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Keynote Address, 2012 Food and Drug Law Institute U.S. and Brazil Conference

Remarks by Deborah A. Autor, J.D., Deputy Commissioner for Global Regulatory Operations and Policy
Sao Paulo, Brazil
September 10, 2012

I am delighted to be here this morning in a room full of people who, in one way or another, have dedicated themselves to product safety and quality worldwide. 

It’s an honor to speak with you today, and I want to thank Susan Winckler, the FDLI staff, and the multitude of others who worked to organize and bring this conference to fruition.

It’s really no surprise that Brazil was chosen as the location for this year’s meeting.  Brazil has seen unprecedented growth in recent years, now boasting the sixth largest GDP in the world.  U.S. President Barack Obama captured the importance by stating earlier this year that Brazil is "not only a leading voice in the region, but also a leading voice in the world."

And I know the world will be a rapt audience when Brazil hosts two of the foremost sporting events—the 2014 World Cup and the 2016 Summer Olympics—which will also be the first time South America has ever hosted the Olympic Games.  Based on the brief, but brilliant, glimpse we got of the capoeira, the samba, and the drummers at the end of this year’s Summer Olympics, I know the 2016 Games will be a vibrant celebration, like none the world has seen.

We can all agree that nothing excites or unites the world like a good sports competition.  Yet, nothing is as important or as central to our success as nations as the health and wellbeing of our people.  Spurred by the rising influence of globalization, we have reached a turning point where trade, economic development, and global health intersect as never before.  And that’s why the presentations, discussions, and exchanges we will have over the next two days are of such importance.

Over the past few decades, the production models that once existed have drastically changed due to global supply chains, international trade, and the global sourcing and manufacture of regulated products. Additionally, more and more products come from developing countries where manufacturing systems may be less sophisticated and regulatory oversight may be little to none.

In the U.S. alone, regulated products originate from more than 150 countries, 130,000 importers, and 300,000 foreign facilities. In the last ten years, the number of imported shipments of FDA-regulated products has quadrupled – from six million to 24 million.

And, there is a tremendous amount of imports generating from this region.  Countries, including Brazil, Mexico, and others located throughout the Americas, produce around 41 percent of all U.S. imports.  Of those imports, 59 percent are medical devices; 40 percent are foods; and the remaining 1 percent is comprised of drugs, biologics, tobacco, and animal feed.

The world has changed, and our historical regulatory approaches and tools—such as hoping to intercept products at our borders—are insufficient. 

Just as HIV/AIDS and pandemic flu have demonstrated the stark reality that disease knows no borders; public health crises, like the melamine and heparin contamination incidents, have vividly demonstrated that the flow of goods, including the foods we eat and the medical products we use, also knows no borders.

As FDA Commissioner Margaret Hamburg has stated, "Today we recognize that to successfully protect U.S. public health, we must think, act, and engage globally.  Our interests must be broader than simply those within our own borders."

In short, to respond to this globalized environment and adequately protect the public, we must work differently and we must work together.   

At the FDA, we fully realize we cannot do it alone.  In response, we’re transforming to an international operating model, outlined in our recent action plan, the "Pathway to Global Product Safety and Quality."  This model is built upon four pillars: global coalitions; global data systems; enhanced risk analysis; and leveraging the efforts of public and private third parties. 

To truly realize this monumental goal over the next decade, FDA will continue to transform from a predominantly domestically focused agency operating in a globalized economy  to an agency fully prepared for a regulatory environment in which regulated products know no borders.  And these four pillars will help us get there. 

The first pillar involves the creation of global coalitions of regulators, focused on ensuring and improving global product safety.  A primary aim of these coalitions would be to develop procedures for more comprehensive and systematic information sharing and deployment of resources.  So, as we move from a primarily domestic orientation to one that treats like risks in equivalent ways, we must push toward mutual reliance—a point where FDA, ANVISA, MAPA, and other regulators can rely on each other, as well as on private third parties, to protect and improve product safety.  

FDA is starting to assess the compliance of foreign firms through a regulatory network, making decisions in some cases based solely on the work accomplished by our foreign partners. 

The second pillar involves building global data systems and networks that allow for regular, systematic information exchange between foreign regulatory partners.  To fully identify risks and emerging trends, and then strategically allocate limited resources, it is essential that regulators be able to aggregate multiple sources of information.  

That means we need to work together to identify critical data elements, such as unique facility identifiers, to better standardize reporting, and create properties for regular systematic information exchanges. 

The third pillar of the Pathway Report involves an increased focus on risk analytics and thoroughly modernized IT capabilities.  Risk analytics can inform our strategies and our priorities in inspections, training, regulatory cooperation, and surveillance efforts and help regulators to make timely, effective decisions.

The fourth and final pillar involves leveraging the efforts of public and private third parties.  One of the most fundamental changes any regulator can undertake is a more effective deployment of its own resources.  We can accomplish this through the strategic leveraging of third parties against risk-based priorities.  We need to ensure that our standards are well understood and fully applied, foster best practices in industry, and foster innovation to drive safety and quality.  Then we need to work with other stakeholders – public and private—to help to ensure compliance, and further best practices and innovation.

Taken together, these four pillars will help move FDA towards strategic and risk-based global industry oversight.  The strategy marries strong global coalitions with cutting-edge data and investigative tools to continue providing the consistently high level of safety and quality assurance the public expects—and deserves.

Part of this transformation is mandated through new legislative authorities FDA received over the past two years intended to modernize our medical product and food safety systems.

The Food Safety Modernization Act and the newly signed Food and Drug Administration Safety and Innovation Act were recognition from the U.S. Congress, industry, and other stakeholders that FDA cannot do it alone.  No one can.  And in reality, no one should.

Globalization requires that all of us—regulators, industry, multilateral and regional institutions, non-government organizations, scientific and research communities, and others – must re-double our efforts to meet our respective and collective responsibilities to assure the safety and quality of global products.

Only by trabalhar em conjunto, or working together, can we weave a global public health safety net that protects and promotes health around the world. 

For our part, the FDA has implemented or participated in a multitude of strategies over the past decade to help build that net, many of which are highlighted in our recent "Global Engagement" report.

These include efforts to harmonize scientifically rigorous standards internationally; strengthen detection and surveillance systems in developing countries; share scientific and technical expertise with fellow regulators; and build capacity around the world in crucial regulatory disciplines.

Although there is much being done, we also recognize that we have much to learn from our regulatory partners around the globe, and we can greatly increase our impact by working together.

Our establishment of 13 foreign posts in strategic locations worldwide, including our three posts in Latin America—Mexico, Costa Rica and Chile—is an effort to build FDA knowledge about the regulatory landscape in the Americas, and help our colleagues better understand FDA’s approaches to product safety and quality. 

It also gives us the opportunity to work more collaboratively in aligning regulatory strategies and systems.   While forging those relationships, our foreign offices can help our counterparts and industry efficiently navigate through FDA standards and regulations.  This role will be critical as we implement components of our new legislative authorities, such as first-time user fees for the generic drug industry. 

The majority of FDA’s global engagement is accomplished through a variety of robust bilateral and multilateral relationships. With some countries, we actively collaborate on inspection report exchanges, joint inspection programs, and parallel assessment of applications. 

We have a relationship with ANVISA that allows us to share important regulatory information via a confidentiality commitment.  And, we continue to explore partnership opportunities with the ANVISA and MAPA that will allow us, both, to better leverage our resources and protect the public.

Although efforts by the United States, Brazil, and other world leaders are important, there are still gaps in the global safety net. It connects back to our idea of trabalhar em conjunto or working together.  In order to have a strong global public health safety net, we need global coalitions. 

In order to have strong global coalitions, we need to strengthen regulatory capacity in developing countries and around the world.

FDA and the Brazilian government are already moving down this path.   For example, ANVISA hosted a meeting this year in Geneva immediately preceding the May 2012 World Health Assembly to discuss the global challenges of sanitary regulations.

Most of us agree on these two things:  all people deserve safe food and access to quality medical products; and, all nations deserve the opportunity to participate in a global economy.   And strong, integrated regulatory systems are the backbone for each. 

This is why FDA commissioned the Institute of Medicine in the United States to identify the core tenets of a regulatory system for developing countries, perform a gap analysis, and recommend strategies for strengthening systems that may fall short. 

IOM’s report, “Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad” was released in April.  And I think the U.S. and Brazil can agree with the IOM’s findings on the essential elements of a strong regulatory system—it should be responsive, outcome-oriented, predictable, risk-based, and independent.

The IOM found that many low- and middle-income countries do not or cannot embody these central characteristics.  They also identified common problematic themes in developing regulatory systems: non-adherence to international standards due to lack of infrastructure, expertise, and equipment; or difficulty controlling supply chains, which makes sense when refrigeration may be a luxury, poor roads make transport erratic, and communication is fragmented between government and those it’s intended to serve. 

But that’s where public health, market incentives, risk-based investments, and international coordination can assist.  And, the U.S. President’s Emergency Plan for AIDS Relief, known as PEPFAR, is a good example of when all of these forces collide.  PEPFAR was established to provide an emergency response of anti-retrovirals to millions of people suffering from HIV/AIDS.  FDA had a role in PEPFAR by creating a “tentative approval” system to assure the safety, quality, and efficacy of anti-retrovirals on patent in the U.S. but desperately needed in AIDS-stricken countries. 

PEPFAR has now treated over 200,000 people and reduced the typical costs of treatment from $10,000 per person per year, to $100 per person per year—all without sacrificing safety or quality of the medications.  With its success, the PEPFAR program is now transitioning from an emergency response to promotion of sustainable country programs, country ownership, and broader health development. 

Delivering needed health products can be an essential, immediate relief.  Building strong regulatory systems is a long-term, sustainable solution that leads to a better public health safety net and ultimately, better global health.

I think we can all recognize that not every developing country’s regulatory system has to be equivalent to that of FDA, ANVISA, MAPA, or other more stringent authorities.  But we do have to help regulators around the world move forward—working together, and leveraging where we can—so that our global safety net can expand. 

And I believe Brazilian regulatory organizations, such as ANVISA and MAPA, have a profound impact on the health of Brazilians and the vitality of its food and medical product industry.  

There are some fantastic examples, here in this region, of what can happen when we work together.  These three programs are a testament to how integrated, global solutions can weave a broader public health safety net and strengthen regulatory systems worldwide.  They also align with some of the pillars I highlighted earlier.  

First, FDA and ANVISA have both been instrumental members of the Pan American Network of Drug Regulatory Harmonization (PANDRH) to better support pharmaceutical regulatory harmonization in the Americas.  Brazil hosted the 2011 PANDRH meeting, which focused on topics such as good clinical and laboratory practices, pharmacovigilance, and combatting counterfeit medications. 

I’m hopeful that PANDRH will allow us to take a strategic approach to the improvement and convergence of regulations, standards development, and implementation, moving toward a global curriculum for regulators and good regulatory practices.  This will help build regulatory capacity and trust in emerging countries while furthering public health across the region. 

Second, we’re currently exploring the idea of a single audit pilot program with ANVISA, Health Canada, and TGA for medical devices.  The goal of the pilot would be to determine if an inspection done by one regulator can count for multiple regulatory agencies. 

If this idea works, it will reduce redundant requirements for firms and save regulatory resources to focus on higher risk inspections in our respective regions.   As we learn to rely on each other’s data rather than needing to gather it on our own, we are all better served. 

Mutual reliance and effective resource utilization are paramount to all of us, but especially to emerging markets.  These concepts allow regulators to depend on resources or components from other regulatory systems, such as laboratory capabilities, rather than each having to stand up its own independent system.

And finally, the last example of collaboration is the PAHO Regional Platform on Access and Innovation for Health Technologies, known as the PAHO Hub, which is an online English and Spanish platform for regulatory exchange.  It creates a virtual community of practice among regulators in the Americas.

The PAHO Hub will allow for essential information sharing about regulatory systems and standards, legal foundations, and institutional structures, and building knowledge networks.   In many ways, it’s similar to what industry may find through FDLI or a trade association—a way to share best practices and collaborate.  And, I believe it’s an excellent example of the type of global networks we need to foster greater collaboration and enhance our ability to make strategic, risk-based decisions.

This tool should be immensely valuable for countries needing to enhance their regulatory systems and learn from those who have a more robust system in place.  But, the PAHO Hub will also help to generate much-needed dialogue and better align practices among all regulators in the Americas.

In the future, we should work to expand the potential of networks for greater data sharing and analysis.  And if we’re really leaping ahead, we can envision global networks that allow for dialogue and sharing not just among regulators, but also including industry, academia, and other organizations.  

Those are just three of the initiatives by FDA, ANVISA, and other regulators in this region, and there are many more happening around the world.   But just as FDA realizes we cannot build the safety net alone, neither can the regulatory bodies build it alone.  It takes all of us.

Expanding the global safety net is the responsibility of many stakeholders—including industry, development partners, and the academic and scientific communities.   And your efforts layered on top of those of global coalitions of regulators allow the safety net to be much wider and stronger.

Just as regulators are coming together through the PAHO Hub to share information and learn from each other, medical product firms should be doing the same, especially when it relates to the interconnected flow of products.  You can share monitoring methods, technologies, and other pertinent information about the supply chain, alerting each other and regulators, when you become aware of problems or vulnerabilities. 

Rx360, an international supply chain consortium of the pharmaceutical and biotech industry and their suppliers, is a good example of this type of collaborative approach.  This organization is working together to create and monitor global drug quality through activities such as sharing information on counterfeits, cargo thefts, and the quality and authenticity of supplies and suppliers, as well as developing standards for audits and certification programs. 

In the past, industry has also been an important partner in encouraging stronger regulatory oversight in developing countries to help maintain the quality and safety of products.  Development partners and academic and scientific communities have also started to understand the value of strong regulatory systems and the backbone those systems can provide to the accessibility and sustainability of programs they support. 

In addition, there are new public-private partnerships for regulatory capacity.   One such example is the African Medicines Regional Harmonization initiative located at the World Bank and supported by partners such as the New Partnerships for Africa's Development, the World Health Organization, Pan African Parliament, the Bill & Melinda Gates Foundation, UK Department for International Development, and the Clinton Health Access Initiative.  This partnership aims to improve public health by increasing access to good quality, safe, and effective medicine through harmonizing regulations and expediting registration of essential medicines.  And there is a similar model being launched for food safety.

We must all participate in and leverage these kinds of efforts to further build and support our global public health safety net and improve product safety and quality worldwide.  Globalization represents opportunities and challenges for all of us—as regulators, members of industry, and others—standing at the nexus of trade, economic development, and global health. 

There is only one path forward—and it’s represented in the multi-colored rings of the Olympic flag we’ll see flying in Brazil in 4 years.  Interconnected.  Interdependent.  Working together.

Building a robust, worldwide regulatory system won’t be easy.  It will require tremendous effort, creativity, flexibility, and vision.  Through our individual and collective efforts, we can weave a global public health safety net that will assure that consumers have access to safe food and high quality medical products—assuring global health. 

Working together.   Trabalhar em conjunto.