For an AIDS-Free Generation: Access to Drugs and Diagnostics Is Essential

By: FDA Commissioner Margaret A. Hamburg, M.D. and HHS Assistant Secretary Jimmy Kolker

Margaret Hamburg, M.D.On World AIDS Day this year, tens of millions of people with HIV are now living healthy, productive lives because of access to safe and lower priced medicines. We rejoice in this achievement, because all people, no matter how rich or poor, deserve to have the medicines they need to live their lives in the best health possible.

We can truly see in our future an AIDS-Free generation because of the wide availability of prevention and treatment tools. But the availability of these drugs and diagnostic tools, especially in Africa, was never a given. Ten years ago, in 2004, the U.S. Food and Drug Administration (FDA) committed to support the President’s Emergency Plan for AIDS Relief (PEPFAR) by introducing an expedited review process to make generic and low-cost treatment more readily available for the most affected countries. PEPFAR requires antiretroviral drugs to be safe, effective, and of high quality and supports their distribution to people needing treatment around the globe. But meeting these requirements can be costly and time-consuming. Those suffering from AIDS cannot wait. The FDA, an agency that is part of the Department of Health and Human Services (HHS), applied the tentative approval process in order to increase dramatically the number of products approved for purchase and distribution by PEPFAR.

Thanks to the commitment of FDA scientists, as of today FDA has issued expedited approval decisions for 179 products, including 39 formulations specifically designed for children that allow flexible dosing across multiple weight bands and many innovative formulations, such as fixed-dose combinations and co-packaged products that improve adherence to treatment and reduce the risk of developing resistance. The 179 tentative approvals allowed PEPFAR to purchase products at a lower cost, leading to cost savings of hundreds of millions of dollars. These savings contributed to additional patients being able to receive treatment.

Jimmy KolkerAccording to UNAIDS, by June 2014, 13.6 million people around the world had access to antiretroviral therapy. This is an important success, but many more people still need access.

Unfortunately, too many countries lack the regulatory capacity to conduct product registrations in a timely manner. This makes it difficult for these countries to provide high-quality rapid HIV tests and treatment.

The FDA and the HHS have been working with the Department of State Office of the Global AIDS Coordinator (S/GAC); the World Health Organization; the Global Fund to Fight AIDS, Tuberculosis, and Malaria; and other organizations to help countries build both their health care systems and regulatory capacities.

Importantly, FDA has partnered with host country health ministries to help strengthen regulatory capacities in support of their public health programs. PEPFAR recently contributed $1.5 million in support of this FDA partnership to further regulatory system strengthening in the East African community.

With these improvements, countries battling HIV and AIDS can build the systems necessary to ensure that patients get the high-quality treatment they need, which one day will lead to the realization of an AIDS-free generation.

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

Jimmy Kolker is Assistant Secretary for Global Affairs in the U.S. Department of Health and Human Services

Ensuring Safe Food and Medical Products: A Partnership with the Mekong Region

By: Margaret A. Hamburg, M.D.

Several years ago I had the opportunity to visit the Mekong Region of Southeast Asia, which includes the countries of Cambodia, Laos, Myanmar, Thailand and Vietnam. I was struck not only by its beauty, dynamism, and diversity, but also by the commitment of health officials there to building strong health systems and cooperating across borders in the face of potential health threats. I learned that by working together with each other and the United States they were able to build an effective rapid response to outbreaks of an emerging pathogen such as the H5N1 influenza virus.

Margaret Hamburg, M.D.I was reminded of my visit this week during my participation at a forum hosted by the Center for Strategic and International Studies entitled “U.S. Health Partnerships in the Mekong Region.” The day’s discussions highlighted the growing strategic importance of the region to the United States and the long-standing and ongoing partnerships between U.S. agencies and regional partners in health and development, including the central focus of the FDA, to ensure the safety of food and medical products in the United States.

Though Americans may not often think about it, the U.S. is increasingly and inextricably linked to the Mekong Region through global supply chains. For instance, about 15% of the seafood we consume in the United States comes from Mekong region countries, arriving on our shores and in our stores after a long and circuitous journey. Consider tuna, which may be caught in the South Pacific, transported to New Zealand for pre-canning, and shipped to Southeast Asia for canning before it finally makes its way to the East Coast of the United States for distribution in this country. 

Why does this matter to FDA? There is a greater likelihood that food will be exposed to pathogens, contaminants or chemical hazards during a journey of this complexity. That’s why we work closely with our regional counterparts in these countries through such organizations as the Association of Southeast Asian Nations (ASEAN) and the Asia Pacific Economic Cooperation (APEC), sharing with them our own regulatory requirements, our knowledge of good manufacturing practices and our laboratory and inspection techniques. Through such information sharing we believe we can prevent tainted or otherwise unsafe foods from reaching our borders. 

But the risk of potentially unsafe food from this area is not our only concern. A significant threat to human safety today involves substandard, falsified and counterfeit medical products that are part of the global supply chain. These products may contain toxic ingredients, or too much or too little of a drug’s active ingredient, and as a result patients could be poisoned or unwittingly receive inadequate treatment for their disease or even no treatment at all. In addition, if too many patients receive only partial treatment, it might foster the development of drug-resistant disease strains. And there’s this too: a high prevalence of substandard and falsified medicines ultimately will erode public trust in the health care system.

Unfortunately, statistics suggest that substandard and falsified products is a problem in the Mekong Region. A recent comprehensive review found that in Southeast Asia, 35 percent of anti-malarial drugs were substandard and 36 percent were counterfeit. And many of the countries in this region have porous borders and face challenges with regulatory oversight and enforcement practices that cannot adequately protect the supply chain. 

FDA is working with the World Health Organization to build a global monitoring system to monitor substandard, falsified and counterfeit medicines, and collaborating with countries in the region to develop and test the system. In addition to cooperating with our regulatory counterparts across the globe on issues of detection, investigation and enforcement, FDA scientists have developed the Counterfeit Detection Device, or CD-3, which can quickly screen for counterfeit products – not just drugs – at any location, including remote communities and border sites. With our international partners, we are currently planning to expand the use of this tool in several field settings, including in the Mekong region.

Building cooperation for this kind of enforcement is essential not just to ensuring the safety of our food and medical products, but as a means of advancing our national security objectives. That’s why meetings like the one I attended this week are so important. They support opportunities to work with our colleagues in the Mekong region on ways to share information and promote stronger, innovative regulatory systems that are critical to the long-term success of our global public health efforts.

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

Stronger Drug and Vaccine Safety Systems Overseas, Safer Products at Home: Highlights from the World Health Assembly

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). 

Margaret Hamburg, M.D.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