"FDA Takes Stance on the Importation of Lethal-Injection Drugs," is the title of Nathan Koppel's post at the Wall Street Journal Law Blog. Here's an extended excerpt:
The nationwide shortage of thiopental sodium, a key anesthetic used in lethal injections, continues to bedevil state prisons.
Hospira, the sole U.S. maker of the drug, has not produced a fresh supply of thiopental for over a year, forcing some states to import the drug from Europe.
Many death-penalty advocates have questioned whether the importation of thiopental violates Food and Drug Administration regulations, given that the FDA has publicly indicated that there are no FDA-approved foreign makers of thiopental.
Today, the agency issued a statement, at the request of The Wall Street Journal, clarifying its position on thiopental imports.
Basically, the agency is taking a hands-off position, stating that it will defer to law enforcement and permit the importation of thiopental sodium going forward.
The FDA “is charged by Congress with protecting the public health,” the agency said in a statement. “Reviewing substances imported or used for the purpose of state-authorized lethal injection clearly falls outside of FDA’s explicit public health role.”
But the agency did have one thing to say that could provide grist for attorneys representing death-row inmates; some advocates have claimed that it is unconstitutional to import thiopental, because of the possibility that foreign-made thiopental will not be sufficiently potent and effective, creating a risk that inmates will suffer a severely painful death.
In its statement, the FDA noted that while it will permit thiopental imports it also made clear that will not vet or vouch for the “safety, effectiveness, purity, or any other characteristics” of thiopental shipments.
Earlier coverage of the FDA position is in the post, "Arizona Lethal Injection News.
Comments