Growing momentum in global health
The FDA steps up its role in international regulatory issues
Although best known for its role in regulating the products that Americans use to protect their health, the US Food and Drug Administration (FDA) has long recognized the importance of improving public health worldwide. The agency has recently taken several steps that demonstrate its continued commitment to global health, and it is critical that the FDA builds on this progress in order to make the biggest possible impact on the lives of people around the world.
In a major development, FDA Commissioner Margaret Hamburg last month announced structural and personnel changes at the agency that will have implications for global health. Under the reorganization, the FDA’s programs will be divided into directories that reflect the agency’s core functions. One of the directories focuses on global issues, and a new directorate for Global Regulatory Operations and Policy will be established.
Global regulatory issues were also in the spotlight at the FDA’s Center for Biologics and Evaluation Research (CBER). The center—whose mission is to ensure the safety and effectiveness of biological products such as vaccines—recently released a strategic plan for fiscal years 2012-2016 that increasingly addresses the center’s role in global public health. Under the strategy, CBER will promote research and collaboration with nonprofit groups, such as product development partnerships (PDPs). It will also increase collaboration with international regulatory partners such as the World Health Organization and national regulatory authorities.
In a separate initiative, the FDA released its “Strategic Plan for Regulatory Science” calling for a modernization of the science used in developing and evaluating health products. A stronger regulatory science capacity at the FDA will have important implications for domestic and global health. Among them will be an improved ability to speed medical products to patients around the world by reducing some uncertainties associated with clinical trials. In addition, the plan aims to facilitate the development of health products for special populations—including patients with neglected diseases of the developing world—for which safe and effective therapies are desperately needed.
Finally, the FDA’s Center for Drug Evaluation and Research (CDER) recently released draft guidance for developing drugs for neglected diseases of the developing world. This new draft follows a separate but similar 2007 neglected tropical disease (NTD) guidance released by CBER. The new guidance is intended to aid drug sponsors in developing drugs to prevent and treat neglected diseases, including tuberculosis (TB), malaria, and several neglected tropical diseases (NTDs) such as dengue fever, cholera, and African sleeping sickness. However, Chagas disease is not included in the guidance, as the diseases covered in the guidance were established by Congress in the Federal Food, Drug, and Cosmetic Act, which does not list Chagas. It is noteworthy that the FDA released this guidance in an effort to aid neglected disease drug development, and it is also critical that Chagas be included in the future.
It is significant that the FDA has taken these recent steps to increase its involvement in global health, adding to its history of engagement around global health products. The FDA should carry this momentum forward and continue to build stronger partnerships with global regulatory partners, enhance its internal capacity in global health, and work closely with groups like PDPs developing global health tools. By seizing on this tremendous interest across the agency to bolster the agency’s role in global health tools, the FDA can continue to have an impact on people’s health around the world. By building global partnerships and boosting its scientific capacity, the FDA will also improve its ability to protect the health of Americans at home. As Commissioner Hamburg said recently, the FDA has “seen the dramatic transformation of globalization—more products, more countries, more access by consumers to global supplies—and this presents an enormous challenge to FDA in ensuring the safety and quality of the products we regulate.”
Additional resources:
