------------------------from the AZ Republic-------------------
E-mails detail FDA's efforts to avoid responsibility regarding execution drug
by Michael Kiefer
Aug. 20, 2011 12:00 AM
The Arizona Republic
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.
By May 2010, sodium thiopental was scarce in the United States, and by late September of that year, as Arizona was preparing to execute its first prisoner in two years, the drug was virtually unavailable domestically because the only U.S. manufacturer had ceased production. Arizona, like other states, scrambled to find it overseas.
The first Arizona thiopental shipment cleared FDA approval on Sept. 28. In a timeline prepared months later, the FDA representative in Phoenix told his superiors that he "assumed entry would be legal."
But then the FDA representative found that Dream Pharma, the British supply house, was not authorized to export it to the U.S. Subsequent e-mails confirmed what Baich and others have said from the beginning: The drug was not approved for use in the United States.
The flurry of intra-agency e-mails of concern began Oct. 27, the day after Arizona executed death-row inmate Jeffrey Landrigan with British thiopental, and two days after The Republic revealed the drug's country of origin. FDA officials began tracking shipments to other states that had been allowed into the country.
By Nov. 5, e-mails were referring to FDA Commissioner Margaret Hamburg's request to investigate how to "extricate FDA from the process." On Nov. 9, the e-mails said the White House wanted the FDA to set up a conference to discuss the matter, even while FDA officials were still trying to figure out how to temporarily defuse the situation with Charles Flanagan, deputy director of the Arizona Department of Corrections. Flanagan was reportedly "very upset" and insisting that FDA personnel return his phone calls about further thiopental shipments that had been detained.
By Nov. 16, the e-mails asked whether the problem could be deferred to the DEA, and then by Nov. 22, the decision seemed made to "defer entirely to Customs." Into mid-December, the White House was asking for a detailed description of the FDA's plan to exercise enforcement discretion and not police thiopental shipments to prisons.
Then the federal government was forced to curtail the imports for another reason. According to one e-mail, the Georgia Department of Corrections asked the DEA to check if that agency had been authorized to import thiopental. It was not, and the DEA was forced to seize its supply of the drug in March. The e-mail goes on to say that the drug might not have been seized had Georgia not asked the question in the first place.
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.
Republic reporters JJ Hensley and Yvonne Wingett Sanchez contributed to this article.