FDA Dragged Into Execution-Drug ControversyDeborah Denno in The Wall Street Journal, February 02, 2011
As state prisons in recent months have searched overseas for supplies of thiopental sodium, a question has lurked in the background: Will the Food and Drug Administration permit thiopental imports, even though there are no FDA-approved, foreign suppliers of the drugs?
Last month, the FDA announced that it would permit prison officials to import thiopental to their hearts’ content. But the agency said it also would not vouch for the safety and purity of imported thiopental.
Today, six death-row inmates from Arizona, California and Tennessee sued the FDA in federal court, claiming the agency has violated federal law by allowing states to import thiopental that has not been reviewed for safety and purity. (Click here for the complaint.)
The death-row inmates are represented by powerhouse law firm Sidley Austin and partner Bradford Berenson, a former associated counsel to president George W. Bush. “The FDA is improperly allowing drugs into the United States even though it won’t stand behind their safety and efficacy,” he said.
Berenson notes that he’s “never had a moral problem with the death penalty.” But, he said, thiopental serves a critical role in executions of rendering condemned inmates unconscious, so that they do not suffer severe pain during the process. “What we are trying to prevent with the suit are inhumane executions,” he said.
“This is the first serious attempt since at least 1985 to look at the FDA’s role in drug shipments to prisons,” said Fordham Law professor Deborah Denno.
“Reviewing substances imported or used for the purpose of state-authorized lethal injection clearly falls outside of FDA’s explicit public health role,” the FDA said in a statement. “FDA does not verify the identity, potency, safety, or effectiveness of substances imported for this purpose.”