Congress highlights new tools for global health
Senate hearing underscores FDA's role in advancing R&D to save lives worldwide
The US Food and Drug Administration (FDA) plays a crucial role in facilitating the introduction of health tools to prevent, diagnose, and treat infectious diseases that affect millions of people worldwide every year. On June 23, a subcommittee of the Senate Committee on Appropriations held a hearing to discuss this crucial role, specifically FDA's review process for products to treat neglected tropical diseases and rare conditions. The hearing was hosted by Senator Herb Kohl—chair of the Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies—and ranking member Senator Sam Brownback. The hearing highlighted the important role that FDA plays in advancing new tools for global health, and speakers proposed ways in which US policies could overcome the scientific and economic barriers that inhibit the development of new drugs, vaccines, and other tools.
Senator Brownback, who has long worked to raise the profile of global health in the US Congress, said during the hearing that US efforts to "save lives" worldwide is "one of the best things we can possibly do. ... We're going to be a stronger country and it's going to be a better world for it.”
Recommendations for US policymakers
Thomas Bollyky, a visiting fellow at the Center for Global Development (CGD) and Global Health Technologies Coalition (GHTC) member, testified at the hearing and examined how the FDA can expand its role in supporting the development of global health products.
"The essence of the problem is this: while philanthropists and private companies have increasingly seen the value in devising products for heretofore neglected diseases, the regulatory infrastructure necessary to develop and introduce these therapies to the developing world is sadly inadequate," Bollyky said in written testimony. He added, "Building the needed regulatory infrastructure is a substantial challenge and unprecedented opportunity to improve the lives of millions around the globe and promote the well-being of Americans at home and abroad. The United States government and FDA in particular should take a leadership role in improving the clinical development and regulatory pathways for neglected disease products."
Bollyky suggested key measures for US policymakers’ consideration, including:
- Simultaneous, coordinated product review by all regulatory bodies—including the FDA, World Health Organization (WHO), and developing country regulatory authorities—involved in the approval of a new global health technology.
- A stronger FDA mandate to support WHO and developing country regulatory bodies, including through capacity building initiatives.
- Enhanced interactions between the FDA and non-traditional product developers, such as public-private partnerships.
FDA's critical role in global health
Jesse Goodman, chief scientist and deputy commissioner for Science and Public Health at the FDA, also testified at the hearing. According to Goodman, "infectious diseases know no boundaries. Threats to health anywhere are threats to everyone."
The FDA has recently taken several steps to enhance its role in reviewing global health products. These include the FDA's program to review HIV/AIDS drugs for the US President's Emergency Plan for AIDS Relief; its willingness to review vaccines for diseases not endemic to the United States; the agency's partnership with global bodies such as the WHO; and newly mandated FDA review groups for neglected diseases in the developing world. Goodman welcomed suggestions from witnesses and members of the committee and stated that the FDA is "fully committed to doing all we can to help facilitate the availability of safe and effective therapies to patients in need.”
Other witnesses at the hearing included:
- Christopher Austin, director of the National Institutes of Health's Chemical Genomics Center
- Gloria Steele, senior deputy assistant administrator for Global Health at the US Agency for International Development
- Emil Kakkis, president and founder of the Kakkis EveryLife Foundation
- Diane Edquist Dorman of the National Organization for Rare Disorders
Additional resources:
