Dr. Shawn Baker on fda: what the evidence says · JRE #2069
SUBJECT: FDA
Not a true/false call. Every claim is logged with its sources; read the exhibits below.
the FDA for new drug, for new drug approvals, it's like 65% of that budget comes from the pharmaceutical industry itself. So they're like, they're paying to regulate themselves.
What the evidence says 01 / RECORD
Baker's figure is essentially correct for the specific budget he is describing, though the claim conflates a sub-agency figure with the FDA's overall budget. Under the Prescription Drug User Fee Act (PDUFA), first enacted in 1992 and renewed roughly every five years, pharmaceutical companies pay fees to FDA to support the review of new drug applications. A peer-reviewed 2022 analysis in Medical Care reported that in 2020, industry user fees totaled $1.3 billion, accounting for approximately 65% of the budget of FDA's Human Drugs Program (the Center for Drug Evaluation and Research, CDER), the FDA's largest sub-unit. That figure applies specifically to the drug-review program's budget, not the FDA's total agency-wide budget, which draws more heavily on congressional appropriations and is funded by user fees at a lower overall share. The underlying mechanism Baker describes, that companies seeking approval pay fees that fund a majority of the review process, is accurately characterized by FDA's own program description, which confirms PDUFA authorizes FDA to collect fees from drug and biologic sponsors to fund and expedite the review process.