Research Roundup: What we’re reading this week

Developing new medical products is a global enterprise, with research and development (R&D) activities spanning national borders and products being introduced in many countries at the same time. A critical part of this global R&D effort is the regulation of new health tools to help ensure that these products are safe and effective before they reach the populations who need them. In countries around the world, regulatory agencies play a critical role in this process, much like the US Food and Drug Administration (FDA) does for health products for American consumers. When creating new tools for diseases of the developing world, product developers sometimes face overlapping and conflicting regulatory processes that can dramatically slow the development and delivery of vital new products to help combat global health scourges like malaria, tuberculosis, and neglected tropical diseases. Delays in the approval of clinical trials can add years to the product development process and can significantly increase costs. Meanwhile, delays in the final approval of a product can lead to unnecessary suffering and death for patients who are unable to access the best possible tools for prevention, diagnosis, and treatment. There has been a lot of talk recently about ways to streamline and harmonize regulatory processes to reduce the time and cost of delivering new products. One such effort is the new East African Community’s (EAC) Medicines Regulatory Harmonization initiative, launched at the end of March in Arusha, Tanzania. Through this program, regulators from six agencies in five East African countries—Burundi, Kenya, Rwanda, Tanzania, and Uganda—as well as Zanzibar will work together to: Establish harmonized procedures for medicines registration. Build regional capacity in regulatory science. Increase access to lifesaving solutions for patients and communities. Representatives from disease-endemic countries, regulatory authorities including the FDA, product development groups, donors and technical partners, and other key stakeholders participated in the launch activities, showcasing the excitement over the steps underway in the region. Participants also highlighted what is at stake in the EAC’s efforts, which are seen as establishing a path forward for other harmonization efforts in regions across Africa and around the world. Over the next several years, support for these efforts—in the form of technical assistance, training opportunities, and political backing—from the FDA and other experienced regulatory authorities will be crucial. The FDA has a vast amount of expertise that can be leveraged to benefit this new initiative, and supporting the EAC would add to recent efforts at the FDA to become increasingly involved in global health issues. By supporting the new EAC regulatory initiative, the FDA can help to make a real impact on the health of patients in East Africa through the delivery of better and safer medicines in the region.

The Institute of Medicine (IOM) yesterday released a new report that stresses the importance of bolstering regulatory systems abroad in order to improve the safety and quality of medical products circulating around the globe. According to the report, many low- and middle-income countries do not have sufficient regulatory capacity, which limits their ability to oversee medical products such as drugs and vaccines. The report emphasizes that strengthening regulatory systems in these nations is critical for the health of Americans—indeed, more than 80 percent of active pharmaceutical ingredients and 40 percent of finished drugs in the United States actually come from overseas. US Food and Drug Administration (FDA) Commissioner Margaret Hamburg stressed this point recently when talking about why Americans should care about global health issues. In addition to securing the safety of the drugs and health products that Americans take, we at the GHTC believe that improving regulatory capacity overseas can have vast benefits for millions around the world. Strong regulatory systems can help guarantee that the safest and most appropriate products are available to populations in need, whether it be drugs to treat more well-known conditions like heart disease, or treatments for lesser-known but hugely devastating diseases like sleeping sickness and hookworm. Improved regulatory capacity in countries with neglected disease epidemics can also help monitor and oversee the safety of clinical trials for desperately needed new health tools. Improving regulatory capacity overseas can have vast benefits for millions around the world. Photo credit: PATH Fortunately, this new IOM report presents 13 steps that the FDA and other organizations can take over the next three to five years to bolster regulatory systems in developing nations. In addition to the FDA, other partners include other federal agencies, international stakeholders like the World Health Organization, private industry, and regulatory authorities in developing countries. For example, the report recommends that the FDA and other federal agencies—including the US Agency for International Development and Centers for Disease Control and Prevention—provide technical expertise, training, and tools to strengthen regulatory systems in developing countries. During the report launch event at the National Press Club, committee member Tom Bollyky from the Council on Foreign Relations said that the FDA and other regulatory stakeholders should build an international community to facilitate this capacity building in developing countries. According to Bollyky, this would include bringing international regulators to the United States, as well as sending FDA staff abroad, to facilitate the exchange of information and expertise. The report also calls on the US Government to work with Mexico, the host of the next meeting of the G20 nations, to add medical product safety to the G20 agenda. This will be an important and critical step to ensure that regulatory capacity building gets the buy-in and support from world governments, including the United States. As committee member Jim Riviere of North Carolina State University said, in order to have a “lasting and multiplier” effect on the safety of health products globally, we need to invest in capacity building and training for regulatory systems in all nations. This is one of the most important steps the FDA and others in the US Government can take to help ensure that new health products are safe and effective before they reach the people who need them most.