The Justice Department Rules That the FDA Cannot Regulate Lethal Injection Drugs

The opinion stems from an injunction currently preventing Texas from importing sodium thiopental.

The Department of Justice (DOJ) recently decided that the Food and Drug Administration (FDA) has no authority to regulate "articles intended for use in capital punishment," including the drugs used in lethal injections.

The opinion was published earlier in May and signed by Trump-appointed Assistant Attorney General Steven Engel:

Electric chairs and gas chambers are "articles" that were created for the sole purpose of capital punishment. Because of this, it is clear that the FDA does not have authority over them. Other articles, such as the drugs used in lethal injections or the guns used in firing squads, were created for functions beyond execution. While the FDA has technically never claimed jurisdiction over the former, its authority over the drugs used for lethal injections is questionable.

For example, the FDA has jurisdiction over hot tubs, saunas, and treadmills, ONLY when they are "intended for medical purposes." The FDA has no authority when they are used for recreational purposes as that is beyond its jurisdiction.

In a similar way, the FDA regulates drugs based on whether or not they "are safe and effective for their intended uses." An article approved for one use is currently not allowed to be imported for a separate use. Sodium thiopental, one of the three drugs used in the standard lethal injection cocktail since the 1970s, is one of the articles in question. Sodium thiopental is an anaesthetic used in surgical procedures. Corrections facilities multiply the normal 300-milligram dosage anywhere from six to 17 times for the purpose of execution.

The DOJ acknowledges that the FDA has jurisdiction over drugs used in animal euthanasia because it is a standard practice accepted in veterinary care. Capital punishment, on the other hand, is not accepted as medical care.

The DOJ also observes that lethal injection drugs would be unable to meet FDA compliance since the agency requires labels to include warnings about "unsafe dosages." It is understood that warning against fatal use would be irrelevant for any drug used for the purpose of death.

Because of these observations, the DOJ concludes that the FDA cannot regulate any article of capital punishment because the intended use, capital punishment, is not medical and therefore falls beyond the FDA's scope. The FDA is only free to regulate the same drugs when used in medical care.

The opinion stems from a years-long fight between the FDA and the state of Texas over an injunction blocking the importation of sodium thiopental. The injunction remains in place for now.

Though states are eager to possess sodium thiopental for executions, U.S. manufacturer Hospira ceased production of the drug altogether in 2011. After the company moved production to Italy, the Italian government demanded that the company ensure that the drugs would not be used to administer the death penalty. Hospira determined that while they did not condone the use of their drug for capital punishment, they did not have the ability to ensure that it would remain out of the hands of U.S. corrections facilities. In a statement following the decision to shut down entirely, the company said it regretted that hospitals "who use the drug for its well-established medical benefits" will no longer have access to the product.

A sodium thiopental shortage caused states to look for other manufacturers and drugs. Oklahoma, for example, began to use pentobarbital, a drug intended to euthanize animals. Opponents renewed their criticism of the drug following two botched executions in Oklahoma in 2014. When the Danish manufacturer announced that it would no longer supply the drug for lethal injections, states turned to synthetic versions.

The FDA has largely lost its claim as any sort of moral gatekeeper. Stories like the one portrayed in the 2013 movie Dallas Buyers Club show how the FDA's heavy-handed regulations punish those seeking life-saving medicine. Rather, the DOJ opinion, as well as Texas' and other states' aggressive fight to access drugs for lethal injection show just how far the government is willing to go to kill.

Public opinion currently supports the death penalty. Pew Research Center found that the decades-long decline in support for the death penalty was thwarted by a rise in 2018. Pew also found in 2015 that the majority of people recognize that there is a risk of putting an innocent person to death and that the death penalty is unlikely to deter serious crime.

Comments

[Zeb]

I oppose the death penalty, but this seems like an appropriate decision.
The way to end the death penalty is to get it abolished by law, not to make it difficult to carry out.

[Diane Reynolds (Paul.)]

This seems to be an oddball technical run-around to deal with the death penalty. I just looked up the drugs used for assisted suicide, an “legitimate medical practice”.

According to Oregon’s February 2017 official report, deaths occurring during the first 19 years under that state’s “Death with Dignity Act” took place after patients took the following drugs[1]:

Secobarbital (Seconal) 59.3%
Pentobarbital (Nembutal) 34.3%
Other 6.5%

Secobarbital (Seconal) and Pentobarbital (Nembutal) are barbiturates (sedatives).
In recent years, Pentobarbital has become unavailable due to protests about its use in capital punishment.[2] Therefore, Seconal has become the most widely use drug to cause death.

Also, the FDA was given authority to regulate tobacco products. Tobacco is a legal product, therefore under the regulatory umbrella of the FDA we can only conclude that they’re “safe and effective”.

[Robert]

FDA was given separate statutory authority to regulate tobacco products, not to use its general authority over drugs and medical devices over tobacco, which the US Supreme Court determined it did not have. FDA has authority over different things as different things.

[MatthewSlyfield]

Personally I think that the death penalty can be morally justified in certain rare cases (serial killers, people who have committed multiple mass murders).

However, I have come the conclusion that governments can not be trusted with it’s administration. They simply aren’t willing to run first instance trials in a way that produces results certain enough for the application of an irreversible penalty.

[ThomasD]

It’s almost pathetic that the FDA was willing to make the arguments they did. There are so many examples of other substances with non-medical uses that the FDA ignores (e.g. epsom salts) but does regulate when employed in or as a medicinal product (magnesium sulfate.) They had to know their arguments couldn’t hold up.

Ordinarily I’d blame typical bureaucratic overreach, but in this case I’d say it had more to do with opposition to the death penalty.

If abortion opponents went to these sorts of extremes they’d be ridiculed to no end.

[ThomasD]

Also, all pentobarbital is synthetic. There is no naturally occurring version of the substance. All barbiturates are made from malonic acid.

[Zeb]

This actually looks a lot like what abortion opponents try to do in many cases. If you can’t get something made illegal, then try to get laws passed that make it more difficult, expensive or inconvenient.

[Diane Reynolds (Paul.)]

I believe they tried to regulate abortion facilities like hospitals… and I remember wondering if anyone on the pro-choice side recognized the irony.

[ThomasD]

“then try to get laws passed ”

Which is true, but entirely unlike what was happening here. This was a case of existing regulation being stretched to unrecognizable reach.

[SIV]

Lol! treason‘s all butthurt that the FDA can’t regulate something.

[Don't look at me!]

The FDA must regulate this stuff. Someone could get killed!

[Juice]

Sodium thiopental is not the only way to kill someone. I still don’t know why CO poisoning isn’t used. The condemned would just quietly fall asleep and never wake up.

[chemjeff radical individualist]

Well, gas chambers have a bit of a bad rap ever since 1945 or so.

[Diane Reynolds (Paul.)]

If you’re going to have the death penalty, and you’re going to use lethal injection to do it, why not use the same drugs they use for assisted suicide, you know, the ones the FDA regulates and claims are “safe and effective”?

[Malvolio]

Just put mask on the condemned and feed pure nitrogen in. He’ll expire painlessly in about two minutes and the gas is harmless when they pull the mask off.

[Brett Bellmore]

Every time you come up with a different means of execution, you have to run the entire legal fight all over again.

Otherwise, yeah, you’d just use inert gas asphyxiation, or CO, or something like that.

[NoVaNick]

Not a fan of the death penalty but if we are going to have it, why not simply use a upper to the back of the head-a lot cheaper and faster. Why do we have to pretend to be humane? Those who want executions certainly don’t care, and those who don’t wont be happy with any method.

[NoVaNick]

I meant bullet to the back of the head

[MatthewSlyfield]

“bullet to the back of the head”

That’s actually a relatively difficult shot, but when done correctly, it’s actually relatively humane. Actual instant death is nearly impossible, but bullet to the brain is about as close as you are going to get.

I like to call it high velocity lead poisoning. 🙂

If you want brutal and gore, how about the guillotine, unlike a bullet, it’s reusable.

It’s bad reputation largely stems not from any inherent aspect of death by beheading, but rather that the French Revolutionaries who were the first to use it made a massive public spectacle out of politically motivated executions.

And like the bullet to the brain, while it looks bloody and brutal, it’s actually relatively humane. The guillotine and fast hanging* are the next closest things to instant death after the bullet to the brain.

*Set up to break the neck rather than strangle the victim (slow hanging). This is the way death by hanging has generally been done in the US through out our history. The big problem is it’s easy to screw up (to get it right, you have to account for victim’s height and weight to determine the length of fall needed and the rope thickness). If you get it wrong you can end up with a slow hang or worse, the condemned survives.

[Brett Bellmore]

Actually, there’s historical evidence, as well as biology, to indicate that the guillotine isn’t anywhere near instant, neither is hanging.

Rather, by severing the spinal cord fairly high up, they both render the executee neurologically unable to thrash around, which looks like instant death. But death in the case of hanging still has to wait on the oxygen in the blood being exhausted, while it’s a bit faster with the guillotine, as the brain no longer has access to blood from the body.

With a bullet to the brain, it’s all over in a fraction of a second.

[Eddy]

“Public opinion currently supports the death penalty. Pew Research Center found that the decades-long decline in support for the death penalty was thwarted by a rise in 2018. Pew also found in 2015 that the majority of people recognize that there is a risk of putting an innocent person to death and that the death penalty is unlikely to deter serious crime.”

What does this have to do with the authority of the FDA?

Their mandate is to protect the public (even against its will) from dangerous food and drugs and medical devices – that is to say, to stop people who use food, drugs and medical devices to eat or to treat disease from being injured by what they eat or use. Even if they want to take the risk of being injured.

In contrast, execution methods are a different subject matter altogether – they’re not being used or sold or marketed as tasty or as having healing properties. The FDA should butt out. And what this means to the death penalty debate is totes irrelevant.

[Diane Reynolds (Paul.)]

Perhaps the FDA should regulate crime. You know, make it safe and effective.

[Diane Reynolds (Paul.)]

When the Danish manufacturer announced that it would no longer supply the drug for lethal injections, states turned to synthetic versions.

So many lessons to be learned here.

[Unicorn Abattoir]

So when their drug of choice was cut off, they found other means?

Seems like I’ve heard this before.

[Rossami]

I do not support the death penalty because I am a firm believer in human fallibility. There are too many documented instances of innocents being wrongly convicted to think that society should take such an irreversible step.

That said, as long as we have a legal death penalty, all these arguments about the means are just silly. They seem to me to stem from a couple of fallacies.
1. The death penalty must be “humane”.
While I don’t think we should torture criminals, I see no moral problem with a means of execution that’s as bad as what the criminal did. Get the death penalty for shooting someone and it’s okay to shoot them, too. Or anything lesser. All this quibbling over degrees of suffering that are below what the average patient experiences in a routine visit to the ER or the dentist seems wrong.
2. The death penalty must be sanitary.
Death is never sanitary. It’s messy, unpleasant and violent in almost all of nature. Yes, observing that violence will be stressful on the people who have to carry out the execution. I’m not sure that’s a bad thing, though. I don’t think I want people to start thinking that it’s easy to kill – even if they are killing for the State.
3. The death penalty must be reliable.
Okay, I’ll give you this one. It’s pretty horrible to be almost-electrocuted. (You end up burning to death instead.) But the standards of reliability are not perfection. Can’t find the vein? Again, that’s no worse than a routine ER visit. Not a sufficient excuse to stop an execution.

I wish the people blocking these drugs would change their tactics. Let’s address the real problem. By all means, let’s end the death penalty. But do it for the right reasons and not by this indefensible incrementalism.

[MatthewSlyfield]

“Okay, I’ll give you this one. It’s pretty horrible to be almost-electrocuted. (You end up burning to death instead.) But the standards of reliability are not perfection.”

I have to disagree with you here, though I’m not a death penalty supporter.

If they put you in an electric chair and you burn/cook to death rather than having your heart stop, there is nothing “almost” about your electrocution.

Rather, if we are going to have the death penalty, there is only one valid measure of reliability for methods of execution. Survival rate.
#of prisoners still alive after/# of dead prisoners.

Things like burning to death rather than heart stopping and difficulty finding a vein for lethal injection may matter from a moral perspective, but when all is said and done, if the condemned died, the execution was successful.

[Rossami]

Perhaps I was unclear. You’ve definitely been executed in that scenario but you haven’t been electrocuted. And given the research that we have about burns and their associated pain, burning someone to death would cross the line in my book to torture. I’d have trouble supporting that even for someone who burned his/her victims to death.

[MatthewSlyfield]

“You’ve definitely been executed in that scenario but you haven’t been electrocuted.”

I disagree with this assessment.

While the outside of the body may start to burn, It’s highly likely that the actual death is not due to the surface burns but rather from the electricity flowing through the deeper tissues of the body effectively cooking the victim to death.

“And given the research that we have about burns and their associated pain, burning someone to death would cross the line in my book to torture.”

And that’s a valid qualitative/moral concern, but it has exactly nothing to do with the “reliability” of the electric chair as a method of execution.

The reliability of any method of doing anything is a matter exclusively of success rate.

How should we define success in the the case of a method of execution? To me, the only measure of success that make sense for methods of execution is dead bodies.

[Malvolio]

If you are “a firm believer in human fallibility”, how can you support any sort of penalty whatsoever? An innocent man sent to jail cannot get that time back, even in the unlikely event he is ever exonerated.

[Echospinner]

No but giving the state the power to execute is a step further.

Libertarians in general are skeptical of the justice system and in favor of prison reform. Eliminating state executions goes along with that.

A historical example. You will find the death penalty in the Bible. The rabbis of the Talmud imposed so many conditions on getting such a conviction that it was virtually impossible. They concluded that “a Sanhedrin (high court) that imposes the death penalty once in seventy years is considered a murderous court”. That pretty much summarizes my attitude about it.

[MatthewSlyfield]

“An innocent man sent to jail cannot get that time back”

This is true, be he can be set free and compensated for the time spent in prison/jail.

Personally, I think one important reform would be to make it mandatory for states to compensate anyone who is released from jail/prison because their conviction was reversed on appeal, for any reason, at some fixed $ / week. and something that would be well above the poverty line.

[Brett Bellmore]

“All this quibbling over degrees of suffering that are below what the average patient experiences in a routine visit to the ER or the dentist seems wrong.”

Got to agree with that. I’ve been through stuff in the ER that would make your hair turn white, and *I* never murdered anybody.

And I didn’t even scream. Much.

Man up, dude, you were hard enough to do the crime, don’t whine about dying being uncomfortable. It usually is, even for the nicest people.

[lafe.long]

Why not just use heroin?

[Sansos]

I am puzzled to this day as to why states don’t use nitrogen asphyxiation its fast painless reliable and dirt cheap.

[MatthewSlyfield]

“its fast painless reliable and dirt cheap.”

All attributes government don’t care about.

I’m waiting for a death penalty state to try a vacuum chamber.

[Brett Bellmore]

Every time they so much as change the color of the chair the guy sits in while being executed they have to work their way back through the courts all over again.

[ThomasD]

The main problem with most forms of gas asphyxiation is that they do take some time, and you will see the person gasping for breath, and possibly changing color.

It’s just not visibly pleasant for everyone involved.

Better to use a paralytic agent – e.g. succinylcholine. A 2 mg/kg bolus does followed by a 15 minute constant infusion. The person will go limp at the first dose, and 15 minutes of anoxia guarantees brain death. If you want to be kind you can knock them unconscious with Versed or Propofol first.