Fighting for Your Life in America: A Study of "Right to Try" Laws throughout the Country

By DelGrosso, Danielle | St. John's Law Review, Fall 2017 | Go to article overview

Fighting for Your Life in America: A Study of "Right to Try" Laws throughout the Country


DelGrosso, Danielle, St. John's Law Review


INTRODUCTION

On June 9, 2011, cancer took the life of twenty-one-year-old Abigail Burroughs.1 Abigail spent the final seven months of her life fighting for access to an experimental drug, Erbutrix, not yet approved by the Food and Drug Administration ("FDA") that her treating physician and family believed could save her life.2 Her efforts were unsuccessful.3

Abigail's death spawned the Abigail Alliance, a non-profit advocacy organization working for FDA regulatory changes that would allow terminally ill patients access to experimental drugs.4 Spear-headed by Abigail's father, Frank Burroughs,5 the Alliance has made noise in the media,6 in the courtroom,7 and on Capitol Hill.8 The commotion prompted "Right to Try" legislation to be passed in thirty-two states,9 and proposed in sixteen others.10 In May of 2016, a federal "Right to Try" bill was proposed in Congress.11 Problematically, not all of these laws look the same.

Congress's bill, the Trickett Wendler Right to Try Act of 2016 ("the Trickett Wendler Act"),12 is named after a young mother of three who lost her battle against Amyotrophic Lateral Sclerosis ("ALS") in March of 2015.13 Trickett and Abigail have similar stories. Both suffered from conditions that would ultimately take their lives,14 were treated with drugs that could not and did not save them,15 and were denied access to unapproved drugs.16 Had the Trickett Wendler Act been law while Trickett or Abigail were alive, their stories may have had different endings.

This Note argues that there should be a federal statute granting terminally ill patients access to experimental drugs, but that the Trickett Wendler Act, as written is not the proper vehicle for change. An ideal congressional "Right to Try" statute should be crafted to make experimental drugs realistically obtainable for terminally ill patients while protecting those patients and their quality of life. The Trickett Wendler Act's weaknesses prevent it from reaching this objective because it is too deferential to already unclear state Right to Try laws. Part I explores the right to try movement generally, explaining what a "right to try" is and the obstacles currently standing in its way. Part II examines and critiques different "Right to Try" laws that have been adopted in the states. Part iii proposes a model congressional "Right to Try" bill.

I. THE RIGHT TO TRY

Essentially, "Right to Try" laws provide terminally ill patients with access to experimental treatments that have successfully passed the first of the FDA's three phases of clinical trials.17 According to FDA guidelines, a drug normally cannot go to market until it has successfully passed a phase-three trial.18 It is only at this point that the drug is considered safe and effective for human consumption.19 Right to Try laws effectively bypass the FDA's system, allowing access to a drug before it receives the FDA's stamp of approval.20 Right to Try proponents say this will reduce terminal patients' waiting time for drugs not yet approved21-time that they simply do not have.

State Right to Try laws embrace the belief that it is a terminally ill patient's fundamental right to access unapproved drugs.22 At the heart of that belief is the idea that a person has the fundamental right to try to save his or her own life.23 Advocates' bottom line is that individuals should not have to ask the government for permission to survive.24

However, there are three chief obstacles to Right to Try laws' success: (1) there is no recognized constitutional right to try; (2) state Right to Try laws are federally preempted by FDA guidelines; and (3) there is no consensus as to whether a right to try should exist.

First, despite proponents' assertions that the terminally ill have a fundamental right to access investigational drugs, courts have not agreed.25 In Abigail Alliance v. Eschenbach, the United States Court of Appeals for the District of Columbia Circuit stated that, "such rights are not set forth in the language of the Constitution," and "there is no fundamental right 'deeply rooted in this Nation's history and tradition' of access to experimental drugs for the terminally ill. …

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