Falsified and substandard medicines provide little protection from disease and, worse, can expose consumers to major harm. Bad drugs pose potential threats around the world, but the nature of the risk varies by country, with higher risk in countries with minimal or non-existent regulatory oversight. While developed countries are not immune, – negligent production at a Massachusetts compounding pharmacy killed 44 people from September 2012 to January 2013 – the vast majority of problems occur in developing countries where underpowered and unsafe medicines affect millions.
It is difficult to measure the public health burden of falsified and substandard drugs, the number of deaths they cause, or the amount of time and money wasted using them. The FDA asked the IOM to assess the global public health implications of falsified, substandard, and counterfeit pharmaceuticals to help jumpstart international discourse about this problem. At the international level, productive discussion relies on cooperation and mutual trust. This report lays out a plan to invest in quality to improve public health.