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Wednesday, April 26, 2017

"Gimme My Drugs"

My last post was a little depressing (even for me) so I thought I’d bring my blog stint to a close with another big event in the death penalty world this past week: the FDA’s final decision on 1000 vials of imported sodium thiopental.

To be (in the United States), or not to beThat’s been the question since 2015, when the drugs were confiscated by customs and border protection pursuant to an FDA-requested hold. The FDA issued its answer late last week—not to be—and on Monday, Texas said it would challenge that decision in federal Court. Gimme my drugs, now.

The backstory on all this is that the FDA is required to refuse entry to imports of “unapproved and/or misbranded” drugs (it originally tried to say that its duty in that regard didn’t apply to execution drugs, but a court in 2012 disagreed so here we are) and in 2015, the FDA warned states that importing the drugs from Harris Pharma, an Indian pharmaceutical company (kinda sorta, more on that in a minute) would be illegal.

Yet, they persisted. Arizona, Texas, and Nebraska bought the drugs from Harris Pharma anyway, so when they arrived at the border in 2015, they were confiscated.  Each state paid Harris $25,000 for the sale.

My sense is that the FDA hoped that would be the end of the matter, but of course that was wishful thinking. Texas eventually sued, alleging that the FDA couldn’t hold the drugs without making a decision on the legality of their being imported.  So the FDA made a decision, which brings us to where we are now.

The FDA has given several bases for its decision.  The vials have “no recommended dose and offer no instructions for reconstituting the powder inside the vials” and “its labeling contains no precautions, contraindications, or warnings, or other information required in prescribing information for health professionals.”  In short, it’s not just misbranded—it’s not branded at all.

And Harris Pharma is not an FDA-approved supplier of sodium thiopental. The last FDA-approved supplier of sodium thiopental stopped making it in 2011 for the very reason that states were using it for executions.

All that is well and fine—but the most interesting part of the story is the one that neither the FDA nor the states are talking about, and that’s Harris Pharma.

Harris Pharma is just a guy. His name is Chris Harris, and he has no pharmaceutical background whatsoever.  Before he was Harris Pharma, he was working with the Mumbai-based Kayem Pharmaceuticals—not working for Kayem (despite showing off business cards that listed himself as Kayem’s “director”) but working with it.  Kayem’s CEO says the company was looking to get into e-commerce, and that he was introduced to Harris online.  He never met Harris, but they had a “commercial understanding.”  That understanding soured when Harris sold 500 vials of Kayem’s sodium thiopental to South Dakota for executions (they expired without ever being used).  That year—2011—Kayem and Harris parted ways, and Harris started Harris Pharma.

That’s the sum of Harris’s pharmaceutical experience. Before working with Kayem, Harris worked in a duty-free shop in the Abu Dhabi International Airport, and then held a handful of jobs at various call centers, staying for around a year at each.

Wait, there’s more. The location of Harris Pharma—where this pharmaceutical company’s manufacturing and distribution business is based—is actually just one of 61 offices on the 8th floor of an office complex in Kolkata.  The office rental company representative who manages the property says that Harris doesn’t manufacture drugs in the rented office (it’s too small to accommodate the sort of lab equipment to manufacture pharmaceutical drugs) and that he only comes in 2-3 times a month.  So where is Harris Pharma doing its business?

Harris Pharma has a second listed business location, the location Harris gave the DEA as an address (Nebraska too)—but that’s a residential apartment and he hasn’t lived there in more than 2 years. Harris’s landlord says he hadn’t paid rent or electricity bills in 7 months, and then just left.

Interestingly, Harris told a former neighbor that his job was manufacturing and selling “sexual feel drugs” on a website.  Kayem Pharmaceuticals does sell drugs to “enhance male sexual performance” so perhaps Harris was selling Kayem’s performance drugs on the sly too.

This is Harris Pharma, the overseas supplier of the drugs that Texas, Nebraska, and Arizona claim that they are entitled to. It’s worth noting that both Texas and Arizona have secrecy laws—and Nebraska is debating one as I write—that would keep us from knowing about any of this if it hadn’t been for  the FDA border spat and some good investigative reporting that followed.

I would probably find all this amusing if not for the fact that we’re talking about the state taking the life of one of its own citizens—the most serious and solemn task it can possibly have.

Posted by Corinna Lain on April 26, 2017 at 01:05 PM | Permalink

Comments

That's a little depressing too, tbh.

Posted by: Joe | Apr 26, 2017 3:17:27 PM

So is the FDA now in the business of approving new drugs for safety and efficacy in executions? Since the death penalty is legal, the FDA would be required to approve a drug for that use (or at least permit human trials...on death row inmates presumably) if given adequate evidence from animal tests, lest they be derelict in their administrative duties. Do opponents of the DP really want that?

I suppose safety in this context would mean the absence of cruel side-effects as the drug offs the condemned, but efficacy is rather easy to demonstrate. Skirmishes like this over the supply of drugs do nothing to resolve the political and moral questions surrounding the DP.

Posted by: M. Rad. | Apr 26, 2017 7:11:53 PM

We're talking about the state taking the life of a reprobate whose case has been kicking around in the courts for 18-27 years, now impeded by lawfare operations contra merely acquiring the dispatch agent. Quit it with the veterinary medicine and put this man in front of a firing squad. You don't like capital sentences, take it up with the Arkansas legislature.

Posted by: Art Deco | Apr 27, 2017 12:02:47 AM

I just don't understand how it is that the same people who are all for assisted suicide, when it comes to the death penalty suddenly act like there is no humane way to do it.
How about just starving them to death, like we do to people who aren't quite into assisted suicide but want to die already.

Posted by: biff | Apr 27, 2017 1:06:32 AM

Assisted suicide involves consensual ending of life, often with physician involvement in various respects. It's more complicated to end life against the will of the persons where it is ethically problematic to have physicians involved. This includes the fact that suppliers do not want to supply drugs to be used in the death penalty context.

Starving people to death can be a quite imperfect means of euthanasia, with suffering involved especially if the person is not actually critically ill but just a healthy person that the state wants to execute, a major reason why people do not want to rely upon it.

Posted by: Joe | Apr 27, 2017 1:25:38 AM

"put this man in front of a firing squad"

Can't do that. The law says to use lethal injection. Don't like it? Take it with the Arkansan legislature. http://law.justia.com/codes/arkansas/2015/title-5/subtitle-1/chapter-4/subchapter-6/section-5-4-617/

Posted by: Joe | Apr 27, 2017 1:32:00 AM

Can't do that. The law says to use lethal injection. Don't like it? Take it with the Arkansan legislature.

Thanks for the attitudinizing. It's just tonic.

I'm happy to suggest that to the Arkansas legislature. I'm not the one who has kept these cases kicking around in the appellate courts for an interminable length of time, nor am I the one filing frivolous lawsuits attempting to stop executions on the absurd premise that the drug cocktails are unfit for human consumption, nor am I knocking about in a regulatory agency putting the squeeze on pharmaceutical manufacturers. Neither the original poster, nor the pettifoggers engaged in this litigation, nor you, give a rip about public opinion in Arkansas or the judgments of the Arkansas legislature.

Posted by: Art Deco | Apr 27, 2017 7:51:05 PM

Not my area, but why is this even a "drug"? The F&D Act defines a drug as a substance for use in "(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, (b) restoring, correcting or modifying organic functions in human beings or animals, or (c) disinfection in premises in which food is manufactured, prepared or kept." An execution chemical is not being used to treat or mitigate any disease or disorder, nor to restore or correct any organic function. In a literal sense, it is being used to "modify" an organic function by terminating said function, but under the eiusdem generis and noscitur a sociis canons one can make a plausible case that "modify" should be understood as modifying in the direction of making the patient in question better, not worse, and execution chemicals most definitely make them worse.

Posted by: TJ | Apr 29, 2017 8:53:20 AM

Whoops, wrong definition. The actual definition is "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." But same point applies. Or is the simple answer because sodium thiopental is in the US Pharmacopeia?

Posted by: TJ | Apr 29, 2017 9:07:01 AM

"give a rip about public opinion in Arkansas or the judgments of the Arkansas legislature"

The comment was partially a response to your own remark, but do care. If you like, can think of it pragmatically as to what would appeal to the public to influence final results here. Typical advocate's technique.

The point does hold: personally, if we have a death penalty, can see various sound arguments to have the firing squad. But, the legislature doesn't offer that option.

And, "squeeze" here means that the regulations (so found a court) require such and such. The rather dubious nature of the people involved in providing the drugs used to execute people to me particularly makes it a sound thing to worry about. The tone suggests not a great support of the argument, but again, such is the law as interpreted. Don't like it, law can be changed.

===

As to definitions, ST is being used as a barbiturate here that "affect the structure or any function of the body of man" and "mitigate" the pain of executions. It also is in general usage as general anesthesia. I would think that if you import a drug, it is regulated generally. Thus, e.g., one of the court opinions cite concern of the drug being released into the general population. The uses of the drug there would be relevant, not only this specific usage.

Posted by: Joe | Apr 29, 2017 10:26:52 AM

1. There is no such thing as a death drug. LI drugs are drugs made by manufacturers & used for an "off-label" purpose. As the DC circuit said in the FDA case, these are "concededly misbranded" drugs. So no, I wouldn't say that the FDA is now in the business of approving drugs for executions--it's in the business it has always been in, which not letting misbranded drugs & drugs from unapproved suppliers into the country. And these drugs are sketch, super-sketch, on both fronts.

2. I've written about the firing squad as a more humane (and economically feasible) alternative to the firing squad. It also solves a central problem with LI: we execute using a method that derives its supply from countries who don't want us to execute. If we don't intl opposition to the dp to get in our way, we really shouldn't depend on pharma to do it. Guns are ubiquitous, so are bullets. But as another commenter wrote, this is a change the legislature must make. If it's more humane, and cheaper, and less easy for abolitionists to frustrate, it's worth thinking about why legislatures haven't flocked to this alternative. I have a work in progress exploring that very question.

3. Whether LI drugs are actually 'drugs' hasn't been questioned by the FDA. Indeed, the FDA enforces its duties here wrt drugs imported for animal euthanasia--no question that these are drugs even though used to put down animals. Another commenter--I think it was Joe--got it right, and that's the fact that big pharma (almost entirely based in Europe) is against their products being used in executions, and that's the rub. That's the difference between using products in animal euthanasia, or even p/a suicide--neither are taboo uses in Europe, as are executions.

Posted by: Corinna Lain | Apr 29, 2017 2:13:21 PM

Is a bullet now a medical device? Sure it does "modify organic functions in human beings or animals", and such is, in fact, its intended purpose. The notion that the regulation of execution by lethal injection was intended by the passage of the Food and Drug Act in the 1930's, when the rate of executions per-capita was about 10 times the current rate, is nearly as farfetched.

Fer chrissake, these materials are being imported under the auspices of a *state government*, under the laws whereof they cannot be used for any other purpose than executions. Is your federalism insurance paid up?
http://prawfsblawg.blogs.com/prawfsblawg/2016/12/message-to-trump-anxious-decentralizers-is-your-federalism-insurance-premium-paid-up.html

Posted by: M. Rad. | Apr 30, 2017 8:58:57 AM

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