FDA China Office’s Lixia Wang Wins Award for HHS Locally-Employed Staff

By: Mary Lou Valdez

The FDA’s mission to ensure that food is safe and medical products are effective for use by U.S. consumers and patients is widely recognized.

Lou Valdez

Mary Lou Valdez, FDA’s Associate Commissioner for International Programs

A lesser-known fact is that the U.S. Department of Health and Human Services (HHS) employs more than 1,700 locally-employed (LE) staff in 60 countries to uphold its mission across five operating divisions, including FDA. Dr. Lixia Wang, a locally-employed staff member working for FDA in China, exemplifies the contributions of our LE staff and is the recipient of the annual HHS LE Staff of the Year Award.

China is a key supplier of goods imported to the U.S. The FDA has made significant regulatory in-roads since establishing its China post in 2008 and in many ways these are due to the contributions made by Dr. Wang and other LE staff in the world’s most populous country.

For example, Dr. Wang was essential in the negotiations of bilateral agreements for the placement of additional staff in China. With Dr. Wang’s contributions, FDA finalized these important agreements, which pave the way for FDA to more than triple its staff size in China. This move will bolster FDA’s work to protect and promote the health of consumers and patients in the U.S. and around the world.

Dr. Lixia Wang

Dr. Lixia Wang in Beijing

Dr. Wang, who has served as Medical Research Scientist for FDA’s China Office since 2009, was cited for her central role in negotiations concerning the Implementing Arrangements with China’s Food and Drug Administration, and Implementing Arrangement Between the Food and Drug Administration and the General Administration of Quality Supervision, Inspection and Quarantine.

In addition, Dr. Wang has made significant contributions to the HHS mission in China since joining U.S. Embassy Beijing in 2006. From 2006 to 2009, she served as senior local staff in the Office of the HHS Health Attaché, and played a key role in strengthening U.S.-China collaboration on infectious disease.

During that time, she also supported the FDA response to emerging problems associated with melamine in dairy and pet products, and worked to address contaminated blood thinner sourced from China. She played a key role in the 2007 negotiations of binding agreements with the Chinese Government on the safety of FDA-regulated products, and on the opening of FDA’s first-ever overseas office in 2008.

FDA congratulates Dr. Wang, and takes pride in the recognition for excellence and commitment to global public health that she brings to FDA with this award.

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs

A Global Fight Against Dangerous Counterfeit and Unapproved Medical Products: From Operation Pangea to FDA’s Global Strategic Framework

By: Howard Sklamberg, J.D., George Karavetsos, J.D., and Cynthia Schnedar, J.D.

Unfolding earlier this month was a global cooperative effort, which included the Food and Drug Administration, to combat the online sale and distribution of potentially counterfeit and illegal medical products. Operation Pangea VIII was a project of massive scope, a lightning move by 115 countries that resulted in more than 2,400 websites being taken offline and the seizure of $81 million worth of potential dangerous illegal medicines and medical devices worldwide.

Howard Sklamberg

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

It’s a sad and cruel fact that drug and device counterfeiting and adulteration pose serious threats to public health. Unapproved and misbranded prescription drug products and unapproved/uncleared medical devices offered for sale on the Internet are potentially dangerous. The illegal sale of these medicines and devices bypasses both the existing safety controls required by the FDA and the protections provided when these products are used under a licensed practitioner’s supervision.

FDA is dedicated to sustaining and expanding the fight against counterfeits as part of our global strategy that leverages resources and expertise, engages the private and public sectors, and is data-driven and risk-based.

We have developed a Global Strategic Framework for counterfeit and substandard medical products (sometimes known by the acronym SSFFC, for Substandard, Spurious, Falsely-Labeled, Falsified, Counterfeit) to help protect consumers by reducing their exposure to counterfeit and substandard medical products.

The framework is focused on three pillars: Prevention, Detection, and Response.

What’s needed is better prevention of market entry of counterfeit and substandard products. Better detection of these products. And, more efficient response when counterfeit and substandard products are found.

FDA developed this framework in order to lay out a strategic vision of what is needed and how these needs can be met globally. There are areas where our expertise can and does contribute to prevention, detection, and response, but there are other areas where other U.S. federal and local government agencies, foreign counterparts, industry, healthcare professionals, consumer and patients, non-governmental organizations, procurement and donor organizations, standards bodies, and others have a role.

George Karavetsos

George Karavetsos, J.D., FDA’s Director, Office of Criminal Investigations

It is important for all players fighting to combat counterfeit and substandard drugs and devices to understand exactly how to best use our resources, knowledge, and experience, and leverage the work of others. This framework helps shape what roles we can play, minimize duplication of effort, and strengthen our global might in this fight against the criminals.

FDA has many ongoing activities and initiatives that support the framework goals. To better prevent counterfeit and substandard products from entering the market, we are working on improving the transparency, accountability, and integrity of the supply chain. Specifically, we are focusing on good manufacturing, distribution, and pharmacy practices, and we’re working for a convergence of global standards to create a more level playing field for the legitimate supply chain.

We are also implementing the new track and trace law (the Drug Supply Chain Security Act), which outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States, no matter where they originate. This is a collaborative effort whereby FDA is working with drug manufacturers, wholesale drug distributors, repackagers and dispensers (primarily pharmacies) to implement the law and develop the new system over the next eight years. Some of the key goals of this system will be to trace the path of drugs at the package-level through the drug supply chain, help ensure they are legitimate products, and enhance the detection of illegitimate drugs.

Cynthia Schnedar

Cynthia Schnedar, J.D., Director of the Office of Compliance at FDA’s Center for Drug Evaluation and Research

To better detect potentially harmful products before they enter the supply chain on their way to patients, we are focusing on improving information-sharing and communication. Also, as part of our effort for better detection, we are improving our surveillance through more efficient investigations of suspect incidents, and more quickly confirming that products are counterfeit. To this end, we have developed new detection technologies, specifically the handheld device, CD3, which uses wavelength detection to detect counterfeit drugs and packaging at our ports of entry.

Lastly, to better respond to incidents in the most efficient manner, FDA’s Center for Drug Evaluation and Research is developing more effective ways to notify the public of confirmed incidents and quicker removal of counterfeit products from the marketplace.

As for enforcement, we will continue to rely on our skilled professionals in FDA’s Office of Criminal Investigations (OCI) to lead domestic and global investigations to combat counterfeits. For example, OCI’s involvement in the past seven years of Operation Pangea has resulted in the seizure of more than $172 million in unlawful medical products — a real testament to effective international partnership.

We fully recognize that there are sophisticated, global criminal networks engaged in money laundering and the preparation and transportation of illegal products around the world. Importantly, we are meeting this global threat with international collaboration. FDA’s Office of International Programs has engaged with the World Health Organization’s Global Surveillance and Monitoring System, the World Bank, and the U.S. Agency for International Development in securing drug supply chains, reducing the threat of substandard drugs and strengthening regulatory systems.

We also collaborate with many foreign law enforcement organizations. For example, we have an OCI agent permanently assigned to Europol, based in The Hague, Netherlands. We also have a longstanding and solid partnership with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA). More recently, OCI signed with the French National Gendarmerie a Letter of Intent to increase law enforcement collaboration.

Moreover, the stakes have grown higher in the U.S. as judges around the country recognize the risks of unapproved drugs in the U.S. marketplace. In January 2015, for example, a Turkish exporter of illegal drugs was sentenced to 30 months in federal prison for his part in the scheme.

As underscored by Operation Pangea last week, our actions to protect the health of Americans from the online sale of potentially dangerous illegal medical products will continue. In the longer term, our focus will be prevention, detection and response. We will need a more coordinated, domestic and global approach that leverages resources, expertise, tools, and trainings, and engages stakeholders, other regulators, and law enforcement.

Through our framework for strategically safeguarding supply chain security and integrity and combatting counterfeit and substandard drugs and devices, we know we are on the right path with the right goal: Protecting public health by helping to ensure that the prescription medications and devices used by health care professionals and patients are safe, effective and of high quality.

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

George Karavetsos, J.D., is FDA’s Director, Office of Criminal Investigations

Cynthia Schnedar, J.D., is FDA’s Director, Office of Compliance, Center for Drug Evaluation and Research

FDA Engages Internationally to Promote Access to Safe, Effective Animal Medicines

By: Bettye Walters, D.V.M.

Regulators around the world are reaching across national borders as they work together to ensure the safety of veterinary medical products.

Bettye WaltersI am a veterinarian on the International Programs Team at the FDA’s Center for Veterinary Medicine (CVM). In this role, I attended the 4th Global Animal Health Conference in Tanzania on June 24 and 25 and participated in the global dialogue about the use and availability of high quality, safe and effective veterinary medical products in developing countries, especially in Africa. FDA embraces the One Health approach, which recognizes the connection between the health of people, animals and the environment.

I was accompanied by my colleague Steven Vaughn, D.V.M., who heads CVM’s Office of New Animal Drug Evaluation. Dr. Vaughn has years of experience exploring the most effective ways to regulate animal medications to ensure that they are high quality and safe.

The conference was attended by leading figures from the world’s governments, academia, industries, and international organizations and its focus was on the concept of “regulatory convergence,” a process that allows countries to bring their regulatory processes into closer alignment. We tackled important ideas related to promoting market control, including the surveillance of veterinary products on the market and improving access to effective animal drugs. We also discussed fostering systems for mutual recognition of regulatory oversight and standards, forming regional organizations, and implementing African regional harmonization initiatives to create a convergence of international guidelines.

If all countries can agree on the testing and safety of animal drugs, each country could have faster access to new medical products and be able to better leverage often-limited resources. While globalization provides many challenges, FDA believes it also offers opportunities for innovation if regulators, industry, and academia are working together for the benefit of all countries.

It’s a small world and solutions to public health problems, for both people and animals, are increasingly found on the world stage. FDA is committed to working with its global partners to promote cooperation in veterinary medicine.

Bettye Walters, D.V.M., is a veterinary medical officer on the International Programs Team at FDA’s Center for Veterinary Medicine.

China’s Pharmaceutical Future – Both Complex and Growing

By: Howard Sklamberg, Richard Moscicki, M.D., and Alonza Cruse

中文(Simplified Chinese)

A visit to any one of the cities we visited on this trip – Shanghai, Nanjing and Beijing – would leave anyone marveling at the scale and trajectory of modern China. But it’s not just the sheer size of the population we were struck by. Rather, it was the seemingly tireless dedication to modernity that provided an almost palpable affirmation of what we already knew: that China — its skylines dotted with construction cranes and landscapes crisscrossed by high speed bullet trains — is inextricably connected with our own country’s economy, and increasingly with our agency’s ever-expanding regulatory mission.

Howard Sklamberg

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

We traveled to China for a few reasons. First, we wanted to gain more on-the-ground insight into how its drug industry works. We also wanted to offer some helpful perspective to Chinese regulators and drug companies about the Food and Drug Administration Safety and Innovation Act (FDASIA), which passed three years ago and is in the process of being fully implemented. In part, the law gave the FDA new authorities to ensure the safety of the global drug supply chain, in which China plays an enormous part. How enormous? After the United States, China ranks second for the number of FDA-registered drug establishments that the agency regulates, and is the sixth largest provider of drugs and biologics to the U.S.

Our itinerary also included a meeting with the Chinese Food and Drug Administration (CFDA) and a tour of a Chinese pharmaceutical manufacturing plant. And if you asked us what the most important by-product of our trip has been, it was these face-to-face conversations with our Chinese counterparts.

Specifically, we discussed the responsibilities of firms in the global drug supply chain. These days, the drugs we have in our medicine chests may seemingly come from one company, but the ingredients in them may actually come from numerous companies and countries. China is a major provider of many of the active ingredients in finished drug products Americans rely on every day.

Dr. Richard Moscicki

Richard Moscicki, M.D., FDA’s Deputy Director, Center for Drug Evaluation and Research

We had productive discussions with the Chinese about how seriously we are committed to making sure that everyone in the drug supply chain – from the companies that make the active ingredients to those that provide the packaging –shares in this collective commitment to quality. As we did when we spoke with our counterparts in India, we stressed that we apply the same quality and data integrity standards to all countries shipping drug ingredients into the United States.

We delivered the same message to a huge crowd of students at an event hosted by China’s Pharmaceutical University in Nanjing. In our remarks, we set forth our expectations for the delivery of drug quality, saying: “…ideally, our approach will complement the baseline, legal requirement of compliance with the higher bar of firms’ self-interest in being recognized for providing quality products and engaging in a different way with FDA.

While in Nanjing, we had productive discussions with students and stakeholders about FDASIA, quality in contract manufacturing, inspections, regulatory science, and expedited approval pathways that FDA is using to accelerate the process for making novel drugs available to patients.

Additionally, we toured a Chinese pharmaceutical facility and met with CFDA to discuss the revision of China’s Drug Administration Law, our own FDASIA implementation, regulatory science matters, as well as continued collaborative activities. We also had a productive roundtable discussion with leaders from 17 prominent Chinese pharmaceutical companies. We addressed pharmaceutical quality, data integrity, and the approval process for generic and innovator drugs.

Alonza Cruse

Alonza Cruse, FDA’s Acting Director, Pharmaceutical Quality Program, Office of Regulatory Affairs

As China’s role on the global stage expands, FDA has significantly increased drug and medical device inspections there, but we need to continue to strengthen our efforts. The Office of Regulatory Affairs and our China office have managed a large number of pharmaceutical inspections. The FDA’s office in China has also strengthened relationships with regulators and helped expand the country’s expertise in regulatory operations. And we have worked with industry and academia to explain our regulations and analyze trends and events that might affect the safety of FDA-regulated products exported from China to the U.S.

Given the volume of U.S. trade with China, we are working to expand our presence there to significantly increase the number of inspections we conduct. Staffing increases will allow FDA to enhance its training efforts and technical collaboration with Chinese regulators, industry and others. In fact, in November 2014, we signed a Memorandum of Understanding with the Chinese government that expands our cooperation and will facilitate those staffing increases.

FDA’s priorities in China match its global priorities: we work to ensure the safety and efficacy of FDA-regulated products. China’s size and relentlessly expanding economy have an increasingly significant impact on the products that Americans consume, particularly pharmaceuticals.

We trust our trip to China added to the growing collaboration between FDA and our counterpart agencies there, ensuring the safety of the pharmaceutical products exchanged between our two nations.

Howard Sklamberg is FDA’s Deputy Commissioner, Global Regulatory Operations and Policy
Richard Moscicki, M.D., is FDA’s Deputy Director, Center for Drug Evaluation and Research
Alonza Cruse is FDA’s Acting Director, Pharmaceutical Quality Program, Office of Regulatory Affairs

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

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

World Health Day 2015: A Global Focus on Food Safety

En Español

By: Michael R. Taylor

Food safety is a public health issue that affects all nations – from the most advanced to the most poor. World Health Day, observed on April 7 each year to mark the anniversary of the 1948 founding of the World Health Organization (WHO), gives us an opportunity to reflect on the progress that has been made to address the need for strong food safety systems, and on the enormous challenges that lie ahead.

Michael TaylorThe global importance of this issue is reflected in this year’s World Health Day theme: “Food Safety: From Farm to Plate, Keep it Safe.”  Keeping food safe, from farm to table, is at the core of our mission as an agency and at the heart of the preventive, risk-focused food safety system envisioned by the FDA Food Safety Modernization Act (FSMA).

We’re not alone in recognizing this critical need. Other countries as well are looking for ways to build preventive, modern food safety systems. Just two weeks ago, my colleagues and I were in India to meet with public health officials, regulators and representatives of industry. We all take the same position on food safety: As nations we must be strong individually and collectively, working in partnership to apply controls as foods increasingly cross multiple borders to reach foreign markets.

The challenges are great, starting with the complexity of a global supply chain in which food sources are far flung. There’s the difficulty of building comparable preventive controls in food systems that can vary widely from nation to nation. There’s also the issue of resources, as nations face financial constraints and competing priorities.

And while we can arrive at the best standards, whether they’re based on FSMA or Codex Alimentarius — a collection of international food safety standards, guidelines and codes of practice — we must find a way to verify that these requirements are being met every day in every country. Rules and regulations alone won’t make foods safe. What matters is how we, as an international community, achieve high rates of compliance with standards that prevent illness.

WHO estimates that each year there are an estimated 2 million deaths worldwide from food and waterborne diseases, including many children. In the United States alone, about 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to the Centers for Disease Control and Prevention.

To bring these numbers down, WHO helps countries prevent, detect and respond to outbreaks of foodborne disease and we are proud to be its partner in advocating for and educating on food safety. This year, in addition to providing a broad opportunity to look at the roles governments and food producers can play in protecting consumers, World Health Day is also focusing on what individuals can do to protect themselves at home by keeping foods free of contamination.

Today WHO will be engaging people worldwide in a social media conversation about food safety. Use the hashtag #SafeFood to share and learn. There will also be a webcast from 10 a.m. to 10:45 a.m. ET in English, and from 11:15 a.m. to noon in Spanish, with a live Q&A session via Twitter and Facebook, using the hashtags: #SafeFood and #SocialGood.

Join the conversation. As individuals, and as nations, we each have a stake in keeping our food safe.

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

From the New CFSAN Director: Reflections on My First Two Months

By: Susan Mayne, Ph.D.

I have been the director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN) for two months now. What I have enjoyed the most about this new job has been getting to know the people in CFSAN, who come from incredibly varied and interesting backgrounds. I am truly impressed by their commitment to excellence and dedication to our mission to protect and promote public health.

Susan MayneI have also been struck by the depth and breadth of expertise involved in every initiative CFSAN undertakes. So many scientific disciplines are involved: We rely on the insights of our medical officers, toxicologists, epidemiologists, biologists, chemists, behavioral scientists, and nutritionists. Working with our scientists are our policy and communications experts, economists and lawyers. We all have the same goal: to give the safety of food and cosmetics and nutrition issues the thorough and careful consideration they deserve.

We stand on two legs: strong science and our ability to create policy and regulatory solutions to address public health concerns. The scientific fields in which we work, from genomics to toxicology, are advancing rapidly. The use of new technologies can make our science better and help us to get the information we need more quickly. Yet the constant evolution and adoption of new scientific methods can also pose unique challenges — for example, in interpreting trends in food safety and foodborne illness.

When considering the science of food and cosmetic safety, we assess the scientific certainty, severity, and likelihood of any given risk, and identify those people who would be most vulnerable. We consider what additional research can be undertaken to better clarify the science for decision-making, and use what we currently understand to determine whether the risk can be avoided.

For each issue, we need to examine the full range of options, ranging from consumer education to regulation to enforcement. For regulatory options we work with our legal teams to consider what is possible within our authorities. What are we empowered to do and how does our work intersect with that of other federal agencies? If we take an action, what is the international context, and are there foreign trade implications? What are the views of groups that will be most affected by our decisions, on both the consumer and industry sides? What are the costs and benefits? Have we thoughtfully considered how to ensure high levels of compliance?

I have observed with a great sense of satisfaction how we work together with other federal partners. For example, leaders from the Centers for Disease Control and Prevention (CDC) visited our center recently to share information and discuss how we can best support each other in our joint commitment to food safety. In the brief time I have been here, I have also observed interactions with the U.S. Department of Agriculture, the National Institutes of Health, and the Environmental Protection Agency.

CFSAN’s work is funded by taxpayers and affects people’s lives every day. Our work has real consequences for consumers, businesses, and industry. I have learned the importance of engaging in meaningful conversations with those outside of government, who are affected by our decisions. As we talk to our industry stakeholders, we benefit from their expertise and better understand the real-world constraints they face, and that ultimately helps us to put forth more effective policy. Similarly, we value hearing the perspectives of consumers, medical groups, and the scientific community, which often highlight areas where additional FDA focus is needed to protect public health. In our communications, we strive to accurately convey the risks and/or benefits of any food or product, and to rapidly communicate any emerging health concerns.

I have observed an amazing array of public health issues coming across my desk at CFSAN over the past two months. I am energized by the diverse breadth and depth of activity, and look forward to the challenges and opportunities ahead, and to sharing my thoughts and experiences with you on Twitter and in future blog posts.

Susan Mayne is the Director of FDA’s Center for Food Safety and Applied Nutrition

In a country full of differences, common ground

By: Michael Taylor, Howard Sklamberg and Camille Brewer

We are headed to a meeting in Delhi. Through our taxi windows a vibrant India swirls around us: green and yellow motorized rickshaws and Vespas dart through the crowded city streets, zipping around buses, trucks and the occasional courageous pedestrian. It looks and feels like no city in the United States.

Michael Taylor

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

We are struck by how different it all seems, with many manifestations of traditional Indian lifestyle and culture — saris and turbans worn by many women and men, cattle and monkeys in the streets, and street food of all kinds — mixing with advanced urban infrastructure, intense commercial activity, and Western brand names all around.

We’ve come to this amazing country to discuss with government officials and industry leaders some important changes to our food safety system that will  affect food exports from here to the United States. But we are also here to sign a Memorandum of Understanding (MOU) with the government of India, “intended to develop opportunities for cooperative engagement in regulatory, scientific, and technical matters and public health protection that are related to…food products.” It admittedly sounds like a bit of legalese, but what it means is that it’s critical that our two nations work together on food safety issues.

Howard Sklamberg

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

Why? Well, India is the 7th largest supplier of food to the United States. The great amount of Indian food products that wind up on the dinner tables of Americans every night — including shrimp, spices, and rice — reflects the increasing globalization of our own country’s food supply, 15 percent of which consists of foreign products. Many of these goods come from any one of India’s 29 states, produced by thousands of different companies.

The signing of this MOU with the Export Inspection Council of India is the next step in enhancing our regulatory cooperation with this nation of 1.2 billion people. Last year, while here, FDA Commissioner Margaret A. Hamburg, M.D., signed a similar arrangement between FDA and the Indian Department of Health and Family Welfare, a Statement of Intent focused on medical and cosmetic product safety.

And while these documents serve as important, even historic, markers of our nations’ shared commitment to quality drug and food products, we’ve also discovered we have a lot in common with those we’ve met on our journey — which is taking us from the stalls of nut and spice vendors in Old Delhi to a shrimp processing facility in a remote part of Andhra Pradesh.

Camille Brewer

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

We had a lot of information to share on this trip. The Food Safety Modernization Act (FSMA), signed into law by President Obama in 2011, mandates a food safety system that is preventive rather than reactive, and in which foreign food producers are held to the same safety standards as our domestic farmers and food companies. Under FSMA’s new import safety system, we will continue targeted border checks, but the new system makes importers in the U.S. accountable to FDA for verifying that their foreign suppliers are using methods to prevent food safety problems that provide the same level of public health protection as those used by their U.S. counterparts.

Under FSMA, this new accountability for importers will be backed up by more overseas inspections by FDA, and, crucial for the purposes of this trip, more active partnership with our foreign government counterparts. We need it to strengthen assurances of food safety and capitalize efficiently on the efforts of all participants in what is becoming a truly global food safety system. FSMA is a game changer for food safety and for our food safety partners around the world, and we wondered how our talk about its implementation would be received.

But the Indians are no strangers to sweeping change to improve food safety.

India Shrimp Plant

FDA’s Howard Sklamberg (left) and Michael Taylor (center) tour Waterbase Ltd, a shrimp processing plant and farm in Nellore, India.

Our counterparts, known as the Food Safety and Standards Authority of India (FSSAI), are also undergoing a significant regulatory overhaul, known as the Foods Safety and Standards Act. Passed in 2006, it was the law that actually created FSSAI. At its core, the Act seeks to ensure that India’s food industry is adhering to international, science-based standards for food safety. Not unlike FSMA, this law poses many challenges in terms of how it can be successfully implemented, with both laws mandating comprehensive change, including marked increases in authority that require new resources to implement.

India MOU signing

FDA’s Howard Sklamberg (left) and Michael Taylor (center) sign a Memorandum of Understanding with the government of India

Although we don’t know most of the 22 official languages spoken here, we nonetheless realized after meeting with FSSAI that we “speak the same language” in terms of our food safety challenges and solutions. The FSSAI leaders conveyed real concern about protecting the Indian consumers they serve and, like us, they understand that in an increasingly global world, you can’t “go it alone” when it comes to food safety. Commissioner Hamburg, speaking of the global drug supply and how to make it safer, once described the need for a “coalition of regulators.” That same need exists for the world’s food supply.

We left our meeting with FSSAI assured that we are on the same page with our Indian colleagues about our food safety goals, as well as the amount of work — and collaboration — needed to achieve them.

The sounds and sights of Delhi and D.C. are certainly different. But with our MOU signed, we look forward to building our partnership with India, recognizing that sometimes the most fruitful relationships result when people with diverse perspectives come together to find common ground.

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

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

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