Texas has had enough of the FDA’s indecision about a lethal injection drug it tried to import back in July 2015. The state is suing to compel the regulator to decide whether it can actually get its hands on the drug to use in its executions.
At issue is thiopental sodium, an old anesthesia med that’s often been a part of execution cocktails. Death penalty states have struggled to get their hands on lethal injection drugs domestically, because drugmakers have worked to block their sales for execution use.
Texas thought it had a solution. In June 2015 it notified the feds it would import thiopental sodium for law enforcement use, and 1,000 vials arrived at the George Bush Intercontinental Airport in Houston late the next month.
But things went awry when U.S. Customs agents, at the FDA's request, seized the imports “for further analysis,” according to the lawsuit (PDF). Texas appealed that seizure to the FDA. In a tentative decision issued last April, the agency said the would-be imports were unapproved drugs and allowing them into the country would violate the Food, Drug, and Cosmetics Act.
Texas appealed again, and now, 17 months after the vials arrived, Texas Attorney General Ken Paxton has filed suit, arguing that the FDA has taken too long to issue a final decision. Paxton called the agency's delay either “gross incompetence or willful obstruction,” according to a statement.
“The FDA has an obligation to fulfill its responsibilities faithfully and in a timely manner,” Paxton said in the statement. “My office will not allow the FDA to sit on its hands and thereby impair Texas’ responsibility to carry out its law enforcement duties.”
According to the suit, FDA detained the drugs on three specific legal grounds, but Texas argued that “none ... is valid.” Instead, the state said a “law enforcement” exemption allows it to import and use the execution drugs.
For its part, the FDA said it “does not comment on possible, pending or ongoing litigation.”
In recent years, states have had a hard time getting their hands on execution drugs, as one by one, drugmakers have cut supply chain links to states where they’re used for capital punishment. Late last year, after picking up Hospira and a set of its drugs that could be used in execution cocktails, Pfizer joined about two dozen other companies to cut off access.
That’s made states look elsewhere, sometimes successfully: California, Nebraska and Arizona obtained sodium thiopental from suppliers in England and India. But the British government has since banned shipments of execution drugs.
And the legal wrangling obviously continues. Arizona also raised objections to the FDA’s drug seizure in Texas, saying that it didn’t violate FDA import rules.
With its new lawsuit, Texas is asking a court to issue a mandatory injunction that would force the FDA to make a decision on the import. It also wants the court to issue a declaratory judgment stating the federal agency has “unlawfully withheld or unreasonably delayed” making its decision, plus any “other relief” as the court decides.