Bioethical Considerations of Right to Try and What It Means for the Patient-Physician Relationship

• Author: Neal K. Patel
• Position: Georgetown University Law Center, J.D. expected 2022; Emory University, B.S. 2018
• Pages: 1189-1202

Bioethical Considerations of Right to Try and What

It Means for the Patient-Physician Relationship

NEAL K. PATEL*

INTRODUCTION

Patients are able to get experimental drugs that have not been fully approved

by the Food and Drug Administration (FDA) in one of three primary ways: (1)

randomized clinical trials, (2) FDA’s Expanded Access Program, and (3) Right to

Try.

1

Randomized clinical trials have been the “gold standard” method of getting

access to experimental treatment options, but this was expanded in the 1970s by

the FDA after the agency received increased pressures from patients who did not

qualify for clinical trials but still wanted treatment options via experimental

drugs.

2

While the Expanded Access Program made experimental drugs a lot more

accessible to qualifying patients, more recently, organizations and the United

States government (state and federal) have sought to further expand access to ex-

perimental drugs by enacting Right to Try laws, which “remov[es] the oversight

and approval of the FDA.”

3

Right to Try is likely a “politically motivated” bend

4

that has proven to be ineffective for a number of reasons. For instance, since its

passing, only two patients have actually participated in federal Right to Try

procedures.

5

In contrast, the FDA’s Expanded Access Program, a very similar

program that has been in place for many years prior to Right to Try, has helped

thousands of patients get access to investigational drugs with the help of FDA

oversight and approval.

6

To contribute to the debate regarding the effects of the

Right to Try, this Note will argue that, while Right to Try is a well-intentioned

* Georgetown University Law Center, J.D. expected 2022; Emory University, B.S. 2018. © 2021, Neal K.

Patel.

1. See NAT’L CANCER INST., Access to Experimental Cancer Drugs, https://www.cancer.gov/about-cancer/

treatment/drugs/access-experimental [https://perma.cc/Y58K-VY7F] (last updated July 22, 2019).

2. See D. Carrieri, F.A. Peccatori & G. Boniolo, The Ethical Plausibility of the ‘Right To Try’ Laws, 122

CRITICAL REV. IN ONCOLOGY/HEMATOLOGY 64, 65 (2017).

3. Id. at 64.

4. See Jennifer Bryne, Right to Try: A ‘Well-Intentioned’ but ‘Misguided’ Law, HEALIO NEWS (Mar. 10,

2020), https://www.healio.com/news/hematology-oncology/20200303/right-to-try-a-wellintentioned-but-

misguided-law [https://perma.cc/9ETF-SKSF].

5. See Arthur L. Caplan, Why the Right-to-Try Law is a Complete Failure, MEDSCAPE (Apr. 16, 2019),

https://www.medscape.com/viewarticle/911220 [https://perma.cc/QA5X-T3QJ].

6. See id.; U.S. GOV’T ACCOUNTABILITY OFFICE, INVESTIGATIONAL NEW DRUGS - FDA HAS TAKEN STEPS

TO IMPROVE THE EXPANDED ACCESS PROGRAM BUT SHOULD FURTHER CLARIFY HOW ADVERSE EVENTS DATA

ARE USED (2017), https://www.gao.gov/products/GAO-17-564#summary [https://perma.cc/KL49-VKKD]

(stating “of the nearly 5,800 expanded access requests that were submitted to FDA from fiscal year 2012

through 2015, FDA allowed 99 percent to proceed”).

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