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.
[PHOTO SOURCE: https://www.smh.com.au/opinion/victorias-proposed-euthanasia-laws-are-flawed-20160620-gpn9p2.html]
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.
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
INTERNET SOURCE:
https://theweek.com/speedreads/841509/justice-department-wants-stop-fda-from-regulating-deathpenalty-drugs
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
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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