The FDA's hands-off statement Tuesday regarding the import of sodium thiopental for use in lethal injections has brought some clarity to an issue dogging state corrections departments. In the statement, the regulator says that it will defer to penal officials and permit the importation of the anesthetic for their use.
The agency justifies its stance by saying Congress has charged it with protecting the public health. "Reviewing substances imported or used for the purpose of state-authorized lethal injection clearly falls outside of FDA's explicit public health role," according to the statement. In addition, the agency is responsible for prioritizing its resources to most effectively do the job that Congress gave it.
Coupled with last December's execution of an inmate in Oklahoma, in which pentobarbital was substituted for thiopental, and a U.S. Supreme Court ruling last fall that death-row inmates are not entitled to know the source of drugs used to kill them, prison officials should soon be able to maintain lethal-injection supplies, rather than attempting to find the drugs. That will make them the envy of those who use thiopental for medical purposes and still must operate within the FDA framework.
Outside the penal system, the thiopental scramble highlights current, ongoing and persistent drug shortages. By the FDA's count, 48 drugs and nine biologics are now in short supply. Prescribers, drug buyers and legislators are beginning to rally around the ideas of importation, substitution and contingency planning.