US Department of Justice says FDA can't regulate execution drugs

US Department of Justice says FDA can't regulate execution drugs
Royalty-free stock photo ID: 795931975 Hands of the girl in handcuffs. arrest. a crime. law. execution of sentences.

For years, Texas and the U.S. Food and Drug Administration have fought a legal battle over whether the state can import drugs used to execute death-row inmates. On Tuesday, the U.S. Department of Justice issued an opinion claiming that the FDA actually has no regulatory power over drugs used in lethal injections.

But how the opinion will affect Texas’ attempt to import an anesthetic once used in executions wasn't immediately clear.

In 2015, the Texas Department of Criminal Justice tried to ship in 1,000 vials of the anesthetic sodium thiopental from overseas. But the FDA seized the drugs at a Houston airport, and, nearly two years later, officially banned their import, ruling that the drugs could not be admitted into the United States because they appeared to be unapproved and misbranded.

The FDA has previously maintained that the import of the drug is illegal because it is not currently approved in the United States. A BuzzFeed investigation of the attempted imports by Texas and other states revealed that the drugs were bought from a salesman in India who claimed to be a drug manufacturer, though records contradicted that claim.

Texas fought the FDA's ruling in court, asking a federal judge to declare the ban unlawful. A decision has been pending more than two years, with the federal agency repeatedly asking for more time to come to an agreement in the lawsuit. In the FDA’s last request for more time in September, officials said the government was “exploring options internally for resolving this lawsuit in a way that would obviate the need for the Court to issue a decision.”

On Tuesday, the DOJ’s legal office issued its opinion in a memo to the U.S. attorney general.

“Articles intended for use in executions carried out by a State or the federal government cannot be regulated as 'drugs' or 'devices' under the Federal Food, Drug, and Cosmetic Act,” the memo begins. “The Food and Drug Administration therefore lacks jurisdiction to regulate articles intended for that use.”

It’s unlikely for the opinion to have immediate effects on Texas, since the FDA is still under an unrelated 2012 federal court ruling to ban the import of sodium thiopental. In a statement sent to Politico, an FDA spokesperson said the agency would “follow the conclusion of the opinion to the extent permissible” by the 2012 order. According to The Washington Post, it wasn’t clear if the federal government will seek to lift that ruling — a move that could result in more legal wrangling.

TDCJ did not immediately respond to the opinion Tuesday evening, with a spokesperson saying he had not yet seen it.

Sodium thiopental hasn’t been used in an execution in Texas or the rest of the country since 2011, when the only U.S. manufacturer stopped selling it because of its use in lethal injections. Since 2012, Texas has used a single dose of pentobarbital to put an inmate to death. It recently obtained 15 new doses of the drug, which would be used in the five executions on the calendar.

When the state first sued the FDA over the blocked import of sodium thiopental in 2017, a TDCJ spokesperson said the department sought the alternate drugs because “we cannot speculate on the future availability of drugs.”


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