A report released this week by a committee of the Institute of Medicine
urged the U.S. Food and Drug Administration and its overseas counterparts from the top industrialized nations to work together to help developing countries improve their regulatory systems for food and drug oversight.
The discovery of a counterfeit version of the cancer drug Avastin earlier this year further underscored the challenges for U.S. regulators as imports increasingly dominate the American market.
The report recommends 13 steps that the FDA and other organizations can take over the next three to five years to enhance the safety systems in developing nations. Partners in this effort include other federal agencies, international organizations, regulated industries, and regulators in developing countries.
The committee’s recommendations include encouraging the development of low-cost technologies to prevent fraud and assessing whether the FDA’s pilot Secure Supply Chain program can be expanded. The report also urged the regulatory agencies in developed nations and industry associations to devise ways to share inspection results and emphasizes the importance of donor investment in developing countries' regulatory systems.
More than 80 percent of active pharmaceutical ingredients and 40 percent of finished drugs come from abroad as does 85 percent of the seafood consumed in the United States, according to federal estimates. Congress expects FDA to inspect more foreign producers as the volume of imports increases, but “given its modest budget, the agency cannot do its job well without substantial improvement in the capacity of its counterpart agencies in emerging economies,” the committee said.
The report also called on FDA and its counterparts in the European Union, Canada, Japan, Norway, Iceland, Switzerland, Australia, and New Zealand to plan a system for mutual recognition of each other's inspections, which would eliminate wasteful duplication.
The committee said in a statement “there is no need for American and European inspectors to examine the same facilities, especially when a vast number of facilities go uninspected,” and “industry associations also should work together to define a reliable way to share internal inspection results among their members within the next three years.”
FDA and other federal agencies, including the U.S. Department of Agriculture, U.S. Agency for International Development, and Centers for Disease Control and Prevention, should provide technical expertise, training, and tools to strengthen the surveillance systems in developing countries, the committee’s report recommended. These agencies could provide this help directly or channel it through international organizations such as the World Health Organization.
FDA and USDA also should provide incentives for businesses and academic groups to collaborate on developing inexpensive technologies that can be used in developing nations to prevent and detect fraud and provide tracking and verification of products along the supply chain, the committee said.
In addition, the committee said the U.S. government should work with Mexico, the host of the next meeting of the G20 nations, to add food and medical product safety to the G20 agenda. As an emerging manufacturing country with an active export economy, Mexico would be an “ideal leader for a global initiative on food and medical product safety,” the committee explained.
The FDA's pilot Secure Supply Chain program is a "promising initiative" that could help enhance control of the food and medical product supply chain, the committee’s report said. The program rewards drug firms that can track their products from manufacture to market with expedited entry into the U.S. market. The committee recommended that FDA evaluate the program after its pilot phase ends in 2014. If the program is successful, the agency should enlarge it to include more medical companies and expand it to food companies, the committee said.