FDA Invites Patient Organizations to Take a Place at the Podium

By: Theresa M. Mullin, Ph.D.

Sometimes, the most valuable thing we can do as regulators at FDA is simply to listen. I’m reminded of that each time we hold a public meeting as part of the Patient-Focused Drug Development (PFDD) program.

Theresa MullinWe began PFDD to more systematically obtain the patient perspective on certain diseases and their treatments. The effort is part of an FDA commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V).

Each public meeting is focused on a specific disease area. Our commitment is to gain perspectives on at least 20 disease areas by the end of FY 2016. And having already held 17 meetings to hear from patients with diseases as varied as breast cancer, fibromyalgia and sickle cell disease, we are well on our way.

What have we learned so far? For one, thanks to PFDD we now have even more first-hand knowledge from those most affected by the diseases. We have heard directly from patients, their families, and care givers about the symptoms that matter most to them; the impact the disease has on patients’ daily lives; and their experiences with currently available treatments. For example, we’ve learned that for diseases that are progressive and severely disabling, patients and their families may consider an “ideal” treatment to be one that at minimum can halt disease progression.

These perspectives are critical to helping us understand the context in which we are making regulatory decisions for new drugs. And they’ll have ramifications for years to come. We believe that the long-term impact of PFDD will be better, more informed FDA decisions and oversight both during drug development and during our review of a marketing application.

Expanding the Benefits of the PFDD Meeting Model

This is a priority for FDA. To that end, we’ve committed to hold meetings for at least 20 disease areas, and are currently planning to hold 24 different disease-focused meetings by the end of FY2017, exceeding our commitment. We recognize, however, that there are many more disease areas than can be addressed in the planned FDA meetings where drug development and regulatory decision making would benefit from a meeting focused on obtaining the patient’s perspective.

To help expand the benefits of FDA’s PFDD initiative, FDA invites the independent efforts of patient organizations to identify and organize externally-led patient-focused collaborations to generate public input on other disease areas, using the process established through Patient-Focused Drug Development as a model. Given the tremendous number of diseases affecting the U.S. patient population and the effort required to conduct a successful PFDD meeting, externally led PFDD meetings should target disease areas where there is an identified need for patient input on topics related to drug development.

We recommend that patient organizations interested in conducting an externally-led PFDD meeting submit a letter of intent so that we are aware of their plans. Submission details and more information on considerations to take into account are outlined on FDA’s website.

Please note that an externally led PFDD meeting and any resulting products, such as surveys or reports, will not be considered FDA-sponsored or FDA-endorsed. And while we can’t guarantee FDA’s specific involvement at every meeting, FDA will be open to participating in a well-designed and well-conducted meeting.

And as the number of patient-focused forums continues to grow, we at FDA will continue to listen and look forward to gaining the additional insights that only patients, their families, and care givers can provide.

Theresa M. Mullin, Ph.D., is Director of FDA’s Office of Strategic Programs in the Center for Drug Evaluation and Research

FDA Enforcement: Protecting Consumers and Enhancing Public Confidence

By: Howard Sklamberg, J.D. and Michael R. Taylor, J.D.

Under the Federal Food, Drug, and Cosmetic Act, companies producing food, including dietary supplement products, for American consumers have a legal responsibility to make them safe. Most companies take this responsibility seriously. FDA will work collaboratively with companies that are making a good faith effort to produce safe products and meet regulatory requirements.

Howard Sklamberg

Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

But when companies fail to meet their responsibility and violate the law in a way that jeopardizes public health, FDA can—and will—move decisively. This fall, for example, a federal court case in New Jersey illustrates the careful field work, close teamwork, and skillful investigation that are hallmarks of FDA criminal enforcement, which plays a vital role in food and dietary supplement safety.

The case involves Raw Deal, Inc., a manufacturer of dietary supplements based in Flanders, N.J. On September 9, Raw Deal’s owner and president, Barry Steinlight, pled guilty to one count of conspiracy to commit wire fraud involving a scheme to introduce adulterated and misbranded products into interstate commerce. Steinlight was sentenced to 40 months in prison and ordered to forfeit $1 million in profits from the fraudulent scheme.

Then, today the company’s former executive vice president, Catherine Palmer, was sentenced to a year’s probation and a criminal forfeiture of $100,000, after she pled guilty to obstructing an FDA investigation.

Last year, we wrote about federal-court convictions in the Peanut Corporation of America (PCA) case involving Salmonella-tainted peanuts and peanut products. In that case, two former officials of, and one broker for, PCA were prosecuted for practices that led to a deadly 46-state outbreak of Salmonella poisoning in 2009.

Michael R. Taylor

Michael R. Taylor, J.D., FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Today, we are highlighting the Raw Deal prosecution, which demonstrates our enforcement work in the dietary supplement field. The convictions arose from illegal practices by the firm, which included manufacturing adulterated and misbranded products by using fillers to cut costs, reusing returned and contaminated products, and falsifying batch records and certificates of analysis.

This story begins more than four years ago. Over the course of those years, FDA undertook a number of enforcement activities before criminal charges were filed by the U.S. Department of Justice:

  • In August 2011, FDA’s Office of Criminal Investigations (OCI), now headed by Director George Karavetsos, received an anonymous complaint that Raw Deal was manufacturing dietary supplements with fillers such as wheat-based products and the food additive Maltodextrin. The complainant also informed OCI that the manufacturer resold returned products that contained such contaminants as E. coli bacteria, lead and mold.
  • During the OCI investigation, FDA’s Office of Regulatory Affairs’ New Jersey District Office received four anonymous letters that described Raw Deal’s adulteration scheme, including the creation of false certificates of analysis.
  • The District Office conducted a compliance inspection and found that the manufacturer substituted ingredients without informing customers of the presence of fillers. As a result, the District Office issued Raw Deal a Warning Letter citing misbranding and adulteration violations.
  • OCI later determined that Raw Deal did not heed this warning and instead continued misbranding and adulterating its products. OCI then obtained and executed a search warrant at the manufacturing facility, with some of the samples collected subsequently revealing the presence of Salmonella, a bacterium frequently associated with foodborne illnesses.
  • This resulted in a Class I recall of certain Raw Deal products in March 2014. This recall classification means the products could cause serious health problems or death.

This case is just one example of FDA enforcement in action. Companies are given the opportunity to correct violations but if they don’t, there are serious consequences. Indeed, during the past two years, FDA criminal enforcement has resulted in 407 cases opened, 348 arrests, 305 convictions, and $694,131,579 in fines and restitutions.

Of note in this case is an excerpt from U.S District Court Judge Esther Salas’ remarks at Steinlight’s sentencing hearing:

“There is nothing more sacred than consumers having some peace of mind that people who are selling these supplements are doing it the right way, and are abiding by the laws and regulations that are put forth to protect the consumer…and my sentence has to be one that promotes respect for the law. Because what the FDA does is so critical…they are making sure that the products that we consume and the products that we use are safe for consumption, are safe for usage. And I am going to sentence you to a sentence, sir, that continues to give them the teeth they need, the power they need, to send a message to our society.”

Criminal enforcement actions protect consumers by punishing violators and deterring bad behavior by others. Strong enforcement helps industry too – by maintaining a level playing field for the production of safe foods and products.

FDA is strongly committed to working with companies that take their safety responsibilities seriously – and equally committed to dealing strongly with those that don’t.

Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Michael R. Taylor, J.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

FDA Launches precisionFDA to Harness the Power of Scientific Collaboration

By: Taha A. Kass-Hout, M.D., M.S. and Elaine Johanson

Imagine a world where doctors have at their fingertips the information that allows them to individualize a diagnosis, treatment or even a cure for a person based on their genes. That’s what President Obama envisioned when he announced his Precision Medicine Initiative earlier this year. Today, with the launch of FDA’s precisionFDA web platform, we’re a step closer to achieving that vision.

Taha Kass-Hout

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

precisionFDA is an online, cloud-based, portal that will allow scientists from industry, academia, government and other partners to come together to foster innovation and develop the science behind a method of “reading” DNA known as next-generation sequencing (or NGS). Next Generation Sequencing allows scientists to compile a vast amount of data on a person’s exact order or sequence of DNA. Recognizing that each person’s DNA is slightly different, scientists can look for meaningful differences in DNA that can be used to suggest a person’s risk of disease, possible response to treatment and assess their current state of health. Ultimately, what we learn about these differences could be used to design a treatment tailored to a specific individual.

The precisionFDA platform is a part of this larger effort and through its use we want to help scientists work toward the most accurate and meaningful discoveries. precisionFDA users will have access to a number of important tools to help them do this. These tools include reference genomes, such as “Genome in the Bottle,” a reference sample of DNA for validating human genome sequences developed by the National Institute of Standards and Technology. Users will also be able to compare their results to previously validated reference results as well as share their results with other users, track changes and obtain feedback.

Elaine Johanson

Elaine Johanson, precisionFDA Project Manager.

Through such collaboration we hope to improve the quality and accuracy of genomic tests – work that will ultimately benefit patients.

Over the coming months we will engage users in improving the usability, openness and transparency of precisionFDA. One way we’ll achieve that is by placing the code for the precisionFDA portal on the world’s largest open source software repository, GitHub, so the community can further enhance precisionFDA’s features.

precisionFDA leverages our experience establishing openFDA, an online community that provides easy access to our public datasets. Since its launch in 2014, openFDA has already resulted in many novel ways to use, integrate and analyze FDA safety information. We’re confident that employing such a collaborative approach to DNA data will yield important advances in our understanding of this fast-growing scientific field, information that will ultimately be used to develop new diagnostics, treatments and even cures for patients.

Taha A. Kass-Hout, M.D., M.S., is FDA’s Chief Health Informatics Officer and Director of FDA’s Office of Health Informatics. Elaine Johanson is the precisionFDA Project Manager.

What We Mean When We Talk About Data

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

Robert M. Califf, M.D., MACC, FDA's Commissioner of Food and Drugs

Robert M. Califf, M.D., Commissioner of the U.S. Food and Drug Administration

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., previously FDA’s Deputy Commissioner for Medical Products and Tobacco, became FDA’s Commissioner of Food and Drugs on Feb. 25, 2016.

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

A Mother’s Loss, an Advocate’s Example, Fuel Our Mission to Keep Foods Safe

By: Michael R. Taylor

For the many people in government, and elsewhere, who have been working on implementation of the FDA Food Safety Modernization Act (FSMA), this has been a week for reflection, celebration, and anticipation. I got to experience all three in the 24 hours I spent this week at the 2015 Food Safety Consortium in Schaumberg, Illinois.

Michael R. TaylorTuesday night I joined the many friends and supporters of the public health organization STOP Foodborne Illness in honoring Nancy Donley for her 22 years of ‎relentless advocacy for improving food safety. She is driven by the memory of her 6-year-old son Alex, who suffered greatly before he died in 1993 after eating a hamburger contaminated with E. coli O157:H7.

This was a time for reflection. Nancy and the many others in the STOP network who have shared their excruciating stories of pain and loss have made it simply unacceptable for those producing food to do anything less than their best to prevent these tragedies from happening.

Nancy, as much as any single person, has catalyzed fundamental change in our food safety culture toward making food safety a central business value for food companies and shifting government oversight toward a model that ensures accountability for minimizing contamination by pathogens.

Nancy has inspired me and many others to see food safety as the deeply personal, primary value it is, and to act accordingly.‎

STOP also honored Walmart’s Frank Yiannas as a STOP Food Safety Hero for his pioneering work to define and instill food safety culture as a primary value in the food industry.

Reflections on Nancy’s and Frank’s contributions are the backdrop for a bit of celebration. Not because the culture change Nancy inspires and the food safety success we seek are complete — far from it. But we are on our way.

The three FSMA rules FDA issued last week to improve produce safety and strengthen oversight of imports, coupled with the preventive controls rules we finalized in September, create a powerful and comprehensive new framework for the prevention of foodborne illness. This framework will be completed next year with final rules on food transport and intentional adulteration. The rules are the product of enormous effort by teams of FDA experts and by the many government, industry and consumer partners whose input has been so important in shaping the rules.

At the conference Wednesday morning, I shared some of these reflections and the sense of celebration and gratitude we are experiencing at FDA. I got some positive nods and no push back, but it was clear that the food safety professionals at this gathering are focused on the future, anticipating the challenges and changes FSMA will bring.

So are we at FDA. We see challenges galore, but also a huge opportunity to fulfill a vision that Nancy and STOP rightfully insist be the guide for our food safety work and our food safety culture.

Food safety is a primary value for many in the food system. It must be so for all.

Science-based prevention is the organizing principle for many food production systems. It must be for all. 

And a spirit of common cause and collaboration on food safety, which has begun to take root in so many positive ways, must be the foundation for all the work ahead to successfully implement FSMA.

So, this week, let’s celebrate where we are as we anticipate and build the future.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Why FDA Should Oversee Laboratory Developed Tests

By: Peter Lurie, M.D., M.P.H.

Today FDA is issuing a report that illustrates the real and potential harms to patients and to public health from certain laboratory developed tests (LDTs) – tests that are designed, manufactured and used in a single laboratory.

Dr. Peter LurieWhen FDA first began regulating medical devices under the Medical Device Amendments in the 1970s, we chose not to enforce applicable regulatory requirements for LDTs because they were relatively simple tests generally confined to local labs, and often used for rare conditions.

But times have changed. LDTs have increased in complexity and availability and are now frequently used to diagnose common, serious medical conditions, including cancer and heart disease, with potentially greater impact on patients. And yet, LDTs are still under a general policy of enforcement discretion. That means they have rarely undergone FDA review to determine whether they are accurate, reliable, and provide clinically meaningful results. It also means that FDA’s own adverse event reporting databases rarely capture problems associated with a faulty LDT. Nevertheless, the Agency was able to pull together 20 case studies based on information available in the public domain that show how lack of LDT oversight may be causing or is causing significant harm to patients.

Some LDTs provide positive results even though the patient doesn’t have the disease. For example, a patient can receive a false positive result from a test that is supposed to determine whether someone has been infected with the bacteria that cause Lyme Disease. Patients may then undergo unnecessary treatments and potentially delay diagnosis of their true condition. Such false positives can be even more detrimental when the test is for ovarian cancer, which could prompt women to remove their ovaries.

The report cites other tests that may produce the opposite problem: false negatives. These tests may suggest that a patient doesn’t have a disease or condition, when in fact they do. That’s the case for a test for the gene mutation that makes an excess of human epidermal growth factor receptor 2 (HER2), which promotes the growth of breast cancer cells. Patients who express HER2 typically take drugs that target HER2, in addition to standard chemotherapy. The majority of tests used to detect HER2 protein or gene amplification are LDTs, but, at least in the past, approximately 20 percent of tests may have been inaccurate. That means that some breast cancer patients may not receive the best treatment when the test fails to detect high HER2 levels.

Noninvasive Prenatal Testing to detect a range of fetal chromosomal abnormalities is an example of testing that may result in either false negatives or false positives. Women with false-positive results may abort a normal pregnancy; women with false-negative results may deliver a child with an unanticipated genetic syndrome. The report also lists tests that have no clear relevance to the disease being tested and others that are based on disproven scientific concepts.

And the costs of this lack of oversight are staggering. We were able to derive an estimate of the public health cost for five of the 20 cited tests. For the CARE Clinical Autism Biomarkers Test alone (one of those cited in the report), FDA economists estimated a total public health cost of $66.1 million.

FDA has proposed to step up our oversight of LDTs. We issued a draft guidance last year which we’re currently working to finalize, that proposes to phase in enforcement of premarket review requirements for LDTs. FDA oversight would help ensure that tests are supported by rigorous evidence, that patients and health care providers can have confidence in the test results, and that LDTs have more scientifically accurate product labeling.

As this report demonstrates, strengthening FDA’s oversight over LDTs is critical to protect both patients and the public health.

Peter Lurie, M.D., M.P.H., is FDA’s Associate Commissioner for Public Health Strategy and Analysis

The Case for Quality: Working with Stakeholders to Improve the Safety of Medical Devices for Patients

By: Howard Sklamberg, J.D., Jeffrey Shuren, M.D., J.D., and Melinda K. Plaisier, M.S.W.

Howard Sklamberg

Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Across FDA, we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive–and increase–product and manufacturing quality. We believe quality can be quantified through close attention to data and consistent review and analysis of that data, which in turn can promote the practice and culture of quality within firms.

The metrics and assessment tools being developed are key parts of the Case for Quality (CfQ). We are working with a wide variety of stakeholders–including the medical device industry, patients, other governmental and academic colleagues, and payer/provider counterparts–to identify and promote practices that will result in higher quality devices.

The CfQ was launched in October 2011 following an in-depth review of device quality data and feedback from both FDA and industry stakeholders. FDA’s analysis flagged manufacturing quality risks and showed tremendous benefits for firms that drive quality organization-wide. They receive fewer complaints and internal investigations per batch of devices manufactured, often house smaller quality staffs, and have lower quality-related costs, compared with competitors.

Jeffrey Shuren

Jeffrey Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health

In the four years since the conclusion of the analysis, FDA has continued to observe that the percentage of inspections calling for official action by FDA has remained static, with the same issues recurring frequently year after year. Given this observation, in addition to FDA inspecting device firms on a regular basis, we are thinking about other ways to support quality beyond inspections and traditional regulatory approaches.

FDA introduced the CfQ in an effort to help device manufacturers elevate their focus from the baseline requirements of compliance with regulations alone, and instead focus on predictive and proactive measures they can take independently to improve quality. CfQ also provides FDA the opportunity to change our approach to focus more on what matters most in assuring product and manufacturing quality and safety for patients.

The CfQ has three priorities for addressing the barriers that were identified:

  1. Focus on Quality. FDA and CfQ stakeholders consider compliance to be a baseline, and have shifted our focus increasingly to characteristics and practices that, when present in day-to-day device design and production, correlate to higher-quality outcomes. Through the CfQ, we are collaborating with internal and external customers to identify characteristics that are critical to the quality of a particular device. This will result in a shared understanding of product features and manufacturing processes most important to patient safety.
  2. Stakeholder engagement. FDA works closely with the device industry and a broad group of customers to collaborate on CfQ and solicit feedback. This effort recognizes the extraordinary impact that engagement and agreement among regulators, industry, patients, providers, and payers can have on device quality.
  3. Data transparency. FDA receives a broad array of quality-related data, including information from recalls and adverse event reports. To support device quality, FDA has made device data (except certain information that we are prevented by federal law and regulations from disclosing) available on open.fda.gov.
Melinda Plaisier

Melinda K. Plaisier, FDA’s Associate Commissioner for Regulatory Affairs

The outcomes of the CfQ will allow stakeholders to focus resources on activities with the greatest impact on assuring that patients and users receive high-quality devices. This effort brings together metrics, successful quality practices, and our partnerships with stakeholders to promote quality and excellence in the medical device industry. It reflects our commitment to ensuring that devices perform as intended, meeting FDA’s mission of protecting and promoting public health.

For more on the Case for Quality initiative, visit http://www.fda.gov/medicaldevices/deviceregulationandguidance/medicaldevicequalityandcompliance/ucm378185.htm.

 

Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy.

Jeffrey Shuren, M.D., J.D., is Director of FDA’s Center for Devices and Radiological Health.

Melinda K. Plaisier, M.S.W., is FDA’s Associate Commissioner for Regulatory Affairs.

Forging the Path Forward toward Global Food Safety

By: Camille Brewer, M.S., R.D., Donald Prater, D.V.M., and Leigh Verbois, Ph.D.

Camille Brewer

Camille Brewer, M.S., R.D., Director of International Affairs at FDA’s Office of Foods and Veterinary Medicine.

These are exciting times for global food safety. In the last few years, China, Europe and the United States – three countries and regions of the world with complex food systems – have begun adopting sweeping modernization of their food safety laws and regulations. This is significant given these three countries together provide nearly half of the world’s foods!

China, Europe and the United States have a long history of partnering to help make sure that the food traded between us meets the robust food safety standards our consumers expect.

For many years, we’ve held regular meetings under our agreements with one another to talk through important issues affecting the safe production of both domestically consumed and internationally traded food.

Donald Prater

Donald Prater, D.V.M., Director of the Europe Office in the FDA’s Office of International Programs.

We’ve also worked together for decades in venues like the Codex Alimentarius Commission to set global standards for food safety. Up until now, discussions between us have largely happened with only two of our three governments in the room.

On November 2, our three countries and regions met in Beijing to take this cooperation to the next level within our more globalized food safety system. We discussed ways the three of us will work together as a group to improve the safety of the food products our countries manufacture and trade.

Leigh Verbois

Leigh Verbois, Ph.D., Director of the China Office in FDA’s Office of International Programs.

Our countries recognize that by gaining deeper knowledge about each other’s food safety systems and sharing timely information for better regulatory decisions and actions, we can move closer to the reality of global regulatory cooperation and alignment. We can also increase our confidence in the food we feed our families, whether it is produced in the United States, the European Union or China.

In the United States, the FDA recently rolled out the first two final rules to implement the landmark FDA Food Safety Modernization Act (FSMA) of 2011, and will release additional final rules this month.

In 2015, China updated its China Food Safety Law of 2009 to better clarify regulatory responsibility, increase penalties for the adulteration of food making it unsafe to eat, emphasize industry accountability, and improve traceability of food supply chains. In 2014, the European Union rolled out Smarter Rules for Safer Food, regulations that streamline the legal framework for food safety.

Trilateral Meeting

Participants representing the U.S., China, and Europe meet to discuss how the three countries and regions will collaborate and cooperate to improve food safety.

With China, the EU and the United States in agreement on our food safety collaboration, we will begin taking action! A first step is setting a meaningful agenda for a meeting before the summer of 2016.

We will be engaging food safety experts and focusing on closer cooperation through technical and scientific exchanges or workshops. These workshops will bring together experts to discuss food safety challenges.

Trilateral handshake photo

From L-R: Mr. Michael Scannell, Director of Food & Veterinary Office, Directorate-General Health and Food Safety-European Commission; Dr. Leigh Verbois, Director of the China Office, United States Food and Drug Administration; and Mr. BI Kexin, Deputy Director-General for Import and Export Food Safety Bureau (AQSIQ) – People’s Republic of China, shake hands at the conclusion of the meeting.

Among the many topics to consider are our respective new food safety laws and regulations, approaches to preventing food safety hazards during manufacturing, and the importance of recordkeeping.

Through collaboration with our Chinese and European colleagues, the FDA will develop a better understanding of our various approaches to keeping food safe.

This type of common understanding is essential in our increasingly globalized world since food safety knows no borders.

 

 

Camille Brewer, M.S., R.D., is Director of International Affairs at FDA’s Office of Foods and Veterinary Medicine.

Donald Prater, D.V.M., is Director of the Europe Office in the FDA’s Office of International Programs

Leigh Verbois, Ph.D., is the Director of the China Office in FDA’s Office of International Programs

Traveling to the Heartland to Discuss Antimicrobial Resistance

By: Michael R. Taylor

One of the great privileges and pleasures of my job is getting to see the food system at work. Whether it’s a big cereal manufacturer in Minnesota, a small New England produce operator, or, most recently, a Midwest cattle feeding operation, I always learn something new, and I get to meet people who are working hard to put food on our tables.

Michael R. TaylorLast month, I traveled with some FDA colleagues to Kansas at the invitation of U.S. Sen. Jerry Moran to learn about the practicalities of beef production, including how animal drugs are being used and managed. Senator Moran, who goes by “Jerry” back home and clearly enjoys being there, graciously accompanied us the whole day. We had a great experience.

For starters, to paraphrase Dorothy, when you spend a day in Kansas, you know you’re not in Washington any more. It’s partly the famous Midwestern friendliness, which we encountered at every turn as we walked the Kansas State campus, toured the K-State College of Veterinary Medicine, and visited Great Bend Feeding, Inc.

But it’s also the tangible presence of the land itself and people who for generations have built small communities on the foundation of agriculture and food production. These are folks who live and work far from Washington, and who often view Washington skeptically, but with whom we have a common cause in providing Americans the safest possible food supply.

FDA’s Center for Veterinary Medicine (CVM) regulates the safety and effectiveness of drugs for both food animals and our pets. When it comes to food animals, this includes ensuring that the meat, milk or eggs do not contain any unsafe drug residues. But it also includes minimizing the risk of antimicrobial resistance, which is a natural biological response to the use of antibiotics, whether in human medicine or in animal production. The public health problem occurs when drugs we rely on to treat human infections are rendered ineffective.

FDA is addressing this problem through an initiative that, by December 2016, will make illegal the use of medically important antibiotics for animal production purposes – such as growth promotion – and bring remaining uses for legitimate animal health purposes under veterinary supervision. CVM’s Dr. Bill Flynn, who is leading this initiative, was my partner on our trip to Kansas.

Kansas Cattle

Cattle on the Great Bend Feeding land in Kansas.

Kansas is a leading beef producer and our trip gave us an opportunity for us to see first-hand the work being done to manage antibiotic use and the real challenges that exist so that together we can find the most practical and effective ways to ensure that these drugs are used judiciously to protect both animal and human health.

Our first stop was Kansas State University’s prestigious College of Veterinary Medicine in Manhattan. Dean Tammy Beckham joined us at the college, which prides itself on teaching, research and service to the community. We met with about 25 students involved in the care of all kinds of animals, from those found on farms, including horses and cows, to companion animals like dogs and cats. We saw a horse and cow being cared for and watched students examine, with great kindness, a tiny dog in a radiology laboratory using computer imaging technology.

We also visited the Veterinary Diagnostic Laboratory, which supports the college’s public role in animal agriculture by examining samples taken from ailing farm animals and helping determine the right treatment. We were joined for the day by Dr. Michael Apley, a professor in the college’s clinical sciences department and a newly appointed member of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. As a researcher and educator who reaches out to the animal production industry, Dr. Apley is at the forefront of efforts to properly manage the use of antimicrobials in food animals.

With Dr. Apley, we drove for more than two hours through the scenic Kansas prairie to reach Great Bend Feeding, a mid-size feed yard with about 30,000 head of cattle. Manager Paul Woydziak is a native of the area and the facility is staffed by local people. This is their life and their livelihood, and they take the issues of food safety and animal health very seriously.

Their job is to optimize the growth of cattle with a custom feeding program, keeping them from 120 to 280 days before they are harvested to enter the food supply. The animals are fed three times a day with feed that is produced in a mill on the property and highly controlled in terms of quality and quantity. Modern day cowboys on horseback constantly patrol the dozens of large pens looking for signs of illness, with potentially sick animals immediately evaluated by a veterinarian.

There are lessons to be learned at farms and feed yards like Great Bend. It is critical that we identify and implement the best “stewardship” practices to ensure that medically important antimicrobials are used judiciously, including for preventing disease in the animals.

And we need solid data to ensure that our strategy to promote judicious use of antimicrobials is working. We were encouraged by the detailed system that was in place at the Great Bend operation for tracking animal health and drug use. Understanding how such information is monitored in actual animal production settings is important to our ongoing discussions about practical strategies for collecting data on antimicrobial use.

So it was a great trip, and we are grateful to Sen. Moran and all of the Kansans who were so generous with their time. Keeping food safe will always involve collaboration between the public and private sectors, and to build that collaboration there is no substitute for being there in person, seeing how our food is produced, and learning from the people who dedicate their lives to that work.

The food safety problem posed by antimicrobial resistance is one that we can solve, working together.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

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