CALIFORNIA (USA): DEPARTMENT OF CORRECTIONS REFUSES TO RETURN SODIUM THIOPENTAL TO FDA

May 25, 2012: California, Nebraska and South Dakota refuse to return sodium thiopental to FDA. California prison officials are defying a U.S. Food and Drug Administration order to return supplies of a foreign-made drug used in executions, saying they disagree with a federal judge's ruling that the drug was imported illegally without an FDA safety review.
The FDA, which also disagreed with the judge and argued that no such review is required, said today that it will appeal the ruling. The dispute adds further uncertainty to the resumption of executions in California, blocked since 2006 by an order by another federal judge who found numerous flaws in the state's procedures for lethal injections. After the sole U.S. manufacturer stopped production of sodium thiopental in 2009, California and several other states got new supplies from a British distributor of Austrian-made sodium thiopental.
The FDA, which tests foreign-made medications for safety and effectiveness before allowing their distribution, approved the drug's shipments without inspection, saying a review of execution drugs was not part of its "public health role."
A judge in Washington, D.C., disagreed in March and told the agency to halt the imports and to tell states to return their supplies to the FDA.
A 1962 law explicitly requires the FDA to test all imported drugs and to ban shipments of unexamined drugs, said U.S. District Judge Richard Leon. He said the agency was violating the law and appeared to be demonstrating a "callous indifference to the health consequences of those imminently facing the executioner's needle."
In response, several states have switched to another anesthetic. Nebraska and South Dakota have refused to surrender their thiopental, saying they have conducted their own safety tests.
California's Department of Corrections and Rehabilitation said in a letter to the FDA dated May 1, and made public Friday, that it would not obey the agency's order to turn over the drug.
The FDA has not acted against states that have disregarded its orders.
Brad Berenson, a lawyer for condemned prisoners in California, Arizona and Tennessee who filed the suit in Leon's court, said Friday that it was "extraordinary for state law enforcement officials to flout the authority of a federal regulatory agency that's backed by the ruling of a federal court."  (Source: San Francisco Chronicle, 25/05/2012)