The United States Food and Drug Administration (FDA) has issued a statement to announce the launch of an interactive database that provides information on the antiretroviral (ARV) treatments currently available for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR). In the statement, the commissioner of the FDA, Stephen M Hahn, MD, commented on the importance of this launch in modernizing efforts to allow ease of access to information for people living with HIV across the world.
The PEPFAR program was created in 2003, and designed to address the global HIV epidemic and meet the widespread need for low-cost ARV. Since its establishment, PEPFAR has facilitated the delivery of low-cost and quality-assured ARVs to >15 million people.
The FDA continually works to ensure that the effectiveness and quality of HIV medications distributed globally though the PEPFAR program are held to the same standard as those intended for sale and use in the United States. However, there are occasions when the FDA issues tentative approval to drugs intended for PEPFAR.
The difference between FDA approval and tentative approval is that medications that receive the latter categorization cannot be sold in the United States as result of patents and other protections for intellectual property. Outside of the United States, tentative approval does allow for both newly branded as well as generic versions of ARVs to be available to all PEPFAR partner countries. FDA approval or tentative approval has been granted to 222 antiretroviral medications since 2004, 194 of which are currently available.
Although a list of all ARVs available in the PEPFAR program has been publically noted on the agency’s website, the transition to a mobile-friendly database empowers and eases the burden on healthcare providers and individuals who want to inform themselves. Users are able to access the full FDA-reviewed product labeling, which includes prescribing information as well as data on the safety and effectiveness of the drug. Data on ARVs indicated for pediatric patients, including location of manufacture, shelf-life, and storage needs, are also available.
Notably, the database is interactive: individuals can readily export reports and collect metrics on mobile devices via this platform. The FDA commissioner highlighted that this an important development, as mobile platforms may be the only mode that allows this information to reach many PEPFAR partner countries.
The commissioner concluded that “[t]he launch of this interactive database marks another step in the agency’s commitments to ensuring information regarding these life-saving ARVs are available to the public and is part of the agency’s continued dedication to fighting the HIV epidemic.”
FDA launches mobile-friendly database with information on life-saving HIV drugs as part of ongoing mission to empower the public through increased access to information and data [press release]. Silver Spring, MD: United States Food and Drug Administration; January 29, 2020. https://www.fda.gov/news-events/press-announcements/fda-launches-mobile-friendly-database-information-life-saving-hiv-drugs-part-ongoing-mission-empower. Accessed January 29, 2020.