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October 25, 2015

Extraordinary tales of extraordinary government dsyfunctionality in execution business

In this recent post I spotlighted the remarkable reporting by BuzzFeed News about the peculiar fellow in India who  has become a central figure in some states' efforts to get their machinery of death up and running again.  Continuing their great investigavtive journalism in this space, BuzzFeed now has up two additional reports documenting how a trio of states apparently violated federal laws in order to try to import lethal injection drugs from this fellow.  Here are links to the two pieces with their extended headlines:

Here is how the second of these two articles concludes:

The FDA has consistently maintained that importing sodium thiopental would be illegal, but the states proceeded regardless. FDA records first reported on Thursday by BuzzFeed News show that two shipments of sodium thiopental made their way to the Phoenix and Houston airports in late July.

On Friday, TDCJ’s Clark told BuzzFeed News that, after obtaining an import license from the DEA prior to the shipment, TDCJ filed the required notice with the agency of the anticipated shipment.

After the shipments were held upon arrival, Arizona Department of Corrections Director Charles Ryan wrote to the FDA in August, asking them to release the drugs. “The Department will not use, or attempt to use, the cargo until it is either unconditionally released by FDA or the Department is otherwise permitted to do so by a Court Order, whichever comes first,” Ryan wrote. “I am writing to advise you that we need to take possession of the shipment.”

The FDA was not persuaded. Domenic Veneziano, who heads the FDA division that handles imports, replied, “FDA has determined that this shipment should not be allowed to move to destination at this time and thus will not be requesting that CBP lift its detention.”

For its part, Texas isn’t giving up yet, with TDCJ’s Clark telling BuzzFeed News on Friday that it “is going through internal proceedings set up for addressing the lawful status of imports with the Food and Drug Administration and is awaiting their decision.”

The FDA confirmed to BuzzFeed News on Friday that it was still holding the shipments. “Courts have concluded that sodium thiopental for the injection in humans is an unapproved drug and may not be imported into the country for this purpose. FDA has notified the state correctional facilities of the status of their respective shipments,” spokesperson Jeff Ventura wrote.

Asked whether, given the FDA’s repeated statements that such importation of sodium thiopental would not be allowed, TDCJ is challenging that position, TDCJ’s Clark responded, “We disagree with your characterization of the FDA’s statement as to the legality of importing sodium thiopental, we are appealing the detention of the drugs through the FDA’s internal proceedings.”

As if this story of government dysfunctionality was not ugly enough on its own terms, this post by Kent Scheidegger at Crime & Consequences contends that the federal government is the one really acting outside the rightful reach of the law.  His post is titled "FDA Blocks Execution Drug Importation Based on Erroneous Court of Appeals Decision," and it makes the case (as was made in a slightly different way by Ohio officials) that the FDA is off-base and over-reaching in this arena.  

In addition to wanting to note that my expertise on the death penalty comes up short when the issues is federal and state squabbles over federal drug and import laws, I am now especially eager to stress that I have been calling for Congress for nearly a decade to conduct hearings and investigate all the difficulties states have been facing with lethal injections protocols and securing executions drugs.   But, as one commentors suggested in response to my post on this topic in May 2014, perhaps the only way we woud get hearing on this topic in short order would be if there was some link to Benghazi.

Some prior related posts:

October 25, 2015 at 05:12 AM | Permalink

Comments

In movie Westerns, executioners are contracted and make their rounds.

Government should hire private contractors for executions.

Posted by: Supremacy Claus | Oct 25, 2015 11:36:01 AM

It would be entertaining for states to apply to the FDA for a Compassionate Use IND, to either make or import thiopental or other barbiturates for each condemned. The FDA routinely approves importation of unapproved medication for single patient use with a prescription.

I knew someone with a personal IND license who imported a drug with a credit card to a British pharmacy. It cost 50 cents a pill. Once approved by the FDA, his IND ended. He then had to buy the same drug from a US pharmacy at $5 a pill.

The regulation allowing such.

http://humansubjects.stanford.edu/research/documents/compassionate_humanitarian_use_FDA_GUI01036.pdf

Posted by: Supremacy Claus | Oct 25, 2015 12:25:01 PM

The appellate ruling regarding the importation of the drugs was joined by "ROGERS, Circuit Judge, and GINSBURG and SENTELLE, Senior Circuit Judges."

KS at his blog argues:

What is "safe and effective" for an execution drug? Effective for this purpose is necessarily the ultimate unsafe.

It means to me a drug that safely and effectively kills someone without unnecessary delay and pain. Sometimes, a drug's point is to kill and the "safety" has to be put into that context. For instance, a drug used to euthanize animals (to be blunt, not that off base comparison, especially given how some view the people being executed) obviously is supposed to kill the animal. But, it is not "unsafe" in context unless it does so in a bad fashion. And, that is the concern -- that the drugs won't be effective in the way intended. If the opinion here is wrong I'll lead to others.

The investigation idea makes sense.

Posted by: Joe | Oct 25, 2015 12:49:26 PM

Joe. Subject reviewed in another comment. Those are not drugs as defined by the law continuing the FDA. The FDA has no jurisdiction.

http://sentencing.typepad.com/sentencing_law_and_policy/2015/08/fda-warns-ohio-not-to-illegally-import-execution-drugs.html

Posted by: Supremacy Claus | Oct 25, 2015 2:28:18 PM

The appellate ruling can be found here -- https://casetext.com/case/cook-v-food-drug-admin -- I don't see any discussion of the "poison" argument.

Sodium thiopental to me arguably is not used as a "poison" in a three drug protocol -- it is used to for anesthesia induction while a second drug paralyzes and a third drug kills the person. This would underline the point that "safe and effective" applies. If it is used as a one drug protocol

Also, it is unclear to me that a "poison" is the same thing as something that is used to euthanize an animal/human or legally execute a person. Finally, the appellate opinion cites 21 U.S. Code § 331 as the relevant provision. This covers "any food, drug, device, tobacco product," and outwith more seems to cover these drugs. SC in his past comment suggests "and" requires each of the four criteria cited exist. But, this doesn't make sense -- the fourth criteria, e.g., covers articles used as a component of something covered in the first three categories.

Anyway, even a one drug protocol is intended in part to kill humanely. This is a major point in lethal injection -- a form of medicized death. If the provision doesn't cover this, does it also not cover euthanasia? Notable loophole.

Posted by: Joe | Oct 25, 2015 3:03:43 PM

The appellate ruling can be found here -- https://casetext.com/case/cook-v-food-drug-admin -- I don't see any discussion of the "poison" argument.

Sodium thiopental to me arguably is not used as a "poison" in a three drug protocol -- it is used to for anesthesia induction while a second drug paralyzes and a third drug kills the person. This would underline the point that "safe and effective" applies. If it is used as a one drug protocol

Also, it is unclear to me that a "poison" is the same thing as something that is used to euthanize an animal/human or legally execute a person. Finally, the appellate opinion cites 21 U.S. Code § 331 as the relevant provision. This covers "any food, drug, device, tobacco product," and outwith more seems to cover these drugs. SC in his past comment suggests "and" requires each of the four criteria cited exist. But, this doesn't make sense -- the fourth criteria, e.g., covers articles used as a component of something covered in the first three categories.

Anyway, even a one drug protocol is intended in part to kill humanely. This is a major point in lethal injection -- a form of medicized death. If the provision doesn't cover this, does it also not cover euthanasia? Notable loophole.

Posted by: Joe | Oct 25, 2015 3:03:43 PM

Joe. One may develop a humane rat poison. It would contain warfarin, a blood thinner approved by the FDA for the dissolution of clots in humans. For its use in rats as a poison, the Agriculture Department would regulate it, despite being an FDA approved medication.

I would like to say, our argument over the word, "and," is what courts are for. However, no one in responsible policy position is going to ever come close to understanding what we are talking about.

Posted by: Supremacy Claus | Oct 26, 2015 3:31:29 AM

Courts held the agency had jurisdiction. There apparently is not circuit split but perhaps the matter is of enough importance to grant cert.

Posted by: Joe | Oct 26, 2015 12:57:34 PM

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