Court bars import of execution drug state had used

The U.S. Court of Appeals for the District of Columbia on Tuesday declared unlawful the importation of an execution drug last used in Arkansas in 2005.

A panel of three judges said in a written opinion that officials with the federal Food and Drug Administration failed to do their jobs by allowing sodium thiopental, a powerful anesthetic used to knock patients out beforesurgeries, to be imported and administered in executions within the United States.

But the order does not require states to surrender any of the medicine they have already received.

The state of Arkansas conducted its last execution on Nov. 28, 2005, under Gov. Mike Huckabee, and some lethal-injection drugs have remained in state hands since then. An official with the Arkansas Department of Correction said Tuesday thatthe state was forced to surrender its overseas supply of thiopental in a 2011 seizure by the federal Drug Enforcement Administration.

The last domestic manufacturer of thiopental stopped making the drug in 2009. Several death-penalty states then began to order it from a United Kingdom wholesaler, which obtained the drug from a facility in Austria. Neither facility was registered with the FDA.

Still, an undisclosedamount of domestically obtained thiopental remained in state possession Tuesday, said Shea Wilson, communications administrator with the Department of Correction. State officials had previously contacted the Arkansas Department of Health to have the medicine incinerated, Wilson said, but received word that the incinerator was not running at the time. The remaining thiopental, Wilson said, is expired and “locked up in a secure area.”

“We couldn’t use it anyway,” she said Tuesday.

No executions have been conducted under current Gov. Mike Beebe who, spokesman Matt DeCample reaffirmed Tuesday, would sign legislation banning capital punishment if it ever reached his desk. The governor declined to schedule executions in May when Attorney Gen. Dustin McDaniel asked him to set dates for seven of Arkansas’ 37 condemned prisoners.DeCample said Tuesday’s ruling reaffirmed the governor’s previous statements about the capital-punishment system being “broken.”

“We’ve been saying for a while now that that is one of the big issues we’re facing right now in Arkansas,” DeCample said. “Not only the litigation and legal challenges but the increasing difficulty of being able to find acceptable drugs as well.”

The appeals court’s decision affirmed a district court’s ruling that barred the FDA from allowing unapproved drugs into the United States, despite the agency’s argument that it had discretion to do so. An unapproved newdrug, Senior Circuit Judge Douglas Ginsburg said in his opinion, referred to medicine neither “’generally recognized among experts … as safe and effective for its labeled use … nor approved by the FDA as safe and effective for its proposed use.”

Under U.S. law, if the officials intercept an unapproved drug, the drug “shall be refused admission,” the courtsaid, quoting the statute.

Dismissing claims that the FDA had discretion to allow the unapproved death-penalty drug into the United States, the court said that “shall” means “must” and thus the statute’s command is mandatory, not optional.

Attorneys for the FDA cited domestic shortages of medically necessary drugs in their arguments, suggestingthere might be times when the FDA would need flexibility. Ginsburg fired back in his opinion.

“By its own account, however, the FDA has ways short of allowing importation of inadmissible drugs to counteract a drug shortage,” he said.

Jeff Rosenzweig, a criminal defense lawyer from Little Rock who has represented death-row inmates, saidTuesday’s ruling highlighted a number of problems affecting the capital-punishment system as a whole. He declined, however, to go into specifics without having first read the whole ruling.

“There are all sorts of issues dealing with improperly obtained drugs, expired drugs, the wrong drugs, misstatements made to procure drugs, all sorts of issues.”

Northwest Arkansas, Pages 9 on 07/24/2013

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