FDA Must Prioritize Biosimilar Drug Plant Inspections Based on Risk, Not Rotation

If you’ve ever had to switch to a biosimilar drug—the cheaper, approved copycat versions of expensive biologic medications—you know how important it is that they work exactly like the original. This bill, the Biosimilar Inspection Modernization Act of 2025, is essentially an upgrade for how the FDA checks the factories that make these drugs, trading a standard schedule for a smarter, risk-based approach.

The Shift to Smart Inspections

Right now, inspections can feel a bit like a routine check-the-box exercise. This legislation changes that by requiring the Secretary of Health and Human Services (via the FDA) to create a risk-based inspection schedule within 180 days of the law passing (SEC. 1). Think of it like this: instead of inspecting every car factory every two years, the safety board would focus on the factory that had three recent recalls and a history of cutting corners. The FDA must prioritize inspections based on a facility’s compliance history, its record of recalls, and the inherent risk level of the specific biosimilar drug being produced.

For the average person, this means the FDA’s limited resources will be directed toward the facilities that pose the highest potential risk to public health. If a facility has a clean record and a history of satisfactory inspections—perhaps even by a trusted foreign partner—it might get inspected less often, allowing the agency to spend more time scrutinizing the sketchier operations. The bill does give the Secretary broad authority to include "Any other factors deemed necessary and appropriate to protect public health," which offers flexibility but also means the FDA gets a lot of discretion in defining what counts as a high risk.

Modernizing the Tool Kit

This bill isn't just about scheduling; it’s about bringing the FDA’s inspection methods into the 21st century. The legislation requires the FDA to update its processes to maximize the use of modern tools (SEC. 4). The big one here is the increased use of remote regulatory assessments. Instead of flying an inspector across the country or the world for a routine check, the FDA can use virtual tools, video conferencing, and digital document review to assess a facility’s compliance. This is a massive efficiency boost, especially for facilities located overseas, which make up a huge portion of the drug supply chain.

Furthermore, the bill pushes the FDA to lean more heavily on mutual recognition agreements with foreign governments (SEC. 3). If a trusted foreign regulatory body—say, in Europe or Canada—has already conducted a satisfactory inspection that meets U.S. standards, the FDA should be able to accept that report instead of duplicating the effort. To figure out how to best implement this, the Secretary has to hold a public meeting within 180 days to discuss expanding the use of these agreements, including for remote assessments and virtual interactions with foreign experts.

Fixing the Home Team

Finally, the bill acknowledges that simply having better tools isn't enough if the internal system is struggling. It mandates that the FDA develop a strategic plan within one year focused on improving domestic inspections (SEC. 5). This plan must tackle specific challenges like recruiting and retaining inspection staff, improving internal communication among FDA teams, and finding ways to communicate better with drug manufacturers earlier in the review process. This focus on staff and communication is crucial because the best policy in the world falls apart if the people implementing it are under-resourced or siloed. Ultimately, this bill is a procedural tune-up designed to make sure the biosimilar drugs you rely on are safe, while making the inspection process faster and more focused for everyone involved.