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Remarks Before the IOM Committee on Regulatory Systems Capacity in Developing Countries

Remarks as Delivered of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
IOM Committee on Regulatory Systems Capacity in Developing Countries
Wednesday, March 2, 2011

It’s a pleasure to be here this afternoon. Before going any further, I’d like to thank this committee in advance for the incredibly important and timely work you will be doing over the next several months.

You have received some background from my FDA colleagues and a Statement of Task, so I know you understand how critical a time this is for FDA in a global context.

You also represent a unique set of perspectives…and include a cross-section of experts in US food and medical product safety, global health policy and implementation, and the animal-human health interface. Simply put, you represent the range and complexity of expertise needed to help us think about a global regulatory system.

Which is we why we hope that through this study you can generate unprecedented dialogue about the central role that strong regulatory systems play in global food security and safety - and global health more broadly.

I believe that, as we work to strengthen health systems and improve health for people everywhere, we must also embrace our common and vital responsibility to strengthen global regulatory capacity around the globe.

Unfortunately, this is something that leaders in policy and the scientific community have not fully recognized - and something we must continue to reiterate and emphasize. We cannot have an effective 21st century health care system, if we do not have an effective 21st century regulatory system for food and medical products. Our ability to promote global public health depends on it.

Though often forgotten, regulatory systems are as integral to successful health care systems as re biomedical research institutions, quality hospitals and clinics, and adequate numbers of well-trained health care personnel. In fact, they are the linchpins for success - and help ensure safe, high-quality, and meaningful interventions for people who need and count on them.

This conversation is happening at a critical time. Today, we face challenges related to an increasingly complex, globalized supply chain as well as tough choices with regard to domestic priorities and development assistance efforts. It is essential that we make a compelling case for investing in regulatory capacity, and we must be completely clear about the human and economic costs of not doing so.

You will be hearing from several of my colleagues in the next few hours, but I’d like to take this opportunity to describe my vision for FDA as a global agency and highlight some key areas that I hope will become focal points of this study.

It merits repeating that we are here today because of the new realities of food and medical product regulation brought about by globalization. We know that the way products are developed, manufactured, distributed, and marketed have changed markedly in the past two decades; the path food and medical products navigate to reach our homes has become significantly more complex; and we have become vulnerable to the impact of poor quality products on the health of individuals and the public health of nations.

In today’s globalized world, FDA’s traditional model of site inspections and border examinations is simply not enough. The products American consumers use are no longer just “our” products. They are global commodities. Which means that ensuring their safety requires a truly global approach.

In 2010 alone, more than 20 million import lines of food, drugs, devices, cosmetics, and tobacco arrived at U.S. ports of entry - more than a three-fold increase in regulated imports from a decade ago. Regulated products come from 300,000-plus facilities in more than 150 different countries all over the world. And they come through more than 300 ports of entry into the U.S.

The numbers are staggering. In the food realm, about 40 or 45 percent of fresh fruit and produce and over 75 percent of seafood we eat in the United States come from other countries. And for medical products, 80 percent of the active pharmaceutical ingredients in our drugs and about 40 percent of the finished drugs themselves come from outside our borders.

At the same time, the supply chain from manufacturer to consumer has become more and more complex, and involves a web of re-packagers and redistributors that makes oversight extremely difficult.

As you can see, it is essential that we take the steps needed to meet these unique public health challenges. But FDA cannot do this alone. We must work with leaders and regulators around the world to leverage our resources, expand present activities, and, importantly, create new paradigms to help us meet our regulatory public health missions. And our vested interests in import safety overall with the interests and activities of other nations.

There are multiple benefits of adequate regulatory capacity around the world. Assuring the strength and science base of a country’s regulatory system has the potential for significant impact not only on the public health of a country and its health care delivery system, but also on the country’s economic development.

Investments in regulatory science and capacity are uniquely positioned to help grow a country’s economy by increasing high-value jobs in key sectors, fostering innovative products that will drive economic development, and enhancing the safety and value of exports.

It can also elevate overall national prosperity and, all told, serve as an important tool for national and international security.

In other words, when governments collaborate and invest in strengthening global capacity to produce food and medical products that comply with rigorous, harmonized scientific standards and regulatory practices, the benefits extend well beyond any one country’s borders - and well beyond public health.

This is particularly important for the developing world, where many of these products are now manufactured and where the consequences of poor quality products are taking their highest toll. Regulatory authorities with experience and resources must take the lead, when requested, in helping to build regulatory capacity in countries that are more resource poor and that are still developing their own systems to produce food and commodities that are safe, wholesome, and meet international safety standards.

We must also create a modern means to share data globally - and not just pieces of data, but all the data we need as a global family of regulators to really work together and leverage our limited resources. And we must use those data and advanced analytics to proactively identify and prevent problems. Detecting and preventing global problems demands global intelligence sharing and data mining.

Also, as the new Food Safety Modernization Act recognizes, we must enlist public and private third parties, as well as industry and other organizations, to support the global safety net for food and medical products. This is essential. Regulators cannot - and should not - do it alone.

This is an enormous set of tasks and challenges for FDA and our counterparts around the world. And that is where this committee can help.

I hope the IOM can help us determine how we can best engage with the global community to help those countries that wish such technical assistance to develop the capacities, competencies, and institutions they need to be functioning, dependable, integral parts of the food and medical products safety and quality assurance regulatory community.

And in doing so, I hope you will focus on a few key questions.

First, what are the core elements of needed pharmaceutical, biologics, medical device, and food safety regulatory systems development in developing countries? This is a basic but important question of what qualities and characteristics make up an effective regulatory system.

What are the essential components? What is the legal framework? How does such a system manage information? How does a regulatory system integrate itself into and leverage the human, financial, scientific, and inspectional resources of counterpart agencies around the world. And, of course, how can we work together to achieve it?

Second, how do we prioritize, in the context of globalization and as a global community, effective, efficient steps to strengthen regulatory systems that ultimately ensure a global product safety net? This is, in part, a resource question - how can we leverage our limited resources to yield maximum impact? Are there opportunities to link our efforts to other international development efforts?

Third, this committee can assist the FDA, our regulatory counterparts, and the development assistance community in identifying how our agency is best positioned to contribute to this agenda, as well as the areas to which others - including bilateral donors, development banks, foundations, academia, industry, and non-governmental organizations - are best suited to contribute.

You can also help us to determine how we, the FDA, can best partner with these other institutions to pool our resources and leave a sustainable footprint.

That is particularly important today. It is unclear whether we will continue to see the levels of support for health development assistance that we have over the past several years - to the tune of nearly $30 billion in 2010 alone. What is clear is that almost every aspect of our global health efforts depends on safe products.

Strengthening regulatory systems can leverage these investments to advance our global health goals - and allow us to do so together. We could even hypothesize that improvements in regulatory capacity, and regulatory science, will unblock bottlenecks, enabling us to more rapidly move from product development to delivery and health outcomes for both developed and developing countries.

To reach and maintain desired health outcomes in key communities, responsible global health programs must recognize and incorporate the critical role of regulatory capacity as a core element of health systems strengthening. What would it take to ensure that regulatory systems are a core element of the Global Fund’s areas of implementation…or to incorporate regulatory systems into initiatives to strengthen global health systems?

On another front, there has been a significant increase in the data being submitted to support US marketing applications that comes from international clinical trials that were conducted in countries that have not been the places in which clinical trials that support US marketing applications have traditionally been conducted. As we review findings, we must know that these clinical trials were conducted ethically and in accordance with internationally accepted scientific practices, and we must know that the assessments were made by clinical investigators with the competence to do so. What forms of regulatory cooperation will help strengthen clinical trials research, access to medicines, and post-market surveillance?

And in the area of Food Safety, the Food Safety Modernization Act calls on HHS to build the capacity of foreign governments with respect to food safety by developing a comprehensive plan to expand the technical, scientific, and regulatory capacity of foreign governments and food industries from which foods are exported to the United States.

In this realm, how can the global community bring food safety standards and preventive controls more centrally into food security efforts as they are formulated upstream? And how do we demonstrate that ultimately stronger systems lead to more reliable markets?

As you grapple with these incredibly important and challenging questions, I want to clarify what we mean by harmonization. The Statement of Task has as an underlying premise the need for strengthened capacity to implement scientific, harmonized standards.

Here, we are referring to harmonization in its broad sense - common understandings for regulators, and a convergence of standards…in other words a shared regulatory perspective and effective regulatory cooperation. Harmonization doesn’t have to mean homogenization. We don’t need to use exactly the same procedures or processes in every country around the world as long as we have a common set of goals and have comparable public health outcomes.

Finally, I encourage you to look beyond FDA. What else is out there and what can others do? We are, after all, in this together. And it’s important for other nations to assume leadership roles and feel ownership, as well.

I hope these remarks serve as a useful guide for you as you determine how to approach the questions at hand. We will gladly give as much feedback and input as possible along the way.

I am confident that your insights will help our agency define our role and allocate the resources we need to effectively help lead the effort to strengthen regulatory systems and support capacity building all over the world. This will have major implications for the American people and for people everywhere - and, as always, I look forward to working with the IOM.

Thank you.

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