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Reconciling States' "Right to Try" Legislation and FDA's Expanded Access Program: Legal Issues.

Robyn S Shapiro1

  • 11 Health Sciences Law Group LLC, Fox Point, WI, USA.

Therapeutic Innovation & Regulatory Science
|September 21, 2018
PubMed
Summary
This summary is machine-generated.

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State "Right to Try" laws offer terminally ill patients access to investigational drugs. This article examines the legal landscape of expanded access to these treatments, considering state and federal government roles.

Area of Science:

  • Medical Law
  • Pharmaceutical Policy
  • Patient Advocacy

Background:

  • Recent enactment of state-level "Right to Try" (RTT) laws.
  • RTT laws aim to provide terminally ill patients with access to unapproved investigational drugs.
  • These drugs have completed Phase I FDA clinical trials and are undergoing further testing.

Purpose of the Study:

  • To discuss the legal complexities surrounding expanded access to investigational drugs.
  • To analyze the roles of both state and federal governments in facilitating or regulating this access.

Main Methods:

  • Review of existing state "Right to Try" legislation.
  • Analysis of the Food and Drug Administration's (FDA) expanded access program framework.
  • Examination of the intersection between state and federal regulatory authority in drug access.
Keywords:
legalright to trystate and federal law

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Main Results:

  • Identifies potential conflicts and synergies between state RTT laws and federal regulations.
  • Highlights the legal challenges in defining eligible patients and investigational products.
  • Discusses the implications for patient access pathways beyond traditional clinical trials.

Conclusions:

  • The current legal framework for expanded access to investigational drugs is complex.
  • Clarification of state and federal roles is crucial for effective patient access.
  • Further legal analysis is needed to ensure patient safety and facilitate promising therapies.