FDA Launches Interactive Database on Antiretrovirals for PEPFAR Countries

Through the platform providers, consumers, and procurers will have access to full prescribing inserts and FDA-reviewed product labeling which will provide additional important information to patients and providers.

The US Food and Drug Administration (FDA) has announced a new mobile feature to improve the availability of information about antiretroviral therapies for people living with HIV in high prevalence areas.

Commissioner Stephen M. Hahn, MD, announced yesterday that a new interactive database will provide information about HIV treatment available for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR) program.

The PEPFAR program was launched in 2003 to address the global HIV crisis in the countries that are affected most by HIV. Since the program launched 17 years ago, 15 million individuals worldwide have been provided access to low-cost, quality-assured, lifesaving antiretrovirals (ARVs). The PEPFAR program remains the largest commitment by any nation to combat a single disease, according to the FDA.

The FDA is responsible for guaranteeing that the safety, efficacy, and quality of ARVs distributed under PEPFAR are the same as drugs used to treat HIV in the United States.

The agency can also issue tentative approvals for some PEPFAR ARVs. Tentative approvals can be granted for ARVs that are not eligible to be sold in the United States due to intellectual property protections such as patents.

Hahn explained that tentative approvals have allowed for both new and generic versions of lifesaving HIV treatments to be made available to nations outside of the United States. Since 2004 the agency has issued approvals or tentative approvals for 222 ARV applications for use in PEPFAR countries. Of these, 194 are still available for use today.

Once the FDA grants an approval or tentative approval for an ARV, the PEPFAR program can purchase the product at a low cost and distribute it outside the United States to countries with high HIV prevalence and burdens.

“By moving to an interactive, mobile-friendly database, we are empowering the public and providers by enhancing the amount and availability of information and data provided on each drug,” Hahn wrote in the announcement.

Through the platform providers, consumers, and procurers will have access to full prescribing inserts and FDA-reviewed product labeling which will provide additional important information to patients and providers.

The mobile feature will also contain information on ARVs that are suitable for use in pediatrics populations, details on drug manufacturing locations, the shelf life of the product, and any storage requirements. The database features an interactive platform which will allow users to export reports, collect metrics, and access the available information on mobile devices.

“Given these numerous improvements, we anticipate that this database will be valuable to various public health stakeholders in the international HIV communities,” Hahn concluded. “The 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.”