Court Bars FDA from Importing Drug Used in Death Penalty
Posted 28 March 2012 | By
A US District Court judge this week barred the US Food and Drug Administration (FDA) from importing an anesthetic drug used in executions, saying FDA's use of enforcement discretion was "callous" and "disappointing," reports Reuters.
"The FDA appears to be simply wrapping itself in the flag of law enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the executioner's needle," wrote Judge Richard Leon in his 27 March decision. "How utterly disappointing!"
The ruling could have profound implications for other FDA initiatives, including its attempts to lessen drug shortages through importing unapproved methotrexate and Doxil. Regulatory Focus reported on 6 March that FDA is allowing the importation of unapproved methotrexate from Canada and the importation of supplies of Doxil-substitute Lipodox from a supplier in India.
The case also has the potential to affect several court cases involving the execution drug, known as sodium thiopental. In the last three months, suits to bar FDA from allowing the import of sodium thiopental have been filed in Tennessee, Arizona, California and Nebraska.
Neither FDA nor the Department of Justice, which represented FDA in the suit, had any comment at the time of the Reuters article's publication.
Reuters - Judge bars import of drug used in death penalty
Regulatory Focus - US FDA Importing Unapproved Drugs to Ease Shortages
Read all Regulatory Focus Articles on Sodium ThiopentalFDA Law Blog - Another Loss in Court for FDA; Judge Leon Rules for Death Row Inmates in Unapproved Thiopental Sodium Case