Assisted Suicide and Lethal Injection: FDA’s Regulatory Dilemma?

By Elizabeth Guo

Two weeks ago, California’s legislature approved a bill that would make California the fifth, and largest state to approve assisted suicide. If Governor Jerry Brown signs the bill, California would join Oregon, Washington, Montana, and Vermont in permitting physicians to prescribe life-ending medications. California was one of 36 states that considered assisted suicide legislation this year. Though none of the bills have become law, the assisted suicide, or “Death with Dignity” movement seems to be gaining strength.

If assisted suicide becomes legal in California, whether and how patients will have access to assisted suicide is a different matter. Secobarbitol and pentobarbital are the most commonly used medications in assisted suicide. Pentobarbital, the cheaper of the two options and the preferred drug of choice, is facing a drug shortage. Pentobarbital is also used in capital punishment, and U.S. suppliers have stopped producing the drug because the suppliers did not want to be associated with lethal injection. The drug shortage has left some patients considering assisted suicide to go through back alleyways to obtain pentobarbital.

Indeed, the Death with Dignity movement is facing many of the same issues that state corrections agencies are facing in obtaining access to lethal drugs. None of the drugs used for assisted suicide or lethal injection are FDA-approved for a lethal purpose. Both groups have faced challenges in importing the drugs from other countries because FDA cannot accepting an imported drug if it appears to violate Food Drug and Cosmetic Act. Both groups have, in some cases, resorted to compounding pharmacies to manufacture lethal drugs from raw materials.

Further, both the Death with Dignity movement and state corrections departments have faced negative publicity associated with complications from lethal drugs. In 2009, one Washington patient took 28 hours to die after taking the drug. Recently, Clayton Lockett’s botched execution renewed national debate about whether capital punishment constituted cruel and unusual punishment. Ethical issues aside, the use and administration of lethal drugs can have serious, unintended medical consequences, exacerbated by the difficulties in finding a reliable manufacturer.

If assisted suicide becomes legal in more states and Death with Dignity becomes the norm, will FDA step in to regulate lethal drugs? FDA’s mission has always been to protect the public health by securing the safe and effective use of foods and medical products. On one hand, preventing serious adverse side effects from using unapproved drugs seems right in FDA’s wheelhouse. On the other hand, how would FDA be furthering its mission of “protecting the public health” by regulating drugs clearly intended to kill people?

Fortunately for FDA, assisted suicide is still the exception to the norm. But if California’s assisted suicide bill becomes law, FDA may be one step closer to confronting the question of whether and how it will regulate drugs for lethal human use.


2015-2016 Peter Barton Hutt Student Fellow During her fellowship year, Elizabeth Guo was a third year student in the JD/MPH Program at Harvard Law School and the Harvard School of Public Health. Her interests lie at the intersection of law, health care reimbursement, and biopharmaceutical regulation. Elizabeth graduated from Harvard University with a BA in social studies, focusing on the bioethics of assisted reproduction in China. Prior to law school, she was a senior associate at Avalere Health working with life science clients on a range of health policy topics, including Medicare coverage and reimbursement, biosimilar regulation, and healthcare quality programs. Elizabeth served as a student editor of the Journal of Law and Technology and a member of the Mississippi Delta Project’s Delta Project’s Food Policy Initiative. Elizabeth's fellowship paper was entitled: "Reputation and Judicial Deference: An Examination of FDA’s Reputation and Judicial Deference to Agency Action."

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