To Improve Food and Drug Safety, Regulatory Agencies Should Adopt Risk-Based Decision-Making, Says New Report


Jan. 15, 2020

To Improve Food and Drug Safety, Regulatory Agencies Should Adopt Risk-Based Decision-Making, Says New Report

WASHINGTON — The goal of achieving universal health coverage by 2030 — one of the United Nations’ Sustainable Development Goals — necessitates that countries strengthen their food and drug regulatory systems as a whole, says a new report from the National Academies of Sciences, Engineering, and Medicine. Stronger Food and Drug Regulatory Systems Abroad recommends strategies and a framework that regulatory agencies worldwide can adopt to support the availability of good quality, safe food and medicines globally and identify areas of greatest risk.

The report also recommends ways that U.S. government agencies, international development donors, and the World Health Organization (WHO) can strengthen the capacity of food and drug regulators, particularly those in low- and middle-income countries. Such investments should prioritize the expansion of WHO’s approval and quality control processes for priority medicines and vaccines; the development of tools for rapidly screening food and drug quality; and improving the evaluation of how well regulatory agencies are performing.

A food or drug safety issue in one country can have public health, social, and economic consequences around the world. Unsafe food kills over 400,000 people a year and costs $110 billion globally in treatment and lost productivity. In sub-Saharan Africa alone, poor quality medicines cause about 70,000 unnecessary deaths from childhood pneumonia and roughly 8,500 to 20,000 deaths from malaria every year.

The report builds on a previous National Academies report released in 2012. Since that report, the regulatory landscape has evolved significantly, due to the growth of the global middle class, shifts in the leading causes of disease and disability, and urban population growth. These changes have increased consumer demand for safer food and medicines — and consequently, the demand for regulators’ time and resources.

“Investing in stronger national regulatory systems and better collaboration among them puts their focus where it should be — on improving public health,” said Catherine Woteki, professor in the department of food science and human nutrition at Iowa State University, and chair of the committee that wrote the new report. “These investments have positive spillover effects for governments, health systems, and the food and pharmaceutical industries.”

One of the biggest challenges facing low- and middle-income countries is limited access to quality medicines. The WHO prequalification process can help regulators in these countries ensure that they are licensing safe, quality-assured medicines. It has traditionally applied to the approval of HIV, tuberculosis, and malaria drugs. Given the growing global burden of chronic diseases, the report recommends that WHO expand its prequalification process to include treatments for cancer and diabetes, as well as high-quality antibiotics that could reduce the global threat of antimicrobial resistance.

The prevalence of informal food and medicine markets also poses another major risk to regulators today. In low- and middle-income countries, street vendors or kiosks that lack refrigeration account for about 80 percent of food sold. Informal medicine sellers are often popular in rural areas and other places pharmacies do not reach. Regulatory agencies should consider risk reduction strategies including accreditation and licensing of sellers (on food handling, local pharmacy laws, good dispensing practices, and other topics), consumer education, and increasing competition from regulated products, the report recommends.

It is difficult for any regulatory agency — even those that are well resourced — to estimate the size and scope of potential food and medicine safety issues. The report recommends that donors including the U.S. International Development Finance Corporation, the International Finance Corporation, and European development banks invest in inexpensive, rapid screening technologies to detect possible fraud or contamination in the food and drug supply chain.

National regulatory authorities should also determine which tasks they could handle on their own, versus those better suited for international sharing or delegation to state and local authorities. For example, the approval of a new medicine may be determined by a country’s own review, a joint review with neighboring countries, or accepting the decision of a trusted foreign authority.

The report recommends that the National Institutes of Health, in collaboration with the U.S. Food and Drug Administration and the U.S. Agency for International Development, develop a network of Global Centers of Excellence in Regulatory Science. These centers, run in partnership with universities or consortia in low- or middle-income countries, would research regional product safety needs and provide strategies to improve local manufacturing and quality control.

It is also vital that regulatory agencies understand how well they are performing in comparison with those in other countries, says the report. Development donors should give incentives for countries to participate in regulatory benchmarking assessments, the report recommends. Benchmarking assessments can make the task of strengthening regulatory systems more concrete and show a system’s relative strengths and weaknesses.  The benchmarking process can motivate improvements to regulatory systems if it is transparent and the results are made public, says the report.

The study — undertaken by the Committee on Stronger Food and Drug Regulatory Systems Abroad — was sponsored by the U.S. Food and Drug Administration. The National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine. They operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln.

Report Highlights

Stephanie Miceli, Media Relations Officer
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