Top Republican eyeing FDA overhaul [View all]

Source: The Hill

02/17/26 3:57 PM ET


Sen. Bill Cassidy (R-La.) on Tuesday unveiled his proposal for modernizing the Food and Drug Administration (FDA), calling on the agency to reform some of its practices and embrace innovations in order to get more products approved for patients.

In the report titled “Patients and families: Building the FDA of the future,” Cassidy, chair of the Senate Committee on Health, Education, Labor, and Pensions, lamented that “unnecessary bottlenecks slow patients and consumers getting the products they need.”

The first issue Cassidy cited in his report was the “reviewer lottery” system that companies report facing when trying to get their products approved by the FDA. Elsewhere in the report, he noted in particular how unpredictability in FDA reviews can impact drugs for treating rare diseases, so-called orphan drugs, by adding additional time and obstacles to approval.

“FDA teams can differ greatly in the extent to which they require testing or impose standards that are not calibrated to the relevant risks. The perceived disconnect between the forwardleaning rhetoric and thought leadership of senior FDA officials and cautious reviewer practice creates further unpredictability,” the report stated.

Read more: https://thehill.com/policy/healthcare/5741597-cassidy-report-fda-innovation/

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More "reinventing of the wheel". The fact that the agency had to go to a "User Fee" model in the early '90s to help fund reviews, means that Congress was refusing to adequately fund the agency from Budget Authority funds to do that type of work.