Understanding the Right to Try Act Editorial


Authors: Agarwal, R.; Saltz, L. B.
Title: Understanding the Right to Try Act
Abstract: Patients with cancer who have exhausted standard treatments often seek access to investigational drugs. Often, however, such access is unavailable, due to either the unavailability of a trial, lack of an open recruiting spot on the trial, even when the trial itself is open, or the inability of the patient to meet one or more trial eligibility criteria. In such settings patients often seek access to investigational agents outside of a trial. The federal “Right to Try” legislation was passed to create an additional avenue, different from the FDA's Expanded Access, or “Compassionate Use” Program, through which patients might obtain access to investigational drugs. A year after this legislation was signed into law, there remains both a limited awareness of it and a substantial degree of misunderstanding on the part of those who are aware of it. The law creates an avenue to greatly facilitate off-study administration when patient, physician, and the manufacturer are all in agreement regarding the off study use of an eligible investigational agent. The law does not, however, empower a patient to impose a demand on either a provider or a drug manufacturer, nor does it require any entity to provide financial coverage for the drug. Eligible drugs are those which are not approved by the FDA for any indication, have completed a phase I trial, have an ongoing pivotal trial, and have an active registration plan. We review the specific law with commentary on its implications for improved access to investigational drugs outside of clinical trials. © 2020 American Association for Cancer Research.
Keywords: review; patient selection; organization and management; food and drug administration; health care quality; medical liability; medicolegal aspect; awareness; decision making; health care access; drug use; drug indication; legal liability; drug legislation; human; priority journal; malignant neoplasm
Journal Title: Clinical Cancer Research
Volume: 26
Issue: 2
ISSN: 1078-0432
Publisher: American Association for Cancer Research  
Date Published: 2020-01-15
Start Page: 340
End Page: 343
Language: English
DOI: 10.1158/1078-0432.Ccr-19-2015
PUBMED: 31666248
PROVIDER: scopus
PMCID: PMC7416898
DOI/URL:
Notes: Review -- Source: Scopus
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MSK Authors
  1. Leonard B Saltz
    761 Saltz
  2. Rajiv Agarwal
    12 Agarwal