Little attention has been paid to the regulatory systems in low- and middle-income countries across the world, causing a huge and negative impact on global public health, argue three employees of the US Food and Drug Administration (FDA) in the latest issue of the Public Library of Science Medicine (PLoS Medicine).
The article, Strengthening Medical Product Regulation in Low- and Middle-Income Countries, was authored by Charles Preston, Mary Lou Valdez and Katherine Bond, all employees of FDA's Office of International Programs.
Much of their article focuses on the issue of regulatory capacity-the ability of countries to train, educate and maintain a regulatory workforce with which to regulate healthcare products. While most high-income countries have sufficient resources to devote to the maintenance and growth of regulatory systems, regulators in resource-starved countries are faced with stiff competition for limited funding and talent.
"The lack of attention to medical product regulatory systems in low- and middle-income countries is a significant gap that needs to be bridged," the FDA staffers wrote. "We propose that strengthening regulatory systems in low- and middle-income countries must become a global health priority, and explain the imperative in terms of globalization and the rapid scale up of medicines to the developing world."
A New Regulatory Paradigm Emerging
The problem for US regulators is clear, they said. While established regulatory systems could once ignore developing regulatory systems because they did not impact them in any meaningful way, increasing numbers of drugs and medical devices are being manufactured abroad. In the US alone, they wrote, 30% of drugs and devices are now imported from foreign sources, and product supply chains are increasingly global as well.
Protecting those products and their supply chains will take a village of regulatory systems, they argue, and high-income countries can no longer ignore the regulatory capacity issues of these systems.
They cite an example involving the accidental poisoning of thousands with diethylene glycol-more commonly known as antifreeze-in Peru after a tainted sweetening agent entered into the supply chain. The product made its way through numerous regulatory areas, eluding detection in every country it entered on its way to Peru. If just one of those regulatory regimes had been able to identify the problem, more than 100 lives could have been saved, they argued.
The Way Forward
But how to help? The trio said some models may be of service. The President's Emergency Plan for AIDS Relief (PEPFAR), for example, allowed FDA to tentatively approve certain drugs for safety and quality, which in turn allowed regulators in other countries to focus their energies on combating other problems. "Systems in many low- and middle-income countries are not equipped to perform such assurance functions," they noted.
The World Health Organization (WHO), too, has been instrumental in facilitating broader approvals under its prequalification program that allow products to get to citizens in low- and middle-income countries faster while consuming fewer regulatory resources.
This is particularly important as one of the greatest threats to public health in these countries is not an unsafe but legally-approved drug, but rather counterfeit and substandard drugs imitating legal drugs, they said.
The authors cited a 2005 case in Niger in which 3,000 people died after being inoculated with a counterfeit meningitis vaccine. Such events cause the public to lose faith in its regulatory system and seek alternatives elsewhere.
The development of basic regulatory science will also be crucial to alleviating the burdens of reduced funding. By sharing FDA's regulatory expertise and methods with their foreign regulatory counterparts, they said they were able to bring products to market at much lower prices, including a legitimate meningitis vaccine available for just $0.50 a dose.
"Garnering support for this agenda is not without its challenges," they conceded. But, "A global dialogue is beginning. Discussions of expanded market access for exports, increased trade opportunities emanating from science-based regulation and regulatory coherence, and more sustainable economic development, should also be included, as they will provide further incentives for countries to come to the table."
"As the challenges of globalization mount, and efforts to provide medical products to low- and middle-income countries scale up, there is no better time to put regulatory system strengthening squarely on the global health and development agenda."