FDA and Pan American Partners Work to Strengthen Regulatory Systems

By: Charles Preston, M.D., MPH

Regulatory systems are essential for good health care because they ensure safe, high quality and effective medicines. However, these systems must be strengthened in many parts of the world — a subject that is a core effort of the Pan American Network for Drug Regulatory Harmonization (PANDRH).

Charles PrestonI had the privilege of representing the FDA at a recent steering committee meeting, and I am happy to report that this network, which includes countries from all over the Western Hemisphere, is ready to adapt to new challenges like globalization, and improve its effectiveness.

In the past, the network has concentrated on upgrading regulatory standards by developing guidances and strengthening regulator capacity through training. There have been many successes, including multiple guidances issued and numerous trainings conducted.  However, there is a recognition that these efforts need new focus.

Thus, PANDRH has a strategic plan for modernizing its activities.

Rather than only developing region-specific guidances, it proposes improving standards by leveraging the work of global bodies, such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, and the Pharmaceutical Inspection Cooperation Scheme.

To strengthen capacity for oversight, PANDRH members will work to develop and implement a globally agreed upon set of regulator competencies, and use this to drive curricula and training objectives in the region. By doing this, the regulatory workforce can be professionalized, which will strengthen it for the future.

Another new emphasis will be to use evidence to help set priorities. The secretariat and PANDRH member states will now analyze data from evaluations of regulatory systems in the region to decide on future activities and benchmark success.

The importance of these changes is obvious: in today’s world of global manufacturing, trade and consumption, national regulators must be truly professional and able to implement global standards.

These are exciting developments that portend an auspicious new direction for PANDRH. FDA will continue its active engagement in the network’s efforts. They are essential to achieving a world in which everyone has access to safe, high quality and effective medical products that can protect or restore human health.

Charles Preston, M.D., MPH, is a medical officer in FDA’s Office of International Programs

Ensuring Pharmaceutical Quality Through International Engagement

By: Howard Sklamberg, J.D.

As we’ve written and spoken so much about, the FDA has had to transform itself from a domestically-focused regulatory agency into a 21st century global health organization.  This transformation has come in the face of economic and technological changes that have revolutionized how we carry out our mission. We live in a world where other countries increasingly produce—at least in part—the food and medical products our consumers and patients use in their daily lives.

Howard SklambergProducts the FDA regulates now come from more than 150 countries—many with much less sophisticated regulatory systems than our own. In this international marketplace, 40 percent of our finished drugs are imported, and approximately 80 percent of the manufacturers of active pharmaceutical ingredients used in the United States are located outside our borders.

Ensuring the quality of products in a global environment is a tall order. At every stage in the production of pharmaceutical products, and all along the global supply chain, things can go wrong.  Products can be improperly formulated, manufactured, or packaged. They can be contaminated or counterfeited. And the challenges are multiplied when the supply chain stretches around the world.

FDA is on the ground, around the world, inspecting facilities, developing relationships and providing advice.

But securing the global supply chain requires more than that. It calls for a cooperative and worldwide endeavor. It means working with our regulatory counterparts abroad to build capacity. It means harmonizing our standards for the sake of safer products and greater efficiency. It means engaging with industry and with regional and international organizations.

The Food and Drug Administration Safety and Innovation Act (FDASIA), which Congress enacted in 2012, included some important provisions designed to improve the safety and integrity of imported drugs sold in the United States. Some of the provisions are focused on FDA’s inspectional activities overseas. For example, FDASIA increases FDA’s ability to partner with foreign regulatory authorities to leverage resources through increased information-sharing and recognition of foreign inspections.

We now have more than 60 agreements with foreign counterparts to share certain information in inspection reports and other non-public information that can help us make better decisions about the safety of foreign products.

This type of collaboration not only increases our ability to evaluate pharmaceutical facilities, but allows experts to learn from each other. The result: an outcome whose sum total exceeds its individual parts.

That is exactly why today we announced an initiative to expand on our existing work to ensure that the public has access to quality pharmaceuticals. Through this initiative, and in cooperation with the European Commission (EC) and the European Medicines Agency (EMA), FDA will aim to deepen our reliance on trusted regulators outside of the U.S. who provide equivalent public safety and quality protection.

This mutual reliance initiative builds on our existing relationships with the EC, the EMA, and member states of the European Union. Under this new initiative, the goal is to increase our exchange, with the EC and the EMA, of information that is critical to making decisions that protect the public health. And together we will be more efficient and effective in targeting our resources for inspecting pharmaceutical operations.

This is the latest step in our continuing efforts to improve the quality of pharmaceutical products – a step that will deploy a dedicated FDA team to work with our European counterparts on a host of issues. The team, which will focus full time on pharmaceutical quality, will include experts from our Center for Biologics Evaluation and Research, our Center for Drug Evaluation and Research, and our Office of Global Regulatory Operations and Policy.

As a public health regulatory agency with a global presence, we look forward to strengthening our mutual reliance and capitalizing on our shared interests. The initiative we embraced today signals yet another important step forward for pharmaceutical quality here in the U.S.—and around the world.

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

Mexico and the U.S.: Progress on Food Safety Partnerships

By: Michael R. Taylor

En Español

Spring may be on the way, but it’s still winter weather in most areas of the country. If you are enjoying fresh avocados, berries or grapes, there is a good chance they came from Mexico. In fact, about two-thirds of the fresh produce imported into the United States comes from our neighbor to the south.

Food safety meeting attendees, Tubac, Arizona

Food Safety Meeting attendees, from left to right:
Samir Assar, Director, Produce Safety Staff
Bonnie Fernandez-Fenaroli, Executive Director, Center for Produce Safety – UC Davis
Lance Jungmeyer, President, Fresh Produce Association of the Americas
Hugo Fragoso Sanchez, General Director of Food Safety for Food, Agriculture and Fisheries, SENASICA
Walter Ram, Vice President of Food Safety, The Giumarra Companies
Mike Taylor, Deputy Commissioner for Foods and Veterinary Medicine

Ensuring the safety of imported produce is a major focus of FDA’s food safety strategy. That is why I am in Tubac, Arizona to meet with Mexican government officials and producers of fresh fruits and vegetables from both sides of the border. The meeting is sponsored by the Fresh Produce Association of the Americas and the Center for Produce Safety in Davis, California – two organizations that take food safety very seriously.

There’s no substitute for face-to-face meetings like this to move the needle forward on food safety. Under the Food Safety Modernization Act (FSMA), FDA is developing standards for produce safety that, when implemented, will raise the food safety bar for produce sold in the U.S., whether grown here or in other countries. However, we also have to focus on how the new standards can be effectively and efficiently implemented. How will government and industry – both in the U.S. and abroad – operate under the new requirements? How can we take best advantage of our collective efforts to understand and prevent foodborne hazards and verify that applicable standards have been met? That, after all, is where the rubber meets the road.

We don’t have all the answers yet, but we do know we can’t do it alone. I’m joined in Tubac by Samir Assar, who heads FDA’s Produce Safety Team, Dominic Veneziano, who directs our import operations; and Bruce Ross, deputy director of FDA’s Latin America office. And we are sharing the podium with Hugo Fragoso Sanchez from SENASICA and Mario Alanis Garza from COFEPRIS – the two Mexican agencies with which we have long worked closely on food safety.

Historically, our government-to-government collaboration has come mostly in response to outbreaks, import alerts and other incidents. Now, we are focused on work we can do together to better understand potential foodborne hazards and take risk-based steps to prevent or minimize them. This means building partnerships to implement FSMA in the United States and at our common border, as well as collaborating with Mexico to support its food safety modernization initiatives.

Food safety partnerships – at the U.S.-Mexico border and across the food system – must, of course, extend well beyond government. The food safety practices of growers and processors, coupled with private sector supply-chain management, are what make food safe. Government establishes the common base of standards and provides a measure of public accountability for food safety, but verification that standards are being met is a joint public-private effort.

So, we are taking advantage of the Tubac meeting to talk to members of the produce industry about how public and private verification efforts can mesh. Our goal is simple: We want to provide the high levels of assurance about the safety of produce and other food that FSMA calls for and consumers expect. And, in a world of finite resources, we can do that only by relying, where possible, on others to complement our own efforts, and by avoiding duplication.

The next step in building our partnership with Mexico is a three-day meeting in late March with our SENASICA and COFEPRIS colleagues that we will be hosting at our Silver Spring, MD, headquarters. That discussion will build on past collaborative efforts on training, laboratory coordination, risk assessment and outbreak response, but it will be looking ahead to how we can build partnerships for the prevention of food safety problems. After the meeting, we will also be engaging our private stakeholders – industry, consumers, and academia – in this dialogue.

“Partnership” is an easy word to say, but making it real is hard work. We have to learn, continuously, about and from each other; and we have to deal with hard issues in order to expand and align our capacities, share data and information across both public and public-private lines, and build the trust that is the basis for mutual reliance. Some of this will be hard, but we wouldn’t be in Tubac if we didn’t think it were possible – and if we didn’t know active partnership is essential to achieving the food safety goals we all share.

We’ll keep you posted on our progress.

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

Visiting India: Sharing a Vision for Strengthening Food and Medical Product Safety

By: Margaret A. Hamburg, M.D.

Fresh mangos, bananas and other native fruits add a pop of color and provide the backdrop while we ride along the busy streets of Delhi. While en route to the first of several meetings I held with Indian regulators, I can’t help but marvel at the vibrant buzz of India’s capital and the progress that has been made since I traveled here years ago as a young woman. Since that time, the rapid globalization of commerce has posed significant challenges to ensuring consumer safety as the number of products and suppliers entering the U.S. has increased. India now represents the 3rd largest trade partner, 2nd largest supplier of over-the-counter and prescription drugs, and 8th largest supplier of food to the United States.

Margaret Hamburg and officials in India

(L-to-R) Arun Panda, Joint Secretary, Ministry of Health and Family Welfare; Shri Keshav Desiraju, Secretary, Ministry of Health and Family Welfare; Shri Ghulam Nabi Azad, Minister, Ministry of Health and Family Welfare; Dr. Margaret A. Hamburg, M.D., Commissioner of the U.S. Food and Drug Administration; Dr. Altaf Lal, Director of U.S. FDA’s India Office; Nancy Powell, U.S. Ambassador to India.

On Monday, I began my first official visit to the country as Commissioner of the FDA. I met with officials from the Indian government who oversee the country’s health-related matters as well as those responsible for overseeing the export of foods to the U.S. and more than 200 countries around the world. These meetings provided the opportunity for me to discuss our shared vision for strengthening the quality of the foods and medical products exported from India to the United States. Ultimately this vision is intended to enhance consumer confidence in these products both at home and abroad.

As two of the largest democracies in the world, our countries have enjoyed an enduring partnership and commitment to collaborate on initiatives designed to enhance both our economies and the lives of the people in our respective countries.

Ensuring that the products distributed in the United States meet our requirements for product safety and quality is among my top priorities as Commissioner. Unfortunately the many Indian companies that understand good manufacturing and quality processes have been overshadowed by recent lapses in quality at a handful of pharmaceutical firms.

While the FDA will take appropriate action against any company that doesn’t meet our requirements, we are also willing to work with them to address their issues. All consumers deserve access to safe and affordable drugs and should not have to sacrifice quality to get that.

Officials at India’s Ministry of Health and Family Welfare share this goal. In the spirit of continued collaboration and a commitment to quality, our agencies signed the first-ever Statement of Intent. Our organizations plan to collectively work together to improve the lines of communication between our agencies and work diligently to ensure that the products being exported from India are safe and of high quality.

While the Statement of Intent is an important milestone, I am proud to report that FDA’s Office in India has already been working closely with India’s drug regulators to reinforce the importance of producing quality products for patients. Drug and food regulators in India have participated in FDA-hosted workshops and observed FDA inspections of manufacturing facilities and clinical sites with operations in India.

During my visit I am eager to learn more about the industries that produce products for the United States and to meet with business leaders where I will reinforce our expectations that they meet our requirements for ensuring that consumers here and around the world have access to safe and high-quality products.

Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

The Road Ahead for Ensuring Access to Quality Drugs for All Americans … New Laws Under “FDASIA” Will Help Pave the Way

By: Howard Sklamberg

In January, I became director of FDA’s Center for Drug Evaluation and Research’s (CDER) Office of Compliance, giving me the responsibility – and great privilege — of playing a lead role in FDA’s work to help protect the American public from unsafe and ineffective drugs. It’s a big job, filled with many challenges.

Fortunately, after three years of service with FDA, most recently as the agency’s deputy associate commissioner for regulatory affairs (our field operation), and 12 years before that as a prosecutor with the Justice Department, I feel prepared to help the agency meet these challenges head on.

I’d like to take an opportunity to share my priorities, as well as my views and perspectives on the goals and challenges ahead for FDA, as we continue to work to ensure access to quality drugs in the United States.

Tragically, last October’s outbreak of fungal meningitis from contaminated methylprednisolone injections that killed over 50 Americans and sickened hundreds more directed FDA’s attention to the immediate public health priority of evaluating the quality of sterile compounded drugs and preventing further incidents. Our efforts have included proposing a new legislative framework for federal oversight, inspecting high-risk compounding facilities that produce sterile drugs, and working more closely with our state partners.

As important as our efforts are in the compounding arena, our compliance challenges extend to many other critical areas, many of which are related to the new and growing global marketplace for pharmaceutical products.

Today, nearly 40 percent of the drugs Americans take are imported and nearly 80 percent of the active ingredients come from overseas sources. A growing number of clinical trials that test the safety and effectiveness of potential new drugs are also moving overseas, making FDA oversight more challenging. Counterfeit drugs are proliferating around the world and sometimes even entering the U.S.supply chain. The ever burgeoning worldwide use of the Internet continues to spawn avenues for illegal online sales of medicines of unknown safety and quality. Also, poor manufacturing practices that lead to facility shut-downs often contribute to shortages of important drugs. We must ensure that wherever drugs are made, wherever their ingredients are from, or wherever and however they are tested and sold, that they meet FDA’s strict standards of quality and that they remain in adequate supply.

Despite these challenges, there’s good news. The Food and Drug Administration Innovation and Safety Act of 2012 (FDASIA) gave FDA powerful new tools to enhance our compliance and enforcement activities including stronger authorities and funding to support the inspection of foreign manufacturing facilities. For example, FDASIA facilitates our ability to partner with and work more effectively with foreign regulatory agencies. FDASIA also gave FDA more authorities to control the drug supply chain.

However, laws on the books do not automatically translate into effective change without effective implementation and enforcement of these laws. So, in addition to continuing our critical work with Congress on appropriate and effective oversight of compounding that exceeds the bounds of traditional pharmacy compounding, my other key priority is to work to implement FDASIA’s provisions, keeping CDER focused globally and armed with the best set of tools possible to do the job. Although we have much more work to do, a vision of enhanced capabilities of ensuring quality drug products for the American public is well in sight.

I have the distinct privilege and responsibility of being part of a fantastic team of dedicated FDA staff that’s really making a difference, and I look forward to continuing to serve the American public in working to ensure access to quality drugs.

Howard Sklamberg is Director of FDA’s Center for Drug Evaluation and Research’s Office of Compliance

Weaving New Threads in FDA’s Global Safety Net

By: Margaret A. Hamburg, M.D.

Drugs manufactured in countries around the world account for 40 percent of the medicines we use in the United States. And an astonishing 80 percent of the active ingredients in the drugs we consume come from abroad.

Margaret Hamburg, M.D.Therefore, it is absolutely essential that we have regulations and procedures in place not just here at home but abroad as well to ensure that the medicines you and I rely on are safe, no matter where they come from. After all, lives and well-being are at stake if drugs are of questionable quality.

One of the greatest threats to safety involves substandard, falsified and counterfeit medical products in the supply chain. For the past several years, FDA has been engaged in global efforts to improve collaboration in preventing, detecting, and responding to this threat.

We have developed strong partnerships with the World Health Organization and the Asia Pacific Economic Community and we also collaborate with such development agencies as the U.S. Agency for International Development and the World Bank.

To further extend our global understanding and impact, in 2011 FDA commissioned a committee at the Institute of Medicine (IOM) to look at how falsified (fake) and poor quality drugs affect the health of people around the world. A report on its findings and recommendations was recently released.

It confirmed FDA’s belief that these fraudulent and inferior drugs are an international problem requiring international cooperation.

Briefly, here are some of the findings of the IOM report.

  • Neglecting good manufacturing practices is the root cause of poor quality drugs. However, quality practices require resources. Many of the countries in which people sorely need medical help just don’t have the financial wherewithal and other resources to mandate and monitor these good practices.
  • Bad medicines, whether sold in street markets or on unregulated websites, are a grave public health problem. They often fail to help—and often harm—the very people who most need them. In addition, they may promote antibiotic resistance which harms us all.
  • Crime and corruption drive the business of falsified medicines, and they are rampant overseas. A month’s supply of the lowest price generic ulcer medicine costs more than three days’ wages for the average government worker in much of Africa, Eastern Europe and the Middle East. The poorest patients have little choice but to buy their medicines from vendors who sell products of questionable quality.
  • In modern supply chains, medicines can change hands many times, in many countries, before they reach patients. Each exchange provides the opportunity for unscrupulous behavior on the part of manufacturers and distributors.

The IOM report recommends that FDA continue to reach beyond our U.S. borders to collaborate with our foreign counterparts in building regulatory strategies for the implementation and control of good manufacturing practices. FDA now has 12 posts around the world that are currently working to do just that with our global partners, as well as with industry and scientific and academic communities in these countries.

The IOM committee believes that we must identify where vulnerabilities exist in the legitimate drug supply chain and identify realistic national and international solutions. The panel also urged Congress to establish a track-and-trace system to keep a record of drugs as they travel from the manufacturer to the patient.

Between social media and up-to-the-second news coverage, the world seems like a much smaller place these days. But as this report makes clear, it’s actually larger than ever, and our challenges to provide a global “safety net” are many and formidable. 

The IOM report is an important resource in our quest to strengthen that safety net. For me, this report reinforces the knowledge that when it comes to ensuring the safety of medicines worldwide, we are heading in the right direction.  

Margaret A. Hamburg, M.D., is Commissioner of the Food and Drug Administration

 

Supporting Africa’s Capacity to Review and Approve HIV/AIDS Drugs

By: Beverly Corey, DVM

Sub-Saharan Africa, the portion of Africa that runs from the Sahara Desert to the Cape of Good Hope at Africa’s southern tip, is more heavily affected by HIV and AIDS than is any other region of the world. In South Africa alone, 17.8 percent of the people have HIV. There were an estimated 22.9 million people living with HIV and 1.2 million deaths in Sub-Saharan Africa in 2010.

Against the backdrop of this harsh reality, FDA has played a critical role in helping to ensure the availability of high quality, safe, and effective treatment therapies. The agency has approved or tentatively approved applications for 155 antiretroviral drugs from Dec.3, 2004 to Nov. 8, 2012, thereby making them available for use as part of the President’s Emergency Plan for AIDS Relief, or PEPFAR. This program, begun in 2004, is the U.S.government’s commitment to support HIV/AIDS treatment for millions of people around the world.

It is clear that the supply of medications to treat HIV/AIDS in Africa must be increased.  One necessary way to address delayed access to medications is to bolster the expertise of African regulators so that they can conduct timely reviews of drug applications. After all, the FDA approval or tentative approval is just one step. Then the therapies must be registered (or approved) by competent drug regulatory authorities in the countries of use.

Some resource-constrained low and middle income African countries have lacked sufficient expertise to conduct registrations efficiently. Focusing on generic drugs will be particularly important there, because generics are less expensive than the brand name products.

Recently, as part of a longstanding PEPFAR mandate for FDA to provide drug registration training for African regulators, the agency had the opportunity to spearhead and provide such training.

Let me share with you what we accomplished. FDA, in collaboration with the Kilimanjaro School of Pharmacy and Purdue and Howard universities, provided a five-day course on the review of generic drug applications and PEPFAR drug reviews.

Thirty-seven regulators and academicians from 17 African countries participated. This first-of-its-kind training, held in Moshi, Tanzania, was aimed at enabling regulators and pharmaceutical school faculty to familiarize themselves with regulatory and scientific methods applied by FDA.

The most exciting, complementary aspect of the training was to introduce the value of integrating regulatory science training into the curricula of schools of pharmacy and other academic institutions in Africa.

FDA and its partners believe that this training course can eventually be turned into a teaching module for use in academic curricula throughout Africa. Such curricula can support a cadre of regulatory affairs professionals to work in government agencies. This would further the availability and the manufacture of quality, safe and effective drug products for the African population. 

If we can contribute to a global curricula for regulators, what a legacy that would be, for both PEPFAR and FDA!

Beverly Corey, DVM, is the Senior Regional Advisor for  Sub-Saharan Africa, FDA Office of International  Programs, US Embassy, Pretoria, South Africa

FDA Commissioner’s Global Health Lectureship: Focusing the Lens on Product Safety

By: Mary Lou Valdez

FDA is responsible for ensuring the safety and quality of tens of millions of foreign shipments of human food, animal feed, medical products and cosmetics that come into the United States every year. Many source countries are part of the developing world that is still forming its economic and industrial base. Thus, we have strong public health interests in making sure that the countries of origin have effective systems of regulatory oversight.

Strengthening the ability of developing countries to regulate their industries could also produce tremendous benefits for the health and quality of life of individuals and communities in those countries. Additionally, the development of stronger regulatory systems in other countries can bolster other U.S. government investments in public health, trade and economic development.  

To enhance FDA’s knowledge of global public health trends, the Office of International Programs launched The Commissioner’s Global Health Lectureship in 2010. The lectureship invites highly respected and recognized leaders in global health to speak to FDA staff, and help the agency explore its role as a public health agency of the 21st century and consider the critical functions of regulatory science and systems that contribute to improved public health. 

Participating thought leaders have included:

  • Julio Frenk, M.D., M.P.H., Ph.D., Dean of the Harvard School of Public Health
  • Margaret Chan, M.D., Director-General of the World Health Organization
  • Sir George Alleyne, M.D., Director Emeritus of the Pan American Health Organization
  • Maria Freire, Ph.D., former President of the Albert and Mary Lasker Foundation and now President of the Foundation for the National Institutes of Health
  • Nils Daulaire, M.D., M.P.H., Director of the Office of Global Affairs, U.S. Department of Health and Human Services
  • Trevor Mundel, M.D., President of the Global Health Program, Bill & Melinda Gates Foundation

These lectures have inspired FDA staff to remain vigilant in protecting U.S. consumers and patients from harmful products, and to take action globally. For example, following Dr. Chan’s lecture, FDA is working with WHO and its member states on a long-term strategy for strengthening the review of applications for new pharmaceutical products and vaccines.  

Similarly, as a result of Dr. Mundel’s lecture, FDA and the Gates Foundation have committed to developing key messages on the strengthening of regulatory systems that the foundation and the agency can consistently and collaboratively deliver to governments and public or private institutions. Here, the Gates Foundation, through its investments in product development partners, supports research and development of medical products to treat diseases affecting poor and vulnerable populations in developing countries. Strong regulatory systems are also essential to ensuring that these products meet science-based quality and safety standards before they are approved for sale, and can be monitored afterwards. The Gates Foundation recognizes the need for regulators to make informed decisions about what products enter their markets. 

Our Global Health Lectureship has provided—and with future speakers will continue to provide—opportunities for FDA staff to engage in issues in new and unique ways, changing the agency’s global lens as we work to expand the product safety net all over the world. To learn more about FDA’s global strategies, read the “Pathway to Global Product Safety and Quality.”     

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

 

Basing Food Safety Standards on Science and Prevention

By: Margaret Hamburg, M.D.

Two of my highest priorities as FDA commissioner have been strengthening the scientific foundation of FDA’s regulatory decisions and ensuring the safety of an increasingly complex and global food supply.

Margaret Hamburg, M.D.That’s why I take such pride in FDA’s proposal of two rules that set science-based standards for the prevention of foodborne illnesses. One will govern facilities that produce food, and the other concerns the safety of produce.

The Preventive Controls for Human Food rule proposes that food companies—whether they manufacture, process, pack or store food— put in place controls to minimize and reduce the risk of contamination. The Produce Safety rule proposes that farms that grow, harvest, pack or hold fruits and vegetables follow standards aimed at preventing their contamination. 

These rules represent the very heart of the prevention-based reforms envisioned by the landmark FDA Food Safety Modernization Act (FSMA) and focus on preventing food safety problems before they happen.

These two rules are also part of a larger, ongoing reform effort, with other rules that set similarly high standards for imported and animal foods to be released in the near future.

In our interconnected world, FDA’s vigilance must extend globally. About 15 percent of our food is imported, and in some categories that percentage is much higher. For example, half of our fruits and a fifth of our vegetables come from abroad. We need a strategy that will address all of these complexities and challenges.

In drafting the proposed rules, FDA conducted extensive outreach and talked with key stakeholders, including farmers, consumer groups, state and local officials, and the research community. They build on existing voluntary industry guidelines and best practices for food safety, which many producers currently follow.

We want to continue to engage the public. So, I encourage Americans to review and comment on these rules, which are available for public comment for 120 days.

I believe this also showcases FDA’s adherence to solid science in its policy- and decision-making. The new draft rules recognize that the science of food safety is constantly evolving and that our oversight must take into account issues such as emerging disease-causing bacteria and new understandings of how hazards can be introduced into food processing.

FDA is committed to working with industry to provide the support they need, especially the smallest businesses. That’s why we are working with stakeholders through the Produce Safety Alliance, the Sprouts Safety Alliance, and the Preventive Controls Alliance to continue outreach efforts and to make educational and technical information readily available to industry.

Meeting the public health demands of a global marketplace. Bringing solid science to bear on our decision making. And safeguarding the well-being of American families with a prevention-focused food safety system. That’s FDA at work in the 21st century.

Margaret Hamburg, M.D., is Commissioner of the Food and Drug Administration

Quick Look at FDA’s Mexico Post and Our Global Work

By Phyllis J. Marquitz, M.Sc., J.D.

En Español

Food is something that we all have in common. It brings people together across cultures, borders and tables. Today, about 49 percent of fresh fruits, 21 percent of fresh vegetables and 85 percent of seafood eaten in the United States are imported. Many of these products originate from Mexico, and the volume of imported goods is increasing.

Plate of musselsIndeed, Mexico ranks second only to Canada as the largest agricultural trading partner with the United States with bilateral trade of over $20 billion, according to the U.S. Department of Agriculture. The ever-increasing imports of food are reshaping the way FDA does business, and the task of ensuring that food is safe and of high quality for American consumers no longer begins or ends at the border.

One important step FDA has taken to ensure the quality of food is to move some of our operations beyond our borders, opening 13 offices in other parts of the world since 2009. The office in Mexico opened in 2010 and is located in the capital, Mexico City, the largest city and most important cultural, educational and financial center.  Our five-person office, which includes one other FDA staffer plus three local employees, is part of the agency’s regional Latin American Office, with posts in Costa Rica and Chile.

Part of what we do is educate industry groups and academia about FDA’s public health regulations so that firms will have the tools they need to implement preventive measures that will help ensure that products are safe throughout the supply chain. In this year alone, our Mexico City office organized 20 outreach events that drew over 1,000 representatives from industry, universities and local governments.

A key part of our job is to help implement existing international arrangements between the United States and Mexico and other foreign governments. These arrangements facilitate and help ensure high quality standards we expect and insist on before any food, drug, or other health care product can be imported into the United States.

To help maintain preventive controls and science-based standards and enable swift regulatory action, we conduct outreach activities, translate documents and exchange strategic, scientific, and regulatory information routinely with our Mexican counterparts. They include the Mexican Federal Commission for Protection for Sanitary Risks, known as COFEPRIS. A recent example was the case of a non-compliant dietary supplement that contained active pharmaceutical ingredients. COFEPRIS acted on FDA’s information by conducting its own product analysis and stopped manufacturing of a product that might otherwise have entered the United States.

We’ve also sponsored pilot projects with Mexican counterparts to increase our knowledge base around the inspection systems in both countries. We need to know specifically how preventative systems work in day-to-day production and how Mexico enforces its regulations to ensure product safety and quality.

Partnerships with regulatory counterparts are also part of FDA’s efforts to protect public health. An example is an FDA Statement of Cooperation with COFEPRIS, signed in June 2012. This arrangement demonstrates a strong commitment at all levels of the U.S. and Mexican Governments to work together on food safety under a recent Food Safety Cooperative Arrangement, signed by the U.S. Secretaries of USDA and the Department of Health and Human Services (FDA’s parent department) and their Mexican counterparts in May 2012 in Geneva, Switzerland.

With the FDA-COFEPRIS arrangement, FDA recognizes that COFEPRIS, through the Mexican Shellfish Sanitation Program (MSSP), has an effective molluscan shellfish sanitary control system in place. FDA and COFEPRIS will oversee continued compliance with the U.S. National Shellfish Sanitation Program requirements through jointly conducted audits of the MSSP. These audits include checking water quality and production standards at the source.

FDA continues to work with its international counterparts and partners to help ensure that safe, nutritious food is produced world-wide – before it is made available to U.S. consumers.

Phyllis Marquitz, is Assistant Regional Director for Latin America (Mexico City) within FDA’s Office of International Programs, Office of Global Regulatory Operations and Policy