January 30, 2020
by Mary Lou Valdez
In today’s global economy, with food and medical products trading across borders, weak regulatory systems in low- and middle-income countries can have significant public health consequences, not just in those countries but in other, more prosperous countries, such as the United States.
Some 10 years ago, our international office, then known as the Office of International Programs, wisely recognized these interconnections and decided to commission the Institute of Medicine (IOM) to study the capacity of regulatory systems in emerging economies and determine what, if anything, could be done to strengthen that capacity.
The resulting report was Ensuring Safe Foods and Medical Products through Stronger Regulatory Systems Abroad, issued in 2012. It called for a risk-based approach that focused on giving more support to surveillance systems in low- and middle-income countries, providing training to regulators in those countries, exploring ways to facilitate work sharing among food and medical product regulatory agencies and taking steps to secure multinational supply chains.
Recently, we decided it was time to revisit the topic and once again commissioned the IOM, now renamed the National Academies of Sciences, Engineering and Medicine (NASEM), to determine how much progress had been made in regulatory system strengthening. On Jan. 15, a NASEM expert panel of food and drug experts issued the report, Stronger Food and Drug Regulatory Systems Abroad, informed by four public workshops, including a meeting in Costa Rica organized by our Latin America Office.
In a briefing to FDA staff on Jan. 13, the committee chair, Dr. Catherine Woteki from Iowa State University, said the panel had identified "evolutionary, not revolutionary" changes in global regulatory capacity. Today, she explained, there is a growing recognition of the interconnectedness of regulatory systems; a growing demand for safe food and quality medicines; and notable improvements in health and nutrition as a result of increasing attention to health from governments, multilateral and donor organizations and rising prosperity across the globe.
What’s especially gratifying is that the report was laced through with examples of how FDA has served as a key catalyst in driving change, including strengthening these regulatory systems, encouraging the development of standards and demonstrating the value of multilateral efforts. This could be seen, for example, in our work supporting global efforts to reduce and report falsified and substandard medicine, combatting the global burden of food-borne disease and encouraging harmonization efforts in the International Council for Harmonisation and other forums.
Nevertheless, the report acknowledges that public health challenges remain. Unsafe food results in over 400,000 deaths a year, according to the World Health Organization, and costs the global economy $110 billion in treatment and lost productivity, the World Bank estimates. Moreover, in sub-Saharan Africa alone, poor-quality medicines cause about 70,000 excess pneumonia deaths and 8,500 to 20,000 excess malaria deaths in children under five, WHO reported in 2017.
To confront these remaining challenges, the report offers a variety of recommendations for action, beginning globally, with multilateral organizations (e.g., the United Nations (UN) Food and Agriculture Organization (FAO) and the WHO), and then with efforts by national governments and regulatory agencies.
For example, drug quality could be improved by expanding the scope of the WHO Prequalification Program, the NASEM Committee recommended. This program provides regulatory assessment, inspection and ongoing quality control for drugs, vaccines and diagnostics that treat, prevent or diagnose HIV/AIDs, tuberculosis, malaria, diarrhea, hepatitis, influenza, neglected tropical diseases and reproductive health. Prequalification gives UN agencies and other large procurers a choice of good quality products to purchase for these conditions and it can serve as a proxy for regulatory approval in low-resourced nations which lack a drug regulatory apparatus. [FDA has been supportive of this program. It recently initiated a pilot program with the WHO to help it speed its assessment of new HIV drugs under the prequalification program by providing lightly redacted or unredacted dossiers of two FDA-approved drugs.] NASEM would expand this prequalification program to include treatments for costly chronic diseases such as cancer and diabetes, and possibly even biologic medicines that present a particular challenge to regulators because of their complexity.
FDA has been encouraging multilateral organizations to put more emphasis on the importance of food safety. Therefore, we found it noteworthy that NASEM proposes to build on existing multilateral support for food safety by having the FAO and the WHO convene biennial meetings of food regulators. The meetings would be modeled after the International Conference of Drug Regulatory Authorities, which seeks to foster consensus-building on drug regulatory questions. The increasing complexity of regulatory work and the interconnected nature of the food supply chain make it necessary for food regulators to have a standing, formal venue for exchange and cooperation, the NASEM committee explained. Moreover, convening food regulators is also an investment in emergency response, they added. Without a regular opportunity to come together, communication will be at best ad hoc.
However, ensuring safe food isn’t fully possible without tackling the prevalence of informal food markets, the report points out. In low- and middle-income countries, street vendors or kiosks that lack refrigeration account for about 80 percent of the food sold, a World Bank study reported in 2019. To better protect consumers who rely on the food from such informal markets, the report recommends that regulatory agencies consider risk reduction strategies such as accreditation and licensing of sellers and consumer education.
One significant theme in the NASEM report is the importance of data collection and, in particular, the need to use such tools as the WHO Global Benchmarking Tool (for medical products) and the WHO/FAO Food Control System Assessment Tool. These tools are designed to shed light on a system’s relative strengths and weaknesses, to determine what progress has been made over time, and to identify areas where multilateral and donor organizations can maximize efforts and investments.
The 2012 report called on FDA to take several actions to strengthen regulatory systems. Perhaps in recognition of all that we have already done, this latest report includes only one recommendation directed at FDA, and even that recommendation is not meant for FDA alone. Instead, NASEM proposes that the National Institutes of Health work in collaboration with the FDA and the U.S. Agency for International Development, to establish a network of Global Centers of Excellence in Regulatory Science for research and capacity building to identify and address the challenges of ensuring food and drug safety in low- and middle-income countries.
It is truly gratifying to see that so much progress has been made over the last decade, as reflected in this report. While NASEM Chairman Dr. Woteki describes what has happened as evolutionary, not revolutionary, I’m somewhat more optimistic than that. Considering where we have come from, it has been revolutionary indeed.
Editor’s note: Mary Lou Valdez was FDA’s Associate Commissioner for Diplomacy and Partnerships. She retired from federal service on January 31, 2020.