Sodium thiopental

Ohio Planned to Import Death Penalty Drug Illegally


August 19, 2015

A letter from the FDA warned the state that importing the drug would break the law.

The state of Ohio planned to illegally import sodium thiopental, a drug used for executions, according to a Food and Drug Administration letter obtained byBuzzFeed through a Freedom of Information Act request.

The June letter says that Ohio planned to “obtain bulk and finished dosage forms of sodium thiopental.” Since the drug is not available in the US, wrote Domenic Veneziano, director of the FDA’s import operation, “we assume this product would be purchased from an oversees source.”

Veneziano reminded Ohio Director of Rehabilitation and Correction Gary C. Mohr that“there is no FDA approved application for sodium thiopental, and it is illegal to import an unapproved new drug into the United States.”

According to BuzzFeed:

The prison Ohio carries out executions in registered for a DEA license to import the drug last year for a “law enforcement purpose,” but until now it was unknown if the state actually intended to use the license.

Ohio, like many other death penalty states, shrouds its execution drug suppliers in secrecy. States argue the secrecy protects their suppliers from intimidation and embarrassment, while death row inmates and open government advocates argue it removes an important check on state power.

When Nebraska received a similar letter from the FDA last year, it came out that the state paid an Indian dealer named Chris Harris more than $50,000 for enough sodium thiopental to execute hundreds of prisoners. (Nebraska has since abolished the death penalty completely.)

BuzzFeed followed up with Ohio corrections department to find out if Harris was the planned supplier for Ohio as well.

When approached by BuzzFeed News about Harris in June, Ohio DRC spokesperson JoEllen Smith said the department’s legal division would have to handle the matter. After spending weeks on the request, she only would say that Ohio had not communicated with Harris’s company, Harris Pharma, but did not specifically answer the question of if the state had purchased from him directly or indirectly. Smith did not respond to follow up questions.

Ohio’s last execution took place in January 2014, when the state gave inmateDennis McGuire 10 milligrams of midazolam, a controversial sedative whose use for lethal injections the Supreme Court recently upheld. Ohio plans a new series of executions beginning in 2016.

Many reputable drug manufacturers don’t want to be associated with the death penalty, much less the botched executions that have prevailed of late. The FDA-approved manufacturer of sodium thiopental stopped making the drug in 2011 so that it couldn’t be used for this purpose. When Missouri announced plans to use propofol, the drug found in Michael Jackson’s body at the time of his death, for executions, its German manufacturer expressed displeasure and threatened to get the European Union to stop exporting it the US completely. Many states are now struggling to find the drugs they need for executions.

This fact is compounded in Ohio, whose governor, Republican presidential candidate John Kasich, signed a “secret executions” bill this winter that exempts anyone participating in a lethal injection from public records requests. Under the law, medical and nonmedical staff, companies transporting or preparing supplies or equipment used in executions, and providers of the drugs used in lethal injections are all protected from public records requests and do not need to reveal their identity or duties.

FDA can’t allow execution drug to be imported


07/23/2013

WASHINGTON—A federal appeals court ruled Tuesday that the Food and Drug Administration was wrong to allow a misbranded and unapproved new drug to be imported for use in executions by lethal injection.

The three-judge panel affirmed a lower court ruling barring the FDA from allowing the importation of sodium thiopental —rejecting the agency’s argument that it had discretion to allow unapproved drugs into the U.S.

The FDA policy “was not in accordance with law,” wrote Judge Douglas Ginsburg of the U.S. Court of Appeals for the District of Columbia Circuit, joined by Judges David Sentelle and Judith W. Rogers. Ginsburg and Sentelle were appointed by President Ronald Reagan; Rogers was appointed by President Bill Clinton.

Sodium thiopental is an anesthetic used to put inmates to sleep before other lethal drugs are administered. The case was brought by death row inmates in Tennessee, Arizona and California.

Among other arguments, the FDA said it needed discretion to import drugs approved overseas but not in this country in order to combat domestic shortages of medically necessary drugs.

“By its own account, however, the FDA has ways short of allowing importation of inadmissible drugs to counteract a drug shortage,” the panel wrote, such as asking other firms to increase production and expediting review of regulatory submissions.

The panel reversed another part of the lower court’s order and allowed state correctional departments to keep stocks of the drug they currently have.

The FDA said it was reviewing the decision.

http://www.mercurynews.com

 

US – States urge feds to help import lethal injection drugs


May 21, 2012 Source : http://edition.cnn.com

A nationwide shortage of a commonly used imported drug used in capital punishment has prompted 15 states on Monday to urge the U.S. Justice Department to intervene. Led by Oklahoma officials, the move comes as the 33 states with the death penalty — all of whom use lethal injection as the primary execution method — struggle to preserve existing stock or search for legally acceptable chemical alternatives. A federal judge in March had blocked the importation of thiopental into states like Arizona, South Carolina, and Georgia saying it was a “misbranded drug and an unapproved drug.” Judge Richard Leon in Washington ordered state corrections departments to return suspected foreign-made thiopental to the Food and Drug Administration. The states called that a “flawed decision” and now want the FDA to appeal that judge’s decision, saying upcoming executions are being undermined. Attorneys General Scott Pruitt in Oklahoma and Marty Jackley in South Dakota are leading the legal effort. “At the very core of the states’ police powers are their powers to enact laws to protect their citizens against violent crimes. As state attorneys general, we are tasked with enforcing those laws, including in instances where capital punishment is authorized for the most heinous of crimes,” according to attorneys general from the 15 states. States argued the federal agency had routinely released the imported drug for executions, a practice suspended after the judge’s ruling. “If the (court) decision is not overturned, we as state attorneys general will be forced to take actions to ensure execution by lethal injection remains a viable option.” This comes after Texas officials disclosed Monday they only have enough drugs on hand for 23 more executions. The next scheduled execution in the U.S. is Bobby Hines in Texas on June 6. Missouri earlier this month announced new protocols, and will use an entirely new drug. Propofol is a surgical anesthetic that in large doses can be administered fatally, but has never been used in the U.S. to put prisoners to death. Officials in Ohio, Texas and other states last year cited a nationwide shortage of sodium thiopental in their decisions to separately use pentobarbital, a barbiturate that has alternately been used to put animals to sleep. Some states use a single execution drug, others rely on a three-drug mixture or cocktail. Pentobarbital has become the new legal flashpoint over capital punishment. It was used in a U.S. execution for the first time in December 2010, when it was administered as the first ingredient in a three-drug cocktail used in a lethal injection given to an Oklahoma inmate. It also has limited Food and Drug Administration approval in smaller doses for humans as a mild anesthetic and to treat some seizures. Many physicians say they no longer administer it to people for medical purposes. The second drug in the three-drug cocktail — pancuronium bromide — paralyzes all muscle movement.The third drug, potassium chloride, induces cardiac arrest and death. In 2009, Ohio became the first state to perform an execution with a single drug, using a higher concentration of sodium thiopental. There were no reported complications and its use encouraged other states to follow suit. The nation’s only manufacturer of sodium thiopental since announced it was stopping production. Many capital punishment opponents claim sodium thiopental, which renders the prisoner unconscious, can wear off too quickly, and that some prisoners would actually be awake and able to feel pain as the procedure continued. The European manufacturers of both pentobarbital and sodium thiopental have opposed using their products for executions in the United States. Pentobarbital is widely available and has been used for physician-assisted suicide, including in Oregon, where the practice is legal in limited circumstances. Nationwide, death penalty use continues to decline. Connecticut recently became the latest state to ban capital punishment, although the 11 people on death row will remain there. Only 43 people were executed in the U.S. in 2011, down three from the previous year, and a 56% decline from 13 years ago, when nearly 100 people were put to death. Eighteen have been executed so far in 2012.

TEXAS – Texas prison system has drugs for 23 executions


May 19, 2012  source : AP

After prodding from Texas AG, prison system says it has enough drugs to execute 23 inmates
Texas prison officials disclosed Friday they have enough lethal drugs to execute as many as 23 people.
In response to this week’s opinion from the state attorney general’s office that said the Texas Department of Criminal Justice could not withhold information about the drug supply, the department said it currently has 46 2.5-gram vials of pentobarbital. A 5-gram dose — about 3.4 ounces — is the 1st lethal drug used during each execution in Huntsville, according to Texas execution procedures.
The prison agency said it had similar supplies of 2 other drugs also administered to condemned inmates. It did not, though, identify suppliers of the lethal drugs, which the opinion also had addressed.
Executions also involve 100 milligrams of pancuronium bromide and 140 milliequivalents of potassium chloride. Texas has 290 10-milligram vials of the pancuronium bromide — 10 are required per execution — and 737 20-milliequivalent vials of potassium chloride — 7 per punishment.
The department’s written procedures call for a matching set of drugs and syringes “in case unforeseen events make their use necessary.” But in a brief statement emailed to reporters late Friday, the agency said a backup set of lethal drugs for executions “is not actually prepared, but an additional dose is available if needed.”
The attorney general’s opinion, dated Monday, was an answer to public information requests filed earlier this year by the Austin American-Statesman and British newspaper The Guardian.
Prison officials had argued that releasing the information could be harmful to employees and provide death penalty opponents a way to harass the drug suppliers with the hope firms would refuse to do business with the state.
“We find your arguments as to how disclosure of the requested drug quantities would result in the disruption of the execution process or otherwise interfere with law enforcement to be too speculative,” Sean Opperman, an assistant attorney general, wrote in the opinion.
The prison agency had 30 days to comply with the opinion or to challenge it in court. The status of the supplier question was not immediately clear.
Opperman said that, while the attorney general’s office “acknowledge(s) the department’s concerns,” the corrections department didn’t show how disclosure of the information “would create a substantial threat of physical harm to any individual.”
Department officials previously had indicated they had a sufficient supply to handle upcoming executions. At least five are scheduled for this summer, including one early next month.
Last year, one of the drugs Texas had used in the process, sodium thiopental, became unavailable when its European supplier bowed to pressure from death penalty opponents and stopped making it. No other vendor could be found, so the drug was replaced by pentobarbital.
The physical effects of pentobarbital on condemned inmates have not been noticeable during the executions, but the financial cost to the state has risen considerably. Prison officials put the cost of the previous mixture at $83.35. It’s now $1286.86, with the higher cost primarily due to pentobarbital.

DELAWARE – How Delaware got rare execution drug


april 22 Sourcehttp://www.delawareonline.com

DOVER — Just days before a manufacturer cracked down on the use of a key execution drug last year, Delaware was able to get a shipment of the sedative from one of the drugmaker’s suppliers through a complicated and secretive procurement process.

Documents obtained by the Associated Press show that the process involved a state official with close ties to the pharmaceutical industry and was kept secret from all but a few Department of Correction officials as it unfolded. Even the attorney general was kept out of the loop for much of the process.

The documents offer a behind-the-scenes look at how Delaware officials navigated a procurement process that can be fraught with political and legal consequences. States have been scrambling during the past two years to revamp their execution procedures and find the sedatives needed to carry them out as manufacturers have sought to keep two key drugs out of execution chambers.

When the DOC needed to replenish its supply of lethal injection drugs last spring, it turned to a man who spent years cultivating contacts in the pharmaceutical industry: Delaware Economic Development Director Alan Levin. Like many other states, Delaware early last year began considering using pentobarbital after supplies of another execution mainstay, sodium thiopental, dwindled and its production was halted in the U.S.

At the time, however, there also was consternation over the use of pentobarbital. The Danish manufacturer of that drug had sought to curb its use in executions by sending letters to government authorities.

Before Levin’s involvement, DOC Commissioner Carl Danberg and his staff had tried other ways of getting execution drugs, including sodium thiopental or pentobarbital, without success. But with a single email, Levin, former head of the Happy Harry’s drugstore chain, was able to get the ball rolling, allowing the DOC to get the drugs it needed in time for an execution last July.

“Once Alan provided me with a contact, things fell into place,” Danberg said.

The department’s previous supplies of lethal injection drugs expired after the 2005 execution of Brian Steckel. The batch of drugs delivered last June was enough for several lethal injections, including that of convicted killer Shannon Johnson, who was executed Friday. The warden of the state prison in Smyrna that houses Delaware’s death row purchased a wine refrigerator to keep some of the drugs at the proper temperature.

Records obtained by the AP after it successfully appealed the DOC’s denial of a Freedom of Information Act request show that Danberg asked Levin last May for help in finding execution drugs.

Levin immediately sent an email to Mike Kaufmann, CEO of the pharmaceutical segment for Cardinal Health Inc., one of the largest wholesale distributors of prescription drugs in the United States. Cardinal also was a supplier for the manufacturer of pentobarbital, Denmark-based Lundbeck Inc., and would later become subject to Lundbeck’s restrictions on distributors providing pentobarbital for use in executions.

“While I know this is a bit of a political issue, since Cardinal is not located in Delaware I believed it may be easier for Cardinal to do this,” Levin wrote to Kaufmann.

“Is this something that Cardinal would be interested in selling to the state of Delaware? If not, do you have any recommendations who else we can pursue? While our need is not immediate, we do believe that we may need the drugs within the next 90 days.”

Three days later,Danberg received an email from Cardinal’s vice president of government accounts. During the next several weeks, Cardinal representatives worked with DOC employees to procure and ship quantities of pentobarbital, pancuronium bromide and potassium chloride.

“I was happy to help facilitate it,” said Levin, explaining that Happy Harry’s, which he sold in 2006 to Walgreen Co., had done business with Cardinal for a decade or more.

“I understand the judicial system,” added Levin, a former prosecutor who noted that he believes in the death penalty.

A Cardinal spokeswoman said the company would not comment on Delaware’s procurement process and that it does not comment on specific interactions with customers.

But the emails show that DOC officials were aware of the sensitive nature of their purchase and they took pains to keep the process quiet.

“This is NOT for discussion or distribution to anyone, including your own staff until we get a chance to discuss,” Danberg wrote in a May 25 email to key lieutenants.

“Emphasize that I do not want this discussed yet. Certainly not until the drugs are on hand. I am not even telling the AG yet,” Danberg wrote.

Asked about the secrecy, Danberg noted that supplies of sodium thiopental — once a key execution drug for many states — dried up because of what he believes was public pressure on the supplier. Many states switched to pentobarbital after the sole U.S. manufacturer of sodium thiopental said last year that it would not resume production.

“I did not want it getting outside the smallest number of people as possible how we were pursuing the chemicals because I wanted to make sure we had a supply of the chemicals first,” Danberg said. ” … I did not want the supplier of the chemicals to go public, to be publicly known, simply because I did not want that source to dry up.”

Danberg’s caution was understandable, given that Lundbeck had stated in January 2011 that pentobarbital was not intended for use in lethal injections. It also sent letters to corrections officials in the U.S. urging them to stop the practice.

US – Lethal Injection As the Death Penalty’s Last Stand


april 16,2012 source :http://www.huffingtonpost.com David A. Love *Witness to innocence*

Are we witnessing the beginning of the end of the death penalty in America? All of it might come down to a basic issue of supply.

So, what do you do if you are a hangman who runs out of rope? To put it in more conventional terms, suppose you are a state that executes people by lethal injection, but you’re running out of the lethal chemicals used to put people down like animals.

Perhaps you’d do what some states have done and buy your chemicals on the black market, so to speak.

In March, Judge Richard J. Leon, a federal judge in Washington, D.C., issued an order andopinion banning the importation of sodium thiopental, an anesthetic and the first of a three-chemical cocktail administered to a condemned inmate. Once the inmate is unconscious, he or she is injected with pancuronium bromide, which paralyzes the person, and potassium chloride, which causes death through cardiac arrest.

According to the judge, it was disappointing that the Food and Drug Administration (FDA) broke the law by allowing shipments of the drug from foreign countries, unapproved for the purpose of executions. Without FDA approval, according to the judge, the sodium thiopental would fail to put the inmate to sleep, causing “conscious suffocation, pain, and cardiac arrest.”

Judge Leon ordered the FDA to notify state corrections departments that they must surrender the drug to the FDA.

The drug is only available overseas, as the only U.S. manufacturer recently ceased production last year amid controversy over its use. Moreover, the European Union recently announcedrestrictions on export of the drug. But with sodium thiopental unavailable, the most logical replacement is pentobarbital. This replacement drug, which is a more expensive alternative, has been used by 12 states to put 47 people to death since 2010, according to the Death Penalty information Center, and is widely used to put down animals. In addition, the chemical is used to treat insomnia and as a seizure treatment for epilepsy.

Manufacturers of pentobarbital, including Danish manufacturer Lundbeck, Inc., have made it known to various states that they do not want the drug used for executions. States such as Arizona, Georgia and Texas apparently have stockpiled pentobarbital and say they have enough supply for this year’s executions.

Texas apparently bought $50,000 worth last year and wants to block information on its stockpile, and the state has accused the anti-death penalty group Reprieve of “‘intimidation and commercial harassment’ of manufacturers of medical drugs used in lethal injections.” Arizonahas had its lethal injection protocols challenged, as inmates have sued the state for giving the state’s corrections director too much discretion. Meanwhile, Ohio just resumed executions after a federally-imposed six-month moratorium because prison officials were not following proper procedures. And Alabama stayed an execution in March after the condemned inmate argued that Pentobarbital does not completely sedate and amounts to cruel and unusual punishment under the Eighth Amendment.

With both domestic and international public pressure on the purveyors of death, it seems they’re feeling the heat, as well they should. Willing executioners are in short supply, and former executioners have seen enough to know they want no part of it. Further, they have likely killed innocent people. Many doctors are unwilling to break their Hippocratic oath to do no harm, or are forbidden to do so.

Used to extinguish 1,100 lives in 35 states — some of them most certainly innocent — lethal injection is the prominent form of capital punishment in the U.S. Marketed as the clean, humane form of capital punishment, lethal injection was billed as the friendly, painless type of execution. But we should ask, how harmless can you really make a lynching?

If lethal injection falls out of favor, either through a dwindling supply of the poisonous cocktail of death, lack of public support or a court ruling, what do the states do after that? Do they return to the hangman’s noose? That seems unlikely, reminds us too much of the strange fruit hanging from the trees that Billie Holiday used to sing about.

What about the electric chair, which has been known to cook people alive? Or the gas chamber, like the Nazis used to do?

Then there’s the firing squad. Better yet, how about stoning, or drawing and quartering, which is really old school?

Here’s a better idea. Just get rid of the death penalty for good. America is the only Western nation that executed people last year. And the U.S. is in the top five of nations that execute, putting us in league with China, Iran, North Korea and Yemen. We’ll never get it right with the death penalty because executions are so wrong.

No matter how the state kills a person, you can’t wipe the blood from your hands.

David A. Love is the Executive Director of Witness to Innocence, a national nonprofit organization that empowers exonerated death row prisoners and their family members to become effective leaders in the movement to abolish the death penalty.

Texas – TDCJ wants to block release of lethal injection drug info


april 3, 2012 source : http://www.chron.com

The Texas Department of Criminal Justice is refusing to disclose the size of its stock of a key pharmaceutical used in executions, saying doing so would endanger its drug makers and suppliers.

The charge comes in a brief filed with the Texas Attorney General’s Office in response to a December query by an British newspaper concerning the contents of state’s death house medicine chest. The agency said releasing such information would provide ammunition for Reprieve, a British anti-death penalty group that successfully has pressured drug makers to stop selling to executioners.

Likening Reprieve’s campaigns to those of violent prison gangs, the brief written by TDCJ Assistant General Counsel Patricia Fleming asserts that releasing information “creates a substantial risk of physical harm to our supplier. … It is not a question of if, but when, Reprieve’s unrestrained harassment will escalate into violence…”

TDCJ is seeking authorization not to answer questions posed in a December public information request by Ed Pilkington, the New York correspondent for The Guardian, a national British newspaper. An attorney general’s response is expected this month.

Pilkington sought to determine how much pentobarbital, one of three drugs used in executions, the death house had in stock. He also asked how the agency met requirements that a second “back up” dose of lethal drugs be available at executions.

“I was very surprised by the language they chose to use, which was pretty inflammatory, really,” Pilkington said. “Obviously, there is an international disagreement over the death penalty. … Usually that discourse is conducted in a civilized manner.”

He called the claim that the prison system’s drug suppliers were in jeopardy, “pretty far-fetched.”

‘Public interest’

Joseph Larsen, a lawyer for the Freedom of Information Foundation of Texas, said Pilkington’s questions go to the “heart of how effectively TDCJ performs its official functions.”

“The whole idea behind the Texas Public Information Act is that the governmental bodies do not get to control the information that underlies political discussion,” he said. “Specifically, the governmental body does not even get to ask why a requestor wants certain information. How then can a governmental body base its argument for withholding on what use it anticipates will be made of the information if released?”

In a 2008 case, the Attorney General’s Office sided with TDCJ in denying Forbes magazine the names of companies that supplied execution drugs, noting that “releasing the names of the companies would place the employees of those companies in imminent threat of physical danger.”

Drug’s maker pressed

An appeals court rejected that ruling the following year.

Pentobarbital was added to the state’s lethal cocktail in May 2011, replacing sodium thiopental after that drug’s maker stopped production, in part because of Reprieve’s anti-drug agitation.

Reprieve followed by directing international pressure on Lundbeck, pentobarbital’s Danish maker, obtaining a July 2011 agreement that the company no longer would sell to prisons in death penalty states. The production plant later was sold, but the new owner abided by the agreement.

Reprieve also targeted a pharmaceutical company that had supplied sodium thiopental to Arizona. On its website, Reprieve posted photos of the supplier’s office along with its tax returns and the name, phone number and address of its owner.

Death Row Inmates Win Order Banning Unapproved Anesthesia


source : http://www.sfgate.com

March 27 (Bloomberg) — Twenty-one death row inmates won an order barring use of sodium thiopental, an imported drug given as anesthesia prior to administration of lethal injections.

U.S. District Judge Richard Leon in Washington today ruled that the federal Food and Drug Administration violated its own rules by allowing entry of the drug into the country without first ensuring its efficacy.

“Prisoners on death row have an unnecessary risk that they will not be anesthetized properly prior to execution,” Leon wrote in a 22-page ruling, adding that the agency had created a “slippery slope” for entry of other unapproved drugs.

In an accompanying two-page order, the judge banned the import of thiopental, calling it a misbranded and unapproved drug, and directed Arizona, California, Georgia, South Carolina and Tennessee and any others with stocks of the barbiturate to send them to the FDA.

Attorneys for the inmates had argued that use of the drug during execution could lead to so-called anesthesia awareness, in which they may experience suffocation, pain and cardiac arrest.

The shipments of thiopental entering the U.S. originated from an Austrian facility owned by Sandoz International GmbH, a German company, according to the complaint. The drug was shipped to the U.S. from a London wholesaler, Dream Pharma Ltd., the inmates said.

Dream Pharma bought the drug from a unit of Archimedes Pharma Ltd., a closely held company based in Reading, U.K., according to the complaint.

Imported Drug

The FDA countered that release of the imported drug within the U.S. was an act of enforcement discretion, and that “reviewing substances imported or used for the purpose of state-authorized lethal injection clearly falls outside of FDA’s public health role,” according to Leon’s ruling.

The judge heard arguments from both sides on Feb. 9.

Leon said there was no dispute that the FDA hadn’t reviewed foreign or domestic thiopental for safety and effectiveness. Because it was unapproved, the federal Food, Drug and Cosmetic Act required the agency to bar its import, he said.

Shelly Burgess, a spokeswoman for the FDA, said she couldn’t immediately comment on the judge’s decision.

The case is Beaty v. Food and Drug Administration, 11-cv- 289, U.S. District Court for the District of Columbia (Washington).

read  momerandum opinion  : click here

read order by Judge Richard J. Leon : click here