By: Margaret A. Hamburg, M.D.
Recently I was privileged to be part of a U.S. delegation to the 66th World Health Assembly (WHA) in Geneva, Switzerland, led by the Secretary of Health and Human Services, Kathleen Sebelius. This is an annual meeting of health leaders from the governments of some 194 nations at the headquarters of the World Health Organization (WHO).
While there, I had the honor of co-hosting a special session on drug and vaccine safety with the Honorable Sherry Ayittey, Minister of Health of Ghana. This was the first time the subject (known technically as pharmacovigilance) has been featured in a special session, and my goal was to outline a vision for the future that benefits our collective interests: a global product safety net, where consumers, industry, governments, and international organizations work together to ensure safe and high quality products, no matter where they come from, or where they are consumed.
The need for such a global product safety net has never been greater.
Drugs and vaccines are reaching unprecedented numbers of people in low- and middle-income countries. The President’s Emergency Plan for AIDS Relief (PEPFAR) alone makes it possible for roughly five million people to take anti-HIV drugs today. Also, new vaccines for malaria and dengue fever and improved vaccines for cholera and typhoid are being introduced into these countries. With greater access comes the corresponding imperative to ensure that these products are safe and of high quality.
During the special session on the safety of drugs and vaccines, I outlined what I hope will become a shared vision for a stronger safety system world-wide.
What the global regulatory community should aspire to is a medical product safety system where product information is immediately and continuously accessible in electronic platforms, allowing optimal detection and analysis of potential problems. Such a system must be able to follow products throughout their lifecycle from development to their ultimate distribution within the global supply chain.
In addition to adverse events, the system should enable detection of many different kinds of product safety issues, including those that result from programmatic/prescribing errors, substandard manufacturing, and falsified products.
There are numerous challenges in weaving such a safety net, but fortunately the basic threads are in place. Data on the state of pharmacovigilance systems are being collected. We have global surveillance capacity through programs managed by WHO, and electronic data systems are now available in some countries. In addition, organizations have developed common naming and data reporting standards for regulators to use. Perhaps most importantly, stakeholders, including financial donors such as the Bill and Melinda Gates Foundation, are beginning to make investments in regulatory systems.
FDA is contributing to many of these advances. In partnership with the U.S. Agency for International Development, we commissioned studies on pharmacovigilance systems in Sub-Saharan Africa and parts of Asia. FDA experts serve on global advisory committees for product safety. FDA has implemented cooperative agreements with WHO to strengthen vaccine safety, and to build a global monitoring system for substandard and falsified products. Further, FDA scientists have recently developed a new counterfeit detection device, which will be field tested in Africa.
Just as diseases know no borders, in today’s globalized world, product safety and quality know no boundaries. Stronger regulatory systems overseas mean safer products at home. The special session at the World Health Assembly was an important milestone in global efforts to weave a product safety net for the world.
Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug Administration