The judge ruled last March that the Food and Drug Administration violated the law by allowing the drug to be imported into the U.S. without following regulatory protocol, since the drugs were slated for executions — a purpose not approved by the agency.
Sodium thiopental is only produced outside of the U.S. because Hospira Inc., formerly a U.S.-based manufacturer, stopped producing the anesthetic in 2011 after controversy about its use in executions.
Thirty-five states use lethal injections to kill death row inmates and over 1,100 people have lost their lives to the method in the U.S. — making it the primary method of carrying out capital punishment.
However, with sodium thiopental nearly impossible to obtain, states are looking to substitutes like pentobarbital or developing new methods of execution altogether.
Pentobarbital, an anesthetic, has been in use by twelve states since 2010 to execute 47 inmates, according to the Death Penalty Information Center. The drug is also used by veterinarians to put down animals.
Yet, pentobarbital is in danger of shortages as manufacturers of pentobarbital for human uses move to prevent its use in executions.
Last August, Lundbeck Inc., a Danish pharmaceutical company that manufactured pentobarbital until late last year, wrote to governors and correctional departments in sixteen states, saying it did not want its drugs used in executions.
“We stated very clearly that we’re in the business of improving peoples lives and using it for capital punishment is against what we do,” Matt Flesch, Lundbeck’s spokesman, told iWatch News.
When that request was ignored, the company switched from using several distributors last June to using a drop ship program, selling its product directly to health care facilities through a single distributor, Cardinal Health. In addition, every medical facility that received the drugs had to sign a document saying the product would not be used for executions or resold for that purpose.
After being ignored and switching to a single distributor in the U.S., Lundbeck finally sold its pentobarbital rights last December to Illinois-based Akorn Inc., after the American company signed an agreement promising not to sell the drug for the purpose of executions.
States stockpiled pentobarbital before the limitations went into place, but they are in danger of running out or having their stockpiles expire as pentobarbital has an expiration date of 18 months.
Oklahoma may already be running out of the drug. The state only has enough pentobarbital to execute three more people, after having purchased enough of the drug earlier this year to execute five people. Two more executions are scheduled for 2012 and over 60 inmates are on death row there.
Actions by judges have created other challenges for the use pentobarbital in executions. In several cases judges have put executions on hold until questions about the drug are answered. For example, a federal appeals court put the execution of Alabama inmate Thomas Douglas Arthur on hold for a fifth time in his 29 years in prison over concerns about pentobarbital.
There are also concerns about the haste with which states switched to using pentobarbital. Megan McCracken, Eighth Amendment resource counsel at the University of California-Berkeley School of Law, said, “There really hasn’t been a thorough look at the use of this drug in a three-drug execution protocol… where the prisoner is paralyzed, and cardiac arrest is induced, shortly after administration of the pentobarbital.”
According to iWatch News, Texas started using pentobarbital last year, without consulting a physician in the process. The ultimate decision was made by correctional department officials.
Another concern is the FDA-approved uses of pentobarbital, which could cause a problem similar to sodium thiopental.
Pentobarbital is FDA-approved for short-term treatment of insomnia and seizure control for epilepsy patients. It’s not approved for use in executions, and it’s unclear if the FDA would approve a drug for such a use.
“FDA has authority to take both administrative and judicial actions to protect the public from dangerous and illegal products, to punish persons and companies who violate the law, and to deter violations,” said an FDA spokeswoman.
In 2008 the Supreme Court upheld Kentucky’s three-drug lethal injection protocol that used sodium thiopental as an anesthetic. The U.S. Supreme Court hasn’t ruled on pentobarbital, but some federal courts and the Florida Supreme Court have signed off on it.
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