Pharmabiz
 

Lawyers ask US Justice Dept to seize imported execution drugs

Our Bureau, MumbaiThursday, April 14, 2011, 13:20 Hrs  [IST]

Lawyers for death row prisoner Carey Dean Moore have asked the US Justice Department to seize the lethal injection drug recently bought by Nebraska from Indian wholesaler Kayem, and to investigate the legality of the purchase.

In a letter to US attorney general Eric Holder, attorney Alan Peterson said, “There is strong evidence indicating that Nebraska illegally imported the drug from India, with no attention to the requirements of the Controlled Substances Act.” He warns that illegally imported drugs may be fake or ineffective, leading to real risks of unnecessary suffering or pain during execution which could also have legal implications in terms of cruel and unusual punishment.

The situation appears similar to the one that led the Drug Enforcement Administration to seize Georgia's entire supply of sodium thiopental, which was obtained from fly-by-night British supplier Dream Pharma. Nebraska paid $ 2,056 to Mumbai-based Kayem Pharmaceutical for the anaesthetic, which has been in short supply since last year.

Kayem, which also sold some of the drug to South Dakota, last week announced it will no longer supply execution chambers because the trade is inconsistent with the ethos of Hinduism.

Meanwhile, Moore's other attorney Jerry Soucie has filed a motion with the Nebraska Supreme Court challenging the legality of Nebraska's purchase and questioning whether it even bought the right drug. Kayem completed a federal Certificate of Origin dated December 8 stating that the drug shipped to the Nebraska Department of Correctional Services was thiopentone thiosol sodium manufactured by Neon Laboratories of Mumbai, India. Given that Nebraska's lethal injection protocol calls for sodium thiopental, it appears the state might have bought a generic version of the drug.

US federal law requires that before a new drug is used in the United States, the manufacturer must file an application with the Food and Drug Administration detailing the drug's safety, composition and manufacturing process. In addition, to market a generic drug in the United States, a manufacturer must file an application showing the Food and Drug Administration has approved the active ingredients of its generic product.

There is no evidence Kayem or Neon Laboratories did either. There is also no evidence that either company is registered with the Drug Enforcement Administration, and therefore authorised to deliver controlled substances to the US. The DEA registration held by the Corrections Department does not authorise it to directly import drugs from a foreign supplier.

“There was found no hint of any compliance with the Controlled Substances Act nor with the United States Attorney General's promulgated regulations regarding the importing of Schedule III controlled substances,” Peterson wrote to Holder. “As noted by the attorney in the Georgia matter, illegally imported thiopental may be adulterated, counterfeit or otherwise ineffective in providing adequate sedation to minimize risks of unnecessary and severe pain in the course of a lethal injection execution. That is a risk with both humane and legal implications, that is to say constitutional issues of cruel and unusual punishment due to unjustifiable risks of excess suffering, physical and mental,” he added.

Sophie Walker, investigator, Reprieve warned, “As yet another international pharmaceutical company is dragged through the US courts, firms must think twice before entering the execution drugs market. If the moral implications of supplying lethal injection drugs are not disincentive enough, the threat of being tied up in years of costly litigation should spook pharmaceutical traders everywhere.”

 
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