Weaving New Threads in FDA’s Global Safety Net

By: Margaret A. Hamburg, M.D.

Drugs manufactured in countries around the world account for 40 percent of the medicines we use in the United States. And an astonishing 80 percent of the active ingredients in the drugs we consume come from abroad.

Margaret Hamburg, M.D.Therefore, it is absolutely essential that we have regulations and procedures in place not just here at home but abroad as well to ensure that the medicines you and I rely on are safe, no matter where they come from. After all, lives and well-being are at stake if drugs are of questionable quality.

One of the greatest threats to safety involves substandard, falsified and counterfeit medical products in the supply chain. For the past several years, FDA has been engaged in global efforts to improve collaboration in preventing, detecting, and responding to this threat.

We have developed strong partnerships with the World Health Organization and the Asia Pacific Economic Community and we also collaborate with such development agencies as the U.S. Agency for International Development and the World Bank.

To further extend our global understanding and impact, in 2011 FDA commissioned a committee at the Institute of Medicine (IOM) to look at how falsified (fake) and poor quality drugs affect the health of people around the world. A report on its findings and recommendations was recently released.

It confirmed FDA’s belief that these fraudulent and inferior drugs are an international problem requiring international cooperation.

Briefly, here are some of the findings of the IOM report.

  • Neglecting good manufacturing practices is the root cause of poor quality drugs. However, quality practices require resources. Many of the countries in which people sorely need medical help just don’t have the financial wherewithal and other resources to mandate and monitor these good practices.
  • Bad medicines, whether sold in street markets or on unregulated websites, are a grave public health problem. They often fail to help—and often harm—the very people who most need them. In addition, they may promote antibiotic resistance which harms us all.
  • Crime and corruption drive the business of falsified medicines, and they are rampant overseas. A month’s supply of the lowest price generic ulcer medicine costs more than three days’ wages for the average government worker in much of Africa, Eastern Europe and the Middle East. The poorest patients have little choice but to buy their medicines from vendors who sell products of questionable quality.
  • In modern supply chains, medicines can change hands many times, in many countries, before they reach patients. Each exchange provides the opportunity for unscrupulous behavior on the part of manufacturers and distributors.

The IOM report recommends that FDA continue to reach beyond our U.S. borders to collaborate with our foreign counterparts in building regulatory strategies for the implementation and control of good manufacturing practices. FDA now has 12 posts around the world that are currently working to do just that with our global partners, as well as with industry and scientific and academic communities in these countries.

The IOM committee believes that we must identify where vulnerabilities exist in the legitimate drug supply chain and identify realistic national and international solutions. The panel also urged Congress to establish a track-and-trace system to keep a record of drugs as they travel from the manufacturer to the patient.

Between social media and up-to-the-second news coverage, the world seems like a much smaller place these days. But as this report makes clear, it’s actually larger than ever, and our challenges to provide a global “safety net” are many and formidable. 

The IOM report is an important resource in our quest to strengthen that safety net. For me, this report reinforces the knowledge that when it comes to ensuring the safety of medicines worldwide, we are heading in the right direction.  

Margaret A. Hamburg, M.D., is Commissioner of the Food and Drug Administration