A Swiss pharmaceutical company has notified the U.S. Food and Drug Administration that it is recalling a supply of the lethal injection drug sodium thiopental held by Nebraska, which could leave the state without a means to carry out executions for the foreseeable future.
"The product is being recalled from the market because it was illegally diverted from the company's supply chain and has been outside the company's control in breach of Naari AG's established standard operating practices," Naari AG says in a document sent to the FDA.
The Journal Star obtained a copy of the document, in which Naari asks that Nebraska officials "immediately quarantine and return to us or FDA any product in your possession. ... The product is being removed from the market with the knowledge of the U.S. Food and Drug Administration."
Sodium thiopental has been in short supply since 2010, when the only U.S. manufacturer, Hospira Inc., ended production because of death-penalty opposition from overseas customers. After that, the European Union banned the export of some barbituric acids, including sodium thiopental, further diminishing the drug's availability for use in lethal injections.
Last year, Nebraska prison officials bought a supply made by Naari from a middleman named Chris Harris, and his company Harris Pharma LLP.
Attorney Jerry Soucie of the Nebraska Commission on Public Advocacy, who represents death-row inmate Michael Ryan, has been arguing that Nebraska should not be allowed to use it because Harris was not authorized to sell the samples meant for use in testing. That, he contends, means Harris misappropriated the thiopental, and Nebraska is in possession of stolen property.
Nebraska prison officials refused a request by Naari to return the drug. Last month, the FDA ordered them to contact the FDA and make arrangements to turn over "any foreign-manufactured thiopental in your possession."
The letter followed a recent ruling by U.S. District Judge Richard Leon that said the FDA ignored the law in allowing foreign-made sodium thiopental into the country.
Similar letters from the FDA went to Arizona, Arkansas, California, Georgia, South Carolina, South Dakota and Tennessee.
Shannon Kingery, spokeswoman for the Attorney General's office, said earlier that the Leon ruling does not apply to Nebraska because the supply of the drug in that case was not made by Naari.
On Tuesday, officials at the Nebraska Department of Correctional Services said they would not respond to the recall.
"All documents examined indicate our department received the sodium thiopental in a legitimate manner," said Robert Houston, director of the department. "NAARI has made their position clear; however, we do not feel a response to this recall notice is necessary or appropriate."
Said Soucie: "It is unfortunate that the Nebraska Attorney General's Office appears to take the position that it can ignore federal statutes and regulations, ignore a clear directive from the FDA and ignore the order of a conservative federal judge from the D.C. court."
"This Nebraska regulatory problem is not just about the rights of death row inmates. These federal statutes and regulations are intended to guarantee the quality of the lethal drugs and protect the employees of the NDCS from the spectacle of conducting a botched execution," Soucie said.
Shelly Burgess, an FDA spokeswoman in Washington, did not immediately respond to a question about what could happen if Nebraska officials do not comply with the recall.
Nebraska is among 10 states that have purchased the drug from foreign sources. The U.S. Drug Enforcement Administration has seized supplies from several because they were imported illegally or because of questions over how they were manufactured.
Nebraska twice has bought sodium thiopental made overseas. The DEA did not seize the first batch -- made by a company in India -- but told the state it could not use it because it was imported illegally. Nebraska then got an import license and bought the supply from Harris.
Judge Leon sided with lawyers for death row inmates in Tennessee, Arizona and California who want to keep out sodium thiopental because it is an unapproved drug manufactured overseas. The Obama administration argued the FDA had discretion to allow unapproved drugs in, but Leon said the FDA's actions were "contrary to law, arbitrary, capricious and an abuse of discretion." He said the law says an article that appears to be misbranded or unapproved "shall be refused admission."
Nebraska's three-drug protocol calls for a dose of sodium thiopental to render the inmate unconscious, followed by pancuronium bromide to paralyze him or her, then potassium chloride to stop the heart.
In his ruling, Leon said the FDA was undermining its own policy of maintaining a closed drug distribution system designed to keep dangerous drugs out of U.S. commerce.
"By opening up the 'closed' drug system by allowing an unapproved drug -- thiopental -- into the United States, defendants jeopardize their own system and threaten the public health by creating a risk that thiopental could incorrectly end up in the hands of the general public," he wrote.
Reach Kevin O'Hanlon at 402-473-2682 or email@example.com.
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