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

Posted on January 29, 2013 by FDA Voice

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

Posted on January 22, 2013 by FDA Voice

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 21^st 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

Posted on January 8, 2013 by FDA Voice

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.

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 21^st century.

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

FDA’s Modern “Corps of Discovery” in China

Posted on May 10, 2012 by FDA_Voice

By: Christopher Hickey, Ph.D.

I love history. I especially love the story of Meriwether Lewis and William Clark who, in their famed venture to explore the newly-purchased Louisiana Territory at the direction of U.S. President Thomas Jefferson, fashioned a lean and mean team largely consisting of seasoned, highly qualified frontiersmen. While Lewis and Clark’s “Corps of Discovery” benefitted to some degree from maps that had been developed by previous explorers who had traversed similar terrain, there was a large swath of territory in the middle of their journey that was literally “off the map”—no non-native groups had ever set foot on those pieces of the North American continent. And while brawny, rough-and-tumble, frontiersmen may have dominated the rolls of the Lewis and Clark expeditionary force, they would have all frozen or starved to death had it not been for the keen and savvy brilliance of Sacagawea, surely one of the unlikeliest heroines in American history.

The Honorable Margaret Hamburg, Commissioner, FDA and Dr. Christopher Hickey, Country Director, FDA China

I also love my job. I run FDA’s China Office. Nearly four years in, I still pinch myself most mornings to make sure I’m actually getting paid to lead this fascinating, unpredictable 21^st century expedition to explore new public-health frontiers for my country.

Like Lewis and Clark, we in the FDA China Office have been fortunate enough to benefit from a surfeit of talented “frontiersmen” – and women! – who’ve volunteered for this pioneering venture. They include inspectors and policy analysts who, in some cases, have served FDA for nearly four decades! They’ve seen marked similarities between the challenges we face in China in 2012 and the challenges FDA faced in regulating domestic U.S.industry several decades ago. Our “pioneers” include FDA food scientists and biochemists with deep, rich expertise who are now applying that knowledge to work in collaboration with Chinese authorities as they develop a regulatory system that will keep pace with increasing Chinese economic growth, and ever-expanding exports to U.S.markets. And our “FDA Corps of Discovery” includes legal, policy and health diplomacy professionals. These professionals apply their knowledge of FDA standards and regulations, as well as their scientific and diplomatic expertise, to enhance the Agency’s knowledge base about China’s regulatory landscape. In addition, they track industry trends to inform U.S. regulatory decisions and actions, and strengthen collaboration on mutual regulatory challenges.

And we certainly find ourselves, like Lewis and Clark, “off the map,” at times. How do you navigate a regulatory system that assigns responsibility to government agencies not by product category but by where the product currently sits in the system of production and distribution? How do you engage a regulatory counterpart that has export promotion as a primary mission? How does FDA engage a regulatory system where the legacy of state-owned enterprises still looms large? These are all “off-the-map” types of questions we’ve had to face.

And we have our Sacagaweas—unsung, unlikely public-health heroes. While U.S.civil servants lead the way for our efforts in China, Chinese nationals play a key role to support our work—liaising with the Chinese Government, negotiating cross-cultural communications, and supporting our inspections throughout China. FDA could not do its work in China—or in any of its overseas offices—without dedicated foreign service nationals.

“Those who cannot remember the past are condemned to repeat it,” Spanish philosopher George Santayana once opined. In FDA’s China Office, we strive to remember the best of our past so that we can know how best to engage our emphatically globalized future.

Christopher Hickey, Ph.D., is FDA’s China Country Director

Collaboration for a Global Product Safety Net

Posted on April 16, 2012 by FDA_Voice

By: Mary Lou Valdez

If it takes a village to raise a child, in today’s economy it takes the support and commitment of a global community to ensure the safety of the food we eat and the medications we rely on.

This point was made clear in an Institute of Medicine report released on April 4. The report was commissioned by the FDA as the agency addresses the challenges of global supply chains, international trade, and foreign sourcing of foods, feeds, and medical products. It complements the FDA Commissioner’s Report on Global Pathway to Product Safety and Quality released last summer.

Imports of food and drug products regulated by FDA have increased by more than 13 percent per year since 2002, resulting in a four-fold increase of products produced outside of the United States. Approximately 50% of the fresh fruits and 20% of fresh vegetables, as well as 80% of seafood consumed in America comes from abroad. Similarly, more than 80 percent of the active pharmaceutical ingredients used to make medicines are imported. To ensure that the vast array of products Americans depend on are safe, FDA focus can no longer be solely domestic – it must be global.

Since many of the products imported are from emerging and developing countries, the FDA asked the IOM to take a look at the regulatory systems in those countries to identify major gaps and to design a strategy for how the FDA, along with other regulators and stakeholders, can help to strengthen their regulatory systems and build capacity.

Not surprisingly, the IOM found that the hurdles are great in some countries where there is inadequate clean water, electricity, transportation, communication systems and Internet access. Their regulatory agencies often operate with a skeletal staff, outdated equipment and limited or non-existent surveillance systems. In some of the least resourced countries there are weak or no laws governing product safety while product safety is not a high priority in others.

The IOM Committee’s strategy was to focus on the nexus of public health, product safety, development and trade, while recognizing that regulatory systems play an important role. The IOM identifies several core elements of a regulatory system: they must be responsive, outcome-oriented, predictable, risk-based or proportionate and independent. Other important commonalities include an enterprise risk management approach to regulation; focus on securing the entire supply chain; develop a profession of regulators – an “esprit de corps”; and make accountability an essential element of their system. The IOM also acknowledges that industry must play a role in ensuring the safety of its imported products.

To help build regulatory capacity, the IOM recommends that the FDA, other federal agencies and international organizations provide technical expertise, training and tools to strengthen the surveillance system in developing countries.

We take pride in the efforts FDA already has undertaken to support and collaborate with regulatory systems across the globe, such as our foreign training programs on good clinical practice inspections and low acid canned food inspections; a medical products information “hub” for the Americas in collaboration with the Pan American Health Organization; our interagency agreements with the US Agency for International Development to better understand pharmacovigilance systems in Africa and Asia; and our involvement with the World Bank’s Global Food Safety Fund, a partnership of public and private organizations intended to boost food safety capacity around the world. And this is only a short list of our activities.

We welcome the IOM’s call to international and intergovernmental organizations to invest more in strengthening the capacity of regulatory systems in developing countries, and to track progress as a priority of development banks, regional economic communities and public health institutions.

We were pleased that the IOM supports the agency’s risk-based strategy for monitoring and inspecting imported products and recommends that the agency extend this approach by working with strong regulators in other countries to plan inspections and pool data.

However, additional legal authorities would be helpful to accomplish this goal. FDA currently is barred from sharing certain non-public information with other regulatory agencies that might lead to timely identification, prevention, and resolution of emerging threats. Nor do we have the authority to use foreign audit data collected by our foreign regulatory counterparts with strong regulatory systems that would better leverage our limited resources.

Other authorities would be helpful to help us better manage risks. These include the ability to refuse admission of a product if inspection of the manufacturing facility is delayed, limited, or denied; and allow FDA to destroy the low value but large number of unsafe drugs that are coming into the country through international mail, typically purchased over the internet. In order to enhance our risk data, we would like additional information such as unique facility identifier as a condition of registration and import that would make it easier for FDA to properly follow a threat through the supply chain.

To ensure that industry assumes appropriate responsibility for their imported product, it would be helpful for manufacturers to account for the quality and origins of the materials that go into their products and require that manufacturers provide complete information to FDA on threats to the drug supply chain. Furthermore, the use of accredited third parties that meet prescribed standards could provide an additional set of eyes to help ensure the safety of the drug supply chain.

Ensuring the safety of imported food and medicines takes all countries working together, including governments, industry, academia, and other stakeholders. But marshalling the forces of this vast community may not be enough to provide the robust regulatory system we need in today’s global marketplace without new authorities to protect the health of the American public.

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs and Director, Office of International Programs

FDA Voice Interviews Deborah M. Autor, Esq.

Posted on February 24, 2012 by FDA_Voice

En Espanol

FDA Voice: Thanks for agreeing to talk with us – can you tell us a little about your job at FDA?

Deputy Commissioner Autor: My goal is to make FDA’s response to globalization challenges and import safety a top priority. A little bit of background – last July 2011, Commissioner Hamburg established the Office of Global Regulatory Operations and Policy (“GO” or “Global Operations”) as one of FDA’s new Directorates. This office provides executive oversight, strategic leadership, and policy direction to FDA’s domestic and international product efforts. I provide broad direction and support to the Offices of Regulatory Affairs and International Programs and I also work on making sure FDA integrates its domestic and international programs to promote and protect public health.

FDA Voice: What brought you to GO?

Deputy Commissioner Autor: There have been fundamental global shifts that have major implications for consumers – and transforming FDA from a domestically focused agency operating in a globalized economy to a truly globally focused public health agency that oversees a worldwide enterprise is a now both a necessity and monumental challenge. Given my almost twenty years of professional experience working on issues related to FDA-regulated products, when Commissioner Hamburg offered me this opportunity to lead GO and help with transforming FDA into a modern public health regulator in a globalized economy, I welcomed the opportunity.

FDA Voice: Tell us more about what you were doing before GO.

Deputy Commissioner Autor: I joined FDA in 2001, and from 2006 to 2011, I served as Director of the Office of Compliance at CDER. Before that, I was a trial attorney at the U.S. Department of Justice, Office of Consumer Litigation, and in private legal practice before that. So pretty much my entire professional career has been focused on FDA-related issues.

FDA Voice: What’s the favorite part of your job at FDA?

Deputy Commissioner Autor: By far, the favorite part of my job is working with the passionate and dedicated people at FDA. They exemplify the best in public service and it’s a privilege to work collaboratively with such great people on critical public health issues.

FDA Voice: What major changes have you witnessed in FDA over the past ten years?

Deputy Commissioner Autor: Global economic conditions and innovations in technology, science, and communications have dramatically changed the landscape of FDA regulated products and, in addition, global production of FDA-regulated goods and materials has exploded over the past 10 years. For example, FDA-regulated products are currently imported from more than 150 countries, with more than 130,000 importers of record, and from more than 300,000 foreign facilities. In 2011, nearly 24 million shipments of food, devices, drugs, cosmetics, radiation-emitting products, and tobacco products arrived at U.S. ports of entry. Ten years ago, that number was closer to 6 million. So you can see how globalization has fundamentally changed the economic landscape in the U.S., and it will continue to have major implications for FDA.

FDA Voice: How can we meet the challenges of globalization?

Deputy Commissioner Autor: We have come up with a plan, and last June, 2011, we published a special report, “Pathway to Global Product Safety and Quality,” which lays out our global strategy and action plan. I hope people will read the plan, but in short it lays out an approach focusing on four pillars of: building global coalitions of regulators; establishing global information sharing and networks; increasing intelligence-gathering and risk analytics; and, leveraging third parties. The Pathway focuses on how FDA, given its limited resources, can have the greatest impact on public health–a goal we all share.

FDA Voice: How do you envision FDA ten years from now?

Deputy Commissioner Autor: Our goal for the future is to build a public health safety net for consumers around the world, created, supported, and maintained by global coalitions of regulators. In the future, we will be operating under a model that relies on strengthened collaboration with other regulators, improved information sharing and gathering, data-driven risk analytics, and the smart allocation of resources, leveraging the combined efforts of government, industry, and public- and private-sector third parties. It is clear that FDA, and our many partners, are ready to face the global challenge together!

FDA Voice: Thank you so much for your time!

Deborah M. Autor, Esq., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy