FDA's specific activities in support of PEPFAR are as follows:
- FDA reviews original marketing applications using its normal standards for approval. Drugs that would otherwise receive “final” approval, but because of the existence of a patent and/or exclusivity, receive “tentative” approval. Drugs that are tentatively approved are not eligible for marketing in the U.S. but can be distributed outside the U.S., and money from the PEPFAR program can be used to procure them, usually at a cost savings to the program.
- FDA reviews amendments to tentatively approved and approved applications that allow for manufacturing changes and other modifications that can lead to reduced cost of ARV drugs.
- Very importantly, FDA engages with ARV companies to assist them in the submission of drug applications for ARV drugs and fixed-combinations needed to meet the demands of worldwide treatment of HIV.
- FDA collaborates with global health entities such as the World Health Organization (WHO), which recognizes FDA-approved or tentatively approved ARV drugs on its lists of quality-assured drugs.
- Yes = Company that sponsored the application is currently manufacturing the finished drug product
- No = Company that sponsored the application is NOT currently manufacturing the finished drug product
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