FDA Launches Public Database Providing Information on HIV Treatments

January 30, 2020 - The Food and Drug Administration (FDA) has launched a public, interactive database that will offer critical information about antiretrovirals (ARVs) to treat HIV.

“This launch is an important step in our ongoing commitment to address the global HIV epidemic and is consistent with our efforts to modernize and improve access to information and unleash the power of data,” Stephen M. Hahn, MD, FDA Commissioner, said in a statement.

The mobile-friendly database will offer a wealth of information on ARVs eligible for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR) program. Created in 2003, the PEPFAR program aims to bring together various federal government agencies involved in fighting the HIV epidemic by creating a unified response and providing targeted treatment interventions.

“Since PEPFAR was launched 17 years ago, low-cost, quality-assured, life-saving ARVs have been provided to more than 15 million people worldwide, and PEPFAR remains the largest commitment by any nation to combat a single disease,” Hahn said.

“The FDA plays a critical role in the global fight against HIV by ensuring safe and effective ARVs are available worldwide, including those eligible for purchase through the PEPFAR program.”

Although the FDA ensures that ARVs intended for the global market are held to the same high standard as PEPFAR drugs intended for the US market, drugs intended for PEPFAR are sometimes issued tentative approval from the FDA.

Tentative approval of ARVs has allowed for new and generic versions of life-saving HIV drugs to be made available internationally. Once a drug receives approval or tentative approval the PEPFAR program can purchase ARVs at low costs and distribute them outside the US to countries with high HIV burdens.

Hahn noted that since 2004, the FDA has approved or tentatively approved 222 ARV applications for use in PEPFAR partner countries, 194 of which are still available today.

“The list of the ARVs eligible for purchase in the PEPFAR program has long been publicly available on the agency’s website. By moving to an interactive, mobile-friendly database, we are empowering the public and healthcare providers by enhancing the amount and availability of information and data provided on each drug,” said Hahn.

“For the first time, healthcare providers, consumers, and procurers will be able to easily access the FDA-reviewed product labeling, which will provide additional important information to patients and healthcare providers such as the full prescribing information (i.e., package insert) that contains a summary of essential scientific information needed for safe and effective use of the drug.”

The database will also include information on which drugs are suitable for pediatric populations, where each drug is manufactured, what its shelf-life is, and if the drug is subject to any storage requirements. Because the database is interactive, users will be able to export reports and collect metrics and will be able to easily access the database on mobile platforms.

Patients, providers, and procurers will have access to FDA-reviewed product labeling and package labels for each drug product, which include dosage and administration information, warnings and precautions, contraindications, and adverse events.

With this new interactive platform, the FDA expects to increase the availability and amount of accessible data on HIV drugs, leading to more targeted treatments and improved outcomes.

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