FROM A GLOBAL PERSPECTIVE
By Gabrielle Lamourelle and Capt. Mary E. Kremzner
December 1, 2020
This World AIDS Day is an opportunity to highlight the availability of an important FDA resource on those antiretroviral (ARV) drugs approved or tentatively approved by FDA and eligible for procurement under the President’s Emergency Plan for AIDS Relief or PEPFAR.
On January 29, 2020, the agency established an interactive PEPFAR Database to provide, for the first time, FDA-reviewed product labeling and packaging information for each approved or tentatively-approved ARV drug product. Prior to the launch of the PEPFAR Database, only basic information about these products was available in a static web table. We recognized the need for improved access to the existing product information, as well as for providers, patients and procurers in nations around the world to easily access added content such as updates on manufacturing sites, shelf-life, storage conditions, current manufacturing status for the finished ARV drug, and much more.
FDA modeled this database after the popular Drugs@FDA Database which provides information about FDA-approved drugs for use in the United States. The product labeling includes, for example, information about dosage and administration, warnings and precautions, contraindications, adverse events, pediatric use, and more, all provided with the authorization of each company that sponsored the application. This searchable database offers interactive dashboards, provides real-time insight into key metrics in case a user wants to conduct data analysis, and also allows users to download the labeling information.
PEPFAR was created in 2003 to bring together the federal government agencies involved in fighting the HIV/AIDS epidemic by creating comprehensive, coordinated and targeted interventions in hard-hit countries. Since PEPFAR’s launch, low-cost, quality-assured, life-saving ARV drugs have been provided through the program to nearly 15.7 million people worldwide, including almost 700,000 children.
FDA plays an integral role in PEPFAR by ensuring safe and effective ARV drugs are available for procurement through PEPFAR so these drugs can get to populations in countries with the highest burden of disease in a timely manner. Since 2004, FDA has encouraged sponsors worldwide to submit U.S. marketing applications for single entity, fixed-combination, and co-packaged versions of previously approved ARV drugs. To minimize delays in approval, FDA uses its existing processes including expedited review for PEPFAR ARV drugs, while ensuring that these products meet the same standards as similar products for the U.S. market and our own population. This review often results in FDA issuing tentative approval for drugs intended for PEPFAR; that denotes the drug cannot be sold inside the United States due to intellectual property protections but can be made available to the international community.
Responsibility for the PEPFAR program is distributed across FDA. The Office of Global Policy and Strategy serves as the FDA point of contact with all outside entities in coordinating agency activities dealing with PEPFAR, including those associated with drug firms seeking to participate in the expedited review process for ARV drugs. The Center for Drug Evaluation and Research, or CDER, approves and tentatively approves ARV drugs that are then available for procurement under PEPFAR and CDER’s Division of Drug Information (DDI) maintains the interactive database. Since the database was launched in January, DDI has implemented 31 updates, revisions or modifications.
Recognizing that not all users may have ready access to a computer, a mobile-friendly version of the database is available as well. In announcing the database in January, FDA Commissioner Stephen Hahn said providing this tool was “consistent with our efforts to modernize and improve access to information and unleash the power of data.”
Since the launch, the database has been utilized by stakeholders 7,381 times and FDA hopes that the information in the database continues to be invaluable to public health stakeholders in the international HIV communities. Although an analysis of the users to date finds that the database has been only lightly accessed by those located in countries that rely on PEPFAR support, we believe that the usefulness of the information in the database is yet to be fully explored by local providers and patients.
Before this launch we had heard anecdotally that due to the tentatively approved status of most ARV drugs available for procurement under PEPFAR, prescribers were forced to make patient treatment decisions without the full labeling available, including information on dosage and administration. We view the database as offering an easily accessible way for providers to get the information they need right at their fingertips.
We recognize that the database was launched only weeks before the beginning of the COVID-19 pandemic, which has naturally dominated the attention of procurers, providers and patients. Going forward, we will be looking for ways to get the word out about this useful information resource and ask our stakeholders to consider ways to do the same. We’ll also be adding new features to the PEPFAR Database based on stakeholder feedback and hope you will check back often to see what’s new.
After all, the PEPFAR program’s continued success in combating HIV will rely on data and information-driven approaches – just what the PEPFAR Database represents.
Gabrielle Lamourelle, MPH, is the acting director of the Office of Global Diplomacy and Partnerships in FDA’s Office of Global Policy and Strategy
Capt. Mary E. Kremzner, PharmD, MPH, BCGP, is director of the Division of Drug Information, Office of Communications, in FDA’s Center for Drug Evaluation and Research