The Latest 'Federal Movement' in the Food and Drug Law Arena: The Federal Right-to-Try or Rather Right-to-Know and Thus Request Investigational Therapies for Individuals with a Life-Threatening Disease or Condition
Indiana Health Law Review, Vol. 16, Issue 1, November 2018
31 Pages Posted: 5 Sep 2018 Last revised: 17 Feb 2019
Date Written: August 27, 2018
Does the recently enacted Federal Right-to-Try Act provide improved access for the desperately ill? Will insurance companies provide reimbursement for a patient to undergo such investigational therapies? Is the manufacturer protected in terms of lawsuits? That is, does the patient relinquish the right to bring a legal action? Will physicians comprehend the pathway and advocate for their patients? Does this new law guarantee “any novel federal right”? The national state movement regarding Right-to-Try state legislation spurred the enactment of the Federal Right-to-Try (Federal Right-to-Try Act) legislation passed in 2018. Yet, even prior to the enactment of the Federal Right-to-Try law, the United States Federal Food and Drug Administration (FDA) has had mechanisms in place for those terminally ill who do not qualify for a clinical trial.
This article provides a Federal Primer on the Investigational Drug, Biologic and Device Process, details a similar national right-to-know movement in the food and drug law arena that led to federal legislation perhaps comparable to how the Federal Right-to-Try Act was enacted and includes a discussion about the state right to try movement which conceivably led to the enactment of the Federal Right-to-Try Act. There are more queries than unambiguous answers regarding the recently enacted Federal Right-to-Try Act. The federal law in essence could prove troublesome and confusing with both the state Right-to-Try measures due to, for instance, issues of national uniformity and preemption. Further, could the recently enacted Federal Right-to-Try Act ultimately be detrimental to the patient in terms of lack of adequate safeguards and perhaps a false unrealistic sense of hope?
Keywords: pharmaceutical law, drug law, right to try, investigational drugs, terminally ill patients, experimental drugs
JEL Classification: K23
Suggested Citation: Suggested Citation