Texas Officials Sue FDA for Access to 1,000 Vials of Execution Drug

WASHINGTON -- The Federal Drug Enforcement Agency last week formally blocked Texas officials from using 1,000 vials of an execution drug that the state had attempted to import from a private manufacturer in India.FDA agents said Texas officials had 90 days to destroy the drugs or return them to India.But Texas officials have been seeking permission to use the drugs for almost two years now -- and they don't want to give them up. So on Monday, the Texas Department of Criminal Justice said it will challenge the FDA’s ruling in federal court.“We are exploring all options to remedy the unjustified seizure” of the drugs, said Jason Clark, TDJC spokesman.The conflicts surrounding the FDA’s seizure of the drug, sodium thiopental, reflects the struggle several states have faced to procure execution drugs for death-row inmates over the last several years.In 2011, members of the European Union stopped exporting sodium thiopental to the U.S. And over the last several years, American companies have stopped producing the drug. So states have turned to alternative means to procure execution drugs.For now, Texas has turned to pentobarbital, a sedative produced by state-regulated pharmacies that are not federally regulated. Clark, the TDCJ spokesman, noted that Texas currently has enough pentobarbital for the five executions currently scheduled.But there are 240 inmates on Texas’ death row, and Texas officials still want to use sodium thiopental in executions, as they did for 30 years.So two years ago, officials in Texas and Arizona both turned to a private manufacturer in India, who said he would be able to supply the sodium thiopental. He shipped Texas’ supply to the George Bush Intercontinental Airport in Houston. That’s when the FDA seized the shipment.For a year and a half, the FDA examined the shipment, declining to issue a final decision about whether Texas could use the drugs. In January, Texas Attorney General Ken Paxton sued the FDA for dragging out the decision.“My office will not allow the FDA to sit on its hands and thereby impair Texas’ responsibility to carry out its law enforcement duties,” Paxton said in a statement at the time.But on Thursday, the FDA announced they had come to a final decision -- and not the one Paxton was hoping for. The drugs, they said, could not stay.“The FDA is required to refuse entry to thiopental produced abroad when it appears the thiopental is misbranded or a new drug,” Todd Cato, a lawyer representing the FDA, wrote.In his explanation, Cato cited a court ruling that requires all imports of sodium thiopental to go through official approval channels and be properly labeled. If a shipment of sodium thiopental appears to violate the law, government agencies are required to block it, a judge determined in 2012.The imports from the India supplier did appear to violate the law in several ways, Cato wrote.“[The vials have] no recommended dose and offers no instructions for reconstituting the powder inside the vials,” Cato wrote. “Its labeling includes no precautions, contraindications, or warnings, or other information required in prescribing information for health professionals.”“We have determined that the thiopental sodium appears to be an unapproved drug and misbranded,” Cato concluded, in the decision the FDA issued last week. The FDA “must refuse admissions to the detained drugs.”Texas officials, who were already frustrated that it took the FDA so long to come to a decision, argue that the 2012 ruling does not apply in certain law enforcement situations.A spokeswoman for Paxton’s office declined to comment, citing the ongoing litigation. But Clark, the TDCJ spokesman, reiterated the agency’s belief that the FDA’s decision is “flawed.”“TDCJ fully complied with the steps necessary to lawfully import the shipment,” he said.Clark said the TDCJ will file its official complaint in court later this week.In the meantime, the 1,000 vials of sodium thiopental remain in storage.  Continue reading...

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