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This is an archive article published on February 4, 2011

Death row inmates sue US agency over ‘unsafe’ drug used in executions

They have said saying the drug has not been reviewed for "safety and effectiveness".

Six death row inmates have sued the US Food and Drug Administration for allowing import of a drug used for executions,saying the drug has not been reviewed for “safety and effectiveness” by the federal agency.

The lawsuit was filed in a Washington DC federal court on behalf of six death-row inmates from Arizona,California and Tennessee.

The lawsuit claims that the USFDA has violated federal law by allowing states to import sodium thiopental,the sedative used in a three-drug execution mixture,and that the drug has not been tested and approved by the agency.

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“The law requires FDA to ensure that only safe,effective drugs are brought into the United States. When the agency allowed states to import unapproved sodium thiopental,it abdicated its responsibilities and violated federal law,” the lawsuit claims.

It said the FDA is neglecting its duty to inspect shipments of sodium thiopental,noting that there are no FDA-approved overseas manufacturers of the drug.

While Arizona,Arkansas,California,Georgia and Tennessee imported the drug from England,Nebraska announced that it had obtained the drug from India.

“From our perspective,the FDA has the obligation to make sure the anesthetic works whether it is used in a lethal injection or used in surgeries. In each case,the purpose is the same — to relieve pain and suffering,” Brad Berenson,the attorney who filed the lawsuit on behalf of death row inmates,said in a statement.

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Berenson said the FDA is “improperly” allowing drugs into the United States even though it would not stand behind their “safety and efficacy”.

“What we are trying to prevent with the suit are inhumane executions,” he added.

The lawsuit claims that unapproved sodium thiopental may not work as intended and may create “unacceptable risks” during executions.

“Whatever one’s views may be on the death penalty,no reasonable person is in favour of botched or inhumane executions. Ineffective anesthesia that subjects condemned prisoners to needless,and indeed unconstitutional,suffering serves no one’s interests,least of all the states’.”

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The FDA had announced last month that it would permit prison officials to import thiopental after Hospira Inc,the lone US manufacturer of the drug had announced it would no longer make the drug.

The federal agency had however said it would not vouch for the safety and purity of the imported thiopental.

“It just seems wrong to allow these suspect goods into the country in violation of federal law just because they’re used on prisoners rather than law-abiding citizens,” Berenson said.

Berenson noted that the lawsuit is “not about halting executions but rather about ensuring that illegal drugs are not used in carrying out otherwise lawful sentences.”

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The lawsuit seeks that the court bars future imports of thiopental and removes supplies already in the possession of state governments.

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