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