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July 23, 2013

Mixed DC Circuit ruling in suit against FDA allowing execution drug importation

As reported in this AP piece, the DC Circuit "ruled Tuesday that the Food and Drug Administration violated its duty by allowing a misbranded and unapproved new drug to be imported for use in executions by lethal injection."  But the ruling also "reversed another part of the lower court’s order and allowed state correctional departments to keep stocks of the drug they currently have."  Here is the concluding paragraph of the unanimous panel ruling today in Cook v. FDA, No. 12-5176 (DC Cir. July 23, 2013) (available here):

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. The district court could not remedy the FDA’s unlawful actions, however, by imposing upon the interests of nonparties 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.

July 23, 2013 at 01:36 PM | Permalink


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From FDCA (definitions).

§ 321(g)(1) The term ‘‘drug’’ means (A) articles recognized in the official United States Pharma
copoeia, official Homoeopathic Pharmacopoeia of the United States, or official National For
mulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles
(other than food) intended to affect the structure or any function of the body of man or other
animals; and (D) articles intended for use as a component of any article specified in clause (A),
(B), or (C).

I do not understand why the defense failed to question the jurisdiction of the court and of the FDA. Thiopental is not being used for ""the diagnosis,cure, mitigation, treatment, or prevention of disease in man or other animals."It is being used in 10 fold higher doses to kill. It might be subject to regulation by the Agriculture department, but definitely not by the FDA.

Posted by: Supremacy Claus | Jul 24, 2013 3:38:06 AM


Unfortunately, I can see execution agents qualifying under (c).

I see an argument against lack of jurisdiction being far stronger on the basis that the FDCA has no private right of action., and so, eeven if the importation is unquestionably against the law there is no _legal_ right that would be vindicated by a favorable ruling.

Posted by: Soronel Haetir | Jul 24, 2013 8:39:56 AM

While it may not ultimately impact the conclusion, the opinion by the DC Circuit missed the most recent Supreme Court decision on the deference to be given an agency's interpretation of the governing statutes -- City of Arlington v. FCC -- in noting that it was unclear what the appropriate scope of deference to the FDA decision was.

Posted by: tmm | Jul 24, 2013 9:54:04 AM

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