A report issued by the Global Health Technologies Coalition (GHTC), a coalition of 40 non-profit groups including the Bill & Melinda Gates Foundation, argues that the US Food and Drug Administration's (FDA) effects are being felt far beyond US borders.
The US health regulatory agency's statutory mandate is ostensibly to ensure the safety and effectiveness of products used by American consumers, but it is "increasingly…playing a role in global health R&D," wrote GHTC in its report, Saving Lives and Creating Impact: Why Investing in Global Health Research Works.
The impact of the agency includes some obvious applications of the US's advanced regulatory capacity and market strength, explains the GHTC report.
"FDA has approved more than 50 drugs, vaccines and diagnostics for neglected diseases, including the first diagnostic test of dengue [fever] in April 2011," wrote GHTC in its report. While these products are approved for US consumers, their approval can "facilitate their introduction into developing countries," explains GHTC.
Likewise, the agency plays an integral role in evaluating the quality of generic drugs and vaccines used by generic countries, including 141 drugs used by millions of patients under the President's Emergency Plan for AIDS Relief (PEPFAR).
FDA's impact also emanates from less conventional means, notes the report.
FDA's regulatory innovations and approved standards are widely copied in countries around the world, accelerating treatments and giving patients access to medicines they otherwise might not have gotten to use, explains GHTC.
FDA's regulators also share their expertise with regulatory professionals and healthcare professionals around the world, says GHTC, through "information sharing, training and mentoring activities."
Some of the specific technologies developed by FDA's research centers have also been critical to developing products. GHTC cites the example of FDA's Center for Biologics Evaluation and Research (CBER) developing technologies that were later used in developing the first long-acting meningitis vaccine for Africa and work done by the FDA-supported Critical Path Initiative, which funds many neglected disease areas.
FDA's Priority Review Voucher Program, too, had resulted in a pathway for the expedited review of products intended to treat neglected tropical diseases, though GHTC notes this pathway has only resulted in one additional product (Coartem, an anti-malarial drug) coming to market.
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