RICHMOND — Pharmacies that go along with Gov. Terry McAuliffe’s plan to secretly supply Virginia with execution drugs risk breaking state and federal laws governing controlled substances, a top administration official said in internal emails going back more than two years.
McAuliffe (D) this week proposed allowing the state to hire compounding pharmacies to make lethal-injection drugs, which have become scarce amid public pressure on American pharmaceutical companies and a European export ban.
He proposed a similar idea last year, but it collapsed in the General Assembly because of concerns over the secrecy provisions meant to shield the pharmacies from political heat. Given the increasing scarcity of the drugs, the plan may have a better chance of being approved when the legislature reconvenes Wednesday.
The state’s top official for pharmacy oversight flagged problems with the idea as early as 2014, according to emails obtained by The Washington Post.
“Under federal law, a traditional pharmacy . . . may only compound pursuant to a valid prescription,” Caroline D. Juran, executive director of the Virginia Board of Pharmacy, wrote in a February 2014 email. “This bill as written authorizes a pharmacy to compound upon written certification by the Director of the Department of Corrections. This would obviously not constitute a valid prescription.”
But the McAuliffe administration said state and federal courts have consistently ruled that executions do not constitute the practice of medicine, pharmacy or anesthesiology, so the normal rules should not apply.
“Virginia’s not the first state to do this,” said McAuliffe’s top counsel, Carlos Hopkins. “To the extent that we’re following the practices of other states, I don’t believe it will be a conflict.”
Juran did not respond to requests for comment.
In her emails, she wrote that if a doctor wrote a prescription for lethal-injection drugs, that would likely violate state and possibly federal laws requiring that drugs be prescribed only for medicinal or therapeutic purposes. And she questioned whether the secrecy provisions would prevent the Bureau of Prisons from investigating a pharmacy if something went wrong with an execution.
Juran consulted William L. Harp, executive director of the Virginia Board of Medicine, on the proposal.
“Is there anything in [the] law that would prohibit a prescriber from issuing a prescription which ‘does harm’?” she wrote to him. “Or is the oath of doing no harm just that??”
Harp replied with examples of unprofessional conduct enumerated in state code. The offenses can result in the suspension or revocation of a medical license, imposition of fines or other punishment by the Board of Medicine.
“Well, let’s see ........... probably only # 8 below,” he wrote. The offense he referred to reads: “Prescribing or dispensing any controlled substance with intent or knowledge that it will be used otherwise than medicinally, or for accepted therapeutic purposes, or with intent to evade any law with respect to the sale, use, or disposition of such drug.”
McAuliffe’s current proposal would address that issue by exempting pharmacies that compound the lethal-injection drugs from normal state oversight.
A 2012 ruling by Richmond Circuit Court Judge Gregory L. Rupe appears to support that approach. “Specifically, the Court rules that execution by lethal injection by the Commonwealth of Virginia is not the regulated practice of medicine, pharmacy or anesthesiology,” he wrote.
The exemptions nevertheless inflamed civil libertarians.
“This is authorized human experimentation in secret without any professional oversight,” said Claire Guthrie Gastañaga of the American Civil Liberties Union. “The director of the Department of Corrections is now going to be able to work with people and get drugs, and all they’re expected to do is make sure it’s listed on the outside of the bottle when it expires.”
Administration officials said federal courts have supported the notion that normal medical and pharmaceutical regulations governing compounding pharmacies do not apply to those mixing execution drugs.
“Four states have successfully proceeded with this legislation, and no court has accepted the arguments against this legislation,” said Brian Moran, Virginia’s secretary of public safety and homeland security.
But Megan McCracken, a lawyer with the Death Penalty Clinic at the University of California at Berkeley School of Law, said federal laws would still apply.
“[W]hile Gov. McAuliffe’s proposed bill would exempt the purchase and provision of compounded drugs from the requirements of VA law, the transaction would nonetheless violate federal law,” she wrote in an email.
Christopher C. Kelly, a spokesman for the federal Food and Drug Administration, declined to comment.