National law firm Alston & Bird is fighting the FDA, asking it to release execution drugs that Arizona imported from India. The state has said it will sue if the FDA doesn't do so.
The Arizona Department of Corrections has enlisted the help of a national law firm in its fight against the federal government to import execution drugs, BuzzFeed News has learned.
Alston & Bird, an Atlanta-based law firm with more than 700 lawyers and offices across the country, has taken on representation of the department in its fight against the Food and Drug Administration, which has detained 1,000 vials of sodium thiopental since this past summer that were slated for delivery to the department.
Arizona, Texas, and Nebraska purchased the drug from a man in India named Chris Harris - a man without a pharmaceutical background. Harris has been the subject of ongoing BuzzFeed News coverage.
The FDA warned Arizona and the other states that importing the drug would be illegal, as it is an unapproved new drug and has no FDA-approved manufacturer. The states ordered the sodium thiopental anyway.
Nebraska's shipment never left India, but Texas and Arizona's shipments did cross the ocean - only to be stopped by the FDA at U.S. airports.
Alston & Bird, which identifies itself as "counsel for the Arizona Department of Corrections," is arguing on behalf of the department that the FDA should release the drugs since they would be used "only for law enforcement."
"The restrictive legend on the label ('For law enforcement purpose only') makes that clear," Alston & Bird partner Daniel Jarcho wrote in a letter to the FDA dated Oct. 23, 2015. "The purpose of [the statutes] is to provide warnings to patients as they take their own drugs."
"Here there will be no lay patient 'users' taking the detained drugs. This is a circumstance in which the imported substance is a drug that will not be used for medicinal purposes at all," Jarcho, based out of the firm's D.C. office, wrote.
Arizona is arguing that, since the drugs are for lethal injection, they are exempt from the requirements the FDA cited in detaining the shipment.
In the letter, Jarcho also "demand[ed]" that the FDA and Customs and Border Protection redact or omit information about the drug supplier "unless required by law to release it," citing Arizona's secrecy law surrounding executions.
BuzzFeed News, however, previously was able to determine that Arizona and Texas purchased the drugs from Harris' company, Harris Pharma. Harris registered a site with the FDA claiming that it could be used to manufacturer drugs, although that site was just a small office space. The location he has provided to the DEA is an old apartment building he no longer lives in - and that he left while still owing rent.
According to FDA documents, the drugs Harris sold were manufactured by a company in India called Health Biotech Limited.
Arizona's letter to the FDA made no mention of a 2012 federal court order that the FDA had "a mandatory obligation ... to refuse to admit the misbranded and unapproved drug, thiopental, into the United States." The order also directed the FDA to stop "permitting the entry of, or releasing any future shipments of, foreign manufactured thiopental that appears to be misbranded or [an unapproved new drug]." A federal appeals court upheld the order in 2013.
Arizona, like Texas and Nebraska, has also enlisted the help of a former FDA employee named Ben England who testified on the other side of the 2012 case. In that case, he argued on behalf of death row inmates that the drugs violated federal law.
In a statement, an Alston & Bird spokesperson would only say, "[W]e are not at liberty to discuss the matter." According to his firm bio, Jarcho previously represented the FDA "in federal court civil and criminal litigation" while working as a trial attorney at Justice Department.
England, who is cc'ed on the Jarcho letter and identified as "Co-counsel" to the Arizona Department of Corrections, has not responded to numerous requests for an interview. England, who previously was a longtime investigator for the FDA, also has been the subject of ongoing BuzzFeed News coverage.
The FDA is continuing to detain the shipments, the Arizona Department of Corrections said. In a recent hearing in a death penalty case, an attorney with Arizona Attorney General Mark Brnovich's office said that the state would sue if the FDA did not release the drugs.
"There's no further administrative exhaustion needed [if the FDA denies the request]?" U.S. District Judge Neil Wake asked.
"No. At that point we would proceed in court to challenge," assistant attorney general Jeffrey Sparks said.
The Arizona attorney general's office told BuzzFeed News this week that it was not representing the Department of Corrections on the FDA appeal, but it did not immediately respond when asked if the office would represent the Department of Corrections if they chose to sue.
Source: BuzzFeedNews, January 29, 2016
