Category Archives: Globalization

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

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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

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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

 

FDA and Sub-Saharan Partners Protecting Public Health

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By: Beverly Corey, DVM

FDA and its partners in Sub-Saharan Africa have made great strides in improving the oversight of the clinical trials of medical products in development—an important advance in protecting public health in both the U.S. and Africa.

This is important not only to protect the Africans who are participating in these tests of medical products, but also because the FDA and other regulatory authorities must rely on the results of these studies when reviewing marketing applications for the products.

FDA’s Office of International Programs (OIP) established its Sub-Saharan Africa Post in Pretoria, South Africa, in June 2011. We have been building regional relationships that allow us to share information about FDA policies and procedures, and to better understand the regulatory landscape there. The latter is no small feat in this vast region of 54 countries with varying degrees of regulatory strengths and capabilities.

However, our collaboration with the Southern Africa Development Community (SADC), which represents 15 African nations, has allowed FDA to strategically engage in strengthening regulatory capacity in the area of Good Clinical Practices (GCPs) and clinical trial inspections. These practices, and the inspections to ensure that they are followed, are designed to protect the integrity of data produced by the trial and the safety of its participants.

This activity has given expertise to regulators who did not think their knowledge base was extensive enough to audit (monitor) and inspect clinical trials. Regulators in countries that once did not audit clinical trials are now doing so. With more than 2,000 clinical trials being conducted in Africa—over half of them in South Africa—this is a momentous public health achievement. 

GCP team members meet with the principal investigator and staff at a TB clinical trial site

The Sub-Saharan Africa Post conducted a successful FDA/SADC Good Clinical Practice Inspection training from August 24-28, 2012, in Lusaka, Zambia. Thirty six drug regulators from 13 SADC countries participated, including Angola, Botswana, Lesotho, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Swaziland, Tanzania, Zambia and Zimbabwe.

This was the third in an FDA training series—typically offered in three to four phases—to develop trainers who have expertise in clinical practices and inspection. These individuals will also be prepared to train others within their agencies and the regulated community.  

This particular workshop was designed to reinforce lessons learned and provide additional inspectional experience for those who completed workshops in the first two training phases in Botswana in 2010 and in Pretoria in 2011. The goals of Phase 3 include reviewing core knowledge and skills, preparing inspection reports and inspectional observations; acquiring additional mock inspection experience at clinical investigator sites; gaining experience with new types of study protocols; and promoting regional networking.

These countries continue to make substantial progress in the oversight of clinical trials. For example, at the onset of our first training, only three of 13 participating countries were involved in how clinical trials are conducted. We now have an additional two countries conducting oversight, with others poised to start soon. Other milestones from our training include important advances towards systematic oversight in Botswana, Mauritius, Swaziland, Tanzania, Zambia and Zimbabwe.

The definitive winner here is public health, both the health of the African people who participate in the trials and the health of the patients who may one day be taking these drugs being studied.

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

 

Basing Food Safety Standards on Science and Prevention

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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

Improving the World through Improved Food Safety

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By: Margaret A. Hamburg, M.D.

Food safety may seem an unusual issue for a lending institution created to encourage growth and reduce poverty in developing countries.

Photo courtesy of the World Bank

The World Bank, however, rightly notes that food safety is not only about public health, as important as that is. It is also critical for economic development, expanded market access and trade, and ultimately for the alleviation of poverty. This week in Paris, the World Bank held its first Global Food Safety Partnership Conference and I was immensely pleased to be able to participate.

The Global Food Safety Partnership (GFSP) is a major milestone on the road to protecting the health of all people in our increasingly interconnected world. Participants represent governments, industry, academia, international organizations and technical bodies.  Among other things, both public and private members are committed to working collectively for stronger food safety systems and strategies.

FDA’s primary mission is to protect the supply of food and medical products in the United States. Increasingly, though, that mission cannot be carried out completely within our borders. Given that we import half of the fresh fruits and 80 percent of the seafood we consume, to name just two commodities, our efforts must be global.

As I noted during a keynote address, the overarching theme of the FDA Food Safety Modernization Act is prevention. The law acknowledges the global movement toward stronger food safety standards and higher assurances that standards are being met, which is a driver of FDA’s transformed import strategy. For FDA, it is essential that we contribute to and rely on capable foreign food safety oversight. Strengthening these food safety systems is the key to maintaining the integrity of the global supply chain. 

Serendipitously, our self-interest coincides with a humanitarian imperative.

Photo courtesy of the World Bank

Up to a third of people in the developing world suffer food and water-borne illnesses every year. More than 2.2 million each year, mostly children, die of those illnesses. Farmers and other food-related enterprises in those countries have little hope of competing in the marketplace as long as their products are suspect.

GFSP is an innovative example of the kind of cooperation we need around the world. It is bringing together food producers and manufacturers, academics, regulators and industry representatives, as well as lenders and borrowers. We all have a collective interest in food safety, and a shared responsibility. When any country improves, everyone wins.

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

A New Partnership with New Zealand

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By: Deborah M. Autor, J.D. and Michael R. Taylor, J.D.

This week, for the first time, FDA and New Zealand’s Ministry for Primary Industries recognized each other’s food safety systems as providing a comparable degree of food safety assurance at a signing ceremony at the Embassy of New Zealand in Washington, D.C.

One practical result of this arrangement is enhanced information exchanges to avoid duplication of efforts: for example, if the two food-exporting countries decide that their food safety programs and practices provide a comparable level of food safety assurance, they can take this into account as appropriate in determining the type and frequency of inspections to conduct of foreign manufacturing establishments and of imported food shipments.

This means the comparable nations can concentrate more resources, including inspections, on foods that present a greater risk, providing for improved food safety overall.

The arrangement with New Zealand is part of an overall strategy for strengthening the global food safety net through closer collaboration with regulators around the world, highlighted in FDA’s report “Pathway to Global Product Safety and Quality.”

Mike Taylor, J.D.FDA recognizes that, while import examinations are an important tool in helping to ensure that imported foods are safe, we can’t examine every food headed for or arriving at our borders. Instead we make risk-based decisions about which shipments need the least and the most scrutiny at the border. Under the new Food Safety Modernization Act (FSMA), FDA is mandated to expand its import tool kit beyond FDA’s border screening to include stronger importer accountability for verifying the safety of food imports, a much strengthened system of private audits, more FDA inspections overseas, and importantly, greater collaboration with foreign regulatory authorities.

Globally, however, there are major differences in the strength of food safety regulatory systems. For years, we have conducted reviews of various food safety policies and programs in place in other countries to provide assurances of the safety of individual products. The systems recognition process that we completed with New Zealand goes beyond our previous commodity-specific evaluation strategy, covering the overall food safety system that is in place, and how it is implemented, and extending to all FDA-regulated food products.

 

In the past, New Zealand and the U.S. had certain commodity-specific arrangements in place such as ones for seafood and dry dairy products. A scheduled review of these arrangements coincided with the time FDA was starting to consider ways to expand the global safety net through enhanced cooperation with other nations. Both countries thought: Why not try to expand beyond these products to include every product regulated by FDA and its counterpart in New Zealand?

Carol Barnao, Deputy Director General Standards, New Zealand Ministry for Primary Industries, and Mike Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine, at the signing ceremony.

That was the start of intense work which began in 2010. FDA, working with New Zealand regulators, comparing every facet of each country’s food safety system—the training of inspectors, procedures for identifying and responding to food safety issues, and legal authority, to name a few.

Once we had confidence in the system on paper, we conducted on-site reviews of the implementation of their programs, to give us an understanding of how their programs worked in practice.

Both countries retain the right to conduct inspections of each other’s products as appropriate. But assured about each other’s competency and commitment, both are more likely to focus their resources on higher risks. Importantly, if a problem does occur, each country intends to work cooperatively on follow up.

The process for conducting systems recognition is still being pilot tested with Canada. FDA will continue to update and refine our process as we work through the pilot with Canada. Systems recognition is voluntary and not required in order for a country to export FDA-regulated foods to the U.S., but any country that believes it can meet the very high bar will have the option of seeking recognition. Meanwhile, we will continue working to foster a global food safety net for all.

Deborah M. Autor, J.D., is Deputy Commissioner for Global Regulatory Operations and Policy

Michael R. Taylor, J.D., is Deputy Commissioner for Foods and Veterinary Medicine

China Takes Steps to Strengthen Food Safety

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By: Camille Brewer, M.S., R.D.

An important message came through loud and clear during FDA’s whirlwind visit to China this month: China is determined to strengthen its food safety system. I had not visited China in nearly 10 years and I was struck by the extraordinary progress in the cities we visited. The towering skyscrapers, tree-lined boulevards, and the obvious signs of a rising middle class demonstrate the reality of an economy that has grown by leaps and bounds. That growth has led to rising consumer expectations, and China is clearly working hard to meet consumer and global expectations for safe food. 

This message was repeated in meeting after meeting that Mike Taylor, Deputy Commissioner for Foods and Veterinary Medicine, and I had with Chinese officials. We saw a clear recognition of the scope and complexity of the challenge as well as a resolve—indeed, an enthusiasm—to take on the challenges head-on, and develop a modern, effective, and efficient food safety system.

Make no mistake: this will not be easy for China.  It has considerable catching up to do in the science and daily practice of food safety and in its legal system.  But the enthusiasm and commitment we saw seems real, and is backed up by action.

China is now implementing its first comprehensive food safety law, which established a Food Safety Committee to oversee all ministries responsible for food safety. The law also calls for the establishment of a national center to focus on risk assessment and risk monitoring to strengthen the scientific underpinnings of food safety regulations.

Earlier this year, China issued a five-year plan for national food safety supervision.  The plan directs the Food Safety Committee and its working office to oversee improvements intended to strengthen China’s food safety regulatory system, emergency response capabilities, supply chain management, surveillance systems, standard-setting activities, and third-party testing. It also calls for improved risk communication and interagency coordination among regulators at central, provincial, and local levels. This plan is testimony to the resolve of the Chinese government to elevate the importance of food safety.

FDA has been working very closely with China for some time to enhance cooperation and address food safety issues of concern. Today, FDA and Chinese food safety authorities renewed an agreement originally signed in 2007. Under the agreement, FDA has helped China to strengthen its regulatory system and better understand FDA’s food safety requirements. This cooperation was made much easier when FDA established offices in China in 2008, enabling us to dramatically increase our inspections and conduct workshops for Chinese government and industry representatives.

On our trip, we also noticed increased consumer interest in food safety. We met with a professor and blogger from China Agricultural University who emphasized Chinese consumers’ concern about economic fraud.  A representative from the Shanghai State FDA and Shanghai Food Safety Committee told us that they have established a consolidated consumer hotline for food safety concerns. 

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

This consumer focus dovetailed well with the presentation made by Mike Taylor at the China International Food Safety and Quality Conference in Shanghai. He noted that consumer confidence in the food supply is an important goal, and what is needed to improve food safety is also what is needed to strengthen consumer confidence in the food they eat. That’s an industry commitment to food safety, credible and effective government oversight, public-private collaboration and partnership, and transparency on the part of industry and government.

He noted that countries other than China are pursuing similar food safety initiatives. In addition to the United States, which is implementing the FDA Food Safety Modernization Act, the Canadian Senate recently passed the Safe Food for Canadians Act, and the Dominican Republic, Madagascar and Vietnam are among countries pursuing modernized food safety laws.

During our trip, we also met with representatives of multinational corporations doing business in China and visited a canned food facility in operation in the Huairou District, a suburb of Beijing.

We know there is still a lot of work ahead to improve food safety worldwide, and efforts by our trading partners must be combined with strong oversight by U.S.government agencies. The FDA Food Safety Modernization Act gives us new tools to improve that oversight, so the elements that are necessary to improve both food safety and consumer confidence are coming together.

The speech presented by Mike Taylor can be accessed at the following link: http://www.fda.gov/Food/FoodSafety/FSMA/ucm326870.htm.

The text of the 2007 agreement, which was officially renewed on December 11, 2012, is available at: http://www.fda.gov/InternationalPrograms/Agreements/MemorandaofUnderstanding/ucm107557.htm

Camille Brewer is Director of International Affairs at FDA’s Office of Foods and Veterinary Medicine

 

World AIDS Day

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By: CDR. Steve L. Morin, R.N., B.S.N.

World AIDS Day has been observed in the United States on December 1 since 1995. When I look back at early World AIDS Day observances, I remember them as a way of raising awareness of the men, women and children who had no advocates, no representation, no medicines, and practically no hope. They eventually died from the disease early in the epidemic.

In the beginning, World AIDS Day was an important platform for the HIV/AIDS community to help raise awareness among the many people who had never known or even met anyone living with HIV/AIDS. In those early years, the focus was on finding a treatment and keeping those diagnosed with the disease alive. 

Last year marked 30 years since AIDS was first reported in the Center for Disease Control and Prevention’s Mortality and Morbidity Weekly Report (MMWR), emerging as a permanent part of our lives. Today, when I think about World AIDS Day, I think of it as a day to acknowledge how far we have actually come in the fight against HIV/AIDS. We’ve come so far—not only in treatment, but also in preventing new infections, and reducing or eliminating the stigma associated with this disease. 

The Food and Drug Administration supports the fight against HIV/AIDS by promoting medical innovation, protecting the blood supply, and reviewing and regulating new and existing medical products, including devices used in prevention, such as condoms and medical gloves. Doctors, nurses, pharmacists, scientists and many others at FDA have worked hard in 2012 to make sure that there are safe and effective medical products and devices available to fight HIV/AIDS. I am happy to say that this year there were four major advances in the battle against HIV. 

  • Truvada is the first HIV drug approved for prophylactic (preventive) use. It has been shown to reduce the risk of sexual transmission of the HIV virus to uninfected adults.
  • OraQuick In-Home HIV Test is the first rapid home-use oral HIV test kit that does not require sending a sample to a laboratory for analysis. This test has the potential to identify previously undiagnosed HIV infections, especially if used by those unlikely to visit a doctor’s office or clinic.
  • Stribild is the first HIV medicine to combine four separate drugs and is the third HIV drug that can be taken once daily.
  • The number of antiretroviral drugs tentatively approved or approved for use under the President’s Emergency Program for AIDS Relief, or PEPFAR, has surpassed 150. PEPFAR is a program to treat those infected with HIV/AIDS in countries that lack the tools needed to fight the AIDS epidemic.

So today, as World AIDS Days approaches, I ask that you take a moment to remember the combined effort of patients, researchers, industry, FDA and other government agencies contributing to the successes in fighting HIV/AIDS. There are currently 36 approved therapies for treating HIV/AIDS in the United States. As new therapies are added to the list of treatments, patients’ quality of life has improved, with fewer side effects and simpler therapeutic regimens that make adhering to therapy easier. People living with HIV are now able to focus on life rather than death. Until there is a cure, we will continue to work together for an AIDS-free world.

CDR. Steve L. Morin, R.N., B.S.N., is a Health Programs Coordinator in FDA’s Office of Special Health Issues

Global Cooperation Helps Expand Safety Net

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By: Margaret A. Hamburg, M.D.

En Español

Em Português

Ensuring that the millions of FDA-regulated products that flood into the U.S. from 150 foreign countries every year are safe and effective can be daunting task. That’s why it was heartening for me to sign two cooperative arrangements this week with some of our international partners that will make this task a little easier. The arrangements also represent encouraging developments in the quest for a global safety net created through international cooperation.

One arrangement, a “Statement of Cooperation” with FDA’s counterpart in Brazil, outlines procedures for enhanced collaboration between our nations on common regulatory issues. The arrangement is particularly critical at a time when Brazil is dramatically increasing its trade with the U.S. The U.S.imported $31.4 billion worth of products (both FDA-regulated and not regulated) from Brazil last year — an increase of 126% from 2000.

Top regulatory officials from four countries, meeting at a summit in Brazil, prepare to sign the "Statement of Cooperation" among their respective agencies. They are, left to right, Paul Glover, assistant deputy minister of Canada’s Health Products and Food Branch, Margaret A. Hamburg, M.D., commissioner of the U.S. Food and Drug Administration, John Skerritt, national manager of Australia’s Therapeutic Goods Administration, and Dirceau Barbano, director chairman of Brazil’s National Agency for Sanitary Vigilance.

The second arrangement, a “Statement of Cooperation” is between the FDA and our regulatory counterparts in Australia, Brazil and Canada. The arrangement creates stronger regulatory oversight that is less burdensome for both industry and regulators as we pool resources to cover a larger global array of medical device manufacturers.

I signed both arrangements while in Manaus,Brazil, in the heart of the Amazon River basin. The heads of counterpart regulatory agencies from around the world had come together to collaborate on ways to help better ensure the safety of products in all countries — an approach we refer to as the global safety net. Thus, this summit was a particularly appropriate occasion for signing these two arrangements.

The already difficult job of ensuring the safety of FDA-regulated products has grown exponentially due to two megatrends: the expansion of global trade, and the need for ever-greater expertise from regulators as innovations bring increasingly sophisticated products to market.

Our strategy is to create coalitions of regulators that bring together the best minds from around the world to work on the common goal of improving product safety and quality. As I outlined in a keynote address I delivered at the conference, we need to develop a strategy that moves us towards routine regulatory coherence and mutual reliance with our regulatory counterparts. While maintaining national sovereignty and individual agency decision-making responsibility, we can do much more to share regulatory information, strategies and resources.

The arrangements I signed while in Brazil stood as concrete examples of the broader concepts discussed at the conference.

The arrangement between the FDA and regulatory agencies in Australia, Brazil and Canada provides for the creation of a single audit program for medical device quality management systems. The four countries, in accordance with their respective legal authorities, would develop a plan to audit, or inspect, a device facility and then the other countries would utilize the regulatory findings.

The four countries also pledged to promote greater global alignment of regulatory approaches and technical requirements.

Standardized oversight procedures will bring more consistency, predictability and transparency to the regulatory process.

FDA Commissioner Hamburg and Dirceau Barbano, director chairman of the National Agency for Sanitary Vigilance in Brazil, review a "Statement of Cooperation" between their respective agencies.

The broad arrangement between Brazil and the U.S. includes a number of provisions. Both countries will consider exchanging information collected during investigations or facility inspections. They will also identify research that supports the scientific basis for regulations and actions.

What is expected is increased understanding of each other’s regulatory systems and an opportunity to explore how to leverage each country’s resources to expand the safety net for both countries.

The arrangements, and the conference, are steps towards a future with better outcomes through global cooperation. I was pleased to be a part of it.

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

 

Better Process Control Schools Around the World

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By: Irene Chan

When you open a can of creamed corn soup, your expectation is that you can consume it without fear of getting sick. We rely on commercially sterile foods, such as canned foods and other shelf-stable vacuum packaged foods, for everyday meals, as well as for emergency situations, such as natural disasters. In all of these situations, the safety of food is vital. The airtight, low-acid environment of many commercially-sterile foods is a prime target for the growth of bacteria that can produce a lethal toxin that causes botulism.

Irene ChanFortunately, since FDA established low-acid canned food (LACF) and acidified food (AF) regulations in the 1970’s, the commercial processing of commercially sterile foods in the United States has become much safer. One of FDA’s requirements is that, with few exceptions, manufacturing supervisors at canneries must have taken an appropriate training course to understand how to make a safe commercially-sterile product. FDA must approve these so-called Better Process Control Schools (BPCS), which numerous large universities throughout the United States offer. These courses provide essential information about how to effectively control the risks associated with the manufacturing of commercially-sterile foods, and how to comply with U.S. law.

With the increasing globalization of the food supply, FDA has recognized that the need for BPCS training has gone beyond our shores. And until recently, it was a challenge for foreign manufacturers to send persons to attend BPCS in the United States because of travel and language barriers. But through FDA’s foreign offices, we have supported local universities throughout the world with the capability to host approved BPCS training courses right where they are needed.

China, where there are several hundred establishments registered with FDA to export canned foods to the United States, is a prime example of a robust food export market. In September 2011, through collaboration between FDA’s China Office and experts in FDA’s Center for Food Safety and Applied Nutrition (CFSAN), the first-ever, locally sponsored BPCS course in China was conducted at China Ocean University in Qingdao, Shandong Province. Attendees were able to obtain the content of the course in Mandarin Chinese from local food technology professors, while an FDA technical advisor was available for questions. This June, the university held its second course, with eager attendees coming from mainland China as well as Taiwan.

Closer to home, the Latin American region has established itself as the pantry for the United States, supplying a myriad of food products throughout the year. There are hundreds of food manufacturers in the region that would greatly benefit from the opportunity to send supervisors to a local, approved BPCS. The Latin America Office has identified three universities as having the knowledge base and infrastructure to conduct BPCS courses: Costa Rica’s Center for Food Technology Research (CITA), Guatemala’s Del Valle University, and Peru’s National Agrarian University- La Molina.  In addition, FDA’s Latin America Office worked with the Inter-American Developmental Bank to obtain funding to provide the approved course materials for the universities in Guatemala and Peru to conduct their own BPCS. These universities will soon provide these courses at a low cost, with capable instructors who speak the local language and understand the local realities of the industry. In Peru, the university recently completed their first BPCS on August 17th, 2012. Representatives from FDA’s Latin America office, FDA’s Office of Regulatory Affairs, and CFSAN were present to answer questions and assist with the delivery of the class. In Costa Rica, CITA has scheduled their first BPCS for August 27-31, 2012, and expects attendees from the Caribbean and Central America region.  These are pilot programs, and we have already heard from other countries and institutions that want to participate in similar efforts.

Indian manufacturers produce hundreds of different varieties of vacuum packed ready-to-eat dinner entrees that are imported into the United States. Before 2011, no in-country BPCS was available for these manufacturers. In March 2011, local faculty at Bhaskaracharya College of Applied Sciences in New Delhi taught a BPCS course for the first time. The course cost each student only about $200—this sum paid for instruction, catering for meals and course materials. Students came from throughout India to attend the course.  A FDA technical advisor’s participation in the course allowed students to ask questions about process filings and engage in technical discussions with FDA. This year, the college held a second class in Sri Lanka for LACF and AF producers located in that country.  A third class is planned for later this year.

The FDA overseas offices are proud to have helped stand up these important training events in various parts of the world, and to support local universities as they develop the capacity to put on these courses. And the next time we open that pouch of vacuum-packed curry lentils, we will know that the effort to keep our food safe is truly global.

Irene Chan is the Deputy Country Director of FDA’s China Office. Edmundo Garcia, Jr., Assistant Regional Director for FDA’s Latin America Office, Daniel Geffin, Food Technologist in FDA’s Office of Food Safety, Food Process Evaluation Team, CFSAN, and Bruce Ross, Country Director of FDA’s India Office, contributed to this post.