Pharmaceutical safety and efficacy
The Industrial Bio-Test fraud is the direct precedent for regulating the testing labs themselves; Good Laboratory Practice was the response. Trial registration is the precedent for evaluation registries.
Path signature
M mandate T trigger M mandate T trigger D delegation M mandate S standards T trigger O oversight P payer shift I independence A access/publication
Similarity of its opening to frontier AI: 0.22 (matched opening MTMTDMS)
Stages reached
| Voluntary | not reached |
| Trigger | 1937 |
| Mandate | 1906 |
| Standards | 1962 |
| Oversight | 1978 |
| Independence | 1998 |
| Access | 2007 |
Mechanisms
| Before reform | Now | |
|---|---|---|
| pays | A | A |
| selects | A | R |
| access | deep | deep |
| publishes | none | public |
| oversees | none | regulator |
Sponsor funds trials and user fees; FDA reviews and inspects labs under GLP; trials registered publicly.
Payer, access, publication
Who pays. Sponsor funds trials and, since 1992, pays user fees for review.
Access. Regulator receives full trial data; inspects sites and labs.
Publication. Approval decisions and labels public; trial registration and results reporting mandated since 2007.
Milestones
| Year | Kind | Event | Strength | Harm | |
|---|---|---|---|---|---|
| 1906 | mandate | Pure Food and Drug Act: labeling and adulteration rules. | 2 | source | |
| 1937 | trigger | Elixir sulfanilamide kills more than 100 people. | deaths: More than 100 deaths | source | |
| 1938 | mandate | Federal Food, Drug, and Cosmetic Act: pre-market safety review. | 3 | source | |
| 1961 | trigger | Thalidomide birth defects. | deaths: Thousands of birth defects and deaths | source | |
| 1962 | delegation | Sponsors design and run the efficacy trials the regulator reviews; contract research organizations grow from the 1970s. | source | ||
| 1962 | mandate | Kefauver-Harris Amendment: proof of efficacy, controlled trials, informed consent. | 3 | source | |
| 1962 | standards | Adequate and well-controlled trials required as the evidentiary standard. | 2 | source | |
| 1976 | trigger | Industrial Bio-Test Laboratories found to have falsified safety studies for hundreds of products. | integrity_failure: Testing lab falsified safety studies | source | |
| 1978 | accreditation | Good Laboratory Practice regulations govern the conduct and inspection of nonclinical testing labs. | 4 | source | |
| 1992 | payer shift | PDUFA: sponsors pay user fees that fund FDA review (payment moves toward the assessed party). | source | ||
| 1998 | independence rule | FDA rule on financial disclosure by clinical investigators (21 CFR Part 54). | 1 | source | |
| 2007 | publication rule | FDAAA mandates trial registration and results reporting on ClinicalTrials.gov. | 2 | source |
seed; secondary sources; verify each milestone against a primary source before citing in the paper Data: data/industries/pharmaceuticals.json