Literature DB >> 30231728

Who Stands to Benefit? Right to Try Law Provisions and Implications.

Lisa Kearns1, Alison Bateman-House1.   

Abstract

As of late November 2016, 32 states had adopted right to try laws. These laws are intended to allow terminally ill patients pre-approval, or "compassionate," access to drugs, devices, or biologics that are in development and have not yet been approved by the United States Food and Drug Administration (FDA). While the laws' intentions and their impact have been examined, little has been written about variations among the state laws. An examination of the specific provisions in and differences among the 32 statutes, and who stands to gain from them, suggests that the benefits of right to try laws are largely rhetorical. So, although the laws have been heralded as pro-patient, they ought to be understood as merely masquerading as patient-centric legislation. We call for a re-examination and amendment or, ideally, repeal of these laws in order to prevent the very real risk of patient harm caused by both some of the laws' provisions and patients' confusion arising from these misleading statutes.

Entities:  

Keywords:  FDA; compassionate use; ethics; expanded access; right to try; right to try law

Year:  2017        PMID: 30231728     DOI: 10.1177/2168479017694849

Source DB:  PubMed          Journal:  Ther Innov Regul Sci        ISSN: 2168-4790            Impact factor:   1.778


  3 in total

1.  Right to Try Requests and Oncologists' Gatekeeping Obligations.

Authors:  Holly Fernandez Lynch; Ameet Sarpatwari; Robert H Vonderheide; Patricia J Zettler
Journal:  J Clin Oncol       Date:  2019-10-15       Impact factor: 44.544

2.  The Critical Role of Medical Institutions in Expanding Access to Investigational Interventions.

Authors:  Kayte Spector-Bagdady; Kevin J Weatherwax; Misty Gravelin; Andrew G Shuman
Journal:  Hastings Cent Rep       Date:  2019-03       Impact factor: 2.683

3.  "I Think It's Been Met With a Shrug:" Oncologists' Views Toward and Experiences With Right-to-Try.

Authors:  Cambray Smith; Jeremiah Stout; Alex A Adjei; Jan Buckner; Mark Wentworth; Jon Tilburt; Zubin Master
Journal:  J Natl Cancer Inst       Date:  2021-06-01       Impact factor: 13.506

  3 in total

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