Appeals Court Rules Against FDA in Sodium Thiopental Importation Case

On July 23, the United States Court of Appeals for the District of Columbia Circuit ruled in Cook v. Food and Drug Administration (FDA) that the FDA cannot permit importation of sodium thiopental into the United States because it is a misbranded and unapproved drug. 

Several prisoners on death row sued the FDA over the decision to permit state departments of correction to import sodium thiopental from overseas companies that are not registered with the FDA.  Sodium thiopental is used in lethal injection protocols.

According to the court's opinion, the FDA argued that "it must have discretion not to enforce § 381(a) in order to combat domestic shortages of medically necessary drugs."  The court disagreed and noted that the FDA has methods other than importation to counteract a drug shortage, such as working with manufacturers to increase production or mitigate quality problems. 

Public reports indicate the FDA is currently reviewing the court’s decision.  

ASA is also reviewing the opinion.

Review the opinion.