Pharmaceutical Business review

US firm sues FDA for importing unapproved lethal injection drug

According to the lawsuit, FDA has knowingly allowed sodium thiopental, which has not been approved by the FDA, to be imported by state corrections agencies for use in executions by lethal injection.

The Complaint alleges that even though FDA is required to prohibit the importation of any drug that is unapproved, misbranded, or adulterated, sodium thiopental was recently imported in three states for use in lethal injections.

The lawsuit has asked the federal district court in Washington, DC, to declare that FDA has violated the US Federal law.

In addition, the court should prohibit the agency from allowing further importation of unapproved sodium thiopental into the United States, and to take steps to destroy unlawful, unapproved product previously used, the lawsuit noted.

Sidley Austin Washington DC office Partner, Bradford Berenson said the lawsuit is not about halting executions but rather about ensuring that illegal drugs are not used in carrying out otherwise lawful sentences.

"Ineffective anaesthesia that subjects condemned prisoners to needless, and indeed unconstitutional, suffering serves no one’s interests, least of all the states" Berenson said.