Did you know that 80 percent of all drug ingredients, and 40 percent of all finished pharmaceutical products, are made outside the U.S.?
Did you know a small, but increasing number of these drugs are fake?
What looks like a very boring academic and institutional report, entitled “Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad,” is in fact a call to arms. A Seattle man is a leading voice in sounding the alarm on the problem of counterfeit drugs.
Fake drugs are on the rise worldwide, including in the United States, and nearly a million people are estimated to die every year due to taking medications that are useless or worse.
The problem of fake or counterfeit medications in the developing world is massive, in some regions estimated to constitute perhaps half of all drugs sold, says the World Health Organization.
It’s still small in the U.S., but it is growing. One of the key warriors against fake drugs worldwide is Andy Stergachis at the University of Washington. Here’s an earlier story about Andy Stergachisand his work aimed at countering the rising threat of counterfeit drugs.
On Wednesday, the Institute of Medicine issued its boringly titled report about ensuring safe foods and medical products. Stergachis, a pharmacist and epidemiologist by training, was one of the co-authors so I asked him a few questions:
Q What is this report intended to accomplish
AS: A growing percentage of FDA regulated products – food, drugs, devices – originate in other countries, including developing countries. For example, some 80% of active pharmaceutical ingredients (APIs), 40% of finished prescription drugs, 85% of seafood is imported to the US. FDA acting by itself cannot assure safety, nor can a reliance on inspections at 300 ports of entry or, when possible, factories.
Improving the capabilities of regulatory agencies in developing countries can help assure the quality of products we import and have the potential added effect of improving the quality of their own in-country food and drug supply. So we were asked to identify the core elements of successful regulatory systems; identify critical issues in developing country food and medical product safety systems; and propose a strategy for addressing those gaps. That’s the 13 recommendations that came out of the report.
Q What are the main challenges to regulating drugs internationally?
AS: The problems we identified were common across developing country food and drug safety systems. Briefly we report on problems in developing countries, i.e., challenges, with: adherence to international standards; controlling the supply chain; infrastructure deficits; legal foundation; staff levels, retention, and morale; coordination among agencies; surveillance systems; communication; and engagement of the public.
Q How bad is the ‘fake drug’ problem today?
AS: This report didn’t look specifically at this issue of quantifying the extent of the problem of substandard, falsified, counterfeit drugs. This is the topic of a new IOM committee that is just now getting started, http://www.iom.edu/Activities/
Q It’s easy to say the FDA should step things up but hasn’t the agency been reduced in staffing and budget?
AS: Costing out the recommendations was beyond the scope of the study. One of the recommendations, however, proposes the agency use risk management to determine how it allocates its resources to both domestic and international programs. Moreover, other recommendations suggest roles for other stakeholders, including those involved in trade agreements, other US agencies, international standard setting organizations, and so forth – FDA cannot do this alone.
Some other stories on the IOM report