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Policy controversy

Big PharmaAtlas

Health & Medicine · Pharmaceutical industry

Competing accounts of whether drug companies steer the FDA and the medicine people get, versus imperfect but still independent public oversight, without offering treatment guidance.

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Timeline

  1. 1962 · eventKefauver-Harris amendments strengthen U.S. efficacy requirements
  2. 1990 · first_appearanceUser-fee funding enters U.S. drug-regulation debate
  3. 1992 · eventPDUFA first enacted
  4. 1992 · first_appearancePDUFA introduces industry user fees for FDA drug review
  5. 1997 · eventEarly multi-year PDUFA reauthorization cycle
  6. 2007 · eventLater PDUFA reauthorization and safety-oversight debate period
  7. 2007 · investigationPost-market safety debates intensify around fee-era incentives
  8. 2012 · popularizationCapture critiques widen in academic and journalistic accounts
  9. 2012 · eventPDUFA reauthorization amid continued capture-versus-oversight dispute
  10. 2017 · eventFurther PDUFA reauthorization cycle
  11. 2017 · amplificationOpioid and accelerated-approval controversies feed independence arguments
  12. 2019 · investigationHouse oversight committee hearing under Chair Elijah Cummings
  13. 2022 · eventMost recent multi-year PDUFA reauthorization window
  14. 2022 · mutationPandemic-era authorization speed reframes capture vs capacity claims

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