Today, Ed Silverman of Pharmalot reviews the opinions of U.S. District Court Judge Richard Leon in a ruling that FDA to exercise appropriate authority over the importation of drugs used for death-row injections. The lawsuit revolves around the fact that the Agency allowed states to import one such drug, sodium thiopental, though there were no approved suppliers and thus no official review regarding safety and efficacy. (Here’s a back story on how Lundbeck and other manufacturers responded to pressure to stop sales of these drugs to the U.S.)
Judge Leon really lets the Agency have it: “FDA has long taken the position that consumers are exposed to a number of risks when they purchase drugs from foreign sources” because, he quoted, the foreign sources may “dispense expired, subpotent, contaminated or counterfeit product, the wrong or a contraindicated product, an incorrect dose, or medication unaccompanied by adequate directions for use.”
Leon says FDA not only ignored its own guidelines, but also the mandates of the Food, Drug & Cosmetic Act: “Simply stating that the FDA decided it would be best not to expend resources to ensure illegal foreign shipments of thiopental were not admitted into the United States is not a reasoned explanation for disregarding the FDA’s regulations, its longstanding practices, or the purpose of the FDCA."
“In the final analysis, 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. How utterly disappointing!”
At the end of his post, Silverman includes an FDA statement on the matter and a link to Leon's full ruling. Highly recommended reading!
--Paul Thomas (@PaulThomasPharm)