FDA Must Bar Imports of Sodium Thiopental

Today the U.S. Court of Appeals for the D.C. Circuit affirmed a lower court decision requiring the Food and Drug Administration to block the importation of sodium thiopental for use in lethal injection because it has not been approved by the FDA. Here is how Senior Judge Ginsburg summarized the court’s holding in the conclusion to his opinion for the court:

The FDCA imposes mandatory duties upon the agency charged with its enforcement. The FDA acted in derogation of those duties by permitting the importation of thiopental, a concededly misbranded and unapproved new drug, and by declaring that it would not in the future sample and examine foreign shipments of the drug despite knowing they may have been prepared in an unregistered establishment.

Although the D.C. Circuit vacated the portion of the lower court’s order that required states to turn over existing supplies of the drug, this decision will make it significantly more difficult to obtain this drug for use in lethal injection. It is also likely to create new opportnities to challenge scheduled executions because each time states revise their lethal injection protocols — such as by changing the drugs used — this creates new opportunities for legal challenges. Then again, perhaps the states will seek certiorari and this case will become another Heckler v. Chaney.