FDA

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

 

SOUTH DAKOTA – Death penalty delay looms

april, 17, source : http://www.argusleader.com

A federal judge’s ruling in March that the Food and Drug Administration allowed unapproved tranquilizing drugs into the country might delay an execution in South Dakota. But it is not likely to ultimately imperil the death penalty here or in 33 other states.

South Dakota Attorney General Marty Jackley acknowledged the planned September execution of Rodney Berget might be postponed as the state and federal government work their way through the ramifications of U.S. District Court Judge Richard Leon’s ruling regarding the drug sodium thiopental.

Berget was sentenced to death after he and two other inmates were convicted of killing prison guard Ron Johnson during an escape attempt last year at the South Dakota State Penitentiary.

South Dakota is among the states that administer thiopental as a tranquilizer in a series of lethal drugs that also paralyze the lungs and stop the heart. However, U.S. drug companies stopped making thiopental several years ago, leaving an Italian company as the only source for the drug.

The Italian government this year barred the thiopental made there from being used in executions, so American states that use the drug are forced to rely on their existing stockpiles. Now, though, the FDA, is being forced to go after those state stockpiles.

In a federal lawsuit brought by death penalty opponents, Leon ruled the FDA disregarded its responsibility to ensure the safety of imported drugs when it allowed Italian thiopental to be brought into this country.

In response to that, the FDA sent South Dakota a letter April 6 telling it “to make arrangements for the return to the FDA of any foreign-manufactured thiopental in its possession.”

Jackley has refused. He sent a letter back the following day saying the state’s thiopental already has cleared customs and been independently tested to ensure it was pure and adequately potent. He invited the FDA to work with the state on further testing if it has concerns about the thiopental in South Dakota’s hands.

But Jackley is walking a careful middle ground. While acknowledging the FDA’s authority to oversee drugs, he is not ceding the state’s right to have a death penalty.

“The state’s position is we have a duty to carry out a judge’s sentence and to serve justice on behalf of a victim’s family. We would hope the federal agencies appreciate that position and work with us to ensure that carrying out the courts’ sentences is done in a constitutional manner,” Jackley said.

While Berget’s scheduled execution probably could be postponed while the drug issue plays out, the May 13 planned execution of Eric Robert, Berget’s accomplice, already has been pushed back by a state Supreme Court review of his mandatory appeal.

Other inmates on the state’s death row, Donald Moeller, convicted in 1992 of rape and murder, and Charles Rhines, also convicted of murder in 1992, have appeals ongoing and no execution dates have been set for them, according to Jackley.

In the short term, states probably can get around the thiopental issue by resorting to other drugs.

“Twelve states that I am aware of have switched to pentobarbital,” said Richard Dieter, executive director of the Death Penalty Information Center in Washington, D.C.

Jackley notes South Dakota’s death penalty statute is written to give the state wide latitude in the drugs it uses to carry out executions. But Dieter and Joan Fisher, a federal defense lawyer in Sacramento, Calif., who founded a pioneering death penalty defense unit in Idaho, suggest the same problem with access in the case of thiopental ultimately could arise with pentobar bital.

Like thiopental, it now is manufactured only overseas.

“This does underscore the fact the U.S. is dependent on overseas for certain drugs. That’s a larger problem,” Dieter said.

“Things are changing so quickly on us it’s hard to keep up with state corrections departments,” Fisher said of the ability of states to use new execution drugs and thereby evade defense attorney arguments that the drugs are not being appropriately regulated by the FDA.

However, while she admits the current furor over thiopental is merely “a speed bump” in blocking executions, she differs with Jackley on the larger issue. Death penalty foes and defense lawyers might find challenges over execution drugs a fertile field for lawsuits, said Fisher.

“I suspect there is the potential for more litigation than the attorney general would like,” she said.

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