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

FDA and CMS Form Task Force on LDT Quality Requirements

By: Jeffrey Shuren, M.D., J.D. and Patrick H. Conway, MD, MSc

Health care providers and their patients expect that laboratory tests used in clinical management of patients should be consistent and of high quality.

Jeffrey Shuren

Jeff Shuren, M.D., J.D.

Under FDA’s proposed framework for the oversight of laboratory developed tests (LDTs), outlined in draft guidance documents issued in October 2014, FDA would oversee the quality of these laboratory tests, alongside the Centers for Medicare and Medicaid Services (CMS), which regulate the laboratories themselves through the Clinical Laboratory Improvement Amendments (CLIA). We have heard stakeholder confusion about the roles of the two agencies in ensuring quality and concerns about potentially duplicative efforts. To coordinate efforts across the Department, FDA and CMS are establishing an interagency task force that will continue and expand on our collaboration related to the oversight of LDTs, which are tests intended for clinical use and designed, manufactured, and used within a single lab. The task force, comprised of leaders and subject matter experts from each agency, will work to address a range of issues, including those involving quality requirements for LDTs.

Patrick H. Conway, MD, MSc

Patrick H. Conway, MD, MSc

Under the proposed LDT framework, FDA would phase in enforcement of premarket review requirements and the quality system regulation for some LDTs. FDA’s oversight of LDTs will assure that the tests are both analytically valid (able to accurately detect analytes) and clinically valid (able to measure or detect the clinical condition for which the test is intended). FDA is currently reviewing public comments on the draft guidances that it received through an open public docket and a two-day public meeting. In response to public comments, FDA may modify the proposed framework when we issue final guidance.

CMS, under CLIA, oversees the labs’ processes, rather than the tests they develop. CLIA and its implementing regulations include requirements for establishing and maintaining quality laboratory operations and ensuring the lab is staffed by qualified personnel. These laws do not require premarket review of tests or any evidence that a test is clinically valid.

When FDA’s proposed framework is implemented, both FDA and CMS will play a role in ensuring that LDTs are high quality—CMS through CLIA by continuing to focus on laboratory operations including the testing process and FDA by enforcing compliance with the agency’s quality systems regulation pertaining to the design and manufacture of the laboratory tests.

Although the roles of the agencies are different, FDA and CMS share an interest in ensuring effective and efficient oversight of LDTs so laboratories can offer tests to the American public with confidence that they are accurate and provide clinically meaningful information without unnecessary or duplicative agency oversight.

The goals of the FDA/CMS Task Force on LDT Quality Requirements include:

  • identifying areas of similarity between the FDA quality system regulation and requirements under CLIA;
  • working together to clarify responsibilities for laboratories that fall under the purview of both agencies; and
  • leveraging joint resources to avoid duplication and maximize efficiency.

The task force is currently exploring areas where collaboration may realize greater oversight efficiency and produce the greatest benefit to patients, providers, and laboratories. The task force understands stakeholders’ concerns about differences in terminology used by FDA and CMS. We intend to clarify the terms used so that labs may better understand what is expected of them.

Our new task force is committed to its stakeholders and intends to provide education and outreach, including an upcoming webinar series, to address additional needs that are identified during this collaboration. We welcome any feedback and encourage you to contact us at LDTFramework@fda.hhs.gov.

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

Patrick H. Conway, MD, MSc, is Acting Principal Deputy Administrator CMS Chief Medical Officer

FDA Celebrates 30 Years of Advancing Health Equity

By: Jonca Bull, M.D.

April is Minority Health Month! I am proud to say that FDA’s Office of Minority Health (OMH), in collaboration with  the Department of Health and Human Service’s Office of Minority Health, is celebrating this year’s theme: “30 Years of Advancing Health Equity, The Heckler Report: A Force for Ending Health Disparities in America.” For us at FDA, this year also marks the 5th anniversary of OMH, which serves as the principal advisor to the Commissioner on minority health and health disparities.

Jonca BullThe Heckler Report was a major, ground breaking document that transformed HHS’s views and actions on minority health. For the first time in history, representatives from each agency convened to talk about minority health and, more importantly, put forth recommendations to achieve health equity. Findings illustrated huge disparities between African Americans and other minorities compared to the population at large for key health indicators, such as life expectancy and infant mortality. Key recommendations relevant to FDA’s mission centered around health information and education, cooperative efforts (inside and outside of the government), health professions development, data development, and developing a research agenda.

Let’s stroll down memory lane and recap FDA’s activities that resulted from the Heckler report.

Health Information and Education 

FDA has developed numerous outreach activities to improve consumer education and access to health information by utilizing the best cultural and linguistic practices to reach diverse minority populations. Hosting symposiums and webinars, participating in conferences, exhibiting in health fairs, and creating consumer educational materials are just some of the activities FDA has carried out to raise awareness and educate the public. Most recently, OMH has created a social media presence on Twitter and Pinterest, and maintains an active listserve with a quarterly newsletter. One of our most successful outreach campaigns has been the “Heart Health Toolkit” for American Heart Month, which reached over 6,000 people in February.

Our most recent consumer outreach occurred on March 25th via a webinar on how the public can respond to requests for comments on regulatory proposals and public health issues by using FDA dockets.

Cooperative Efforts/Health Professions Development

OMH embraces the notion that protecting the public’s health cannot be done in isolation. We have focused on four areas to improve stakeholder relations:

  • Work with Industry to increase diversity in clinical trials;
  • Work with minority serving institutions and organizations to implement strategies and programs to improve regulatory science (specific to minorities);
  • Provide platforms for stakeholders to become informed and involved about our work; and,
  • Host and promote mentoring programs to encourage minorities to stay in scientific and academic careers.

Data Development and Research Agenda

We have a robust research agenda that focuses on advancing regulatory science related to eliminating health disparities. The agenda consists of various intramural and extramural grant programs, giving preference to minority-serving institutions. FDA also promotes and funds research that aims to increase the quantity, and improve the quality, of data on minorities, and to make these efforts transparent to the public.

In short: FDA has been and will continue to be committed to narrowing the health disparities gap. OMH will continue our legacy of creating culturally and linguistically tailored tools, materials, and resources for minority communities to increase their awareness and understanding of FDA’s mission and of the products that FDA regulates, increase their participation in clinical trials, and increase diversity in the workforce. This ensures better representation in the workforce, and most importantly: better health for all minorities!

More information about specific programs can be found on our website.

The Heckler Report can be found at: http://collections.nlm.nih.gov/catalog/nlm:nlmuid-8602912-mvset.

Jonca Bull, M.D., is Director of FDA’s Office of Minority Health

Reducing the number of unapproved drugs while working to prevent drug shortages: a job that calls for strong collaboration in FDA

By: CAPT Val Jensen and Cynthia Schnedar

Val Jensen

CAPT Valerie Jensen R.Ph., Associate Director of the Drug Shortage Staff, Center for Drug Evaluation and Research, FDA

Several of FDA’s recent drug approvals highlight how different parts of FDA work together to achieve the same goal: ensuring an adequate supply of FDA-approved drugs for U.S. consumers. Our drug shortages team partners with many groups within the agency to achieve this goal. One of these partnerships is with our unapproved prescription drugs staff.

Patients and doctors alike may be unaware that some prescription drugs are not FDA-approved, because versions of some of these products have been marketed for decades, often with little data to demonstrate whether these drugs are safe and effective. At FDA, one task of our unapproved prescription drugs team is to identify these products, and encourage companies to remove unapproved versions from the market, and begin the application process to obtain FDA approval.

A growing number of manufacturers have successfully obtained approval for formerly unapproved products. For example:

  • Bloxiverz (neostigmine methylsulfate injection), marketed by Éclat Pharmaceuticals and approved to reverse the effects of certain neuromuscular blocking agents after surgery, was approved in 2013, and,
  • Vasostrict (vasopressin), marketed by Par Sterile and approved to increase blood pressure in adults in vasodilatory shock whose blood pressure remains low despite administration of fluids and other efforts to raise it, was approved in 2014.
Cynthia Schnedar

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

Such approvals highlight the strength of collaborations between FDA’s shortages staff, our unapproved drugs team, and the Office of New Drugs. These approvals are crucial for FDA: once a drug is approved, we know what ingredients are in the drug, how it is made, and that it has been shown to be safe and effective for its labeled use. Approval of formerly unapproved products also helps alleviate FDA’s concerns about a potential market disruption or shortage of these drugs, because the manufacturers of approved drugs have invested in a manufacturing process that helps to ensure the drug is produced the same way every single time, lowering the risk for shortage.

However, prescribers and their patients may sometimes think there is a shortage of product because once the manufacturer can produce an approved drug in sufficient quantities to meet market demand, the unapproved versions transition out of the market. To help allay such concerns, FDA’s unapproved drugs team works closely with the drug shortages staff to share information about the availability of the newly-approved product from the manufacturer, information that is then conveyed to patients and providers. This strong relationship between the different parts of the Agency facilitates adequate supply of safe and effective, FDA-approved drugs.

FDA is aware of another access-related issue as well when unapproved drugs are approved. If a single manufacturer is the sole maker of a newly-approved product, the price of the drug may be higher than what patients and prescribers paid for the unapproved drug. FDA welcomes manufacturers’ sensitivity to pricing of these newly approved versions. However, FDA is charged by Congress to ensure that drugs are safe, effective and properly labeled and does not factor costs into its drug approvals or safety related decisions. While approved drugs may cost more, patients are assured a safe and effective product.

FDA encourages companies to apply for approval of generic versions of newly-approved drugs since this would be anticipated to foster competition and promote price reductions. For example, neostigmine, a formerly unapproved drug, now has two approved manufacturers. FDA expects to receive more applications for approvals in the future.

Making safe and effective medicines available to patients is our number one goal. While working to bring FDA-approved drugs to market frequently involves exceptional challenges and complications, we believe that in the long run, our efforts enhance public health for all Americans.

CAPT Valerie Jensen R.Ph., is Associate Director of the Drug Shortage Staff, Center for Drug Evaluation and Research, FDA

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

Providing Timely Patient Access to High-Quality, Safe and Effective Medical Devices

Jeffrey Shuren, M.D., J.D.

We know that patients with life-threatening or irreversibly debilitating conditions lack treatment and diagnostic options. For these patients, earlier access to promising new devices is critically important. At the same time, delayed access may mean the difference between life and death, or may result in irreversible disability.

Jeffrey ShurenIn weighing the benefits and risks of new technologies for these patients, we understand the need to place greater weight on the benefit of earlier access, and to also account for the risks of delayed access. That’s why  we’ve developed the Expedited Access Program (EAP): to speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions without compromising FDA’s high standards for safety and effectiveness.

Under this voluntary program, sponsors of devices for life-threatening or irreversibly debilitating conditions that meet an unmet need can request an EAP designation. Also under this program, CDRH staff- including senior management – work collaboratively with developers of such devices earlier and more often. These efforts include the creation of a Data Development Plan that provides predictability and leverages postmarket data collection. The Data Development Plan will shift premarket data collection to the postmarket setting, to the extent appropriate, taking into account the public health benefit of these devices, while still meeting the U.S. approval standard of reasonable assurance of safety and effectiveness. Starting April 15th, this program will be up and running and we will begin to accept requests for EAP designation.

The premarket data must be adequate to support FDA’s high standard for premarket review but can include data based on an intermediate endpoint or a surrogate endpoint reasonably likely to predict clinical benefit.

Another important feature of the EAP is how FDA decides that the benefits of a novel device for patients with life-threatening or irreversibly debilitating conditions outweigh its risks. Under the EAP, FDA may accept a greater degree of uncertainty if it is sufficiently balanced by other factors, including the probable benefits to having earlier access to the device.

If, after careful analysis, FDA determines that some data can be collected after the device is on the market, then patients in need will benefit sooner. A few of the factors that can enter into this analysis include a low probability of serious harm, a high likelihood that postmarket surveillance can quickly identify instances of serious patient harm and a high likelihood that postmarket data collection will be completed in a timely manner.

We consider this balancing of premarket and postmarket data collection to be so important that we made it one of our three 2014-2015 strategic priorities, along with strengthening the clinical trial enterprise and providing excellent customer service.

Today, we’re taking steps to implement that priority. In addition to issuing a guidance document outlining our EAP program for devices to treat or diagnose life-threatening or irreversibly debilitating conditions, we’re issuing a guidance on balancing premarket and postmarket data collection. It describes the circumstances under which postmarket data collection is appropriate for PMAs, whether or not they meet the criteria for the EAP, and provides many useful examples.

Once EAP products come to us for review, they will qualify for priority review. This feature, combined with the other elements of the EAP program, will reduce the time it takes to develop important new medical devices for patients with unmet medical needs and it will do so without ever lowering our standards.

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

FDA to Industry: Let’s Increase the Availability of Safe, Effective Animal Drugs

By: Martine Hartogensis, D.V.M.

Just as drugs for people benefit from FDA review to ensure their safety, effectiveness and quality, so do drugs for animals.

Martine HartogensisUnfortunately, this fact is ignored by some companies that sell unapproved animal drugs. By bypassing the FDA’s drug approval process, these firms potentially put the health of animals—and people—at risk. That’s why the FDA is working to get these products off the market.

There are different pathways to FDA approval and legal marketing of an animal drug product, but each pathway requires a drug company to expend both time and financial resources to generate the appropriate scientific evidence to support the approval. Companies that bypass the FDA drug approval process may be endangering the animals given unapproved drugs and people who either handle the unapproved drugs or eat food from animals treated with them. In addition, those who market unapproved drugs have an unfair competitive edge, and might prompt others to also break the law in order to compete in the marketplace. This slippery slope leads to a diminished supply of animal drugs that have been reviewed by the FDA for safety and effectiveness.

FDA’s rigorous review process also makes certain that the manufacturing process preserves the drug’s strength, quality and purity, and ensures that it has been consistently produced from batch to batch. FDA also requires that the product labeling is truthful and complete.

In some circumstances, the unapproved drug may be the only one of its kind available. In these cases, FDA often works with the company to develop the evidence that the product is safe and effective. Making innovative, FDA-approved animal medications legally marketable is an important part of FDA’s mission to protect the public health.

But while being helpful, FDA is also stepping up efforts to combat illegal animal drug sales, both on the ground and online.

We’ve recently issued warning letters to several marketers, distributors and manufacturers of unapproved animal drugs and expect to issue more in the coming year. Our enforcement actions could include seizures of violative products and/or injunctions against manufacturers and distributors of unapproved animal drugs. We also continue to regularly update the agency’s web page on unapproved animal drugs with information for veterinarians and industry.

We’ll continue to do all we can to make the animal drug approval process as straightforward and efficient as possible. But we need industry to do its part, so that we can continue to make more safe and effective drugs available to veterinarians, animal producers and pet owners.

Martine Hartogensis, D.V.M., is Deputy Director, Office of Surveillance and Compliance at FDA’s Center for 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.