Wednesday, July 24, 2013

D.C. Circuit Court Blocks Import of Lethal Injection Drug’s  Blog of LegalTimes yesterday reported “the U.S. Food and Drug Administration was wrong in allowing states to import a ‘misbranded and unapproved new drug’ used in lethal injection cocktails without first examining it, the U.S. Court of Appeals for the D.C. Circuit ruled unanimously on July 23rd., upholding a trial judge's order blocking the FDA from allowing continued imports of sodium thiopental. The court found the agency ‘acted in derogation’ of its duty to examine foreign shipments of a drug prepared by a company not registered with the FDA and  rejected the agency's argument that it had discretion in deciding whether to review the shipments and could permit unreviewed imports in deference to law enforcement agencies.”

    District Court Judge Richard Leon had found back in March 2012 that the FDA acted "arbitrarily and capriciously and abused its discretion" in permitting shipments of thiopental without examining it. The federal Food, Drug, and Cosmetic Act is clear that the agency ‘shall’ review and block drugs in violation of the law.” (District Court's ruling)

 “The Food, Drug, & Cosmetic Act imposes mandatory duties upon the agency charged with its enforcement.” the Circuit Court concluded in its ruling. “The FDA acted in derogation of those duties by permitting the importation of thiopental, a conceededly 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. The district court could not remedy the FDA’s unlawful actions, however, by imposing upon the interests of non-parties to this suit. The order of the district court pertaining to the thiopental already in the possession of the states, quoted in the paragraph above, is therefore vacated, but the underlying judgment of the district court is affirmed.”

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