives do we get a chance to do something so big?

On the other hand, one of our greatest stresses was how little we could do to help defeat the virus. Often the most we could do was keep people clean and hydrated while hoping their bodies would develop antibodies.

It was especially hard emotionally when we lost a patient at night. Because Ebola patients are most infective right after they succumb to the disease, we could not risk moving them over the dimly-lighted pathway to the morgue.

The Public Health Service officers were the only people working in the hospital. They performed every job, even those most unpleasant, and did it regardless of rank, exalted skills, or letters after their names. Yet all came away happy about the role they played.

For my part, I am both humbled and intensely proud of these men and women — of their skills, dedication, selflessness, ruggedness and resiliency. I wish all Americans could share some measure of my joy.

CAPT Edwards is a Public Health Service officer who serves in FDA’s Office of Regulatory Affairs. The U.S. Public Health Service Commissioned Corps is made up of 6,500 public health professionals who provide leadership and clinical service roles within the federal government agencies to which they are assigned.

Rare Diseases at FDA: A Successful Year for Orphan Products

By: Gayatri R. Rao, M.D., J.D.

2014 was a strong year for rare disease product development at FDA. It was also a year of significant firsts.

Dr. Gayatri RaoIn recognition of Rare Disease Day, February 28th, we want to reflect on the progress we have made thus far as we renew our commitment to rare disease patients. A rare disease is generally defined as a disease which affects fewer than 200,000 Americans a year. At FDA, the commitment to increase access to diagnostics and treatments to change the day-to-day reality of those living with rare diseases began over 30 years ago with the passage of the Orphan Drug Act.That commitment has steadily increased since then.

In 2014, we received our highest number to date of new requests for orphan drug designation. We received over 440 requests while just 7 years ago, we received less than half of that. We designated and approved more orphan drugs in 2014 than we had in previous years – nearly 300 drugs were designated and 48 were approved, including both novel and repurposed drugs. In 2014, 41% of all novel new drugs approved by the Center for Drug Evaluation and Research were for the treatment of rare diseases. Many of these orphan drug approvals were new and innovative, including Sylvant, to treat Castleman’s disease, which results in excessive lymph node growth, and Impavido, to treat forms of the tropical disease, leishmaniasis.

2014 was also a year of firsts for rare disease product development:

There were firsts in device development. For example, the Center for Biologics Evaluation and Research approved its first device through the Humanitarian Device Exemption (HDE) pathway. This device, CliniMACS CD34 Reagent System, helps to mitigate potentially serious immune reactions associated with stem cell transplantation in patients with acute myeloid leukemia.

FDA produced in 2014 its first agency-wide blueprint to accelerate the development of therapies for pediatric rare diseases – a report and strategic plan outlining how to address issues for developing products for this population.

2014 saw the issuance of the first rare pediatric disease priority review voucher for the treatment of mucopolysaccharidosis type IVA (Morquio A syndrome), a rare lysosomal storage disease which affects about 1000 patients in the United States and can lead to debilitating and life-threatening abnormalities of bones, joints and the heart.

In recognition of Rare Disease Day 2015, the international rare disease community is coming together to pay tribute to the millions of individuals impacted by rare diseases all over the world. Through the solidarity and commitment of many stakeholders – patients and families, healthcare professionals, researchers, companies, and policy makers – the awareness of the daily challenges that are unique to each rare disease and the efforts to create solutions has risen exponentially in the past several decades. As members of the rare disease community, we are proud of our collective accomplishments but remain acutely aware of how much more there is still to be done. Given how 2015 is already shaping up, we expect that by working together, we will continue to make great strides in developing much needed products for the millions of patients living with rare diseases.

Gayatri R. Rao, M.D., J.D., is FDA’s Director for The Office of Orphan Products Development

Shedding some light on FDA’s review of sunscreen ingredients and the Sunscreen Innovation Act

By: Theresa M. Michele, M.D.

With recent record snowfalls in many parts of the country, the use of sunscreens may not have been on many people’s minds. But here at FDA, sunscreens have been a front-and-center issue.

Theresa Michele, M.D.On November 26, 2014, Congress enacted the Sunscreen Innovation Act (SIA) that provides a new process for the review of safety and effectiveness of nonprescription sunscreen active ingredients. Among other things, the SIA creates timelines for FDA review.

Before the law was enacted we followed the regulatory process known as the Time and Extent Applications process, or TEA process for sunscreen active ingredients. This regulatory process provides, among other things, a mechanism for sponsors to request that FDA evaluate active ingredients that are used in over-the-counter (OTC) drug products, particularly those marketed in other countries. The TEA process can be summarized in two basic steps. Step 1 is FDA’s determination of eligibility, made upon a showing that the ingredient has been marketed over-the-counter in one or more countries for a material time and extent. Step 2 is FDA’s evaluation of the data to determine whether the ingredient is generally recognized as safe and effective (GRASE) for its intended use in an OTC drug product as described in the relevant regulation. If, after review of the data, FDA ultimately finds the ingredient to be GRASE for its intended OTC use, the ingredient may enter the U.S. marketplace. There were eight TEAs for sunscreen ingredients submitted to FDA before the SIA went into effect.

On January 7, we met the first requirement of the SIA. In doing so, we announced our tentative determinations that six of these ingredients are not GRASE for use in sunscreens because we need more data from the manufacturers to help establish the safety and effectiveness of these products.

Today, we completed another requirement by taking initial action on the last two pending ingredients, ecamsule and enzacamene. We tentatively determined, as we had with the other six ingredients, that we need more data to decide if these ingredients are, in fact, GRASE for use in OTC sunscreen products. Information about the SIA and our recent actions under the law are available on our new web page for this topic.

At this time there is not enough generally available data to determine whether any of the ingredients under review meet FDA’s safety and effectiveness standards.

We know our careful actions to seek more information may be disappointing to some who would like to see additional sunscreen products on the market immediately, but I’d like to take this opportunity to clarify some misconceptions about the SIA and the process for making sunscreen ingredients available for use in OTC products marketed without individual premarket review in the U.S.:

  • The law does not change FDA’s standard for general recognition of safety and effectiveness. The SIA requires strict deadlines for FDA to take action on these ingredients, but it does not relax the FDA’s scientific standards for evaluating the ingredient’s safety and effectiveness, or our need for adequate data on which to base such determinations.
  • The law does not provide FDA with additional resources. Recognizing the public health importance of sunscreen use, the FDA is proceeding as quickly as practicable to meet the requirements of the legislation. To assist in this process and to reduce the negative impact on other work, FDA is requesting funds for implementation of the SIA as part of the President’s fiscal year (FY) 2016 budget.
  • The SIA does not guarantee that products with additional sunscreen ingredients will be on the market in a specified timeframe. Because additional data are needed for each of the eight sunscreen ingredients, timelines for FDA actions are triggered by industry’s submission of required data.
  • There is apparent confusion as to why ingredients that have been on the market for years in other countries cannot be used in the U.S. without further review by FDA. While information on marketing history in other countries is helpful, what we can learn from it is limited. For example, such information doesn’t tell us anything about the long-term effects from use of the ingredient or how much is absorbed. Because of the widespread daily use of sunscreen products by a broad population, including babies and pregnant women, FDA has proposed data requirements that will allow us to determine that sunscreen ingredients are generally recognized as safe and effective. These data requirements were unanimously supported by a panel of scientific experts at a recent public Advisory Committee meeting on sunscreens.

We cannot achieve success in bringing additional sunscreens to market on our own. FDA is committed to doing our best to meet the new statutory deadlines, and we will be transparent in our process and progress. Successful implementation of the SIA will require a cooperative effort with industry and other stakeholders. We look forward to continuing this important work.

Theresa M. Michele, M.D., is the Director of the Division of Nonprescription Drug Products in FDA’s Center for Drug Evaluation and Research’s Office of New Drugs

The Meaning of Wearing Red

By: Margaret A. Hamburg, M.D.

Last night I had the pleasure of attending the annual Woman’s Day Red Dress awards ceremony in New York City. The event is one of the highlights of American Heart Month, and it was created by that magazine to educate Americans about, and help fight, heart disease, which has become the number one killer of women. Many are surprised to learn that while breast cancer is the cause of death of one in every 31 American women, one of every three women dies of heart disease. So I found it particularly meaningful, both as a doctor and a woman, to be honored for FDA’s work to improve women’s cardiovascular health.

Commissioner Hamburg at Event

FDA Commissioner Margaret A. Hamburg, M.D., at the Woman’s Day Red Dress awards ceremony in New York City

One of our efforts toward this end that was cited by the magazine was the proposal to update the Nutrition Facts Label. The proposed updates would more prominently highlight calorie and serving size information, inform consumers about “added sugars,” update the daily values for nutrients, and ensure that the serving size requirements reflect the amounts of food people actually consume. They would encourage consumers to use the label to take note of foods high in sodium, saturated fat, and trans fat, which can increase the risk of coronary heart disease.

We also published final rules on restaurant menu and vending machine labeling. Calorie information is the key component of these requirements, and obesity is associated with a range of heart disease related problems. The new rules also require that other nutrition information, such as sodium, is provided upon the consumer’s request. High sodium intake can increase blood pressure, a major risk factor for heart disease. As with the nutrition facts label, these menu labeling requirements will give consumers nutrition information they need to be able to make healthy food choices for themselves and their families.

Another part of FDA that matters for cardiovascular health is our Center for Tobacco Products. Though its work is designed to protect the health of all Americans, it has special significance for women who, sadly, are catching up to men in the prevalence of tobacco-related diseases.

In the last 50 years, a woman’s risk of dying from smoking has more than tripled, and is now equal to that for men – not what we desire when we talk about equality. The more than 20 million women in the U.S. who smoke cigarettes are at risk not just for heart attacks, lung cancer, and strokes, but also emphysema and other serious chronic illnesses such as diabetes.

Our actions on smoking and nutrition have been complemented by the work of the Office of Women’s Health. Its outreach initiatives have helped provide women with tips and resources they can use to make better heart health decisions for themselves and their families. This Office has also supported research on treatment of heart disease in women.

FDA’s responsibilities also include reviewing, approving, and helping advance new and innovative medical products to diagnose, treat and prevent heart disease, including life-saving medical devices such as artificial hearts, stents, and heart valves, essential tests like echocardiograms, and important drugs for hypertension, lowering cholesterol and treating other aspects of cardiovascular disease.

Over the years, FDA’s support of women’s health has grown thanks to scientific advances, changes in society, and improvements in the agency itself. We will continue to promote these goals, not just in the area of cardiovascular health, but in women’s health more generally.

Of course, we can’t do it alone. And that’s why I sincerely welcome such events as the National Wear Red Day and Woman’s Day’s Red Dress awards. They help focus our nation’s attention and energy on the fight against women’s heart disease to which we, at FDA, are fully committed.

Margaret A. Hamburg, M.D., is the Commissioner of Food and Drugs

Measles Vaccine Is Safe and Effective – And Should Be Used

By: Margaret A. Hamburg, M.D.

In recent weeks we’ve seen an alarming outbreak of measles; a highly contagious and serious virus, especially in babies and young children who have not been vaccinated. This outbreak is particularly disturbing because measles was effectively eliminated from the United States in 2000 thanks to nearly universal vaccination, the single best way to prevent the spread of this disease.

Margaret Hamburg, M.D.Vaccination works with the body’s natural defenses to help it safely develop immunity to the measles. When more people are vaccinated, there are fewer opportunities for the disease to spread. A community generally needs more than ninety per cent of its members to be immunized against the virus in order to protect those who can’t be.

Today, there are two safe and effective FDA-approved vaccines. More than 95% of the people who receive a single dose will develop immunity. And a second dose conveys immunity to nearly everyone who did not respond to the first dose. Simply put, these vaccines are safe and effective, and serious side effects are rare.

Before the first measles vaccine was approved in 1963, hundreds died from the disease each year. Others developed pneumonia, lifelong brain damage or deafness.

Let’s not return to these grim statistics. There is no shortage of measles vaccine. It should be used by everyone who has not been vaccinated to prevent measles and the potentially tragic consequences of the disease.

Margaret A. Hamburg, M.D., is the Commissioner of Food and Drugs

Technology Transfer—Transforming Food Safety with the GenomeTrakr Collaboration

By: Alice Welch

In my last blog post I discussed how FDA’s Technology Transfer program helps drive innovation by building collaborations that can solve today’s public health challenges using leading-edge science. This blog post describes one of those FDA collaborations—a pathogen detection network that is transforming food safety.

Alice WelchAccording to the Centers for Disease Control and Prevention (CDC), foodborne disease outbreaks are responsible for about 48 million illnesses, 325,000 hospitalizations, and 3,000 deaths every year in the United States. The annual toll for Salmonella poisoning alone in this country is 1 million illnesses, 19,000 hospitalizations, and nearly 400 deaths. As the world becomes even more interconnected, FDA has recognized the urgency of creating new approaches and better tools to detect food contamination and stop outbreaks in their tracks.

The FDA-established GenomeTrakr is an innovative response to this global public health challenge. Using a cutting-edge technology called Whole Genome Sequencing (WGS), FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Regulatory Affairs (ORA) are collaborating with federal and state public health laboratories to build a publicly accessible genomic database called GenomeTrakr. GenomeTrakr enables us to compare some of the bacterial pathogens that cause foodborne diseases and trace them back to their sources faster and more precisely than traditional methods.

WGS is a laboratory process that identifies the complete DNA sequence of an organism’s genetic material at a single time. The process is being used together with GenomeTrakr to identify pathogens isolated from food or environmental samples and compare them to pathogens isolated from sick patients. If the isolates from food or environmental samples match the pathogens taken from the sick patients, scientists can establish a reliable link that helps characterize the size and location of the foodborne disease outbreak. It can even help public health officials determine which ingredient in a multi-ingredient food is causing the outbreak—so that we can get contaminated food out of the food supply. Used by epidemiologists in combination with traditional methods, WGS is advancing our understanding of contaminations in the food supply.

Pathogens evolve very quickly and have thousands of genetic variations. After spending time in a particular geographic location, a pathogen like Salmonella begins to acquire unique genetic signatures that identify it as coming from that location. Until recently, some strains of Salmonella have looked much the same to us, no matter where we found them, because some of the older methods of testing have been unable to distinguish between certain strains of pathogens. But WGS can detect unique signatures within and between species with far greater precision than previous methods, which makes it one of our biggest secret weapons in tackling foodborne illness outbreaks.

FDA scientists and our collaborators in federal and state public health laboratories are using WGS and the GenomeTrakr database to identify those unique signatures. The signatures can often tell us, for example, if a Salmonella that has contaminated a certain part of the food supply is from the U.S. West Coast, New England, or even Germany. FDA and state lab scientists upload the entire genome sequence for a pathogen into the GenomeTrakr database at the National Center for Biotechnology Information, where it’s available for further use. As the database continues to grow, it’s becoming an increasingly powerful tool to help investigations home in faster on the root causes of outbreaks and track their location.

The potential of technologies like WGS to enhance food safety could not be realized without the development of a powerful database like GenomeTrakr. But to build that kind of database FDA needed to form a web of collaborations. Enter FDA’s Technology Transfer team. It plays a critical role in working with our researchers to create the successful relationships that make huge databases like GenomeTrakr work.

To achieve CFSAN’s vision, FDA’s Technology Transfer team worked with CFSAN researchers to create agreements tailored to the project’s needs. The team drafted collaboration agreements that included provisions for establishing relationships between FDA and state laboratories to perform WGS and upload genome sequences into GenomeTrakr. Once CFSAN’s project concept and goals were established, Technology Transfer experts negotiated and put agreements in place so FDA could begin linking federal and state partners to advance the use of WGS across public health.

Since the first state public health lab collaboration was established in February 2012, FDA, along with other international, federal, and state laboratories have added genome sequences for more than 11,000 isolates to the GenomeTrakr database, and we are already seeing impressive results! In early 2014, through a partnership with CDC, FDA and state department of health laboratories used GenomeTrakr to match environmental and food samples with human biological samples, which helped FDA confirm the source of Listeria in an outbreak.

This collaboration is just one of many that our Technology Transfer team has helped create to support FDA efforts to speed innovation in public health. Stay tuned for my next post, where I’ll discuss an FDA invention that is preventing hundreds of thousands of Africans from contracting the debilitating disease of Meningitis.

Learn more:  Whole Genome Sequencing: The Future of Food Safety

HHS Innovates Award Paves Way for the Future of Food Safety and PulseNet

Alice Welch, Ph.D., is Director of FDA’s Technology Transfer Program

FDA’s FY 2016 Budget Request

By: Margaret A. Hamburg, M.D.

Margaret Hamburg, M.D.FDA oversees products that represent more than 20 cents of every dollar that American consumers spend. Today, FDA presented its FY 2016 budget to Congress.This sensible budget request will help ensure that FDA can continue to fulfill its vast responsibilities to protect the public health, safety, and quality of life of the American public.

I want to share the cover letter that I wrote to Congress outlining some of our specific proposals.

 

Letter from the Commissioner

I am pleased to present the FY 2016 Food and Drug Administration (FDA) Budget.

FDA fulfills its important mission to promote and protect health in an increasingly complex and globalized world in many ways.  The scope of our work includes assuring that foods are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, vaccines and other biological products, and medical devices intended for human use are safe and effective; and regulating tobacco products.  We also play a lead role in protecting the public from electronic product radiation and assuring that cosmetics and dietary supplements are safe and properly labeled.  Finally, we have devoted – and will continue to devote – substantial resources to advancing the public health by helping to speed product innovations.

FDA’s responsibilities continue to expand as we work to fulfill the mandates of groundbreaking legislation passed in recent years, including the Family Smoking Prevention and Tobacco Control Act of 2009, the Patient Protection and Affordable Care Act of 2010, the Food Safety Modernization Act (FSMA) of 2011, the FDA Safety and Innovation Act (FDASIA) of 2012, and the Drug Quality and Security Act of 2013.  Further, with so many FDA-regulated products manufactured in whole or in part outside of our borders, FDA is keenly focused on the complexities of regulating in a global marketplace.

In FY 2014, we took important steps to finalize a key set of proposed food safety rules; worked to improve the safety of compounded pharmaceutical products by conducting more than 90 inspections and implementing compounding legislation through proposed regulations, guidances, and other actions; published the “deeming rule” to extend FDA’s tobacco authority; and collaborated with federal, international, and industry partners to expedite the development and availability of medical products.  In addition, FDA has worked intensively to respond to the Ebola epidemic in West Africa by facilitating the development and availability of investigational diagnostics, therapeutics, and vaccines with the potential to help combat the epidemic.

FDA continues to seek new ways to obtain the most public health value for the federal dollar as we implement expanded authorities.  The products that FDA regulates are essential to public health, safety, and quality of life and represent over 20 cents of every consumer dollar spent on products in the United States.  Yet, in terms of our FDA budget, each American taxpayer contributes approximately $8 per year for the vast array of protections and services provided by FDA.

In FY 2016, we are requesting essential and timely resources to address critical food and medical product safety issues.  Mindful of the fiscal environment, we have identified targeted reductions where possible and identified long-term needs for additional user fees to balance budget authority growth.  FDA is requesting a total of $4.9 billion to support our various mandates to protect the American people.  This includes a $148 million budget authority increase to focus on the following:

  • delivering a farm-to-table system of prevention, including improved oversight of imported foods, through effectively implementing the final rules required by FSMA;
  • combating the growing threat of antibiotic resistance – in which drugs become less effective, or ineffective, against harmful bacteria;
  • promoting the development and appropriate use of reliable molecular and genetic diagnostics – precision medicine tools – to “personalize” the diagnosis, treatment, and prevention of disease;
  • implementing key FDASIA requirements to improve medical product review and inspections;
  • addressing the safety of compounded drugs;
  • continuing implementation of new requirements for review of sunscreen ingredients under the Sunscreen Innovation Act; and
  • supporting modern facilities to provide the laboratories and office space needed to meet FDA’s expanded legislative mandates.

As a science-based regulatory agency with a public health mission, FDA plays a unique and essential role in promoting and protecting public health and safety.  We are committed to meeting the needs and expectations of the American people.

Margaret A. Hamburg, M.D.

Commissioner of Food and Drugs