Another heparin-like crisis is inevitable under the current regulatory system that monitors the global drug supply, FDA Commissioner Dr. Margaret Hamburg said at a food and drug safety symposium last week on at the Council on Foreign Relations (CFR). The global supply chain has rendered the agency’s “traditional model” of inspections and import surveillance obsolete, Hamburg said, and the global scope of the prescription drug market demands a new cooperative model in which international regulators share best practices, help build lateral regulatory capacity, and work with all stakeholders to keep substandard, adulterated, and counterfeit drugs off shelves.
In a round table discussion following her speech, Dr. Hamburg expanded on the idea of this global alliance:
I think the time has come that we really need to create and formalize a global alliance of regulators that are committed to solving these problems together, to sharing information in new ways, sharing best practices in new ways, even sharing the workload in new ways, and importantly, working with industry and other stakeholders because it is a shared responsibility that goes beyond government....She tied these efforts to the “critical central role of the consumer,” and said that “at the end of the day, it's all about serving them and protecting and promoting their health and well-being.”
To us, “role” suggests action, but in such a splintered drug supply chain involving 300,000 facilities in 150 countries--and 150 different regulatory systems--sometimes it’s hard to see what this consumer role or action might look like. At a CFR panel later in the week, Caroline Smith DeWaal from Center for Science in the Public Interest offered one vision:
We really need consumers to demand safe food and safe drugs from their government. And the industry plays a major role, but consumers can demand from their political players that these systems be implemented. But systems shouldn't be stovepiped just for exports. They really need to benefit the consumers in those countries.You can watch the symposium, and find links to the transcripts and backgrounders here. This expert round-up published after the symposium does a good job of identifying some ways to get at the safety challenges posed by the global drug supply, including:
- thinking about counterfeits through a safety lens, not just a patent-based one
- considering affordability as a potential driver of or toward growing counterfeit markets
- developed nations’ involvement in helping to build regulatory capacity in manufacturing hubs in the developing world
- meaningful international regulatory cooperation/communication
- the place of inspections in a resource-limited drug safety system
The drug safety issue is a problem that has two components. One is, how do we protect the legal supply chain? If all my active ingredients and many of my finished products are produced overseas, I can't possibly inspect all those plants that are producing them, so what is the answer to that? We have to take different approaches, collaborate more, share more information, and generally have a global alliance of regulators who will try to get a grip on this very complex supply chain.These CFR conversations provide potential answers to what is a daunting web of policy questions. Encouragingly, so do some recent U.S. legislative efforts. For more on those proposals to protect the drug supply, visit the Pew Prescription Project and SafeRxWatch.The other aspect is: What do we do about drugs, which are essentially illegal [because they are complete fakes or contain fake components that can sicken or kill people]? They are not submitted to regulators, they come into the country illegally or they are produced in the country illegally, and they can do enormous harm to individuals.
--Kate Petersen, PostScript blogger