July 23, 2013 FDA Racks Up a Circuit Court Loss in Imported and Unapproved Thiopental Sodium Case; Will It Jeopardize FDA’s Drug Shortage Program? By Kurt R. Karst –

In a unanimous decision handed down on July 23rd by a 3-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit in Cook v. FDA (Case No. 12-5176), the Court largely affirmed a March 2012 decision from the U.S. D.C. District Court (Judge Richard J. Leon) permanently enjoining FDA from permitting the entry of (or releasing any future shipments of) foreign manufactured thiopental into interstate commerce.  The decision is a blow to FDA on several fronts.As we previously reported (here, here, and here), the case stems from a February 2011 lawsuit (amended in July 2011) brought against FDA by death row inmates in three states, over the importation of unapproved thiopental sodium, one of the drugs used by some states to administer a lethal injection.  The Plaintiffs alleged that FDA committed violations of the Administrative Procedure Act (“APA”) and the FDC Act.  Specifically, Plaintiffs alleged that FDA violated the law by improperly allowing shipments of a misbranded and unapproved new drug to enter the U.S., contrary to the statute (FDC Act § 801(a), 21 U.S.C. § 381(a)), and that FDA departed from longstanding policies and undermined the purpose of the FDC Act by permitting entry of the drug into the country.  Judge Leon agreed and concluded his opinion with a rather colorful statement:

In the final analysis, the FDA appears to be simply wrapping itself in the flag of law enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the executioner’s needle.  How utterly disappointing!

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