New report stresses strengthened regulatory systems abroad

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.

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.