Is the FDA Responsible for Blocking Imports of Drugs like Thiopental?

As stated in an article by The New York Times on May 14, 2019, the Food and Drug Administration has been found by the Justice Department to lack the legal authority to regulate drugs that are used to carry out death sentences by legal injection.

This makes it possible for states to use scarce death penalty drugs, even if their use is not approved.

Steven Engel, the head of the Justice Department’s Office of Legal Counsel, posted a 26-page memo signed on May 3 regarding the situation. In it, he concluded that the FDA has no right to regulate drugs used in death penalties because they are not considered as “devices” or “drugs” as defined within the Federal Food, Drug and Cosmetic Act of 1938.

Again – that was back in 1938.

Times Have Changed – Or Have They?

Under the Federal Food, Drug and Cosmetic Act of 1938, drugs that affect or alter the body are not allowed to be brought to market in the U.S. unless and until it obtains FDA approval as safe. However, in a Supreme Court ruling in 2000, the court held that the FDA lacked legal authority to regulate tobacco because it could not be used safely – yet, there was no indication that Congress had ever intended it to be banned.

Mr. Engel explains that the law that gives the FDA the power to ensure the safety of drugs and devices “cannot sensibly be applied” to death penalty drugs. Why? Because doing so would mean those drugs and devices would be banned by the act. He stated, “Yet, the Constitution and laws of the United States presuppose the continued availability of capital punishment for the most heinous federal and state crimes.”

You might be wondering: “Isn’t that more of a subjective interpretation rather than a definition?”

Maybe.

However, interpretations of federal law and the Constitution by the Office of Legal Counsel are binding across the entire executive branch. Therefore, Engel’s decision means that the FDA can no longer interfere with attempts by the states to import death penalty drugs. One such drug is sodium thiopental, which is an anesthetic that is used in combination with other drugs to make a lethal injection cocktail. The injection works to paralyze the muscles and stop hearts from beating.

The Battle for Thiopental

Thiopental hasn’t been manufactured in the United States since 2009, when the last American manufacturer stopped production of it. States that use the death penalty have encountered delay after delay in carrying out death sentences using lethal injection due to a shortage of the drugs used for that intent.

In 2011, some inmates on death row sued the FDA to try to force it to block imports of thiopental as an unapproved and misbranded drug. In 2012, a Federal District Court judge ruled that the Food and Drug Administration had a legal duty to block imports of thiopental and no discretion to choose to not do so. An appeals court followed suit, unanimously agreeing with the decision.

The FDA accepted that decision and in 2015, it impounded shipments that two states (Texas and Arizona) sought to import. The FDA stated that it was an unapproved drug and it could not be imported under that 2012 court ruling.

Engel states that the rulings from 2012 hinge on the question of whether the FDA had the power to choose not to use its drug enforcement authority on an imported drug. He claims the courts didn’t address the broader question regarding the FDA’s jurisdiction, opening the door for the Justice Department to freely decide that the agency had no legal right to block the imports.

Back to the question of whether the ruling is subjective in nature…

Engel stressed that even if the question of whether the Food, Drug and Cosmetic Act of 1938 should apply to an “unsafe” substance like lethal injection drugs were subjective, it needed to be interpreted in a way that respects the rights of the 50 states to decide for themselves to have the death penalty or not. He explained that the principle of federalism is to provide “further support for the conclusion that the FDCA should not be read to regulate – and therefore, effectively prohibit – the states’ administration of capital punishment.”

This issue came to light early in the Trump Administration when in January of 2017, Texas sued the FDA and asked a judge to order the agency to release the shipment of thiopental that it had tried to import in 2015.