Death row gone rogue: It’s time to regulate lethal injection drugs 

The efficacy and safety of execution by lethal injection depends on the efficacy and safety of the drugs used to put people to death. But in the last few years, the process of procuring lethal injection drugs has come to resemble the wild west. Death penalty jurisdictions are doing whatever they can, including circumventing the law, to get what they need to carry out executions.

On May 21, a group of eight Democratic senators, led by New Jersey’s Cory Booker and Massachusetts’s Elizabeth Warren, asked the Department of Justice to help remedy this situation by rescinding a Trump-era Office of Legal Counsel memo that said the Food and Drug Administration cannot regulate execution drugs. They wrote separately to the FDA urging it to use its regulatory authority to “secure the integrity of the supply chain for lethal injection drugs, minimizing the risk of botched executions and more broadly assuring the public health and safety of the drug supply chain.”  

The changes they are calling for are long overdue, and they offer the Biden administration another chance to make good on its announced opposition to capital punishment. But before we look more closely at what the lawmakers are proposing, we must revisit the history of lethal injection drugs in the U.S. 

From 1982, the year of the first lethal injection execution, to 2009, the meaning of “lethal injection” remained clear and consistent: it referred to three drugs, to be employed in a similar way across states. First came an anesthetic, sodium thiopental, used to produce a loss of consciousness; then a second drug, pancuronium bromide, paralyzed the inmate; and finally, potassium chloride was used to stop their heart. 

In 2009, however, the company that produced sodium thiopental said it would temporarily stop manufacturing the drug, thus depriving states of one of the three drugs in the original protocol. Two years later it stopped doing so permanently. 

At the same time, bowing to pressure from death penalty abolitionist groups, other manufacturers in the United States decided to limit the distribution of drugs used for lethal injections. 

For the first time since lethal injection began to be used, states were forced to develop new drug protocols to carry out their executions. By 2012, there was not a single state in the country still using the original three-drug formula. Instead, states were executing people with a variety of novel drug combinations.  

Initially, in an effort to keep executions going during this drug shortage, states began to swap drugs with one another. California gave some of its pancuronium bromide inventory to Arizona in exchange for a supply of sodium thiopental. In the eastern United States, Georgia and Arkansas turned to Tennessee for help. Oklahoma circumvented the sodium thiopental shortages by simply replacing that drug with another, pentobarbital. 

With supply chains in the United States cut off, death penalty states turned to European drug companies. But drug companies in Europe and elsewhere were not happy about corrections departments using their sodium thiopental in executions. 

With this limited availability, some states turned to less prominent drug sources. Arizona and Georgia purchased 150 vials of sodium thiopental, 450 vials of pancuronium bromide, and 180 vials of potassium chloride from a tiny, obscure drug company called Dream Pharma whose offices were located in the back of a west London driving school. Texas and Arizona purchased lethal drugs from an under-regulated distributor overseas. 

These efforts point to the lengths to which death penalty states would go to obtain drugs for use in executions — whether or not they could be confident in those drugs’ efficacy. What’s more, the unwillingness of companies to readily provide their drugs for lethal injection has led to price increases and questionable delivery methods. In 2020, for example, Arizona officials spent an astonishing $1.5 million to procure lethal drugs from a source that the state has refused to disclose. 

Other death penalty states, including Georgia, Texas, Oklahoma, Virginia, Missouri, and South Dakota, have turned to less regulated means to obtain drugs for their execution protocols. One example of this was their growing reliance on compounding pharmacies to produce small batches of drugs specially for them. Unlike larger operations, compounding pharmacies are not subject to extensive regulation by the FDA. 

This was the situation in 2019, when Donald Trump’s Justice Department issued its memo, as part of the administration’s effort to make it easier for states and the federal government to put people to death. 

The “FDA has not historically exercised jurisdiction over articles intended to carry out a lawful sentence of capital punishment,” the memo states. “Congress has repeatedly authorized the death penalty on the assumption that there are lawful means to carry it out, but the regulation of such articles…would effectively require their prohibition because they could hardly be found ‘safe and effective’ for such an intended use.” 

The memo continues, “we thus conclude that, when an article’s intended use is to effectuate capital punishment by a state or the federal government, it is not subject to regulation” under the Federal Food, Drug and Cosmetic Act. 

The Democratic senators who wrote to the Biden Justice Department and the FDA believe that if this country is going to continue carrying out lethal injection executions, they should be subject to exacting scrutiny.  

The memo, which they label “misguided” is “inconsistent with the principles of fairness and justice, undermines drug safety, and facilitates legally dubious state execution methods. It blocks the FDA from intervening when states obtain unmarked vials from underground suppliers, inject their citizens with contaminated solutions, and cause needlessly painful deaths.” 

When states go rogue in their efforts to obtain execution drugs, as they have for more than a decade, they undermine this country’s commitment to treating even those we execute humanely. As the senators note, the opinion in the memo “leaves individuals on death row with no regulatory protection from ‘an unnecessary risk that they will not be anesthetized properly prior to execution’ or will face ‘a painful and prolonged dying process.'” 

The senators are right to call on the Biden administration to live up to its commitments to “public health, racial justice, and human rights.” To do so, the administration will have to take steps to ensure that, wherever they are used, lethal injection drugs are subject to the most stringent regulation and control.  

Austin Sarat is the William Nelson Cromwell Professor Jurisprudence & Political Science at Amherst College.