A U.S. Justice Department lawyer today urged a federal appeals court in Washington to overrule a judge who blocked the import of a drug used in lethal injections.
U.S. District Judge Richard Leon ruled last year that food and drug regulators had a mandatory duty to disallow the entry of the drug, sodium thiopental, because it fails to meet certain requirements under federal law. The plaintiffs, represented by a team from Sidley Austin, are a group of death row inmates in Arizona, California and Tennessee.
The closely watched case before the U.S. Court of Appeals for the D.C. Circuit tests the scope of FDA's discretion to decline to enforce its own regulations. The appellate panel—senior judges David Sentelle and Douglas Ginsburg, sitting with Judge Judith Rogers—didn't immediately rule following an hour-long hearing.
The prisoners' lawyers contend the FDA lacks discretion to pass up enforcement. The federal law in question, the challengers argue, mandates that the agency "shall" refuse the admission of a foreign drug that is unapproved in the United States. "Normally, that's a mandatory expression," Sentelle said in court today.
A Justice Department lawyer, Daniel Tenny, arguing for the FDA, said that "shall" only comes into play if the agency concludes that the foreign drug violates U.S. requirements. The law, Tenny said, doesn't force the FDA to block the import of every foreign drug that hasn't received regulatory approval.
"FDA has long declined to take enforcement action against every article whose importation into the United States may be unlawful, instead focusing its resources on imports likely to have the greatest effect on the public health," he wrote in his brief.
The trial judge's ruling, Tenny said, has wide-reaching, adverse implications for the import of drugs from overseas. "You can't limit that holding to thiopental," he said.
The FDA exercises enforcement discretion when it comes to medically necessary drugs that are in short supply in the United States, he continued. Food and drug regulators also use discretion regarding the import of drugs, in small quantity, for personal use, he said. (In court papers, DOJ lawyers said the personal-use discretion includes drugs labeled in a foreign language and drugs that a person began taking while abroad.)
There is no U.S-based manufacturer of thiopental, a drug that Justice Department attorneys said was long been used as an anesthetic before the Federal Food,Drug and Cosmetic Act was enacted in 1938.
The government said doctors in recent years have largely stopped using thiopental as an anesthetic, instead choosing other drugs. The death row prisoners contend that thiopental, the first drug administered in a three-drug procedure, may fail to anesthetize properly.
Sidley appellate litigation partner Eric Shumsky in Washington said there's no wiggle room in the law: Congress intentionally used the word "shall" in describing the action FDA must take when confronted with an unapproved, misbranded foreign drug.
"There is no approved sodium thiopental—period," Shumsky told the D.C. Circuit panel.
Leon ruled in March 2012 that the government's "actions also create a slippery slope that other unapproved foreign drugs may be allowed to enter into the United States to the detriment of the general public."
The FDA, Leon wrote, "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. How utterly disappointing!"
Leon ordered the three states to return unused thiopental. The states, however, were not a part of the litigation in the trial court. In court today, Sentelle questioned whether Leon had the authority to force the states to return their supplies of the drug.