Biomanufacturing Excellence Act of 2025
- Bill Number
- H.R. 6089
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Science, Technology, Communications
- Status
- Introduced
- Latest Action
- 2025-11-18: Referred to the House Committee on Science, Space, and Technology.
- Last Updated
- 2026-06-09T08:06:14Z
AI-Generated Summary
Purpose of the Legislation
The Biomanufacturing Excellence Act of 2025 aims to create a National Biopharmaceutical Center of Excellence to advance biopharmaceutical manufacturing (the production of medicines using biological systems). It seeks to boost U.S. innovation in biotechnology, reduce reliance on foreign supply chains, enhance national security, improve health outcomes, and build a skilled workforce in the biotech sector.
Key Provisions
- Findings and Sense of Congress: Recognizes biotechnology's potential to transform medicine, agriculture, and military capabilities; emphasizes the need for U.S. leadership to avoid foreign dominance; highlights barriers like scaling production and infrastructure needs; supports establishing a center for innovation, collaboration, and training.
- Establishment of the Center: Amends the National Institute of Standards and Technology (NIST) Act to add a new section creating the National Biopharmaceutical Manufacturing Center of Excellence. NIST's Director will competitively award a grant or agreement (a flexible funding tool) to a non-federal eligible entity, such as a public-private partnership, university, or consortium.
- Objectives of the Center:
- Develop flexible manufacturing technologies, improve processes and equipment, and reduce supply chain bottlenecks, focusing on products vital to U.S. security (national, health, economic).
- Promote "good manufacturing practices" (standards for safe, consistent production), quality design, and standardization to streamline regulation.
- Provide workforce training in partnership with educational and community groups.
- Foster collaborations with universities, manufacturers (small to large), governments, nonprofits, and others.
- Share research data and best practices with federal agencies overseeing biotech.
- Funding and Operations:
- Funds can support facility construction, collaborative research on scaling production, workforce programs, and related development.
- Applications due within 180 days of enactment; must detail past experience, plans for innovation and training, partnerships, and infrastructure use.
- Selection based on potential impact, past performance, regional workforce support, leveraging existing initiatives, location near biotech hubs, timeline, co-investments, and other factors.
- Reporting Requirements: NIST must submit reports to Congress—one year after award (on setup), one year after operations start (on progress), and five years after (final evaluation)—all publicly available online.
- Other Elements: Requires intellectual property guidelines for center research, modeled on existing programs like Manufacturing USA. Authorizes $120 million for fiscal year 2026. Defines key terms like "biomanufacturing" (using biotech for production), "biopharmaceutical" (drugs from living cells), and "biotechnology" (engineering living organisms or their products).
Significant Changes to Existing Law
- Inserts a new Section 36 into the National Institute of Standards and Technology Act (15 U.S.C. 271 et seq.), redesignating the prior Section 36 as 37.
- Introduces a dedicated federal mechanism for biopharmaceutical manufacturing innovation, expanding NIST's role beyond traditional standards to include grants for public-private centers focused on biotech scaling and security.
- No direct repeals or overhauls, but it builds on existing frameworks like Manufacturing USA by mandating biotech-specific collaborations and reporting.
Potential Impacts
- Government Agencies: NIST gains oversight of a new center, requiring coordination with agencies like those handling biotech research (e.g., sharing data on best practices). Could streamline federal regulation of innovative manufacturing by standardizing processes, easing approvals for new drugs.
- Citizens: Improves access to advanced, less invasive treatments by accelerating biopharma production; creates training opportunities and jobs in biotech, particularly in manufacturing and related fields, boosting economic opportunities in various U.S. regions.
- International Relations: Strengthens U.S. competitiveness in global biotech by reducing foreign supply dependencies (e.g., for critical medicines), potentially enhancing health and economic security amid rivalries with other nations; promotes U.S. leadership in setting global standards for biomanufacturing.
Main Stakeholders Affected
- Federal Government: NIST (lead implementer), other executive agencies (e.g., those regulating drugs or coordinating biotech), and Congress (via reporting).
- Industry and Nonprofits: Pharmaceutical manufacturers (small, medium, large), public-private partnerships, and nonprofits involved in biotech research and training.
- Educational Institutions: Universities and community colleges partnering on workforce development and research.
- Workers and Communities: Individuals seeking biotech jobs, especially in manufacturing; regions with biotech clusters benefiting from infrastructure and training.
- Broader Public: Patients and consumers gaining from faster, more reliable drug production tied to national security needs.
Notable Legal, Constitutional, or Political Implications
- Legal: Authorizes flexible funding (grants or "other transaction agreements") to encourage innovation without rigid procurement rules, potentially speeding up public-private deals; requires IP guidelines to protect inventions while enabling collaboration, aligning with existing federal tech-transfer laws.
- Constitutional: Falls within Congress's commerce and spending powers to promote economic and health security; no apparent First Amendment or due process issues, as it focuses on voluntary partnerships and competitive awards.
- Political: Bipartisan introduction (by Reps. Houlahan, Baird, Ross, Rouzer) signals broad support for biotech investment; emphasizes national security to appeal across aisles, but could spark debates on funding priorities or industry favoritism; the $120 million authorization may face scrutiny in budget negotiations, highlighting U.S. strategy to counter global biotech competition.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Houlahan, Chrissy [D-PA-6]
Cosponsors (16)
Rep. Baird, James R. [R-IN-4], Rep. Ross, Deborah K. [D-NC-2], Rep. Rouzer, David [R-NC-7], Rep. McBride, Sarah [D-DE-At Large], Rep. Bilirakis, Gus M. [R-FL-12], Rep. Auchincloss, Jake [D-MA-4], Rep. Sessions, Pete [R-TX-17], Rep. McClain Delaney, April [D-MD-6], Rep. Bice, Stephanie I. [R-OK-5], Rep. Davis, Donald G. [D-NC-1], Del. Moylan, James C. [R-GU-At Large], Rep. Sorensen, Eric [D-IL-17], Rep. Harrigan, Pat [R-NC-10], Rep. Riley, Josh [D-NY-19], Rep. Thanedar, Shri [D-MI-13], Rescom. Hernández, Pablo Jose [D-PR-At Large]
Recent Actions
- 2025-11-18: Referred to the House Committee on Science, Space, and Technology.
- 2025-11-18: Introduced in House
- 2025-11-18: Introduced in House
Bill Versions
- Biomanufacturing Excellence Act of 2025 — issued 2025-11-18 — PDF (14 pages)