What the GAO found
In 2012, the Department of Health and Human Services (HHS) established a program to improve local infrastructure and expertise to produce medical countermeasures—such as drugs and vaccines—in response to public health emergencies. This program, known as the Centers for Innovation in Advanced Development and Manufacturing (CIADM), initially consisted of three sites responsible for, among other things, the rapid creation of a pandemic response. During the period before the COVID-19 pandemic, HHS funded the manufacturing facilities of small batches of drug substances for other manufacturers. During the COVID-19 pandemic, HHS provided increased funding to reserve capacity to manufacture products on a larger scale to support the pandemic response. However, HHS said the sites face challenges in reliably manufacturing products on a larger scale, such as poor quality control, which led to the eventual shutdown of one site due to cross-contamination.
An internal HHS review found that the lack of regular production work by HHS or other manufacturers prevented the sites from developing the capability to rapidly produce countermeasures on a large scale, as the program intended. HHS and site officials identified several reasons for this underutilization, including a lack of dedicated funding from HHS and challenges in attracting outside manufacturers to use the sites for countermeasure production.
HHS is ending the CIADM program and plans to transition to a new program model—the National Biopharmaceutical Manufacturing Partnership (BioMaP). BioMaP is early in its development and it is not clear how BioMaP will address some of the challenges facing the CIADM program, as in the following examples.
- BioMaP is expected to use a different contractual structure designed to provide more incentives for industry partners to participate. However, this different structure requires additional experience for effective management. Additionally, HHS told GAO that its contracting staff had previously faced resource challenges using this different contracting structure for other programs during the COVID-19 pandemic. HHS officials said in April 2022 that the agency has half the staff needed to manage the contract portfolio. This creates a risk that the agency will not have sufficient resources and expertise to effectively manage this different structure.
- HHS does not have a sustainable source of funding for the new program model and has not yet developed detailed plans or budgets. HHS officials said that without sustained funding for BioMaP or a similar program, the agency will not be prepared to respond to the next pandemic.
As HHS develops its plans for a new countermeasure manufacturing program model, incorporating an approach to address these challenges and risks would provide HHS with greater confidence that it can avoid repeating the challenges of the CIADM program.
Why did the GAO do this study?
The COVID-19 pandemic and other recent public health emergencies highlight the threat of widespread illness and death from new and emerging infectious diseases. GAO has identified HHS’s leadership and coordination of public health emergencies as a high-risk area because of the need to be prepared and respond effectively to future public health threats.
The CARES Act includes a provision for GAO to report on its ongoing surveillance and oversight efforts related to the COVID-19 pandemic. This report examines (1) how HHS used CIADM program funds before and during the COVID-19 pandemic, (2) what challenges affected the effectiveness of the CIADM program in developing and producing countermeasures, and (3) how HHS plans to use its new model program to address the challenges of the CIADM program.
To address these objectives, GAO examined HHS documents and best practices for program risk management and interviewed and reviewed written correspondence with representatives of HHS and the three CIADM sites.