PolicyBrief
S. 1387
119th CongressApr 9th 2025
National Biotechnology Initiative Act of 2025
IN COMMITTEE

This Act establishes the National Biotechnology Initiative to coordinate federal efforts across multiple agencies to advance U.S. national security, economic productivity, and global competitiveness in biotechnology through strategy, research, workforce development, and regulatory streamlining.

Todd Young
R

Todd Young

Senator

IN

LEGISLATION

New Biotech Act Creates Coordination Office, Authorizes $112M to Streamline Regulations and Boost U.S. Competitiveness

The National Biotechnology Initiative Act of 2025 is the federal government’s attempt to get its act together on biotechnology. Think of it as a massive, government-wide effort to make sure the U.S. stays ahead in the race to use biology for everything from new medicines to sustainable manufacturing.

This bill doesn't just fund research; it fundamentally reorganizes how the government handles biotech. It creates a brand-new entity called the National Biotechnology Coordination Office (NBCO) within the Executive Office of the President and an Interagency Committee composed of high-level officials from nearly every major federal department—from Agriculture and Defense to Health and Energy (Sec. 3, Sec. 4). The goal is to stop agencies from tripping over each other and instead coordinate R&D, data management, and, most importantly for businesses, the regulatory path for new products.

The Data and the Dollars

If you work in tech or science, you know data is king. This bill treats biological data—the stuff that powers genetic research and AI-driven drug discovery—as a “national strategic resource” (Sec. 3(c)). The NBCO is tasked with coordinating the creation of data standards so that all that biological information can actually talk to advanced computing systems. This means faster scientific breakthroughs, but it also raises the stakes for data security, which the bill explicitly addresses by mandating agencies improve cybersecurity for sensitive biological data (Sec. 6).

To fund the new coordination hub, the bill authorizes the National Science Foundation (NSF) to spend $112 million between fiscal years 2026 and 2030 (Sec. 4(g)). This money is specifically for staffing and running the new Office, signaling a serious, long-term commitment to this coordination effort.

Cutting Through the Red Tape (Maybe)

For anyone trying to launch a biotech product—whether it’s a new crop, a diagnostic tool, or a manufactured protein—the biggest headache is often navigating the regulatory maze between the FDA, EPA, and USDA. This bill aims to fix that. The NBCO must work to "streamline" regulations, especially for products that are "well-understood" or similar to things that occur naturally (Sec. 4(d)(6)).

Here’s the catch: the bill gives the Director of the NBCO and the Office of Management and Budget (OMB) significant power to resolve regulatory deadlocks. If the agencies can’t agree on a clear path for a new type of product, the OMB Director steps in to negotiate a binding interagency agreement (Sec. 4(g)(2)). This centralization of power could lead to much faster approvals, which is great for the economy, but it also means a single office is now calling the shots on safety and risk assessment across multiple specialized agencies. The NBCO must publish a public regulatory streamlining plan within one year of the law passing.

The Workforce and the Warning Signs

The bill places a huge emphasis on building up the domestic biotech workforce, from supporting curriculum development in high schools and colleges to funding fellowships that let graduate students work in industry settings (Sec. 6). This is excellent news for students and workers looking to pivot into a high-growth sector like biomanufacturing.

However, there are a couple of provisions that raise eyebrows. First, the Director can convene expert groups to guide the Initiative without following the standard rules for federal advisory committees (Sec. 5). This means these groups—who will be shaping policy—won't have the usual transparency requirements, making it harder for the public to see who is advising the government and why. Second, the bill broadly mandates that agencies analyze and counter national security threats from "adversarial countries" trying to acquire U.S. biotech capabilities or data (Sec. 6). While protecting intellectual property is crucial, this broad mandate could lead to overly restrictive measures on data sharing and international collaboration, potentially slowing down scientific progress in the name of security.