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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 role, specifically the FDA’s review process for products to treat neglected tropical diseases and rare conditions.

The hearing was hosted by Senator Herb Kohl (D-WI)—chair of the Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies—and ranking member Senator Sam Brownback (R-KS). Speakers highlighted the FDA’s important role in advancing new tools for global health and proposed ways in which US policies could overcome the scientific and economic barriers that inhibit the development of new drugs, vaccines, and other tools.

Thomas Bollyky, a visiting fellow at the Center for Global Development and a member of the Global Health Technologies Coalition (GHTC), testified that 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.

“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,” Bollyky added. “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 new global health technologies.
  • A stronger FDA mandate to support WHO and developing-country regulatory bodies, including through capacity-building initiatives.
  • Enhanced interactions between the FDA and nontraditional product developers, such as those who develop products through public-private partnerships.

FDA enhancing its role

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.”

The FDA has recently taken several steps to enhance its role in reviewing global health products. These include establishing the FDA’s program to review HIV/AIDS drugs for the US President’s Emergency Plan for AIDS Relief; declaring willingness to review vaccines for diseases not endemic to the United States; forming partnerships with global bodies such as WHO; and mandating new FDA review groups for neglected diseases in the developing world. Jesse Goodman, chief scientist and deputy commissioner for Science and Public Health at the FDA, welcomed suggestions from witnesses and members of the committee. He said the FDA is “fully committed to doing all we can to help facilitate the availability of safe and effective therapies to patients in need.”

“Infectious diseases know no boundaries,” Goodman said. “Threats to health anywhere are threats to everyone.”

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; and Diane Edquist Dorman, vice president for public policy at the National Organization for Rare Disorders.

About the GHTC

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.

More information

Posted June 29, 2010.