The Arizona Republic reports, "E-mails detail FDA’s efforts to avoid responsibility regarding execution drug. It's written by Michael Kiefer with additional reporting by JJ Hensley and Yvonne Wingett Sanchez.
In late September 2010, the Arizona Department of Corrections obtained the drug sodium thiopental from a small pharmaceutical supply house in London to carry out an execution by lethal injection in October.
The supply house was not registered with the U.S. Food and Drug Administration to export the drug, nor was the drug approved by FDA, but FDA officials in Phoenix nonetheless allowed the drug into the country.
Though the Corrections Department fought hard in court to keep the source of the drug secret, days before the October execution was carried out, The Arizona Republic learned that it had been imported from England.
From documents obtained this week from the FDA under the Freedom of Information Act, The Republic has learned that the revelation touched off inquiries into how the drug made it to Arizona and other states that had already been importing it from England and elsewhere.
Then, the FDA, the U.S. Drug Enforcement Administration and the U.S. Customs and Border Patrol all consulted with the White House to address questions about the legality of the imports and to justify bending the rules to get it to prisons for executions.
The documents released by the FDA offer an insider’s view of an agency struggling to keep itself from being dragged into the national legal debate over drugs used in state executions. Some of the released documents were supposed to be redacted to conceal certain details, but encryption failed.
Those e-mails show, among other things, that the FDA, with the approval of unnamed persons at the White House, shifted responsibility for allowing the drug’s import to Customs. That was done to avoid legal liability and to shield the FDA from any appearance of involvement with the death penalty.
One high-placed FDA official wrote on Nov. 2 that even if the agency issued a statement that it had not reviewed the drugs for “safety, efficacy or quality . . . it will insert FDA into the death-penalty cases because attorneys will try to use the statement as a means to open proceedings on the safety of the imported drugs.”
By the end of 2010, the FDA officially stated it would “continue to defer to law enforcement on all matters involving lethal injection,” and the e-mails show that it had deferred approval of the drug imports to Customs.
When asked for comment, Shelly Burgess, an FDA spokeswoman, said in an e-mail response, “This involves a matter in litigation and the agency does not comment on matters of litigation.”
Dale Baich of the Federal Public Defender’s Office in Phoenix, one of the plaintiffs in a lawsuit seeking to force the FDA to police the drug imports, also received the FDA documents whose redactions were visible. He said he declined to review them because of attorney ethical considerations.
“It is hard for me to say because I have not seen the documents,” Baich said. “But it appears that the FDA was concerned, as were we, about how Arizona obtained the drugs. We have alleged the drugs were illegally imported and the FDA fell short in its duty under the law. This information seems to support our claims.”
The American Civil Liberties Union of Northern California is also suing the FDA for information about thiopental imports, and this week’s FOIA release was partly spurred by the ACLU’s requests.
The FDA meanwhile, asked the federal public defender, the ACLU and The Republic to return the unredacted materials. The Republic declined.
And:
In late June, DEA officials told the Arizona Department of Corrections not to use thiopental in its execution of inmate Donald Beaty. A different drug was used instead and has been used since. It had almost been foretold in a March 16 memo from an FDA attorney.
“I am trying to test a hunch and that hunch is that between bad publicity, lawsuits, and product seizures, there will be less of a desire to bring this product in,” he wrote.
The most recent lethal injection coverage from Arizona begins at the link. A direct jump to earlier coverage of Arizona's foreign sourced sodium thiopental is also available. Related posts are in the lethal injection index.
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