LITTLE ROCK — The Arkansas Department of Correction on Thursday withheld information about its purchase of a British supplier’s lethal injection drug, saying the information is exempt under the state’s Methods of Execution Act.
The Arkansas Democrat-Gazette requested information about the purchase on Wednesday, a day after reporting allegations in a lawsuit by death-row inmates that the department bought the drug from a “ramshackle” business run from the back of a British driving school.
Attorneys for the inmates contend the department cannot guarantee the drug works because it has not been approved by the federal Food and Drug Administration.
In denying the newspaper’s Freedom of Information Act request, Assistant Director Dina Tyler cited the Methods of Execution Act, passed in 2009, which exempts from public disclosure “any and all matters related to the policies and procedures for the sentence of death.”
The law also says that the“choice of chemical or chemicals that may be injected, including the quantity, method, and order of the administration of the chemical or chemicals,” are subject to public disclosure.
But Tyler said this section dealing with public disclosure doesn’t apply to information about where the department buys the drugs.
Releasing the information “could subject the retailer, the wholesaler or the manufacturer to protest,” Tyler said. “We’re trying to avoid that.”
She added that the department has enough of the drug on hand for several executions.
“We do feel very comfortable with our supply and who manufactured it,” Tyler said.
A shortage of sodium thiopental, a powerful barbiturate used to render inmates unconscious before the killing drugs are administered, has sent states across the country scrambling to acquire doses and has caused executions in some states to be delayed.
Last month, the sole U.S. manufacturer, Hospira Inc. of Lake Forest, Ill., announced that it would no longer produce the drug, which no other company has been approved by the FDA to manufacture.
Even before the announcement, however, Arkansas and other states had turned to overseas manufacturers that have not been approved by the FDA.
In the 11-page filing in Pulaski County Circuit Court last week, attorneys for the inmates say they learned last month that Arkansas bought the drug in September from Dream Pharma, a West London company. Dream Pharma reports that it obtained its supply from another British company, Archimedes Pharma Ltd., which obtained it from manufacturer Sandoz International of Vienna, the filing says.
The attorneys describe Dream Pharma as a “ramshackle, one-man operation run from the back of a driving school, Elgone Driving Academy.” A phone message and e-mail to Dream Pharma weren’t returned Thursday.
Because the FDA hasn’t approved the sodium thiopental, the attorneys argue, it could be ineffective. They contend that that raises the possibility that an inmate would feel pain when the other drugs are administered.
On Thursday, Arkansas had not yet responded to last week’s filing, which came in a lawsuit challenging the Methods of Execution Act. Tyler said the Correction Department is confident that its sodium thiopental is effective. Arkansas’ executions have been put on hold while the lawsuit is pending before Circuit Judge Tim Fox.
Arizona used sodium thiopental that it purchased from Dream Pharma when it executed inmate Jeffrey Landrigan in October, said Barrett Marson, a spokesman for the Arizona Department of Corrections.
“There were no problems whatsoever” with the drug’s effectiveness, Marson said.
The FDA has said it is “exercising enforcement discretion” in allowing states to import sodium thiopental that has not been approved for medical uses. It says it has a long-standing policy of “deferring to law enforcement on matters involving pharmaceuticals for lethal injection.”
A lawsuit filed against the FDA on Wednesday by attorneys for death-row inmates in Arizona, California and Tennessee says Arkansas, Arizona, California and Tennessee all bought sodium thiopental from Dream Pharma last year before British authorities banned such exports in November.
According to FDA documents, a shipment of the drug from Dream Pharma to Arkansas was stopped in Memphis in September after the FDA determined it was “a new drug without an approved drug application.”
Later the same month, the shipment was released to be used by the Correction Department in executions, with the FDA saying it was not giving its assurance that the drug “complies with all provisions of the Food, Drug, and Cosmetic Act, or related Acts, and does not preclude action should the product later be found to be violative.”
The documents say the shipment contained one or more boxes of 25 500-milligram vials, or 12.5 grams of the drug per box. The number of boxes included in the shipments and the price has been redacted from the documents, which were released to death-penalty opponents under a federal Freedom of Information Act request.
Arkansas’ lethal-injection protocol calls for 3 grams of the drug to be administered, with another 3 grams available as a “backup” in case theinitial dose isn’t enough, Tyler said.
In a Sept. 28 e-mail to prison officials in California, an Arizona official said his agency “followed the lead of Arkansas” in buying the drug from a London company. Marson, the Arizona Department of Corrections spokesman, confirmed that officials with his agency learned about Dream Pharma from their counterparts in Arkansas.
Arkansas later provided sodium thiopental to Oklahoma that was used in the Oct. 14 execution of Donald Ray Wackerly, who was convicted in the shooting death of a Fort Smith man in 1996.
Jerry Massie, a spokesman for the Oklahoma Department of Corrections, said he didn’t know if the drug came from Dream Pharma, adding that there were no problems with the execution.
Arkansas Correction Department e-mails indicate that Arkansas also provided doses of the drug to Tennessee in September. Dorinda Carter, a spokesman for the Tennessee Department of Correction, declined to comment on where her state got the drug.
“We think it’s such a sensitive issue to begin with, and if some of those details could remain confidential, it would be beneficial for everyone,” Carter said.
In the federal lawsuit filed Wednesday, attorneys for the Arizona, California and Tennessee death-row inmates contend the FDA’s practice of allowing the drug into the country is an “abuse of discretion.”
The attorneys want a federal judge in Washington, D.C., to prohibit the FDA from allowing any further shipments into the country and to order the agency to “immediately take steps to recover and remove from interstate commerce all shipments of foreign thiopental that have been released by the FDA into interstate commerce during the preceding twelve months.”
While British authorities have banned such exports, states have turned to other countries, said Megan Mc-Cracken, an attorney and consultant to the Death Penalty Clinic at the University of California, Berkeley, School of Law. Prison officials in Nebraska last month said they bought 500 grams of the drug from a company in India for $2,000.
“When you’re talking about an unapproved drug, the presumption is it is an unknown entity that is not safe and effective,” McCracken said.
Arkansas, Pages 11 on 02/04/2011