On September 23, the Global Health Technologies Coalition and representatives from other leading global health organizations testified at a pivotal public hearing hosted by the US Food and Drug Administration (FDA). The hearing examined the FDA’s role in regulating and reviewing crucial global health technologies, such as vaccines, drugs, microbicides, diagnostics, and other tools that save lives worldwide.
Speakers offered the FDA several recommendations for expanding its effort to advance global health products, including the following:
The hearing was “extremely helpful” to the FDA’s neglected disease review group, said Leonard Sacks, acting director of the agency's Office of Critical Path Programs. He added that the hearing was only the “beginning of a process” and that there is “a lot of work ahead” for the FDA and its partners to help ensure the safety of health tools to prevent, diagnose, and treat infectious diseases that affect millions of people worldwide every year.
The hearing was hosted by the FDA’s newly mandated review group for neglected diseases of the developing world in preparation for a report the group will deliver to Congress next year on the topic.
Housed at PATH and funded by the Bill & Melinda Gates Foundation, the Global Health Technologies Coalition includes more than 30 organizations advocating for research and development of tools to prevent, diagnose, and treat global diseases so health solutions are available when populations need them. For more information about the coalition, please see the GHTC website.