US regulators have announced a five-year, multimillion-dollar contract with the World Health Organization (WHO) intended to support regulatory science and enhance global regulatory capacity through improved harmonization and the development of standards.
The Office of International Programs
The funding opportunity is made available through FDA's Office of International Programs (OIP), now headed by John Taylor, acting deputy commissioner, and Mary Lou Valdez, associate commissioner for international programs.
OIP has been aggressively trying to build both FDA's international presence and the capacities of its international counterparts in recent years.
Its regulatory staff has consistently argued that FDA and other regulators need to pay more attention to the regulatory capacity - the ability of countries to train, educate and maintain a regulatory workforce with which to regulate healthcare products - of the developing world.
"The lack of attention to medical product regulatory systems in low- and middle-income countries is a significant gap that needs to be bridged," Valdez and others wrote in October 2012. "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."
The problem, they explained, is that with global healthcare product networks going global, it helps alleviate burdens on FDA if it is able to have its global counterparts stem the flow of substandard or counterfeit goods before they reach US shores.
"FDA recognizes that it must transform itself from a largely domestically-focused agency reacting to a globalized world, to one that proactively engages in a regulatory environment in which product safety and quality know no borders," wrote Valdez in a statement in April 2012 supporting FDA's "Global Initiative."
Recent IOM Report
The Institute of Medicine (IOM), a healthcare-focused think tank funded by the US government, also weighed in on FDA's approach toward international regulation, calling on it to boost attention on foreign regulators to stem the tide of substandard and falsified medicines and improve product regulation.
The report argued that regulators in low- and middle-income countries should use the International Conference on Harmonisation's (ICH) Common Technical Document (CTD) to better harmonize review and registration procedures and save costs. The same model is already used in the US, EU and Japan, as well as a number of non-ICH member countries.
Those same regulators should also be engaged in developing strategic plans for compliance with quality and manufacturing standards on a standardized basis, the report added.
The report also called for linking global pharmacovigilance databases as a means to detect the proliferation of substandard or counterfeit medicines and coordinate international responses.
No global surveillance system yet exists despite the World Health Organization's (WHO) ongoing efforts, it noted.
At the time of the report's publication, FDA Commissioner Margaret Hamburg said her agency recognized that "all countries need to work together to ensure safe medicinal products for their citizens due to the increasing complexity of the global economy."
"FDA remains committed to engaging with multiple stakeholder groups to advance global solutions and minimize exposure of consumers to unsafe products," she added.
New Efforts, New Money
At the core of FDA's funding announcement is a question: What are the minimum requirements necessary to have a well-functioning regulatory system?
It's a question that unsurprisingly harkens back to the IOM report, which explained that the answer to the question lies not in any single factor, but rather several: good government, good manufacturing/clinical/laboratory practices (GxPs), staff training and education, product quality monitoring, pharmacovigilance, risk assessment and management, and the ability to respond to emergencies.
The answer to the question also requires something else: a catalyst and money.
The catalyst chosen by FDA is the World Health Organization, which provides substantial regulatory support to many of its 193 Member States, including on all of the aspects listed above. This support, FDA noted, includes setting standards, "articulating evidence-based policy options," and supporting regulatory agencies.
As it just so happens, that is exactly what FDA is looking for.
"The goal of the Cooperative Agreement is to strengthen global regulatory capacity through activities that may include: Development of global norms and standards for product regulation; generation and analysis of evidence of regulatory systems performance; and provision of technical support to national regulatory systems strengthening efforts," FDA wrote.
The second requirement, money, will come from FDA in the form of a five-year, $7.5 million contract ($1.5 million per year, with the option to stop after one year).
FDA said it plans to work with WHO to:
- share scientific findings
- assist WHO Member States to implement internationally-recognized standards and guidelines, including those from the ICH
- engage with regulatory stakeholders
- assess the current state of global healthcare product regulation
- enable or strengthen data and information systems to help drive evidence-based regulatory decisionmaking
- strengthen national and international regulatory systems regarding the previously identified factors (e.g. GxPs, good government, staff training, etc).
The program is scheduled to start on 10 September 2013.
Federal Register Notice