Regulatory Focus™ > News Articles > FDA, South Dakota in Tussle Over Regulation of Lethal Injection Drug

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

Posted 18 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is currently embroiled in an escalating fight with South Dakota's government over the regulatory quality-and legal status-of a drug intended to be used to put prisoners to death, reports KSFY News.

The drug, an anesthetic known as sodium thiopental, is a staple of a three-drug cocktail commonly used to execute prisoners on death row.

Anti-death pentalty advocates have increasingly been targeting the drug, which is no longer produced by any domestic manufacturer and must be imported, because executions cannot proceed without the prisoner being in an unconscious state.

Only a few other drugs, including pentobarbital, can be substituted to achieve the same effect.

Many foreign manufacturers refuse to sell the drug to entities known to use it for execution purposes making its procurement something of a shell game.

Battles over the drug have escalated sharply recently, with US District Court Judge Richard Leon barring FDA from allowing the drug to be imported.

"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," wrote Judge Richard Leon in his 27 March decision. "How utterly disappointing!"

In its fight with South Dakota, FDA is arguing the state's supply of sodium thiopental does not meet quality standards set by the agency as a result of the drug's manufacturing facility experiencing problems, which were unspecified.

South Dakota's Attorney General Marty Jackley disagrees, saying the drugs have tested safe and will not be turned over without a court order.

Jackley offered to let FDA test the drugs to confirm regulatory compliance and said he felt comfortable the state will be able to hold onto the drug.

"We will reach that resolution that as long as meet testing standards, they will allow us to keep it in our inventory," Jackley said in a statement to KSFY News.

Read more:

KSFY - FDA requests lethal injection drug used in SD

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

Regulatory Focus - Inmates Sue Agency to Stop Import of Drugs

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

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