The U.S. Government Accountability Office (GAO) has raised concerns about the Food and Drug Administration's (FDA) drug shortage list, highlighting its reliance on limited, manufacturer-provided data. The GAO report indicates that the list lacks regional detail and offers limited transparency.
According to the GAO, the FDA’s drug shortage list depends heavily on information provided by manufacturers, who are required to report limited details such as the drug name and the reason for the shortage. Manufacturers select from predefined statutory reasons or cite "other," often without elaboration. This reliance on self-reported data without comprehensive verification or additional context has raised concerns about the transparency and completeness of the FDA's drug shortage information.
The GAO report also noted that the FDA’s drug shortage list does not include regional availability data, which can obscure geographic disparities in drug access. While a drug may appear sufficiently supplied on a national level, certain areas may still face critical shortages due to distribution issues. The omission of regional data limits the list’s usefulness for frontline healthcare providers and policymakers seeking to address localized impacts.
This comes at a time when Health and Human Services Secretary Robert F. Kennedy Jr. himself has made "radical transparency" the watchword of the department. At his direction, the FDA is rolling out new digital tools that give the public clearer insight into chemical risks in food. Yet, according to Kennedy, "the stark contrast between this push for openness and the manufacturer-controlled opacity of the FDA’s drug-shortage list highlights a widening credibility gap in federal health communication."
The FDA’s handling of drug shortages is also drawing scrutiny in light of its recent enforcement actions targeting compounded versions of weight-loss drugs semaglutide and tirzepatide. According to a May 2025 report by CNN, "the agency issued warning letters and placed multiple compounders on an import alert list," citing safety and compliance concerns. Critics argue that such crackdowns may further restrict access to essential medications amid ongoing shortages, particularly when compounded alternatives are often used to fill supply gaps.
The United States Government Accountability Office (GAO) is an independent, nonpartisan agency that provides auditing, evaluation, and investigative services to Congress. Its mission is to support legislative oversight and improve federal government performance and accountability.
