Booker, Warren Call On Federal Agencies to Regulate Lethal Injection Drugs

WASHINGTON, D.C. – Today, U.S. Senators Cory Booker (D-NJ), Elizabeth Warren (D-MA), and several of their colleagues sent two letters to federal agencies urging immediate action to regulate drugs used in lethal injections. In a letter addressed to the U.S. Attorney General Merrick B. Garland, the Senators called for the immediate rescission of a 2019 Office of Legal Counsel (OLC) opinion regarding the Food and Drug Administration’s (FDA) ability to regulate drugs intended for use in executions. In a second letter, the Senators wrote to Robert M. Califf, Commissioner of the Food and Drug Administration (FDA) and Anne Milgram, Administrator of the Drug Enforcement Administration (DEA), to highlight concerns regarding the procurement and use of lethal injection drugs in correctional facilities across the nation.

In the letter addressed to Attorney General Garland, the Senators urged DOJ to overturn the 2019 OLC opinion, addressed critical flaws in the opinion, and emphasized the risks it poses for individuals on death row, including the potential for additional botched executions if the FDA is barred from regulating these drugs.

“The Department of Justice’s (DOJ) OLC opinion incorrectly found that the Food and Drug Administration (FDA) lacks jurisdiction to regulate drugs intended for use in executions. The opinion is deeply flawed — both legally and morally — and has posed unnecessary risks for individuals on death row, including the risk of suffering a botched execution. You have the authority to reverse the opinion without waiting for the DOJ Office of Legal Policy’s (OLP) ongoing review of the federal death penalty protocol. We urge you to do so immediately,” the Senators wrote. 

The senators underscored the disproportionate impact of flawed execution protocols on communities of color, citing alarming statistics that reveal racial disparities in death row populations and the increased likelihood of botched executions for Black Americans.

“We urge you to immediately rescind the 2019 OLC opinion on FDA jurisdiction over execution drugs. The DOJ under the current Administration has reversed previous OLC opinions that were legally unsound and should do so here. President Biden committed this Administration to public health, racial justice, and human rights. While we are pleased that DOJ has imposed a moratorium on federal executions pending a review of policies and procedures, that deliberative process does not prohibit rescission of the OLC opinion,” the Senators concluded. 

In the letter addressed to FDA Commissioner Califf and DEA Administrator Milgram, the Senators expressed deep apprehension over the current practices surrounding the acquisition of lethal injection drugs, citing instances of botched executions, compromised drug supply chains, and threats to public health. They stressed the importance of FDA and DEA intervention to enforce federal drug laws and uphold safety standards in drug administration.

The Senators called on the FDA and DEA to investigate and enforce regulations related to the procurement, manufacturing, distribution, and use of lethal injection drugs. Additionally, Senators Booker and Warren request transparency and accountability from the agencies, seeking detailed information on their efforts to address the issues raised.

Although lethal injection is the most common method of execution, the drugs used in lethal injection were not developed for the purpose of an execution, “Instead, corrections officials use ordinary medicines developed to treat pain, seizures, and more, but in lethal combinations and quantities. Though these are ordinary medicines, in the lethal injection context the FDA typically has not exercised its regulatory authority over the drugs — even when their use may clearly violate requirements related to supply chain security, prescriptions, branding, adulteration, and more. Lethal injection drugs also include controlled substances (such as fentanyl and pentobarbital) regulated by the DEA, but the DEA likewise at times takes a hands-off approach when the drugs are used for lethal injections.”

“The FDA and DEA should begin to adequately regulate lethal injection drugs. Historically, these agencies have often declined to regulate drugs when they are used in executions. However, the growing body of evidence demonstrating the avoidable health risks of lethal injection practices — both for individuals on death row and the general public — should compel the FDA and DEA to robustly exercise their jurisdiction in this area,” the Senators wrote.  

“The black-market methods being used to obtain execution drugs don’t just expose prisoners to prolonged and excruciating executions; they also endanger the wider patient population by bringing substandard drugs into the system. It is vital federal drug law is properly enforced in all cases, and we urge the Administration to act on this,” said Maya Foa, Joint Executive Director of Reprieve.

The letter to the DOJ is cosigned by U.S. Senators Alex Padilla (D-CA), Mazie Hirono (D-HI), Peter Welch (D-VT), Amy Klobuchar (D-MN), Raphael Warnock (D-GA), Jeff Merkley (D-OR), and Ed Markey (D-MA).

To read the full text of the letter to the DOJ, click here.

The letter to the FDA and DEA is cosigned by U.S. Senators U.S. Senators Alex Padilla (D-CA), Mazie Hirono (D-HI), Peter Welch (D-VT), Amy Klobuchar (D-MN), Raphael Warnock (D-GA), Jeff Merkley (D-OR), and Ed Markey (D-MA).

To read the full text of the letter to the FDA and DEA, click here.