Food and Drug Administration (FDA)
FDA approvals apply to the US, but affect research globally
The US Food and Drug Administration (FDA) is best known for its work to regulate health products for US consumers. The agency’s principal function—formal approval to market and distribute new or improved drugs, vaccines, devices, and other materials—applies only to the domestic market.
Nonetheless, the FDA has a history of leveraging its regulatory expertise to benefit people worldwide and is playing an increasingly vital role in global health issues. The FDA plays an important role in efforts to ensure the safety of health tools to prevent, diagnose, and treat infectious diseases that affect millions of people worldwide every year.
A history of global engagement
The FDA has a history of sharing its knowledge to benefit communities abroad. Several initiatives and programs leverage the agency’s regulatory knowledge for global health issues. For example, the FDA:
- Approves new global health products for use in the US, which can facilitate their introduction into developing countries. The FDA has approved more than 50 drugs, vaccines, and diagnostics for neglected diseases, including the first diagnostic test for dengue in April 2011.
- Evaluates the quality of generic drugs for developing country use. Since 2004, the FDA has approved over 141 generic AIDS drugs that have been given to more than 2.1 million patients under the President’s Emergency Plan for AIDS Relief.
- Actively partners with the World Health Organization (WHO) to verify vaccine quality. The FDA has worked with the WHO to verify the quality of seven US licensed vaccines, including a rotavirus vaccine that has already been introduced in five developing countries.
- Creates new regulatory approaches to accelerate development of global health products, including the development and review of improved standards and principles for the registration of new drugs, vaccines, and diagnostics against neglected diseases, especially tuberculosis.
- Runs the priority review voucher program, which awards a voucher for future expedited product review to the sponsor of a newly approved drug or biologic that targets a neglected tropical disease.
- Established the Global Regulatory Operations and Policy directorate, which is solely focused on global issues, to reflect the FDA’s core function in this area.
Building capacity in endemic countries
FDA expertise is also leveraged to benefit local regulatory authorities in endemic countries, in order to strengthen these countries' capacity to protect the health of their populations. For instance, the FDA has collaborated with the African Vaccine Regulatory Forum, which provides national regulatory authorities on the continent with expertise and opportunities for information sharing and capacity building.
For more information on the above data, please see:
US Food and Drug Administration.
FDA Office of International Programs.
The FDA’s role in global health. Global Health Technologies Coalition.
The African Vaccine Regulatory Forum.
Strengthening national regulatory capacity. PATH.
