FDA Continues its Collaboration with Canada in Phase 2 of the U.S.-Canada Regulatory Cooperation Council

By: Lou Valdez, M.S.M.

For more than 30 years, FDA has enjoyed a robust partnership with our Canadian regulatory colleagues. In FDA, we are excited to build upon this relationship in Phase 2 of the U.S.–Canada Regulatory Cooperation Council (RCC).

Lou ValdezThe RCC was established in 2011 by U.S. President Barack Obama and Canadian Prime Minister Stephen Harper to develop smarter and more efficient and effective approaches to regulatory cooperation between the two countries. The RCC aims to bring the U.S. and Canadian regulators and stakeholders closer in terms of sharing information, combining expertise, eliminating duplicative work and creating an enabling environment to foster and facilitate ideas.

In Phase 1 of the RCC, our governments identified important regulatory issues to work together to improve. For example, as a result of the cooperation between FDA and Health Canada, we reduced the regulatory burden for industry through the development of the Common Electronic Submission Gateway (CESG). Led by our FDA Medical Product Centers, the CESG allows industry to simultaneously submit electronic applications to both FDA and Health Canada for pharmaceutical and biological products.

In Phase 2, over the next three years, FDA has committed to work with the Canadian Food Inspection Agency (CFIA) and Health Canada in the areas of:

  • Food Safety
  • Medical Devices
  • Over-the-Counter Drug Products
  • Pharmaceutical and Biological Products, and
  • Veterinary Drugs.

Together with CFIA and Health Canada, we developed five individual work plans describing specific activities within the above areas and two Regulatory Partnership Statements outlining the institutional frameworks for this cooperation.

Throughout the implementation of these work plans, American and Canadian stakeholders will have opportunities to engage with the regulatory agencies to provide updates on significant industry and consumer trends and associated implications for regulatory systems.

FDA is committed to continuing our valued partnership with Canada and using the RCC as an important tool upon which to build. Learn more about FDA’s work under the RCC at http://www.trade.gov/rcc/.

Lou Valdez, M.S.M., is FDA’s Associate Commissioner for International Programs

Veterinary Feed Directive Will Protect Both People and Animals

By: Michael R. Taylor

For the past several years, the FDA has been taking steps to fundamentally change how antimicrobials are legally used in food-producing animals. The agency is moving to eliminate the use of these drugs for production purposes – such as speeding weight gain – and bring their remaining therapeutic uses in feed and water under the supervision of licensed veterinarians. These changes are critical to ensuring these drugs are used judiciously and only when necessary for legitimate animal health purposes.

Michael TaylorToday, we added another element to our overall strategy, one that recognizes the important role that veterinarians fulfill as guardians of animal health and preservers of judicious use of medically important antimicrobials. The Veterinary Feed Directive (VFD) final rule lays out what veterinarians must do when they need to authorize the use of these products in feed to protect the animals they serve.

This rule is a key piece of FDA’s initiative to combat the overuse of antimicrobial medications — including antibiotics — in both people and animals, which has created a global health crisis. Disease-causing bacteria commonly develop resistance to the medications created to kill them, but misuse of these important treatments ups the ante. FDA is particularly concerned about the use of “medically important” antibiotics in animal agriculture because they are also used to treat human disease and could become useless if bacteria become resistant to their effects.

Of course, change takes time. Since December 2013, we have been implementing a plan with animal drug companies to phase out the use of medically important antibiotics for enhanced food production. We have been working since then with drug companies, animal producers and veterinarians to change how these antibiotics are used in animals that enter the food supply, such as cattle, hogs and poultry.

Partnership and collaboration is delivering results. All 25 affected animal drug companies agreed to work with FDA to remove production uses for growth promotion and feed efficiency from the approved uses of their drug products, and move the therapeutic uses of these products from over-the-counter availability to a marketing status requiring veterinary oversight. By December 2016, we expect to see significant changes in the way medically important antibiotics are used in animal agriculture as compared to how they have been used for decades.

What will this mean in practice? Once these changes are fully implemented, it will be illegal to use these medically important antibiotics for production purposes, period. Instead of having unrestricted over-the-counter access, animal producers will need to obtain authorization from a licensed veterinarian to use these medications for therapeutic uses — for prevention, control or treatment of a specifically identified disease.

The VFD rule respects the diversity of circumstances that veterinarians encounter on the farm, but also ensures that their oversight is in line with nationally consistent principles. They will be required to have sufficient knowledge of the animals being treated by examining them or visiting the facility at which their care is managed.

Specifically, veterinarians play an important role in animal and human health and their oversight, as an integral part of the VFD process, will help ensure that medically important antimicrobial drugs will be used in feed according to label directions and only when appropriate to meet specific animal health needs. That means using a product for a specifically-identified disease, at the right dose, and for the period of time stipulated on the product label.

We aren’t done yet. The next step is getting the data we need on how medically important antibiotics are now being used on farms, information that will be essential to measuring the impact of our judicious use strategy. Right now we collect antibiotic sales and distribution data but do not have explicit regulatory authority to require data to be submitted on how antibiotics are actually being used in farm animals. We are evaluating how to obtain additional detailed information on such things as the species, indication, dose, and duration of use in order to better understand links between usage patterns and trends in antibiotic resistance. This will help provide a more comprehensive and science-based picture of antibiotic use and resistance in animal agriculture. FDA is actively engaged with the U.S. Department of Agriculture, the Centers for Disease Control and Prevention, and a wide array of stakeholders to fill this need. We plan to hold a public meeting this summer to discuss how to collect and present this data.

Finally, FDA has been actively engaging veterinary organizations, animal producer organizations, and other stakeholders to express concern about some currently-approved preventive, therapeutic uses of medically important antibiotics that have no limit on how long they can be given to the animal. This is not what we consider a judicious use. We believe that veterinarians should work with their clients to explore alternative approaches for managing certain animal health conditions, and we will be working with animal producers and drug companies to make any needed changes in approved conditions of use.

Antimicrobial resistance is everyone’s problem. It requires determination and cooperation to make the changes needed to protect the utility of these life-saving drugs. We are grateful for the way our partners and stakeholders across the food system are responding to this challenge.

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

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

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

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

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

Aspirin Therapy: Who should use it?

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

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

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

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

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

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

Drug Trials Snapshot: Savaysa

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

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

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

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

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

www.fda.gov/minorityhealth

@FDAOMH

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

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

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.

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