Regulatory Focus™ > News Articles > Inmates Sue Agency to Stop Import of Drugs

Inmates Sue Agency to Stop Import of Drugs

Posted 10 February 2012 | By Alexander Gaffney, RAC 

Death row inmates incarcerated in Tennessee, Arizona and California argued on 9 February that the US Food and Drug Administration (FDA) is breaking the law by allowing the importation of sodium thiopental-an anesthetic drug commonly used in a cocktail of execution drugs-after its manufacturer halted domestic production of the drug in 2011.

The inmates contend that FDA does not have the authority to allow the drug to be imported because the drug product does not have marketing approval from FDA. Lawyers for the Obama administration contend the agency has wide authority to allow unapproved pharmaceutical products in to the US, and asked US District Judge Richard Leon to dismiss the case.

The tactic of suing FDA over the import of sodium thiopental is a recent strategy used by some inmates who wish to delay-or even halt-their executions. Many states have turned to an alternate product, pentobarbital, for their executions to avoid the lawsuits altogether.

The recent lawsuits mirror recent attempts in Nebraska to delay execution. Lawyers for inmate Michael Ryan recently sued the state of Nebraska, demanding that they produce documents proving that Nebraska had legally obtained their stock of sodium thiopental. The state countered with documents showing that it had legally obtained the drug through a third-party intermediary, as Swiss-based Naari AG, the drug's manufacturer, refuses to sell the drug to any entity it believes will use the drug in an execution.

Ryan's lawyers went on to counter that the drug samples were "wrongfully diverted", and were thus in violation of import restrictions put in place by FDA, the US Drug Enforcement Agency and US Customs and Border Protection (CBP).

DEA has previously seized sodium thiopental stocks from states that had purportedly obtained sodium thiopental that had dubious pedigrees, delaying other executions.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe