^{Letter Text to DOJ (PDF) | Letter Text to FDA and DEA}

May 23, 2024- Washington, D.C. – On Wednesday, U.S. Senators Elizabeth Warren (D-MA) and Cory Booker (D-NJ) led several of their colleagues in urging federal agencies to take immediate action to regulate drugs used in lethal injections. Lethal injection is the most common method of execution, but departments of corrections are turning to increasingly questionable suppliers and unregulated drugs that are contributing to botched, painful executions. 

In a letter addressed to the U.S. Attorney General Merrick B. Garland, the senators call for the Department of Justice (DOJ) to immediately rescind the department’s Trump-era opinion saying the FDA cannot regulate drugs intended for executions. 

“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,” wrote the senators. “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 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.

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), pushing them to enforce their drug regulations in the context of lethal injection drugs in correctional facilities across the nation.

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. 

“(C)orrections 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,” wrote the senators. “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 current practices for acquiring lethal injection drugs have led to botched executions, compromised drug supply chains, and threats to public health. The senators stressed the importance of FDA and DEA intervention to enforce federal drug laws and uphold safety standards in drug administration.

Additionally, Senators Warren and Booker requested transparency and accountability from the agencies, seeking detailed information on their efforts to address the issues raised.

“The FDA and DEA should begin to adequately regulate lethal injection drugs. 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,” concluded the senators.

Both letters were consigned by U.S. Senators Alex Padilla (D-Calif.), Mazie Hirono (D-Hawaii), Peter Welch (D-Vt.), Amy Klobuchar (D-Minn.), Raphael Warnock (D-Ga.), Jeff Merkley (D-Ore.), and Ed Markey (D-Mass.).

“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.
Source: Senator Elizabeth Warren