WASHINGTON — The Justice Department argues in a new legal opinion that the Food and Drug Administration does not have authority over drugs used in lethal injections, a stance sure to be challenged by death penalty opponents.
The legal opinion, issued this month, said: “Articles intended for use in capital punishment by a state or the federal government cannot be regulated as ‘drugs’ or ‘devices.’ ”
States, including Nebraska, have struggled in recent years to obtain drugs for lethal injections, which remain the country’s primary method of execution even as the number of executions has declined.
In 2010, a batch of Nebraska’s lethal injection drugs delivered by a broker from India were destroyed after federal officials determined that the Nebraska Department of Corrections lacked the proper importer’s license.
In 2015, the FDA blocked Texas from importing shipments of an anesthetic from an overseas distributor, finalizing the decision two years later. The agency argued the importation was illegal because the drug, sodium thiopental, was not approved in the United States and was improperly labeled. It also cited a 2012 federal injunction barring the agency from allowing the drug’s importation.
Texas responded to the FDA’s move by suing the agency in early 2017, saying it was interfering with the state’s responsibility to carry out its law enforcement duties. The lawsuit was filed shortly before President Donald Trump took office. Trump and his attorneys general have supported capital punishment.
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The new legal opinion from the Justice Department sides against the FDA and with Texas. It argues that drugs intended for executions are different from any others, noting that “they exclusively inflict harm” and “are not intended to produce any benefit for the end user.” The lawsuit argues that if the FDA had jurisdiction over drugs meant for executions, it would have similar power over other areas — such as firearms — which the agency has not sought to regulate.
The Justice Department’s opinion is unlikely to have any immediate effect because the FDA is still operating under the 2012 injunction.
The opinion seems aimed at “giving a green light” to corrections officials to look abroad for drugs needed for executions, said Deborah Denno, a law professor at Fordham University and a death penalty expert.
“I think this has very broad ramifications, unfortunately,” Denno said in an interview. “This is intended to allow departments of corrections to access drugs outside the country because they’re having so much difficulty doing so.”
While European companies have objected to their products being used in executions, corrections officials could have more luck turning to countries such as China or India, Denno said. “It has the potential to open the floodgates,” she said.
The legal opinion was issued after a protracted battle between the FDA and the Justice Department over the regulation of lethal injection drugs.
More than a year ago, then-FDA Commissioner Scott Gottlieb and then-Attorney General Jeff Sessions had a heated argument in the White House Situation Room, according to people with knowledge of the matter.
Sessions wanted the FDA to allow drugs used for executions to enter the country without undergoing agency scrutiny. Gottlieb refused, saying that such a move could undermine the agency’s authority.
States’ difficulties in obtaining lethal injection drugs stem from drug companies’ objections to having their products used in executions.
For many years, states relied on a combination of three drugs to carry out death sentences: an anesthetic, such as sodium thiopental; a paralytic; and a product meant to stop the inmate’s hearts. But Hospira, maker of sodium thiopental, said in 2011 that it would stop producing the product because of its use in executions.
Then states began turning to new combinations and execution protocols. Nebraska last year became the first state to use fentanyl in an execution, combining it with three other drugs to execute Carey Dean Moore, who was convicted of killing two Omaha cabdrivers. Other states debated or adopted options including nitrogen gas or firing squads.
Despite the 2012 injunction, states continued to order sodium thiopental from overseas. BuzzFeed News found that at least three states — Nebraska, Texas and Arizona — had tried to import drugs from a supplier in India despite getting warnings from the FDA in 2015.
Nebraska officials, following the August execution of Moore, said they would be seeking a new supplier of execution drugs. A recent public records request by the ACLU of Nebraska, however, failed to show any progress in that effort.
Two of the four drugs used to execute Moore have since expired. The state’s supply of fentanyl expires July 31, and its supply of diazepam expires Sept. 30.
World-Herald staff writer Paul Hammel contributed to this report.
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