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Via fdaimports.com
Ben England, a former Food and Drug Administration investigator, testified in federal court on behalf of death row inmates four years ago. Now, he's the leading consultant and lawyer for states trying to import execution drugs — over the explicit warnings of his old employer that it is illegal to do so.
Records obtained by BuzzFeed News detail England’s extensive involvement in four states’ attempts to import sodium thiopental for use in executions over the past year. The records also highlight the close attention the federal agency has been paying to his moves — up to the highest levels of the FDA.
Although no one is saying so publicly, the moves suggest both sides see the issue potentially ending up back in court.
Earlier this year, the Arizona Department of Corrections acknowledged it had hired a firm to represent it in its efforts to import execution drugs, the result of an open records lawsuit brought by the Arizona Republic, but the state attempted to keep the identity of the firm a secret. Texas, for its part, redacted the name of the firm representing the Texas Department of Criminal Justice on a contract for outside counsel.
The firm, it turns out, that is representing those two states is the same one, FDA documents show: FDAImports.com, run by England and affiliated with his law firm, Benjamin L. England & Associates.
In late July, the FDA detained illegal shipments of sodium thiopental from a seller in India that were on their way to Arizona and Texas. As soon as the FDA detained the shipments, England sent separate emails to the head of the FDA’s import division, informing the agency that he was representing the two states and asking to discuss the detention “at your earliest convenience.”
BuzzFeed News has previously reported that Ohio's Department of Rehabilitation and Correction also has paid England for work. Ohio has so far agreed to pay England up to $60,000 over a two-year period, documents provided to BuzzFeed News by ODRC show, although the state redacted what specific services England is providing it.
In spite of the FDA’s insistence that states cannot legally import sodium thiopental, Ohio has argued that it should be able to do so legally. The director of FDA’s import operation, however, reaffirmed to Ohio in a letter dated Nov. 19 that the drug is unapproved by the agency. Approving a new drug is an involved process that can take years.
BuzzFeed News has reported previously that a fourth state, Nebraska, also has enlisted England’s services. There, the state paid England to register the execution drug seller’s facilities and the drug with the FDA. The seller is a man in India named Chris Harris, who has sold execution drugs illegally numerous times although they have never been used in an execution. Harris also sold the drugs to Texas and Arizona that are being detained by the FDA.
Late on Dec. 4, Nebraska Gov. Pete Ricketts announced that the state was abandoning its attempts to import the drug.
The FDA's decision to detain those drugs should not come as a surprise to these states — or to England. The FDA had already warned England that importing sodium thiopental would be illegal. In June, FDA Director of the Office of Enforcement and Import Operations Douglas Stearn wrote to England, informing him “on the regulatory status" of the drug.
“Please note that there is no FDA approved application for sodium thiopental, and it is illegal to import an unapproved new drug into the United States,” Stearn wrote, adding that “any shipment would not be allowed into U.S. commerce.”
But Texas and Arizona paid to import it anyway, and Nebraska unsuccessfully attempted to import the drug as well — a shipment that didn’t even make it out of India.
Arizona and Texas have appealed the FDA's decision to detain the drugs through the agency's normal procedures. Internal FDA documents obtained by BuzzFeed News show that process employed thus far by the agency has been very intentional. High-ranking officials at the agency have been aware of and followed the states’ attempts to illegally import the drug for months, these records show.
In the wake of a 2012 court order, which followed several states’ overseas importation of the drug, the FDA enacted stringent new guidelines on how to handle future shipments. The guidelines dictate that the shipments are to be detained and not released “without direct instructions to do so from District or Headquarters management.”
Documents show that in May of this year, following news reports about Nebraska’s attempts to import sodium thiopental, FDA Commissioner Stephen Ostroff asked to be briefed on “the history of the importation of sodium thiopental.”
In June, the FDA issued a “SPECIAL ALERT” to import managers, asking them to “be on the lookout for shipments of sodium thiopental.” The import managers were given the strict guidelines the FDA enacted in 2012.
The documents show that the FDA also called FedEx that month to warn the company that someone might try to use its shipping service to attempt to import sodium thiopental. In late August, Harris attempted to send the drugs to Nebraska using FedEx. The company, however, did not allow the drugs to leave India.
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via Food and Drug Administration
The recent aggressive moves from the FDA represent a change for the agency, which fought in court from 2011 through 2013, unsuccessfully, to keep out of the business of regulating some states’ lethal injection-based execution efforts.
The FDA — in the course of fighting a lawsuit brought by prisoners from Arizona, California, and Tennessee — then acknowledged that it was choosing not to enforce the federal law that bars importation of adulterated, misbranded, or unapproved new drugs when it allowed the importation of sodium thiopental. It argued, however, that the “FDA’s non-enforcement decision is the reasonable result of FDA’s ‘complicated balancing of a number of factors which are peculiarly within its expertise.’”
In his 2012 opinion rejecting that argument (which was later upheld by a federal appeals court), Judge Richard Leon wrote that “the FDA appears to be simply wrapping itself in the flag of law enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the executioner's needle.”
His response: “How utterly disappointing!”
Leon’s order, issued June 22, 2012, and still in effect today, bars the FDA from allowing sodium thiopental to be brought into the U.S. if it is misbranded or an unapproved new drug. For this reason, the FDA continually points to the fact that there is “no FDA approved application for sodium thiopental” and bars importation.
Notably, before Leon’s ruling, there was another lawsuit — brought solely by Arizona inmates — aimed at stopping that state’s overseas execution drug importation attempts. As part of their case, inmates argued that Arizona was violating the law by attempting to import sodium thiopental from an online, overseas pharmacy. The suit also alleged Arizona intentionally minimized orders to reduce FDA scrutiny.
The inmates brought in an expert to testify as to why the whole process was illegal: Ben England.
England is, the inmates argued, an expert regarding the FDA’s processes, having worked for the agency from 1986 through 2003 and in private practice advising clients on FDA matters since then. Although he started out with the agency as a biologist, according to a copy of his resume submitted to the court, England moved into compliance and enforcement four years into his 17 years with the agency. Over the course of his time at the FDA, England was a compliance officer, a special agent with the FDA’s criminal investigations arm, and a senior legal adviser for regulatory matters.
On Dec. 5, 2011, England testified for the inmates that Arizona’s attempts at execution drug importation in 2010 — attempts that included sodium thiopental — were illegal.
“I was able to determine … that the September 2010 shipment was composed of drug products that were unapproved by the Food and Drug Administration and they were misbranded in that they were not listed with FDA as required by the law,” England testified, adding that the state’s later attempt to minimize the size of orders was itself “improper and in violation of customs regulations.”
In a corresponding expert report he submitted, he similarly concluded that “[i]mportation of such drugs lacking an approved new drug application on file with the FDA for such intended uses is a prohibited act under the FDCA, and punishable as a strict liability misdemeanor” — also specifically noting “FDA’s vigilance in attempting to keep unapproved new drugs from entering the U.S. market from foreign sources.”
Now, however, England has switched sides — representing state officials in Arizona and Texas — and is pressing the FDA to allow the sodium thiopental it detained this summer to be imported to the states for execution purposes.
England has not provided comment to BuzzFeed News about his representation of the states or his sparring with his former longtime employer, the FDA.
Even as the FDA is hearing Arizona and Texas’s challenges, the agency suggested in a letter to Ohio that no change in its policy has been reached at this point. On Nov. 19, the FDA’s Domenic Veneziano wrote that the agency’s June letter stands — noting specifically that there is “no FDA approved application” for the drug currently.
But if the FDA denies Arizona or Texas’s challenges, the states could try to challenge the FDA’s interpretation of the 2012 court order — or the court order itself — by going back to court. Texas has shown a particular affinity toward challenging Obama administration actions in recent years. It currently has lawsuits pending challenging aspects of Obamacare, Obama’s immigration executive actions, and the administration’s refugee policy.
Texas is not alone. In August, Ohio officials retained England’s company for up to another 100 hours worth of work over the next year, records the state recently released show — a number that likely could be increased if corrections officials there deem it necessary.
Read the documents:
