Unit 1012 Cover Photo

Unit 1012 Cover Photo

Sunday, May 19, 2019

DOJ Bars FDA From Regulating Death Penalty Drugs


On May 3, 2019, Steven Engel, head of the department's Office of Legal Counsel, posted a common-sense opinion that the FDA has no business approving execution drugs.


"Consistent with the agency's practice in this area for several decades before 2017, we thus conclude that, when an article's intended use is to effectuate capital punishment by a state or the federal government, it is not subject to regulation under the (Federal Food, Drug, and Cosmetic Act)."


            We, the comrades of Unit 1012: The VFFDP, thanks the DOJ for telling the FDA to butt out. FDA do not seem to have a problem with drugs for euthanasia and abortion but have such a big problem with execution of murderers. 


A demonstration earlier this year in Canberra taught people how to test the purity of euthanasia drug Nembutal.
Pentobarbital (INN, AAN, BAN, USAN) or pentobarbitone (former AAN and BAN) is a short-acting barbiturate. Pentobarbital can occur as both a free acid and as salts of elements such as sodium and calcium. The free acid is only slightly soluble in water and ethanol.
One brand name for this drug is Nembutal, coined by John S. Lundy, who started using it in 1930, from the structural formula of the sodium salt—Na (sodium) + ethyl + methyl + butyl + al (common suffix for barbiturates). Nembutal is trademarked and manufactured by the Danish pharmaceutical company Lundbeck (now produced by Akorn pharmaceuticals) and is the only injectable form of pentobarbital approved for sale in the United States.
In high doses, pentobarbital causes death by respiratory arrest. In the United States, the drug has been used for executions of convicted criminals. Lundbeck (one of many manufacturers) does not permit its sale to prisons or corrections departments to carry out the death penalty.


The Justice Department wants to stop the FDA from regulating death-penalty drugs
4:47 a.m.

In an opinion earlier this month, the Justice Department's Office of Legal Counsel decided that the Food and Drug Administration "lacks jurisdiction" over drugs used to kill inmates through lethal injection, The Washington Post reports. The Justice Department is siding with Texas, which sued the FDA in early 2017 over the agency's 2015 seizure of 1,000 vials of the anesthetic sodium thiopental — once commonly used in lethal-injection cocktails — from an unregistered overseas distributor.

The issue has caused tension in the Trump administration. More than a year ago, the Post reports, Attorney General Jeff Sessions and FDA Commissioner Scott Gottlieb — both of whom left the administration last year — had a heated argument in the White House Situation Room, with Sessions demanding that Gottlieb allow execution drugs into the U.S. without any scrutiny and Gottlieb refusing.

The Justice Department's new opinion is pretty sweeping, arguing that "articles intended for use in capital punishment by a state or the federal government cannot be regulated as 'drugs' or 'devices'" by the FDA. But the opinion applies only to the death penalty, the OLC added, not whether the FDA "has jurisdiction over drugs intended for use in physician-assisted suicide."

It isn't clear what affect the OLC decision will have. Imports of sodium thiopental have been blocked under a federal injunction since 2012. Hospira, the sole U.S. maker of sodium thiopental, stopped producing it in 2011, citing its use in capital punishment. The OLC opinion seems aimed at "giving a green light" to states to import execution drugs from China, India, and other countries that don't object to their use in executions, Deborah Denno, a law professor at Fordham University, tells the Post. "It has the potential to open the floodgates."

But the 2012 injunction is still in effect for now, the Post notes, and "it is not clear whether the Justice Department will seek to have that injunction lifted, a move that could spark a long legal tussle." Peter Weber




DOJ Bars FDA From Regulating Death Penalty Drugs
By: s.e. smith
May 19, 2019
About s.e.
Follow s.e. at @sesmith

In a blow to death penalty abolitionists, the Department of Justice just issued an opinion stating that the Food and Drug Administration lacks regulatory authority to oversee materials used in executions.

Somewhat ironically, the agency noted the FDA’s mission involves determining whether items are “safe and effective” — and therefore overseeing equipment and drugs used in capital punishment would fall outside the FDA’s purview. The opinion appears calculated to break the current critical shortage of drugs used in executions, and it will undoubtedly be subject to legal challenge.

While the combination of drugs used in executions varies, one of the core components is sodium thiopental, which has not been manufactured in the United States since 2009. That led states to work through stockpiles of the drug and then to look overseas. But then, in response to a federal injunction, the FDA started blocking the import of sodium thiopental and other anesthetics that could be used to execute incarcerated people. Meanwhile, some countries and companies declined to sell to the U.S., fearing their medications might be used in executions.

The Trump administration has been fighting with the FDA over this, and the DOJ opinion appears to be the next strategic move. The FDA cannot regulate these drugs in an execution context, but the old bans still stand, creating a somewhat awkward standoff. Some states are clearly hoping it ends with being allowed to import these drugs, and here’s where the situation gets very unpleasant.

Without FDA oversight, states could theoretically order from anywhere — with India and China both indicating they’re willing to supply to death penalty states. But the drugs may not necessarily perform as advertised. They could have impurities, contamination or flaws in manufacturing that make them ineffective or cause severe complications, such as excruciating pain or prolonged executions. The agency actually seized imports of these drugs in 2015, setting off a legal battle as states sued to get them back.

The DOJ argues that capital punishment is lawful and states that choose to use it should be able to do so without federal interference. By regulating the drugs, the FDA could close off one avenue of capital punishment — though states have also used gas, firing squads, hanging and electrocution in the past. A shortage of execution drugs has certainly slowed the rate of capital punishment across the country, though of course incarcerated people sentenced to death are still trapped in prisons.

This opinion contradicts that of federal courts — an issue that will almost certainly be flagged in impending lawsuits. Of course, states could get around this issue entirely by banning the death penalty and moving on to other options for accountability, such as the use of restorative justice.
Intriguingly, the DOJ made much of the fact that these drugs are used explicitly to harm people and with an intent to kill. But it also stressed that this opinion was narrow — saying it didn’t speak to whether the FDA could regulate drugs used in physician-assisted suicide.

Physician-assisted suicide is gaining traction in many states, while the anti-abortion movement has taken it up as an adjacent cause, pushing to repeal or oppose laws and ballot initiatives that support it. This opinion from the DOJ would seem to suggest that the FDA is within its scope in this context, even though these drugs are similarly used with the goal of killing the patient.





A Common-Sense Ruling on Death Penalty Drugs
Debra J. Saunders
Debra J. Saunders

Posted: May 19, 2019 12:01 AM

The opinions expressed by columnists are their own and do not represent the views of Townhall.com.

WASHINGTON -- If there's one thing that tells you government in America is too big and unaccountable, it's when one branch of government stops another government from doing what it was set up to do, even if it's not the first agency's job. Case in point: Under President Barack Obama, the Food and Drug Administration stopped multiple states from carrying out executions because the agency had not approved the drugs they intended to use for lethal injection. Really.

President Donald Trump's Department of Justice is changing that.

On May 3, Steven Engel, head of the department's Office of Legal Counsel, posted a common-sense opinion that the FDA has no business approving execution drugs.



"Consistent with the agency's practice in this area for several decades before 2017, we thus conclude that, when an article's intended use is to effectuate capital punishment by a state or the federal government, it is not subject to regulation under the (Federal Food, Drug, and Cosmetic Act)."

Engel's reasoning was simple. The FDA is supposed to determine if drugs or devices are "safe and effective for their intended uses -- a goal that markedly conflicts with the purpose of execution." This is something FDA officials should not have to be told.
How did this insanity get started?

In 2009, the U.S. manufacturers stopped producing sodium thiopental, a drug commonly used in three-drug lethal injection protocols. States that needed the drug began to look for supplies abroad.

In 2011, convicted killers from Arizona, California, and Tennessee sued to prompt the FDA to block the importation of sodium thiopental. In 2012, a federal judge issued a permanent injunction against the importation of the drug on the grounds it was FDA-unapproved and misbranded.

The FDA cited that injunction after it seized thiopental shipped to Arizona and Texas in 2015.

"We have single federal judges all over the country who are just deciding" that they can bend the law to their politics, argued Michael Rushford, president of the pro-death penalty Criminal Justice Legal Foundation in Sacramento, California. If governors and state attorneys general choose not to combat such rulings, "three people can shut down a law."

It didn't matter that the U.S. Supreme Court had upheld the constitutionality of lethal injection under a three-drug protocol by a 7-2 vote in 2008. Death penalty opponents can be highly successful in gaming the system because players in that system want to be gamed.

Nor did it matter that, in 2000, the Supreme Court ruled Congress did not give the FDA authority to regulate tobacco, "because there is no safe or therapeutic purpose to smoking," wrote Justice Sandra Day O'Connor. Likewise, there is no such thing as a safe execution, but if at first, you don't succeed ...

Obama's FDA went along with a bad judicial decision without regard to Supreme Court rulings and states' rights because it could grind down legal policies virtually anonymously.

Obama, by the way, said he was in favor of the death penalty. In his 2006 book, "The Audacity of Hope," Obama explained, "While the evidence tells me the death penalty does little to deter crime, I believe there are some crimes -- mass murder, the rape, and murder of a child -- so heinous, so beyond the pale, that the community is justified in expressing the full measure of its outrage by meting out the ultimate punishment."

Then he let his FDA do the bidding of death row inmates who could not win in court.

In 2015, a legal challenge to a different drug upheld Oklahoma's three-drug protocol by a 5-4 vote. Writing for the majority in the Glossip decision, Justice Samuel Alito argued, "Because it is settled that capital punishment is constitutional," it "necessarily follows that there must be a (constitutional) means of carrying it out."

All four inmates behind the suit had been sentenced to death for heinous crimes. One hired a man to bludgeon his employer to death. One murdered his 9-month-old daughter by snapping her spine in half. One murdered a food service supervisor in prison, and the fourth anally raped and murdered an 11-month-old girl.

Wednesday, President Donald Trump told the 38th Annual National Peace Officers' Memorial Service that he believes in the death penalty and "it's got to be fair, but it's got to go fast." Already, his Department of Justice had told the FDA to stick to its mandate.

"There really is a new sheriff in town," marveled Rushford, "which is wonderful."


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