A group of death row inmates had sued the FDA last year over improperly allowing shipments into the country of sodium thiopental, a sedative used as the first of three drugs administered in carrying out executions.

A year ago, state officials in Tennessee and Kentucky turned over their supplies of the drug to the FDA amid an investigation into how it was imported. U.S. authorities seized a supply of thiopental from state of Georgia.

The FDA had sought to have the challenge dismissed, arguing that it was using its discretion by allowing the shipments into the country and also that it deferred to law enforcement with respect to the drugs used for executions.

U.S. District Judge Richard Leon sided with the inmates, criticizing the FDA for departing from its longstanding practice of not allowing unapproved drugs into the United States.

"The FDA appears to be simply wrapping itself in the flag of law enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the executioner's needle. How utterly disappointing!" Leon wrote in his 23-page opinion.

He also ordered that the FDA notify all state correctional departments with thiopental made overseas that they are not allowed to use it and that they must return their supplies to the agency immediately.

With the supply of thiopental dwindling, Leon noted, some states have switched to pentobarbital to sedate death row inmates before they are injected with the cocktail of other drugs used to carry out death sentences.

There have also been legal challenges to the use of that drug centered on concerns that it takes too long to sedate an inmate before the rest of the lethal drugs are administered.

Two of the death row inmates who sued the FDA were executed last year by the state of Arizona.

Fordham University law professor Deborah Denno called the decision "very important" and said if the thiopental was obtained from overseas, "we don't know the conditions under which those drugs were housed and transported, which could affect their quality."

A spokesman for the Justice Department, which represented the FDA in the case, declined to comment. The agency could appeal.

Bradford Berenson, a lawyer for the death row inmates, said: "It's unfortunate that FDA behaved as if there were some kind of death penalty exception to the clear requirements of federal law but gratifying that a federal judge recognized that no such exception exists."

The case is Beaty et al v. Food and Drug Administration et al in U.S. District Court for the District of Columbia, No. 11-cv-289.

(Additional reporting by Mary Wisniewski in Chicago; editing by Mohammad Zargham)

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