Thursday, January 13, 2011

Long neutral, FDA helps states get drug needed for executions

Administration helps two states get solution Ohio used in 2010

The Food and Drug Administration, which long has maintained it has nothing to do with drugs used in executions, has quietly helped Arizona and California obtain a scarce type of anesthetic so the states could continue putting inmates to death.

The shortage of sodium thiopental has disrupted executions around the country. But newly released documents show the FDA helped import it from Britain.

Most state prison systems use sodium thiopental to put inmates to sleep before administering pancuronium bromide, a paralyzing agent, and potassium chloride, which stops the heart.

But the drug has been in short supply since the spring of 2010, when Ohio almost had to postpone an execution because it did not have enough.

The sole American manufacturer, Hospira Inc. of Lake Forest, Ill., has blamed supplier issues for its inability to make the drug, which is marketed to render patients unconscious, not for lethal injections. Any remaining batches expire this year.

After Arizona officials explained their need, an FDA official recommended a shipment of the drug "be processed expeditiously to us as it was for the purpose of executions and not for use by the general public."

The information is contained in an e-mail from an Arizona prison official to the California prisons agency obtained by the American Civil Liberties Union through a public records request. The ACLU then posted it online.

The ACLU accused the FDA of trying to hold two contradictory positions at once.

"The FDA is actively assisting these states, but they're not enforcing the law, and they're not doing anything to determine that the drugs are what they're claimed to be and that they work properly," said Natasha Minkser, death penalty policy director for the ACLU's Northern California chapter.

A federal lawsuit in Arizona challenges the use of overseas drugs, saying they might be substandard and could lead to botched executions if they do not put an inmate to sleep properly.

The FDA would not comment on its role in helping either state.

The agency is required by law to assure the safety and effectiveness of drugs imported for medical purpose. But agency officials maintain that their oversight does not extend to drugs for executions, citing a 1985 Supreme Court ruling.

"Reviewing substances imported or used for the purpose of state-authorized lethal injection clearly falls outside of FDA's explicit public health role," agency spokesman Christopher Kelly said.

Records show many states have scrambled to find enough of the drug, but at least one state has managed to avoid the shortage by switching from sodium thiopental to pentobarbital, a drug commonly used to put animals to sleep. Oklahoma has conducted two executions with the new drug.

Source: Lancaster Eagle Gazette, January 12, 2011

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