The civil law suit, Beaty v. FDA, is available in Adobe .pdf format.
Today's New York Times carries, "F.D.A. Sued Over Drug Used in Executions," by John Schwartz.
Lawyers in Washington sued the Food and Drug Administration on Wednesday on behalf of death-row prisoners, demanding that a Federal District Court prohibit importation and use of sodium thiopental, a drug used in many executions. When the sole supplier of the drug in the United States stopped producing it, executions were delayed in several states, and states obtained the drug from overseas suppliers. The agency has long said it has no authority over executions. The lead lawyer in the suit, Bradford A. Berenson, said it was “not about halting executions but rather about ensuring that illegal drugs are not used in carrying out otherwise lawful sentences.”
"Lawsuit seeks to block imports of key execution drug," is the USA Today post by Kevin Johnson,
The lawsuit alleges that large amounts of unapproved sodium thiopental have been imported by at least six states: Arkansas, Arizona, California, Georgia, Nebraska and Tennessee.
"Death Row Inmates Sue U.S. Over Importation of Execution Drug," by Tom Schoenberg for Bloomberg.
The suit said the FDA allowed states to import “bulk amounts” of thiopental, which hasn’t been sold in the U.S. since 2009 when the sole U.S. manufacturer, Hospira Inc., stopped producing it.
The inmates are seeking an injunction barring future imports of thiopental and the removal of supplies already in the possession of state governments.
The shipments of thiopental entering the U.S. originated from an Austrian facility owned by Sandoz International GmbH, a German company, according to the complaint. The drug was shipped to the U.S. from a London wholesaler, Dream Pharma Ltd., the complaint claimed. Dream Pharma bought the drug from a unit of Archimedes Pharma Ltd., a privately held company based in Reading, U.K., the inmates said in the complaint.
"US inmates challenge importation of execution drug," by Lucile Malandain for AFP.
Arizona used imported thiopental for the execution of Jeffrey Landrigan in October, with the approval of the Supreme Court, but under a flood of public criticism.
The last doses of thiopental made in the United States will reach expiration this spring, which will put American states that practice the death penalty at a crossroads.
"FDA's own regulations preclude the importation of any unapproved new drug and any drug that is not listed with FDA and produced at a registered foreign source," the lawsuit states.
They accuse the agency of being "arbitrary and capricious" and that its agents have "never inspected the processes used to manufacture the thiopental."
"Whatever one's views may be on the death penalty, no reasonable person is in favor of botched or inhumane executions," Bradford Berenson, a lawyer for the plaintiffs, said in a statement.
"Ineffective anesthesia that subjects condemned prisoners to needless, and indeed unconstitutional, suffering serves no one's interests," he said.
Michael Kiefer files an updated report for today's Arizona Republic, "Execution drugs: Arizona inmate lawsuit seeks FDA policing."
In mid-October, Donna Benjamin of the American Society of Health-System Pharmacists, which tracks drug shortages, said there were no approved manufacturers of thiopental outside the U.S., and the FDA wasn't aware of any sites making thiopental that would import it.
"Any import to alleviate a drug shortage would have to come from an FDA-approved source," she said.
And Shelly Burgess, a spokeswoman for the FDA, told The Republic in October, "For any product that is planned to be made available in the U.S., FDA would have to first evaluate any potential risks associated with that product including where it is manufactured and whether it meets FDA quality standards."
In November, Dr. Murray Lumpkin, a deputy FDA commissioner, told British government officials, "There are no approved or permitted foreign sources of sodium thiopental."
Nevertheless, the drug was getting through customs, signed off by FDA.
Five shipments from Dream Pharma were seized in Memphis by the FDA between June and November. But all were eventually released.
The Arizona shipment sailed through Customs in Phoenix with approval of the Los Angeles office of the FDA on Sept, 29. According to Cattani, the state has since obtained another shipment.
But then, the FDA changed its tune.
On Dec. 30, Burgess told The Republic that the agency would exercise "enforcement discretion" on the matter.
"Reviewing substances imported or used for the purpose of state-authorized lethal injection clearly falls outside of FDA's explicit public health role," she said. The agency would "continue to defer to law enforcement on all matters involving lethal injection . . . "
"Suit could halt executions in states, including Tennessee," is the report in today's Tennessean.
Wednesday's lawsuit demands that FDA follow its congressional mandate to screen "all commercial shipments of drugs, as well as all shipments of controlled substances."
It points out the diligence with which FDA prevents states and individuals from obtaining cheap prescription drugs from Canada, while allowing states to import sodium thiopental.
"The law requires FDA to ensure that only safe, effective drugs are brought into the United States. When the agency allowed states to import unapproved sodium thiopental, it abdicated its responsibilities and violated federal law," said Bradford A. Berenson, a partner in the law firm Sidley Austin LLP, which filed the suit in Washington, D.C.
The firm has expertise in FDA licensing and is working with the Federal Public Defender's Office in Phoenix on the suit.
The suit asks the FDA to not only ban further imports of the drug but to recall the shipments that have already been delivered.
Earlier coverage of the FDA lawsuit begins at the link.