LAUSR

Key Points Question What is the timing and duration of investigational drug availability through the US Food and Drug Administration’s (FDA’s) expanded access program? Findings In this cross-sectional study of 92 FDA-approved drugs with associated expanded access programs, the median premarket expanded access availability was 10 months. Of 92 expanded access programs, 64 (69.6%) were initiated within the 6 months preceding or following a new drug’s application submission to the FDA. Meaning The FDA and the pharmaceutical industry have established a balance between investigational new drug access and patient safety that may be compromised by policy makers seeking to speed access to investigational medicines through the Right to Try Act.