OP-ED: The FDA is on a collision course with the courts
The Justice Department has added another level of confusion to the nation’s already muddled capital punishment system, advising the Food and Drug Administration that it lacks the authority to regulate the importation of drugs used in lethal injections. As a consequence, the Justice Department said, the FDA can’t stand in the way of states acquiring them from manufacturers overseas, potentially a key source of these compounds.
Yet the advice contradicts a federal judge’s ruling in 2012, later upheld on appeal, that the FDA must enforce its regulations, including banning drugs entering the country for unapproved purposes or with improper labeling. Up to that point, the agency had refrained from interfering with the drug imports.
So now what we have is a situation kind of like when your father tells you to ignore an order your mother gave you. What’s a child to do?
At this point, it seems mom wins. Obeying the advisory opinion by the Justice Department’s Office of Legal Counsel and letting the drugs come in would mean violating a court order.
Justice essentially takes Texas’ side in a dispute with the FDA over the state’s attempt to import sodium thiopental, a drug that pharmaceutical companies refuse to make in the U.S., in part because it is used in lethal injections. States have used it as the first dose in a three-drug protocol; sodium pentothal renders the condemned insensate, a second drug paralyzes and the third stops the heart.
If the condemned is not rendered unconscious, the paralytic and heart-stopping shots can cause excruciating pain but prevent the inmate from showing it, experts say.
Without access to sodium thiopental and similar drugs, some states have turned to using midazolam, a relatively mild sedative not intended to render a patient insensate, as the first drug in the sequence. That had led to some tortured executions, yet the Supreme Court’s 2015 Glossip decision reinforced the court’s view that “some risk of pain is inherent in any method of execution.”
Europe bans export of pharmaceuticals for use in executions, so states that want to use sodium thiopental and related drugs have contracted with compounding pharmacies, which specialize in crafting one-off drugs for use by people who, for instance, are allergic to some ingredients in mass-produced drugs.
Many of those states also have dropped a legal veil of secrecy over the procurement process, so the public doesn’t get to know how much the state is paying in tax dollars to whom to supply the execution drugs. So much for transparency. It says something that many such pharmacies, and the states that turn to them, insist on doing so in the shadows.
That brings us to the remaining sources of lethal-injection drugs, and the focal point of the new Justice advisory opinion: China, India and other countries less concerned with whether their products, designed to alleviate suffering, are used to kill people. That has involved dealing with some sketchy characters, as Buzzfeed reported a few years ago.
The advisory says that the FDA can’t regulate drugs imported for executions because they are not a “drug” or a “device” under the Federal Food, Drug and Cosmetic Act of 1938, which says drugs can’t enter the country unless the FDA has approved them as safe. In 2000, the Supreme Court ruled that the FDA couldn’t regulate tobacco because there was no safe use for it.
The Justice advisory, relying on that interpretation, says drugs imported for executions aren’t intended for safe use and thus fall outside the FDA’s control.
Never mind that the drugs are to be administered to a human being. Even if the intent is to kill the person, the drugs ought to be regulated to ensure they are what they are purported to be, and will do what they are expected to do.
Look for a legal challenge coming soon to a court near you.