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FDA Sued Over Shipments of Drug Used in Executions

By Pharmaceutical Processing | February 4, 2011

A federal lawsuit filed against the FDA urges a judge to block imports of a key drug used in the
nation’s executions that has been in short supply since the sole U.S. maker
decided to stop producing it.

The lawsuit filed Wednesday in federal court in Washington,
D.C., claims the FDA has knowingly allowed state corrections officials to
import sodium thiopental, the sedative used in a three-drug execution cocktail,
that has not been approved by the agency.

“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,” said Brad Berenson, the attorney who
filed the lawsuit on behalf of death row inmates in California,
Arizona and Tennessee.

The shortage has delayed executions in several states, and
an Associated Press review found that at least five states — Arizona,
Arkansas, California,
Georgia and Tennessee — had to turn to England for their supply of the
drug. Nebraska,
meanwhile, secured a stockpile from an Indian firm.

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

“From our perspective, the FDA has the obligation to
make sure the anesthetic works whether it’s used in a lethal injection or used
in surgeries,” Berenson said. “In each case, the purpose is the same
— to relieve pain and suffering.”

The FDA did not immediately respond to requests for comment,
though the agency has long maintained it has nothing to do with the drugs used
in executions. But its role has come under more scrutiny after the lone U.S.
manufacturer of sodium thiopental, Hospira Inc., announced it would no longer
make the drug.

Most of the 35 states with capital punishment have already
run out of sodium thiopental or will soon, and in many places switching to a
different sedative could prove to be a difficult process fraught with legal
challenges, according to the AP review.

Oklahoma
adopted a new drug, pentobarbital, last year as part of its three-drug
combination. And Ohio
announced last week it would become the first state to use only pentobarbital
to put inmates to death.

 

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