Food and Drug Administration
The FDA regulates food safety, pharmaceuticals, medical devices, cosmetics, and tobacco products - about 25% of all consumer spending in the US. As the world's most influential drug regulator, FDA approval is often the prerequisite for global market access.
The FDA's dual mandate creates inherent tension: approve drugs too quickly and patients are harmed by unsafe products; approve too slowly and patients are harmed by delayed access. This tension shapes everything the agency does.
About 65% of FDA's drug review budget comes from 'user fees' paid by the pharmaceutical companies being regulated. This PDUFA (Prescription Drug User Fee Act) system, started in 1992, created faster approvals but also potential conflicts. The FDA approves drugs based on company-funded trials that companies design.
Key Facts
Power Dynamics
Broad authority over product approval and enforcement
Industry funds majority of drug review; Congressional pressure (especially for rare diseases); patient advocacy groups influential for accelerated approval
- Advisory committees can sink approvals
- Congressional appropriations
- Industry lawsuits
- Citizen petitions (often industry-funded delay tactics)
- Pharmaceutical manufacturers (funding)
- Patient advocacy groups
- Congressional oversight
- Academic researchers
Revenue Structure
Food and Drug Administration Revenue Sources
- User fees (PDUFA, etc.) 45% →
- Congressional appropriations 55%
From industry being regulated
Dependent on industry fees for drug review; creates structural incentive alignment with industry
More industry-funded than most international drug regulators
Decision Dynamics at Food and Drug Administration
COVID vaccines approved in months via EUA (Emergency Use Authorization)
Some drug categories (Alzheimer's) have gone decades without approvals
Clinical trial requirements are rate-limiting; safety signals can pause everything
Failure Modes of Food and Drug Administration
- Thalidomide disaster (pre-1962 reforms)
- Vioxx withdrawal (2004)
- Opioid crisis approvals
- Accelerated approval controversies (Aduhelm)
- Type II errors (delays) less visible than Type I errors (bad approvals)
- User fee dependence
- Revolving door with industry
If accelerated approval drug causes major harm, political backlash could freeze innovation pathways
Biological Parallel
Like a cell cycle checkpoint that can cause cancer if too permissive or prevent healing if too restrictive. The FDA faces asymmetric accountability: bad approvals (Vioxx, thalidomide) create scandals and reforms, while bad rejections (or delays) harm invisible patients who never get treatment. This pushes toward caution, creating 'drug lag' compared to some other jurisdictions.
Key Agencies
Drug approvals
Vaccines and biologics
Medical devices