The FLASH Act of 2025 amends the Public Health Service Act to expand BARDA’s (Biomedical Advanced Research and Development Authority) contracting and procurement tools. It authorizes follow-on production contracts for prototypes developed under BARDA-supported transactions, allows BARDA to procure supplies for experimental or test purposes, and enables the acquisition of innovative commercial products and services through general solicitations with competitive processes. The bill establishes conditions for these authorities, including how follow-on awards may be made to initial transaction participants without traditional competitive procedures in certain cases, and sets thresholds, oversight, and definitions to govern these purchases. In practical terms, the bill aims to accelerate development, testing, and deployment of medical countermeasures and related technologies by expanding BARDA’s ability to move from early prototypes to production, obtain necessary experimental supplies, and acquire innovative products and services more quickly, while imposing some reporting and procurement controls.
Key Points
- 1Follow-on production contracts: A transaction supporting the design/development of a prototype may lead to a follow-on production contract or transaction for the participants in that initial project, including all subprojects. In some cases, these follow-on awards may be made without the usual competitive procedures if initial competitive selection was used.
- 2Prototype subprojects included: Any prototype subprojects awarded within a transaction to carry out BARDA authorities are included in the follow-on production arrangement.
- 3Narrow exception to competition: An exception to competitive procedures allows follow-on awards to initial participants without contest based on prior competitive selection, even if such follow-on wasn’t listed in the original RFP.
- 4Procurement for experimental/test purposes: The Secretary may purchase medical countermeasures, products, supplies, reagents, materials, and related designs for experimental or test purposes to support public health and health security.
- 5Noncompetitive procurement option: Purchases for experimental/test purposes may be made by contract or by other types of transactions using noncompetitive procedures.
- 6Acquisition of innovative commercial products and services via general solicitation: The Secretary can acquire innovative commercial products/services through broad solicitations and peer review, treating such general-solicitation procedures as competitive for purposes of competition laws.
- 7Financial and procedural limits: For general-solicitation acquisitions, contracts/agreements exceeding $100 million cannot be entered into unless a written determination supports mission needs; such contracts must be fixed-price (including fixed-price incentive).
- 8Congressional notification: If an award exceeds $100 million under general-solicitation authority, the Secretary must notify specified House and Senate committees within 45 days, including product/service description, requirement gap, contract amount, and contractor identification.
- 9Definition of “innovative”: An innovation can be a new technology/process/method, or an existing technology/method that is new to the Federal Government as of proposal submission.