The Biomedical Advanced Research and Development Authority, part of the Department of Health and Human Services, is authorized to award other-transaction agreements for advanced research and development of medical countermeasures. Those instruments sit outside the Federal Acquisition Regulation. Officials have described them as tools to move faster with industry, including firms that do not ordinarily sell to the government.

Other-transaction authority for BARDA is rooted in statute and in HHS practice that predated the coronavirus pandemic. Public budget justifications and BARDA annual reports have listed OTAs among the vehicles used for vaccines, therapeutics, diagnostics, and manufacturing scale-up. The record shows that use of flexible instruments expanded when Operation Warp Speed and related HHS and Department of Defense efforts sought compressed timelines.

The Government Accountability Office examined federal pandemic contracting in a series of publicly released reports. Those reviews did not allege that every other-transaction award was unlawful. They did describe patterns that, according to GAO, reduced competition, limited visibility into pricing and performance, and complicated oversight compared with FAR-based contracts.

GAO has reported that agencies, including HHS, made extensive use of other-than-full-and-open competition during the public-health emergency. The office has also noted that other-transaction agreements are not subject to many FAR clauses that ordinarily require certified cost or pricing data, specified audit access, or standard subcontracting rules. According to GAO, that flexibility can speed awards but can leave agencies with fewer tools if costs rise or deliverables slip.

Public GAO products on COVID-19 contracting have highlighted incomplete data in government-wide systems. The Federal Procurement Data System and related reporting, GAO found, did not always capture other-transaction awards with the same completeness as traditional contracts. The office recommended better tracking so Congress and inspectors general could see who received funds, for what, and under which competitive conditions.

HHS and BARDA have publicly argued that medical countermeasure development involves technical uncertainty and private-sector partners that may refuse FAR terms. Officials have said other-transaction agreements allowed cost-sharing, milestone structures, and intellectual-property arrangements that standard contracts might not accommodate. The department has also pointed to emergency authorities and the need to reserve manufacturing capacity before clinical results were complete.

GAO’s pandemic-procurement findings were not limited to BARDA. The office reviewed Defense Production Act actions, interagency agreements, and awards by the Department of Defense, HHS, and other buyers. Across that set, GAO described instances of sole-source or limited-source awards justified by urgency, of modifications that increased ceiling values, and of documentation that did not always explain why a particular firm was selected.

Inspectors general at HHS have likewise issued public reports on COVID-19 spending, including contracts and agreements for personal protective equipment, testing, and therapeutics. Those products, like GAO’s, are unclassified. They have described control weaknesses, inconsistent file documentation, and challenges in verifying that goods met specifications. They have not, in the public record, equated other-transaction use with fraud in every case.

The distinction between FAR contracts and other-transaction agreements matters for protest rights and for how disputes are resolved. Bid protests at the Government Accountability Office typically cover procurement contracts, not all OTAs. Courts and boards have treated other-transaction instruments differently depending on whether they resemble procurement contracts. GAO has recommended that agencies document the legal basis for using an OTA and the extent of competition actually obtained.

Public dockets and award announcements show BARDA OTAs with large pharmaceutical manufacturers and with smaller biotechnology firms. Ceiling values in some publicly reported awards reached hundreds of millions or more, often structured around development milestones rather than a single firm-fixed price. According to agency materials, those structures were intended to share risk. GAO has cautioned that milestone payments still require verification that milestones were met.

Competition under OTAs can take the form of a competitive process among a consortium or a limited solicitation rather than a full-and-open FAR competition. GAO has found that agencies sometimes relied on existing consortia or prior relationships. The office has said that such approaches can be lawful under OTA statutes but should be documented so reviewers can see whether other capable sources were considered.

Pandemic-era findings also addressed surge manufacturing and industrial-base investments. Public budgets show HHS and Defense funding for fill-and-finish capacity, raw materials, and domestic production. GAO reported that some of those efforts used flexible authorities and that outcomes—whether capacity remained available after the emergency—were not always measured against original justifications.

HHS has stated in public testimony and reports that it has taken steps to improve award files, data reporting, and use of competition when time permits. GAO has closed some recommendations and left others open, according to its public recommendation databases. The office has continued to list pandemic contracting and medical-countermeasure acquisition among areas of high risk or ongoing watch.

Congressional committees have held hearings on Warp Speed, BARDA, and COVID spending. Witnesses from GAO described data gaps and the tradeoff between speed and accountability. Administration witnesses described lives saved and products delivered under compressed schedules. The public record contains those competing characterizations; it does not contain a single official conclusion that other-transaction awards were, as a class, either indispensable or abusive.

What the budgets, inspectors general, and GAO dockets already show is a durable split in the toolkit: FAR contracts with denser clauses and protest pathways, and other-transaction agreements with fewer of both. BARDA’s statutory OTA role did not begin in 2020. The pandemic, according to GAO, stress-tested that role at scale and left a documentary trail of faster awards, thinner files, and incomplete government-wide data.

Subsequent BARDA solicitations and HHS acquisition policy memos in the public domain have continued to list other-transaction authority among available instruments for chemical, biological, radiological, and nuclear threats and for emerging infectious disease. GAO’s pandemic findings remain the principal unclassified assessment of how those instruments performed when the government bought at emergency speed. The office has not claimed that traditional contracting would have produced identical products on the same calendar. It has claimed that competition, cost insight, and reporting were weaker than under the FAR, and that agencies should close those gaps when they next use OTAs at volume.