It’s time to actively and aggressively pursue FDA Commissioner Peggy Hamburg’s call for a regulatory Marshall Plan to help build, nation-by-nation, global systems for both quality and safety. A high tide floats all boats.
A new IOM report concludes the FDA should invest in advancing the regulatory capacity of developing low and middle income nations in order to secure the pharmaceutical supply chain and safeguard the American public.
The report, Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad, recommends 13 steps FDA and other regulatory bodies can take in the next five years to improve the regulatory systems of developing nations.
Rather than try to inspect all foreign establishments itself—something IOM conceded was unrealistic given FDA’s limited budget—FDA should instead invest in improving other regulatory systems to accomplish its goals of ensuring a safe pharmaceutical supply chain.
After all, as Peggy Hamburg has repeatedly said, ““We can’t inspect our way out of this problem."
The IOM reports, “The FDA should use partnerships to drive improvements in supply chain management. The committee recommends that the FDA work with strong regulators in other countries to plan inspections and pool data. There is no need for American and European inspectors to duplicate each other’s work, especially when a vast number of facilities go uninspected … One promising initiative is the two-year FDA Secure Supply Chain pilot program, which rewards firms that trace their products thoroughly from manufacture to entry into the United States.”
“The report urges FDA and its technologically advanced counterparts in the European Union, Canada, Japan, Norway, Iceland, Switzerland, Australia, and New Zealand to plan a system for mutual recognition of one another's inspections, which would eliminate the wasteful duplication of effort,” wrote IOM in a statement.
FDA, the European Medicines Agency (EMA), Australia’s Therapeutic Goods Administration (TGA) and the World Health Organization have all announced their participation in a global active pharmaceutical ingredient inspection program that might go a long way toward accomplishing IOM’s recommendations—something IOM agrees with in principle.
IOM also called on industry association to “define a reliable way to share internal inspection results among their members within the next three years.
With scare resources, perhaps the best place to start is by committing to common standards for data capture and reporting.
After all, knowledge is power.
