Court finds FDA must block imports of all misbranded or unapproved drugs to the US

By June 26, 2012 October 25th, 2019 No Comments

In 2011, several death row inmates brought a suit against the Food & Drug Administration (FDA), alleging that the FDA had violated federal law by allowing shipments of misbranded, unapproved drugs – in this case, thiopental – to enter the US for use in lethal injection executions.

United States District Court for the District of Columbia sided with the death row inmates, holding that federal law imposes a mandatory obligation on the FDA to “refuse to admit the misbranded and unapproved drug, thiopental, into the United States” and that “the FDA was required under the FDCA to reject the shipments in the interest of public safety.”

In so holding, the court declared that the FDA has authority to regulate the distribution of drugs in the US “to promote public health and safety,” that the FDA “has long taken the position that consumers are exposed to a number of risks when they purchase drugs from foreign sources,” and that the FDA had “acted in a manner contrary to the public health.”

Finally, the Court declared that “by establishing a ‘closed’ drug distribution system, the import provisions of the FDCA protect the public from the risk that potentially unsafe drugs obtained from foreign sources will enter into the marketplace … By opening up the ‘closed’ drug system by allowing an unapproved drug – thiopental – into the United States, [the FDA] 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.”

Since this ruling, Nebraska, South Dakota, Ohio, Arizona and Texas have attempted to import foreign-manufactured thiopental from unregulated suppliers in India for use in lethal injections.

In each case, the unapproved drugs were seized at customs and confiscated by the FDA.

Read the court's ruling