FDA Approves OxyContin with Unsubstantiated Safety Claims

Timeline Eventconfirmed
regulatory-capturefdarevolving-dooropioid-crisisdrug-approvalpharmaceuticals
Regulatory Capture
Actors:Food and Drug Administration, Purdue Pharma, Dr. Curtis Wright, Sackler Family
1995-12-20 · 1 min read

The FDA approved Purdue Pharma's OxyContin application, including a scientifically unsubstantiated claim that delayed absorption 'is believed to reduce the abuse liability of a drug.' This approval occurred without clinical trials to prove the safety claim and marked the beginning of aggressive marketing that would fuel the opioid crisis. The approval demonstrated regulatory capture as two principal FDA reviewers later joined Purdue Pharma, including Dr. Curtis Wright who left the FDA less than two years after approval and joined Purdue on October 9, 1998, with a substantially higher salary. The FDA's label claim became central to Purdue's marketing strategy, enabling sales to grow from $48 million in 1996 to $1.1 billion in 2000. The agency didn't modify the problematic label until 2001, removing the abuse liability claim and admitting it lacked data to establish the true addiction rate.

Sources

  1. How FDA Failures Contributed to the Opioid CrisisJournal of Ethics - American Medical Association(2020-08-01)
  2. How the FDA Approved OxyContin: The 1995 Decision That Started America's Opioid CrisisGovFacts(2024-03-15)
  3. GAO Report: OxyContin Abuse and Diversion and Efforts to Address the ProblemU.S. Government Accountability Office(2004-01-01)
  4. An FDA Official Who Led the Approval of OxyContin Got a $400,000 Job at Purdue Pharma a Year LaterYahoo News(2022-07-15)
  5. FDA 'Highly Culpable' for Opioid Crisis, Says 'Empire of Pain' AuthorYahoo Finance(2022-04-13)