Case studies
Purdue Pharma + the Sacklers — OxyContin
FDA approvals + DEA controlled-substance schedule + DOJ criminal case + state AGs + bankruptcy + the opioid epidemic.
1996–present
FDA
DEA
DOJ
HHS-OIG
CDC
Purdue Pharma's OxyContin (approved by FDA in 1995) is the textbook case study of pharmaceutical regulatory failure. Marketed as low-addiction, it fueled the opioid epidemic. Purdue pled guilty to felony misbranding in 2007 ($634M) and to three federal felonies in 2020 ($8.3B). The Sacklers' settlement is still being litigated. CDC tracks 800k+ opioid-related overdose deaths in the years since.
FDA approval + marketing
FDA approved OxyContin under NDA 020553 in 1995 with a label downplaying addiction risk. The MS Contin contradiction — Purdue's own earlier morphine — was never reconciled in the labeling.
DEA controlled-substance scheduling
OxyContin is Schedule II. DEA Decision-and-Orders for pharmacies and distributors that allegedly diverted oxycodone — many tied to Purdue's distribution network — appear in our DEA dataset.
DOJ criminal case (2007 + 2020)
Purdue pled guilty to felony misbranding in 2007 ($634.5M) and to conspiracy to defraud the US and pay illegal kickbacks in 2020 ($8.3B + corporate dissolution).
The body count: CDC overdose mortality
CDC's overdose mortality tracker (83k+ records in our system) shows the opioid epidemic Purdue helped fuel. The 'opioid' category now drives a majority of US drug-overdose deaths.