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FDA Can't Ignore Importation of Execution Drug

A D.C. Circuit decision on Tuesday has put a legal stop to the importing of an unapproved drug used for executions, which had been passed through by the FDA.

The Food and Drug Administration (FDA) had allowed sodium thiopental, a misbranded and unapproved drug used as an anesthetic in the lethal injection process, to be imported into prisons, and the D.C. Circuit denied their discretion to allow unapproved drugs into the U.S., reports The Associated Press.

The FDA overstepped its bounds by allowing drugs which were not approved for use in lethal injections to be imported and used in U.S. prisons.

State Prisons Import Thiopental

The appellants in Cook v. FDA are prisoners who were sentenced to death under the state laws of California, Tennessee, and Arizona, states which (at the time of the complaint) had been executing prisoners using a three-step system which included sodium thiopental ("thiopental") as the anesthetizing first step.

Thiopental is currently an unapproved drug, and the last domestic source quit making the drug in 2009, prompting state prisons to order thiopental from a wholesaler located in the United Kingdom, Dream Pharma Ltd.

The FDA initially intercepted the shipments of thiopental under the misbranding portion of the Food, Drug, and Cosmetics Act (FDCA) (as well as being an unapproved drug), but allowed the initial and future shipments to proceed after speaking with state officials about its intended use for executions.

Instead, the FDA released a policy statement explaining it does not approve of thiopental's use in executions, but it would essentially turn a blind eye and exercise its discretion in not reviewing any shipments of thiopental that came in through Customs.

FDA's Discretion Claim

The prisoners pleaded to the Cook Court to have the FDA enforce its governing statutory laws under the Administrative Procedure Act.

The FDA fired back by claiming that its enforcement discretion under 21 U.S.C. § 381(a) is not subject to judicial review, which is buttressed by the Supreme Court's decision in Chevron U.S.A. v. NRDC.

Under Chevron, the Court should respect "legitimate policy choices" made by an agency when a challenge focuses outside whether it is a "reasonable choice within a gap left open by Congress" and more to the central wisdom of the agency in general.

D.C. Circuit Can Review Discretion

In response to FDA's application of Chevron, the Cook Court regurgitates about a half-dozen D.C. Circuit cases that have allowed review of agency decisions without being frozen out by Chevron (like this recent EPA case) and explains that when a statute imposes mandatory duties, an agency has no wiggle room for enforcement review.

The D.C. Circuit has a Supreme Court case on point, Heckler v. Chaney, where death row inmates complained about lethal injection drugs that were misbranded and unapproved and the FDA's refusal to do anything was upheld.

However, Chaney allows for review of the agency's decision when there is a clear "legislative direction in the statutory scheme," and the Cook Court found that § 381(a) unambiguously (by frequent use of the word "shall") binds the FDA to inspect and review imported drugs, as well as refuse admission those who appear to violate the FDCA.

What follows is an interesting academic discussion about the imperative case in English, but ultimately the D.C. Circuit determined the law creates a clear mandate that the FDA cannot deny. The agency was then derelict in its duties by allowing the blind importation of thiopental.

Bottom Line

It isn't clear why the FDA thought allowing the wholesale importation of a non-approved drug used in killing people would somehow go unnoticed, but there when a clear statutory duty is imposed, agency discretion is at its nadir.

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