If you could redesign FDA from the ground up, what would it look like? That's the fundamental question underlying the 2025 BioCentury Back to School essay, authored by our Washington Editor Steve Usdin, who has been a leading voice on regulation and policy for over two decades.
The topic is especially meaningful in this era of FDA turmoil, when regulatory risk has piled on top of the market pullback, making biotech appear an unusually hazardous domain for investors.
But while the current landscape has underscored the need, FDA reform has been on the table long before this administration came into power.
FDA has earned its status as the gold standard of drug regulation, but continued long-term primacy cannot be taken for granted. The agency's complex structure and the industry's changing global dynamics pose real challenges. Political interference in scientific decisions is no longer hypothetical; at the same time, the idea that dramatic change is infeasible has also had a reality check.
In a multipart package, Usdin takes a blank sheet of paper and outlines the overarching structure and philosophy of a regulatory agency focused on medical products. His thought experiment is designed for a biotech industry entering a new era of rapidly accelerating scientific discovery, where AI and digital technologies will upend old-school methodologies, even as the trust gap between the scientific establishment and the public continues to widen.
The piece is informed by Usdin's deep knowledge of FDA and drug regulation, as well as insights from his extensive network of thought leaders from former FDA heads to current biopharma executives and investors.
On The BioCentury Show this week, Usdin and I discussed the key arguments, and some specific concepts, within Back To School.
Usdin makes the case for a comprehensive rebuild that would separate medical products regulation from FDA's other responsibilities, while also dissolving some of the silos within the agency that no longer make sense, such as the separate centers for drugs, biologics and devices (CDER, CBER and CDRH). Instead, he envisions an FDA organized around therapeutic areas, modeled on the success of the Oncology Center of Excellence, and supported by cross-functional centers with expertise in fields such as toxicology, manufacturing and biostatistics.
He also emphasizes the need to embed a greater culture of learning at the agency. One proposal is the creation of non-partisan review boards after major controversies or public health failures, along the lines of investigations by the National Transportation Safety Board (NTSB) after a plane crash. Collaborative models, external engagement, and remaking advisory committees are also part of the blueprint.
In what I think is one of the most interesting sections, he argues that FDA can take lessons from other global agencies that are innovating in areas from AI to CMC. Japan's PMDA, for example, uses a multitiered grading system to assess CMC quality, helping determine whether an on-site inspection is necessary or a desktop review will suffice. Europe's EMA relies on technically experienced reviewers and prioritizes quality improvement over fault-finding to enable an innovation mindset rather than a compliance one.
Across all of this is the need for political independence, balanced with accountability to the public, and a move to rebuild trust. The FDA commissioner should have the same kind of independence as the head of the Federal Communications Commission (FCC) or Securities and Exchange Commission (SEC), with a tenure longer than the lifetime of a president's term. And Usdin makes the, perhaps controversial, argument for doing away with user fees and instead having Congress appropriate the funds, noting that even if PDUFA's industry funding does not exert undue influence, the perception of regulatory capture is growing.
There's a lot to sink your teeth into in this year's Back to School, but the structures and rules it outlines are only part of what an agency rebuild will take. FDA can only ever be as good as its people. Beyond stemming the loss of regulatory staff, the goal should be to aim higher by fostering a culture that values thought leadership, embraces digital and AI fluency, and prizes turning fresh ideas into action.