State and Federal Governments Butt Heads After Court’s Decision.

State and federal government butt heads

 

The FDA warned Texas, Arizona, and Nebraska that buying thiopental from Harris would be illegal, and that they would block the shipments if they tried it.

The states tried it anyway.

Harris shipped the drugs to Nebraska, Texas and Arizona last year. Nebraska’s shipment never left India; The state tried to get a refund but Harris refused. Texas and Arizona’s shipments were seized at the airport by Customs and Border Patrol, under orders from the FDA.

Since then, the states hired a former FDA investigator and a well-connected law firm to try to convince the federal government to allow the drugs into the country.

In January, Texas sued the FDA for detaining the drugs without making a final decision, prompting the FDA to agree to provide one in April. Both Texas and Arizona have publicly indicated that they intend to sue the FDA if the drugs were formally denied.

The deadline for making the final decision was Thursday. The Justice Department announced the decision in a court filing on Thursday afternoon.

“[T]he United States Food and Drug Administration (FDA) has issued a final decision, refusing admission of the detained drugs into the United States,” the lawyers wrote.

In a statement, the FDA said the drugs would now have to be sent back to the supplier or destroyed, adding that its hands were tied because of an injunction put in place years ago.

“The FDA previously exercised enforcement discretion regarding the importation of sodium thiopental used for lethal injection,” FDA spokesperson Lyndsay Meyer said in a statement.

“However, in 2012 the United States District Court for the District of Columbia issued an order that permanently enjoins the agency from” allowing foreign thiopental that appears to violate federal law.

“As such, the court order requires the FDA to refuse admission to the U.S. any shipment of foreign manufactured sodium thiopental being offered for importation that appears to be an unapproved new drug or a misbranded drug.”

In a statement, the Texas Department of Criminal Justice criticized the decision to block the drugs.

“It has taken almost two years for the Food and Drug Administration to reach a decision which we believe is flawed,” TDCJ spokesperson Jason Clark said.

“TDCJ fully complied with the steps necessary to lawfully import the shipment. We are exploring all options to remedy the unjustified seizure.”

Published first on: Buzzfeed

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