Prevalence of Publicly Available Expanded Access Policies image

Clinical Pharmacology & Therapeutics, March 23, 2018
Emily Jung (Petrie-Flom Student Intern), Patricia J. Zettler, Aaron S. Kesselheim

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The Food and Drug Administration's expanded access program allows patients with serious or immediately life‐threatening conditions to seek access to experimental drugs and treatments from their manufacturers. The 21st Century Cures Act of 2016 sought to increase the transparency of manufacturers' approaches to expanded access by requiring public listing of five key pieces of information about their expanded access programs: 1) relevant contact information, 2) procedures for making requests, 3) general criteria used to evaluate requests, 4) length of time anticipated to acknowledge receipt of requests, and 5) a reference to pertinent information on ClinicalTrials.gov. Manufacturers were given 60 days from the Act's enactment, or until February 11, 2017, to post this information. We reviewed a sample of pharmaceutical manufacturers' expanded access policies to determine what information is readily available to patients online, including assessing whether the information described in the Act is available.

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bioethics health care reform health law policy pharmaceuticals public health regulation