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For lethal injection drugs, Nebraska may try to skirt FDA

cigaretteman

HB King
May 29, 2001
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The last time Nebraska imported a lethal injection drug, four years ago, state officials worked closely with the Drug Enforcement Administration.

Nebraska’s prison director is banking on the same approach this time, recently obtained documents show, even though the U.S. Food and Drug Administration says the hard-to-get lethal drug can’t be legally imported.

State officials have been vague about how they intend to get past the apparent FDA roadblock, saying only that they have followed proper channels and still expect to receive the foreign-made sodium thiopental.

But based on records recently provided to a committee of state senators, prison officials are trying to have the drug shipped, not as a medicine through the FDA, but as a controlled substance through the DEA.

Such an approach faces little chance of success, according to federal officials.

“If the FDA says you cannot import it, we would not ignore that,” said Barbara Carreno, a spokeswoman for the DEA.

The DEA falls under the control of the U.S. Justice Department. When asked whether Nebraska could import the drug as a controlled substance for use in a lethal injection, a department spokesman said: “It seems unlikely.”

Gov. Pete Ricketts said this week that state officials have been trying to work through the FDA issues, although he offered no details.

“We’re going to figure this problem out,” the governor said.

Ricketts announced May 14 that the Department of Correctional Services had purchased $54,400 worth of sodium thiopental and pancuronium bromide from a distributor in India to replace expired drugs in the department’s inventory. The substances are part of Nebraska’s three-drug protocol that would be used to execute a death row inmate.

The governor made the announcement as the Nebraska Legislature debated a bill to repeal the death penalty. Lawmakers subsequently passed the bill and overrode the governor’s veto of the legislation.

Ricketts and Attorney General Doug Peterson have said they believe the repeal does not legally apply to the state’s 10 death row inmates. In addition, death penalty supporters have launched a referendum petition drive in an effort to overturn the repeal law at the ballot box.

So the push to import the two lethal drugs remains ongoing.

But those efforts were cast into doubt May 29 when an FDA spokesman said the sodium thiopental would be refused admission into the United States.

The fast-acting anesthetic renders an inmate unconscious so he doesn’t feel paralysis and pain from the second and third drugs in the injection sequence. Sodium thiopental is no longer made domestically, and European producers have outlawed its sale for executions.

In 2013, a federal appeals court upheld a lower court order that said the FDA must regulate foreign-made execution drugs and block their importation when they fail to meet the agency’s standards. Peterson, the attorney general, has said the ruling does not affect Nebraska since the state was not a party to the lawsuit, but lawyers who have represented death row inmates sharply disagree with his position.

Although sodium thiopental is still used medically in developing counties, the drug no longer appears on the FDA’s list of approved medications, said Jeff Ventura, a spokesman for the agency. But it does remain categorized as a controlled substance, which falls under the purview of the DEA.

The last time the state obtained sodium thiopental from the same Indian supplier, in 2011, it did so using an importer’s license issued by the DEA. That supply expired in early 2014.

In the latest request, Scott Frakes, Nebraska’s corrections director, sent a May 26 letter notifying the DEA that he had sought the importation of 1,000 vials of sodium thiopental. The mailing included photocopies of the department’s controlled substance registration certificate, which was obtained from the DEA.

Frakes also included a form in which he indicated that the drug was to be exported June 15 from Kolkata, India, and arrive approximately June 18 in Omaha.

The records recently surfaced in response to questions from an 11-member special committee created by the Legislature to oversee the Corrections Department in the wake of last year’s sentencing miscalculation scandal. In a May 18 letter, committee members sought answers to 13 questions about the lethal drugs.

Frakes did not answer a committee question about whether the manufacturer is FDA-approved, but instead provided a copy of the department’s DEA importer’s license.

When contacted recently, several committee members said they were not yet prepared to comment about the director’s responses to their inquiry.

Nebraska last executed a death row inmate in 1997, when the method was electrocution. After the State Supreme Court declared the electric chair unconstitutional, the state switched to lethal injection in 2009.

http://www.omaha.com/news/crime/for...cle_4852ec0c-8d0c-55cc-842f-4bee7563bea2.html
 
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