Regulatory Focus™ > News Articles > Judge's Order Banning Enforcement Discretion Appealed by FDA

Judge's Order Banning Enforcement Discretion Appealed by FDA

Posted 29 May 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) said it has appealed a decision issued in March 2012 by US District Court Judge Richard Leon, who said the agency erred in allowing a drug commonly used in executions into the country without first testing its effectiveness, reports Bloomberg.

The drug, sodium thiopental, has been at the center of numerous courtroom skirmishes between proponents and opponents of the death penalty. Opponents hope that by restricting access to the drug-one of only a few used in a multi-stage lethal injection drug cocktail-they can curtail the rate of prisoner executions.

In his 27 March decision, Leon said FDA's use of enforcement discretion-the agency's doctrine of selectively enforcing regulations-was a public health hazard.

"By opening up the 'closed' drug system by allowing an unapproved drug -thiopental-into the United States, defendants jeopardize their own system and threaten the public health by creating a risk that thiopental could incorrectly end up in the hands of the general public," Leon wrote.

"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," continued Leon. "How utterly disappointing!"

The decision was immediately controversial, and a group of 15 states urged FDA to appeal the decision, saying the decision was "flawed" and violated their ability to enforce their own laws and judicial decisions.

"At the very core of the states' police powers are their powers to enact laws to protect their citizens against violent crimes," said the states' attorneys general in a joint statement. "As state attorneys general, we are tasked with enforcing those laws, including in instances where capital punishment is authorized for the most heinous of crimes."

After Leon's decision, several states, including South Dakota and Nebraska, had outright refused to return stock of the drug, saying they complied with all federal regulations and had obtained their respective drugs legally.

As Regulatory Focus has previously reported, the decision could have wide-ranging implications for the agency. Leon's decision argued FDA was bound to the Federal Food, Drug and Cosmetic Act's provisions mandating all drugs be reviewed for safety and effectiveness before being allowed on the market. Because the agency also uses enforcement discretion as a means to combat drug shortages, this could affect its ability to import unapproved analogues to drugs experiencing shortages.

The case is Beaty vs. Food and Drug Administration, 1:11-cv- 00289, U.S. District Court, District of Columbia (Washington).


Read more:

Bloomberg - FDA Is Appealing Court Bar To Drug Used In Executions


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