Prevalence of Publicly Available Expanded Access Policies

Jung EH, Zettler PJ, Kesselheim AS - Clinical Pharmacology & Therapeutics

  • Price, Value, and Access
  • Regulation and Clinical Evidence

Summary:

The 21st Century Cures Act of 2016 required pharmaceutical manufacturers to publicly post 5 key pieces of information about their expanded access programs by February 2017 to improve transparency for patients with serious or life-threatening conditions seeking experimental treatments. The authors reviewed a sample of manufacturers’ online expanded access policies to assess compliance with these requirements and determine what information is readily available to patients.

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