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Food and Drug Administration (FDA)
Federal Regulatory Agency
Drug and Food Safety Regulator
Overview
The FDA is the federal agency responsible for protecting public health by regulating food, drugs, medical devices, vaccines, and tobacco. It has faced persistent criticism for regulatory capture by the pharmaceutical industry, approving drugs with inadequate safety data, fast-tracking approvals under industry pressure, and the revolving door between FDA leadership and the companies they regulate. The opioid crisis, in which FDA approved OxyContin with misleading labeling, killed over 500,000 Americans.
Key Affiliations
Controversies & Concerns
OPIOID CRISIS: Approved OxyContin with label claiming low addiction risk, contributing to epidemic killing 500,000+ Americans
REVOLVING DOOR: Pattern of FDA commissioners and officials moving to pharmaceutical industry positions
ACCELERATED APPROVAL ABUSE: Fast-track approvals of drugs with limited evidence, later found ineffective or harmful
PHARMACEUTICAL INDUSTRY FUNDING: User fees from drug companies fund majority of drug review operations
ADUHELM CONTROVERSY: Approved Alzheimer's drug Aduhelm despite advisory committee voting against it, controversy led to congressional investigation
Related Investigations (2)
Sources & Documentation
2 documented sources from official records, investigations, and reports
Personal Information
- Also Known As
- FDA
Education
Key Timeline
1906
Federal drug regulation begins with Pure Food and Drug Act
1938
FDA established after sulfanilamide disaster kills 107
1995
FDA approves OxyContin with misleading "low abuse potential" label
2007
FDA Amendments Act gives agency more post-market safety authority
2021
Aduhelm approval controversy, advisory committee members resign in protest