07/23/2013
WASHINGTON—A federal appeals court ruled Tuesday that the Food and Drug Administration was wrong to allow a misbranded and unapproved new drug to be imported for use in executions by lethal injection.
The three-judge panel affirmed a lower court ruling barring the FDA from allowing the importation of sodium thiopental —rejecting the agency’s argument that it had discretion to allow unapproved drugs into the U.S.
The FDA policy “was not in accordance with law,” wrote Judge Douglas Ginsburg of the U.S. Court of Appeals for the District of Columbia Circuit, joined by Judges David Sentelle and Judith W. Rogers. Ginsburg and Sentelle were appointed by President Ronald Reagan; Rogers was appointed by President Bill Clinton.
Sodium thiopental is an anesthetic used to put inmates to sleep before other lethal drugs are administered. The case was brought by death row inmates in Tennessee, Arizona and California.
Among other arguments, the FDA said it needed discretion to import drugs approved overseas but not in this country in order to combat domestic shortages of medically necessary drugs.
“By its own account, however, the FDA has ways short of allowing importation of inadmissible drugs to counteract a drug shortage,” the panel wrote, such as asking other firms to increase production and expediting review of regulatory submissions.
The panel reversed another part of the lower court’s order and allowed state correctional departments to keep stocks of the drug they currently have.
The FDA said it was reviewing the decision.
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