USA: SODIUM THIOPENTAL IMPORT RULED ILLEGAL BY APPEALS COURT

July 23, 2013: The U.S. Court of Appeals for the District of Columbia Circuit unanimously affirmed a lower court ruling that the Food and Drug Administration (FDA) failed to fulfill its duties under the Food, Drug, and Cosmetic Act (FDCA) when it permitted without inspection the importation of foreign drugs for use in lethal injections.
The Court concluded, "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."
In 2009, the last U.S. manufacturer of sodium thiopental announced it would cease production of the drug commonly used by states in lethal injections. Some states then turned to international manufacturers and imported drugs which were not approved by the FDA. The ruling rejected the FDA’s claim that it had discretion to allow unapproved drugs into the U.S.. But the panel reversed another part of the lower court's order and allowed state correctional departments to keep stocks of the drug they currently have.
The court can’t require states to turn in the drug to the FDA because they weren’t a party to the suit, wrote Judge Douglas Ginsburg of the U.S. Court of Appeals for the District of Columbia Circuit, joined by Judges David Sentelle and Judith W. Rogers. Ginsburg and Sentelle were appointed by President Ronald Reagan; Rogers was appointed by President Bill Clinton. Six states -- Arizona, Arkansas, California, Georgia, South Carolina and Tennessee -- received shipments of sodium thiopental at issue in the complaint.
The original ruling was that of U.S. District Judge Richard Leon in Washington. The case is Cook v. U.S. Food and Drug Administration, 12-05176, U.S. Court of Appeals, District of Columbia (Washington). (Source: Associated Press, 23/07/2013)