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Regulatory Focus™ > News Articles > Nebraska Raises Stakes in Battle With FDA, Won't Surrender Supply of Controversial Drug

Nebraska Raises Stakes in Battle With FDA, Won't Surrender Supply of Controversial Drug

Posted 23 April 2012 | By Alexander Gaffney, RAC 

The state of Nebraska, engaged in an ongoing battle with the US Food and Drug Administration (FDA) over its supply of an controversial anesthetic drug used in executions, confirmed it will defy an FDA order to hand over remaining supplies of sodium thiopental, reports The Associated Press.

In a statement released 20 April, Nebraska's state attorney general's office said they believed a court order, issued by Federal District Court Judge Richard Leon, was incorrect.

Leon's order found supplies of sodium thiopental, an anesthetic and integral part of a three-drug cocktail used in executions, to have been improperly imported in violation of FDA's enforcement discretion.

"The ruling ordered the FDA to notify states with foreign-manufactured stores of the drug that its use is illegal and that it must be surrendered," reports The Associated Press. "The state attorney general, Jon Bruning, said that Nebraska's supply was bought from a different source from the one cited in the case before Judge Leon, and that Nebraska's drug "was approved for importation" by the F.D.A., the Drug Enforcement Administration and Customs officials."

"Other than the court's erroneous order, we are unaware of any evidence or reasons why the Department of Correctional Services should be required to return any thiopental in its possession," wrote James Smith, assistant attorney general for Nebraska.

Nebraska Attorney General Jon Bruning urged FDA to appeal the ruling, and called FDA's decision to enforce it "arbitrary, capricious and an abuse of discretion."

The development is only the latest in a long line of heated-and at times confusing-developments involving sodium thiopental.

Because the drug is one of only a small number permitted to be used in executions, anti-death pentaly advocates have been aggressively targeting the drug using drug importation regulations to remove and block stock of the drug from coming into the country.

While a number of inmates have sued FDA in the past to stop the drug's importation, few appeared to have been successful.

Leon's decision on 27 March dramatically reversed that trend, and called into question FDA's ability to use enforcement discretion in any case.

"By opening up the 'closed' drug system by allowing an unapproved drug -thiopental-into the United States, defendants jeopardize their own system and threaten the public health by creating a risk that thiopental could incorrectly end up in the hands of the general public," Leon wrote.

"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," continued Leon. "How utterly disappointing!"

As Regulatory Focus reported in March, the ruling could have profound implications for other FDA initiatives, including its attempts to lessen drug shortages through importing unapproved methotrexate and Doxil. FDA is currently allowing the importation of unapproved methotrexate from Canada and the importation of supplies of Doxil-substitute Lipodox from a supplier in India.

The actions by Bruning to defy FDA and Leon's order will likely move the case into further stages of litigation, as Nebraska argues Leon's order does not apply to it because it was sourced from a different supplier and had an approved license to import from the Drug Enforcement Administration, reports The Journal Star.

Read more:

The New York Times - Nebraska: State Will Not Surrender Execution Drug

WXOW - Neb. refuses order to surrender execution drug

Journal Star - Bruning urges FDA to appeal lethal injection drug ruling

Regulatory Focus - FDA, South Dakota in Tussle Over Regulation of Lethal Injection Drug

Regulatory Focus - Import Regulations Used as Delaying Tactic in Nebraska Execution Case

Regulatory Focus - Court Bars FDA from Importing Drug Used in Death Penalty

Regulatory Focus - Inmates Sue Agency to Stop Import of Drugs

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