State's Stock of Lethal Injection Drug May Not Be In Compliance With FDA


Lincoln– On Tuesday, a Federal Circuit court in D.C. ruled that a drug commonlyused in lethal injection must obtain U.S. Food and Drug Administration (FDA)approval.

The drug, sodium thiopental, has been atopic of controversy in Nebraska due to the manner in which the state haspurchased the current supply. On Wednesday, the ACLU of Nebraska filed an openrecords request to determine if Nebraska's existing supply would be impacted bythe ruling.

The court upheld a lower court ruling whichfound that drugs imported by states for use as anesthesia prior to executionare subject to the same FDA requirements applicable to all imported drugs. Mostimportant, the drugs must be reviewed for safety and effectiveness and mustcome from FDA-registered foreign drug providers.

"The court's decision should be a warningto the state of Nebraska: don't purchase drugs without going through the FDA,"said Amy Miller, Legal Director for the ACLU of Nebraska.

"If Nebraska tries to use unapproved drugsfrom fly-by-night dealers, it once again shows that the death penalty is brokenbeyond repair and cannot guarantee it achieves real justice," she said.

Five states were included in the complaintreviewed by the D.C. Circuit Court. The ruling did not immediately require Nebraskato turn over its supply of sodium thiopental.

It did make it clear, however, that anydrugs entering the U.S. need FDA approval and that foreign-made sodiumthiopental cannot be approved by the FDA.

"The records we've reviewed so far indicatethat should the supply of sodium thiopental be challenged in court, it will notpass the legal standard set forth by the D.C. Circuit," added Miller.

"We've filed an open records request todetermine if Nebraska has found an additional supply or if it is continuing towaste taxpayer dollars purchasing an illegal drug," she said. "Our hope is thestate will hand over its stock voluntarily without needing to resort to acostly lawsuit."

The ACLU's existing documents, from earlierin 2013, show the state had two batches of sodium thiopental which is used tocause paralysis.

One batch expired in May and the otherbatch is set to expire in December. Due to the recent ruling, the ACLU says itis unlikely that the existing would not stand up to a legal challenge.

"Resorting to illegal practices andblack-market drug distributors isn't what the people of Nebraska should expectfrom their government," said Miller. "We're asking Nebraska to come clean aboutits supply of sodium thiopental. If the state did not seek FDA approval thenofficials should dispose of the supply immediately."