ACLU of Nebraska Seeks Further Information About Lethal Injection Drugs Obtained without FDA Approval

A recent Federal Court decision ruled that drugs such as those used in Nebraska cannot be used without FDA approval.


July 24, 2013

CONTACT: Amy Miller, (402) 476-8091,

LINCOLN - On Tuesday, a Federal Circuit court in D.C. ruled that a drug commonly used in lethal injection must obtain U.S. Food and Drug Administration (FDA) approval. The drug, sodium thiopental, has been a topic of controversy in Nebraska due to the manner in which the state has purchased the current supply. On Wednesday, the ACLU of Nebraska filed an open records request to determine if Nebraska's existing supply would be impacted by the ruling.

The court upheld a lower court ruling which found that drugs imported by states for use as anesthesia prior to execution are subject to the same FDA requirements applicable to all imported drugs: most important, the drugs must be reviewed for safety and effectiveness and must come from FDA-registered foreign drug providers.

"The court's decision should be a warning to 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 drugs from fly-by-night dealers, it once again shows that the death penalty is broken beyond repair and cannot guarantee it achieves real justice."

Five states were included in the complaint reviewed by the D.C. Circuit Court. The ruling did not immediately require Nebraska to turn over its supply of sodium thiopental. It did make it clear, however, that any drugs entering the U.S., including sodium thiopental, need FDA approval and that foreign-made sodium thiopental cannot be approved by the FDA.

"The records we've reviewed so far indicate that should the supply of sodium thiopental be challenged in court, it will not pass the legal standard set forth by the D.C. Circuit," added Miller. "We've filed an open records request to determine if Nebraska has found an additional supply or if it is continuing to waste taxpayer dollars purchasing an illegal drug. Our hope is the state will hand over its stock voluntarily without needing to resort to a costly lawsuit."

The ACLU's existing documents, from earlier in 2013, show the state had two batches of sodium thiopental which is used to cause paralysis. One batch expired in May and the other batch is set to expire in December. Due to the recent ruling, the ACLU says it is unlikely that the existing would not stand up to a legal challenge.

"Resorting to illegal practices and black-market drug distributors isn't what the people of Nebraska should expect from their government," said Miller. "We're asking Nebraska to come clean about its supply of sodium thiopental. If the state did not seek FDA approval then officials should dispose of the supply immediately."