A group of nine Senate Democrats urged the Department of Justice to rescind a Trump-era legal opinion stating that the Food and Drug Administration cannot regulate drugs intended for use in executions.
The “deeply flawed” opinion not only increases the risk of botched executions, but also compromises the supply chain of drugs in the U.S., which puts the broader public in danger, the lawmakers wrote in a letter sent Tuesday to Attorney General Merrick Garland. In a second letter, the same group of Senators called on the FDA and the Drug Enforcement Administration to exercise their authority to regulate how prisons obtain and use drugs to carry out lethal injection executions. Sens. Elizabeth Warren (D-Mass.) and Cory Booker (D-N.J.) led the two letters, the existence of which were first reported by HuffPost.
Lethal injection is the most common method of execution in the U.S., but the drugs used were not created to kill death row prisoners. Instead, prison officials acquire medicines like midazolam, pentobarbital and fentanyl, but administer lethal doses to the condemned. The lawmakers argued that the drugs, which are also controlled substances, fall squarely within the FDA and DEA’s regulatory authority. The FDA regulates drugs and the DEA regulates controlled substances ― but the agencies’ approach to enforcement has historically been inconsistent.
“The practices we are seeing amount to illicit drug trafficking by state officials, which endanger the patient population by bringing substandard drugs into the system, and risk causing excruciating and prolonged executions,” Maya Foa, the joint executive director of Reprieve U.S., a human rights nonprofit organization, said in a statement. “Congress is right to raise the alarm ― particularly given the recent history of opioid deaths partly arising from lax enforcement. It is vital that federal drug law is properly enforced in all cases, and we urge the Administration to act on this.”
The FDA, DEA and DOJ did not immediately respond to requests for comment.
Over the past decade, corrections departments have scrambled to find drugs to use in lethal injections, thanks to European Union export controls and various pharmaceutical companies banning the use of their products in executions. As a result, prison agencies have turned to “increasingly questionable suppliers willing to sell concoctions designed to kill,” the lawmakers wrote, citing Nebraska’s effort to illegally import execution drugs from a businessman in India with no pharmaceutical background.
Some corrections departments have turned to compounding pharmacies, which combine or alter drugs, sometimes creating lower-quality products. Louisiana and Missouri have gotten execution drugs from a compounding pharmacy that was put on probation after nearly 2,000 violations of state pharmacy guidelines, and Texas has obtained drugs from another pharmacy that was put on probation after its drugs led to children being hospitalized, the lawmakers noted.
To evade transparency, corrections officials have paid for drugs in cash, transported them in private planes, and lied about the intended use of the drugs. At least twenty states have restricted access to information about the source of lethal injection drugs. These drug secrecy laws “shield lethal drug supply chains from oversight by the FDA, DEA, and state boards of pharmacy, creating a ‘regulatory vacuum [that] endangers public health,’” the lawmakers wrote, quoting an amicus brief filed by medical experts in a lethal injection case before the Supreme Court.
The use of unregulated, low-quality drugs leads to botched executions, the lawmakers continued, citing sub-potent drugs that fail to reduce pain, sedatives that fail to sufficiently anesthetize, expired drugs that block IV lines, and drugs delivered in unmarked boxes that turn out to be the wrong substance. Individuals who have experienced botched executions have been observed to gasp, heave, writhe and vomit as they die. Even when executions go as planned, those killed show signs of extreme suffering, including sensations of drowning, suffocating or being burned alive.
People who are unconcerned with capital punishment should still care about lethal injection drugs being regulated, the lawmakers argued. Lax regulation can “compromise the drug supply chain and introduce needless health risks for the broader public,” they wrote, noting an instance where drugs intended for lethal injection were smuggled out of a California prison, and another where unapproved drugs from overseas ended up at a pharmacy in Georgia. “Further undermining public health, prisons frequently stockpile medications that are in short supply to use for executions, diverting those drugs from legitimate medical treatments,” they continued.
In 2019, as the Trump administration geared up to end a de facto moratorium on federal executions, the DOJ issued an Office of Legal Counsel (OLC) opinion advising that the FDA did not have jurisdiction over lethal injection drugs.
“It paved the way for President Trump to secure unregulated drugs via a secret supply chain in order to fast-track more federal executions during his last year in office than occurred during the previous 56 years combined,” the lawmakers noted. During his last six months in office, Trump’s administration executed 13 people.
The OLC opinion “was wrongly decided” and conflicts with court precedent, as well as the FDA’s own assertions of its jurisdiction, the lawmakers noted, urging the Biden administration to reverse the memo.
Shortly after Joe Biden entered the White House, the Justice Department formally reinstated the federal execution moratorium and announced a sweeping death penalty policy review. However, the Justice Department has continued to seek and defend federal death sentences, and Biden has made little progress toward his campaign promise to work to end the federal death penalty.
Meanwhile, Republican operatives are plotting to dramatically expand the use of capital punishment if Donald Trump, the GOP’s presumptive 2024 presidential nominee, wins a second term.