Blue Bell and the Very Real Impact of the Food Safety Modernization Act

By: Michael R. Taylor

Could the deadly outbreak of illnesses tied to contaminated ice cream have been prevented? It’s an important question, one that is on the minds of many in the wake of the multi-state outbreak of Listeria monocytogenes tied to ice cream produced by Blue Bell Creameries.

Michael TaylorAbove all else, we need to acknowledge the tragic aftermath. Our hearts go out to the friends and family members of the victims – the 10 people who were hospitalized and the three who died.

Our mission in the face of such tragedies is to work to keep them from happening again, first by investigating the cause. If products are found to be contaminated with Listeria monocytogenes or other pathogens, we work with companies to recall anything that has the potential to cause illness. The FDA joins with other federal agencies, states, and industry, while also communicating directly with consumers — all in an effort to ensure that more people don’t get sick or worse.

But more needs to be done, and more is being done. Congress passed the FDA Food Safety Modernization Act (FSMA) in December 2010 because of outbreaks like this, because of a widespread concern among legislators, consumers and industry about foodborne illnesses that kill thousands each year.

Ultimately, the only way we will achieve the goals that we are focused on—the goals that consumers expect us to achieve, and that industry wants us to reach—is if we have a system in which industry is systematically, every day, putting in place the measures that we know are effective in preventing contamination. And it’s not only a domestic issue; it’s an import issue. We’ve got to build prevention into the food safety system globally.

There’s no magic wand here. This is the most sweeping regulatory overhaul in the agency’s history and we’ve got to work systematically to put the right regulations in place. In the four years since FSMA became the law, we have been actively establishing the regulations that we will be issuing in final form beginning later this year.

For example, the preventive controls for human food rule, if finalized as proposed, would require that companies like Blue Bell have a written food safety plan, based on an analysis of likely hazards, and companies would have to show us that plan during inspections. Listeria monocytogenes is a classic example of a hazard that a company should be controlling. Under the proposed standards, companies would be required to have the right controls in place to minimize hazards and would have to verify that their controls are working.

We have in FSMA not only new, enforceable standards, but much stronger inspection and enforcement tools to make sure the standards are being met, such as access to company records and mandatory recalls –authorities we didn’t have before. Most companies want to do the right thing; many are doing it now. Through this law we want to promote strong food safety cultures and create real accountability throughout the industry.

We see broad support for implementing FSMA throughout our stakeholder community and among many people we talk to in Congress. President Obama’s 2016 request for $109.5 million in new budget authority to implement FSMA is crucial. If we receive that funding, we can move forward to implement this new, modern system in an effective and timely way. If we do not get the funding, we will lose momentum, and implementation will be badly disrupted.

No law can guarantee zero risk, from contaminated ice cream or any other food that has come in contact with a dangerous bacteria or other harmful substance. But FSMA is about providing assurances that the food system is doing everything it can to prevent problems and to provide food in grocery stores and restaurants that is as safe as it possibly can be.

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

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 Reaches Out to Minorities During Hepatitis Awareness Month

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

Did you know that millions of Americans (mostly baby boomers) are living with chronic Hepatitis and up to 2/3 may not even know they are infected? Annually, in May, the public health community commemorates “Hepatitis Awareness Month” to bring attention to this disease, its symptoms, testing, and treatment options. This year, we are working with the Centers for Disease Control and Prevention (CDC) to conduct outreach for minority groups most affected by Hepatitis: Asian/Pacific Islanders (API) and African-Americans (AA).

Jovonni SpinnerWhat’s the issue?

Hepatitis, which means “inflammation of the liver”, can cause nausea, abdominal pain, jaundice, joint pain, and malaise. Chronic hepatitis can lead to serious complications like cirrhosis, end-stage liver disease, or cancer. Hepatitis A (HAV), hepatitis B (HBV), and hepatitis C (HCV) are the most common strains found in the United States. Knowing your status and getting treatment early can potentially prevent these life threatening complications.

The statistics below show alarming disparities in the number of APIs and AAs being diagnosed with and dying from hepatitis.

Asian/Pacific Islanders

  • 50% or more of Americans living with chronic HBV are APIs
  • APIs experience mortality rates from HBV 7 times greater than Whites

African-Americans

  • 25% of all patients living with HCV are AAs
  • Among 45-65 year old AA’s, HCV-related chronic liver disease is the leading cause of death
  • HCV accounts for 8% of all AA deaths compared to 4% of White deaths
  • Patients with sickle cell disease (which primarily affects AAs) are at increased risk for contracting hepatitis if they received a blood transfusion prior to 1992, when blood banks began screening blood.

What is FDA’s Role?

FDA is committed to advancing the health, safety, and well-being of all Americans through the regulation of diagnostic tests, medicines, and vaccines, as well as monitoring post market safety of healthcare products and ensuring diversity in clinical trials. The most recent safety warning about possible side effects of hepatitis drugs can be found on FDA’s safety bulletin.

One area that my office specifically focuses on is increasing diversity in clinical trials. Data has shown that African Americans and other races respond differently to hepatitis treatments. For example, in the VIRAHEP-C clinical trial, 28% of African-Americans were cured by the tested treatment, compared to 52% of whites. These results highlight why it is important to increase diversity of participants in clinical trials so we can learn how all groups respond to FDA regulated products, thus helping to ensure the safety of medical products for all.

We are actively spearheading FDA’s efforts on the FDASIA 907: Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data. Under our leadership, we help the agency improve the quality and quantity of data collected; increase clinical trial participation; and increase the transparency of clinical trial data. In addition to the information on our website, we created a clinical trials brochure which discusses the importance of volunteering in clinical trials.

Call to Action

May 19th is National Hepatitis Testing Day!

Spread the word to increase testing and early treatment. These resources are available to help your community:

Patients and health professionals can receive updates about drug approvals, drug safety updates and other issues related to hepatitis by subscribing to the Hepatitis Email Updates.

More information about FDA’s OMH can be found here: www.fda.gov/minorityhealth

Follow us on Twitter @FDAOMH

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

Biosimilars: New guidance from FDA to help manufacturers develop more treatment options

By: Leah Christl, Ph.D.

FDA has taken important new steps to continue to help manufacturers develop biologic products called biosimilars. Biosimilars are highly similar to, and have no clinically meaningful differences from, an already approved biological product. Biosimilars can provide more treatment options for patients, and possibly lower treatment costs.

Leah ChristlIn early March, FDA approved the first biosimilar, Zarxio (filgrastim-sndz), a biosimilar to Neupogen (filgrastim), used to help stimulate growth of white blood cells in patients with cancer and help them fight infection.

That’s a great start and we are pleased to see the progress. Manufacturers are working hard to develop more biosimilars for the U.S. market. By nature, biologic products are highly complex molecules, so developing biosimilar versions of these products is challenging. FDA is also working hard to help those manufacturers bring more biosimilars to the market.

Over the past few weeks, we have released four guidances for industry — useful tools to help manufacturers navigate the new terrain of biosimilar development.

  • One assists companies in demonstrating that a proposed product is indeed biosimilar to an existing biologic product, and is intended to provide clarity to manufacturers about the expectations for a biosimilar development program.
  • A second focuses on the analytical studies that demonstrate that the product is “highly similar” to an existing biological product, which supports the demonstration of biosimilarity.
  • A third guidance answers common questions about the biosimilar development and application process and contains information intended to provide a better understanding of the law that allows biosimilars development. 
  • A fourth, still in draft form — which means we are accepting public comment — answers a variety of additional questions that have arisen regarding the biosimilars development process.

Each of these guidances was developed to help industry more efficiently and effectively develop new biosimilars for patients in need.

Many of our most important, but also expensive, drugs are biological products. These products are used to treat patients who have a variety of serious and life-threatening medical conditions including rheumatoid arthritis, psoriasis, diabetes, and cancer.

Having more approved biosimilars is good for public health. FDA looks forward to continuing to help manufacturers develop these important products.

Leah Christl, Ph.D., is FDA’s Associate Director for Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research

The 2014 FDA Food Safety Challenge: And the Finalists Are…

By: Palmer Orlandi, Ph.D.

I am delighted to announce the finalists in FDA’s first Food Safety Challenge, a ground-breaking effort to better protect our food supply by fostering innovation in technologies that will more quickly detect pathogens in produce.

Palmer OrlandiLast September, we invited scientists, academics, entrepreneurs, and innovators from all disciplines to compete by submitting concepts that could improve and accelerate the detection of these disease-causing bacteria in foods. We received 49 submissions.

The five finalists whose proposals will enter the next phase of the Food Safety Challenge are teams of researchers from these companies and universities:

  • Auburn University, Auburn, Ala.
  • Pronucleotein Inc., San Antonio, Texas
  • Purdue University, West Lafayette, Ind.
  • University of California, Davis, Calif.; Dr. Bart Weimer; and Mars, Inc.
  • University of Illinois, Urbana-Champaign, Ill.; and Purdue University

(Purdue is represented twice, teaming with University of Illinois colleagues in one proposal and going solo in another, with different researchers on each team.)

Each team has developed ingenious new technologies for detecting food pathogens that could be real game changers in our ongoing fight against foodborne illness. They will each receive $20,000 and advance to the next stage in the Challenge. The winner or winners (there can be more than one) will share the remainder of the $500,000 total prize.

But before I describe the next step, let me remind you why this Challenge is vital to FDA’s mission to promote and protect the public health.

  • The Centers for Disease Control and Prevention (CDC) estimates that foodborne illness sickens 1 in 6 Americans  annually, resulting in about 3,000 deaths.
  • The overall negative economic impact of foodborne illness in the United States may be as high as $77 billion per year.
  • Salmonella is the leading cause of death and of hospitalization related to foodborne illness.

We believe that by reaching out through this Challenge to entrepreneurs, academia, and the larger scientific, innovation and problems-solving communities, we can view our food safety problems through a different lens. It’s a way to consider approaches, and possible solutions, through the eyes of innovative thinkers, and to use technologies we may not have considered.

What Happens Next?

Now that our panel of expert judges from FDA, CDC, and the U.S. Department of Agriculture has narrowed the competitive field down, we enter the Field Accelerator phase of the Challenge. With the guidance of FDA food safety and pathogen-testing experts, finalists will

  • refine their submissions,
  • clarify their concepts,
  • maximize their impact on food safety,
  • check that they are in line with FDA’s needs and capabilities,
  • and ensure that the proposed ideas can be reasonably executed.

The finalists will participate in a “boot camp” with FDA experts on May 13, 2015 to help strengthen their concepts and applicability to FDA’s testing process. “Demo Day” will be held on July 7, 2015 in College Park, Md. The finalists will present their improved proposals to the judges and a live audience in FDA’s Center for Food Safety and Applied Nutrition headquarters.

I, for one, can’t wait to see the solutions the finalists will come up with. We believe that by thinking outside the box, we can find new ways to help assure the American public that the foods they eat and serve their families are safe.

Palmer Orlandi, Ph.D., is Acting Chief Science Officer and Research Director in the FDA’s Office of Foods and Veterinary Medicine.

FDA Science Forum to Focus on Emerging Technologies

Dr. Luciana Borio, FDA’s Acting Chief Scientist, invites you to the FDA 2015 Science Forum at our White Oak headquarters in Silver Spring, Maryland on May 27-28. We’ll be showcasing exciting, cutting-edge regulatory science research. For more information and how to register for the forum before the deadline of May 15, 2015, go to The FDA Science Forum.

Learning from the Oneida: Food and Fellowship at the Heart of a Community

By: Michael R. Taylor

All over the country, local food systems produce, market, and distribute foods that nourish their communities. In our travels over the past few years, seeking input on proposed rules to implement the FDA Food Safety Modernization Act (FSMA), we have seen first-hand just how important these grassroots systems are to the American way of life.

Oneida Food Distribution Warehouse in Oneida, Wisconsin

Warehouse Supervisor Leonard Stevens with Deputy FDA Commissioner Michael Taylor at the Oneida Food Distribution Warehouse in Oneida, Wis. The Oneida Food Distribution Program feeds low-income members of the community.

I saw another impressive example of a community-centered food system when my colleagues and I toured the Oneida Nation in Wisconsin last month and met with members of the tribe, who are justifiably proud of their farming traditions. We met the people behind the Oneida Community Integrated Food Systems (OCIFS), established in 1994, which provides education about food, nutrition and health, and integrates locally produced foods into the Oneida community and institutions.

It is an impressive system. It includes a 6,000 acre farm, where they raise Black Angus cattle and bison; a 40-acre apple orchard that offers 34 varieties of apples, as well as other fruits and vegetables; an 80-acre organic farm that has community gardens and a cannery, and offers workshops on cooking and gardening; a food distribution program that feeds low-income members of the community; and a market in which the Oneida sell what they have planted, produced and harvested.

The community produces more than food. It also encourages healthy-eating. There is a state-of-the-art health center that focuses on weight management and diabetes prevention, striving to empower members of the community to make positive life choices. The facility is evocative of the tribal culture and sophisticated in its delivery of health services. They have had incredible success in improving diabetes outcomes in terms of care and prevention.

We toured and met with tribal leaders. Then we had a frank discussion about the important relationship between the FDA and the more than 560 federally recognized American Indian and Alaska Native tribes and villages. The Oneida Nation is a sovereign state, as are the other tribes, and federal agencies have an obligation to consult them in certain matters of importance. From their standpoint, the sheer number of federal agencies they have to deal with—including FDA, the U.S. Department of Agriculture, the Environmental Protection Agency, and the U.S. Fish and Wildlife Service—can be a source of frustration and confusion.

From FDA’s perspective, the challenge of working effectively with hundreds of diverse, sovereign tribal governments mirrors the challenges we face across the breadth of FSMA implementation.

The Oneida Nation is emblematic of the diversity of our food system. This diversity is a great strength, but it’s also part of what makes implementing FSMA and achieving food safety a daunting task. It’s doable, however, because, whether they’re sending their products around the world or around the corner, all participants in today’s food system have the same stake in food safety. It is FDA’s mission to reach across this broad spectrum, create standards that are feasible for all food producers, and support their food safety efforts any way we can.

This demands collaboration and partnerships. Our partnership with American Indian and Alaska Native tribes is among the building blocks of the modern food safety system mandated by FSMA. I was inspired by what I saw in our trip to the Oneida Nation, by their cultural commitment to the health of their community and their willingness to embrace new technologies while staying true to traditions. They lend rich color to the kaleidoscope that is our global food system.

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

FSMA: The Future Is Now – Stakeholder Perspectives

On April 23-24, 2015, FDA hosted the “FDA Food Safety Modernization Act Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.” The national public meeting in Washington, D.C., continued on the second day with a panel discussion on stakeholder perspectives.

Participants: Sandra Eskin, J.D., Director, Food Safety, The Pew Charitable Trust; Leon Bruner, D.V.M., Ph.D., Executive Vice President for Scientific and Regulatory Affairs and Chief Science Officer, Grocery Manufacturers Association; Marsha Echols, J.D., Legal Advisor, Specialty Food Association; Richard Sellers, Senior Vice President of Legislative and Regulatory Affairs, American Feed Industry Association; David Gombas, Ph.D., Senior Vice President of Food Safety and Technology, United Fresh Produce Association; Sophia Kruszewski, J.D., Policy Specialist, National Sustainable Agriculture Coalition; Stephanie Barnes, J.D., Regulatory Counsel, Food Marketing Institute. Moderator: Roberta Wagner, Director for Regulatory Affairs, Center for Food Safety and Applied Nutrition, FDA.

FSMA: The Future Is Now

By: Michael R. Taylor

FDA is holding the “FDA Food Safety Modernization Act Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.” The two-day national public meeting in Washington, D.C., began Thursday, April 23, 2015 with a panel discussion by top FDA leaders on the overarching philosophy and strategy. Participants: Michael Taylor, J.D., Deputy Commissioner for Foods and Veterinary Medicine; Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy; Melinda Plaisier, M.S.W., Associate Commissioner for Regulatory Affairs, Office of Global Regulatory Operations and Policy; Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition; Bernadette Dunham, D.V.M., Ph.D., Director, Center for Veterinary Medicine. Moderator: Kari Barrett, Advisor for Strategic Communications and Public Engagement, FDA

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

Congratulations to FDA’s Dr. Richard Pazdur, recipient of the AACR’s prestigious Distinguished Public Service Award

By: Stephen Ostroff, M.D.

In the past five years, FDA’s Center for Drug Evaluation and Research (CDER) has approved more than 40 novel cancer treatments, offering hope to many patients who previously had few or no treatment options. Among these products are new and cutting-edge targeted therapies—sometimes called “precision medicines”—tailored to treat patients based on their individual characteristics.

Acting FDA Commissioner, Stephen Ostroff, M.D.

Acting FDA Commissioner, Stephen Ostroff, M.D.

This achievement is a tribute to the dedicated CDER scientists and clinicians who support innovative development of cancer drugs, and evaluate the safety and effectiveness of new products for FDA approval. They are led by the dynamic and creative thinker, Dr. Richard Pazdur, a 16-year FDA veteran whose name has become synonymous with excellence in cancer drug research, development, evaluation and approval.

It is with great pride and admiration that I share with you today that the American Association for Cancer Research (AACR) has awarded its 2015 Distinguished Public Service Award to Dr. Pazdur. AACR selected Dr. Pazdur for this award based on his “extraordinary, steadfast leadership in scientific and regulatory affairs” and his “unwavering commitment to ensuring the development of safe and effective treatments for cancer patients.” The Association also noted that Dr. Pazdur’s “important work has been and continues to be nothing short of spectacular, and it is saving lives every day from this most feared disease that affects so many.”

Dr. Richard Pazdur (left) receives the 2015 Distinguished Public Service Award from AACR President Dr. Arteaga

Dr. Richard Pazdur (left) receives the 2015 Distinguished Public Service Award from AACR President Dr. Arteaga. Photo by © AACR/Todd Buchanan.

As director of the Office of Hematology and Oncology Products (OHOP) at FDA, Dr. Pazdur leads a staff of more than 150 oncologists, toxicologists, and other specialists dedicated to approving safe and effective drugs for cancer and blood-related conditions. Dr. Pazdur and his staff are committed to facilitating rapid development, review, and action on promising new treatments to combat these diseases and improve patient outcomes. Dr. Pazdur and the OHOP staff are also committed to outreach with the oncology community. In 2005, Dr. Pazdur established the Oncology Program, which coordinates oncology activities within FDA as well as with external stakeholders providing OHOP with a unique infrastructure within CDER to interact with professional societies and patient advocacy groups.

We are grateful for Dr. Pazdur’s sustained contributions and look forward to many more years of his leadership, and his adept and proficient manner in helping patients in need.

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