Regulatory Focus™ > News Articles > 2019 > 5 > FDA to Follow DOJ Memo on Limiting its Regulation of Execution Drugs

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Posted 15 May 2019 | By Zachary Brennan 

FDA to Follow DOJ Memo on Limiting its Regulation of Execution Drugs

2704 The thorny issue of whether the US Food and Drug Administration (FDA) can oversee the importation of execution drugs just became a bit thornier, as the Department of Justice (DOJ) said in a memo that when a drug’s intended use is for capital punishment, “it is not subject to regulation under” the Federal Food, Drug, and Cosmetic Act (FDCA).

The dispute over whether the drugs should fall under FDA’s jurisdiction comes as states nationwide are seeing a shortage of certain execution drugs, after the sole American manufacturer of sodium thiopental ceased production in 2009, which led several states to resort to using other drugs, like the sedative midazolam, which caused botched executions in Oklahoma in 2014 and Arizona in 2016.

Several states have also attempted to import sodium thiopental from dubious foreign suppliers. But in 2012, the US District Court for the District of Columbia issued a permanent injunction in the case of Beaty v. FDA, requiring FDA to block illegal imports of sodium thiopental on the grounds that they were unapproved and misbranded.

Now, the DOJ is making the case that FDA should not be able to block imported execution drugs. And FDA is saying it will follow that DOJ opinion as well as it can.

An FDA spokesperson told Focus: “DOJ’s Office of Legal Counsel issued an opinion concluding FDA does not have jurisdiction over drugs or devices intended for use in the death penalty. FDA will follow the conclusion of the opinion to the extent permissible by the Beaty v. FDA order, which relates to sodium thiopental. Drug products that are not intended for use in lethal injection remain subject to FDA regulation.”

DOJ Memo and Counter Points

In explaining why FDA should not regulate drugs intended for executions, Steven Engel, assistant attorney general of the Office of Legal Counsel (OLC), wrote: “The FDCA cannot be read as authorizing FDA to effectively ban capital punishment, because that reading would contravene or render moot a host of federal statutes that presuppose the lawfulness of capital punishment.”

He also said there is nothing unusual about DOJ’s conclusion that articles intended for use in capital punishment fall outside FDA’s jurisdiction, even though the same articles could be subject to regulation when intended for other uses.

For example, FDA has classified hot tubs, saunas and treadmills as devices for some purposes, but not for others, he wrote. “Therefore, finding that substances fall outside FDA’s jurisdiction when they are intended for use in capital punishment does not bear upon FDA’s potential jurisdiction over other intended uses of the same substances,” Engel said.

Patricia Zettler, associate professor at Georgia State University College of Law, told Focus that “it’s a clever move for the OLC opinion to extend its analysis to means of execution other than lethal injection, to try to sidestep the argument that blocking imports of unapproved drugs is not the same as the FDA prohibiting the death penalty. But the opinion that drugs used for lethal injection are not actually drugs stretches commonsense, and in my view is inconsistent with FDA’s statute and public health mission.”

She also explained how regulating drugs that can be used for lethal injection as drugs under FDA’s statute is not the same as prohibiting the death penalty because “such drugs may not pose the same regulatory questions as other means of execution, such as guns, and it’s not at all clear to me that FDA couldn’t determine that a drug is ‘safe and effective’ for lethal injection. Indeed, as noted in a footnote of the OLC opinion, FDA has long asserted jurisdiction over drugs intended for animal euthanasia, and has approved drugs for that purpose.”

She further explained how the OLC opinion could open the door for drugs to enter the US outside the legitimate supply chain and then be diverted into the supply chain.

The DOJ memo is “silent on the important public health ramifications of its position,” Zettler said. “Among other things, introducing unapproved drugs of uncertain provenance into the US supply is worrisome, and may be particularly when those drugs may be controlled substances or otherwise pose risks of misuse or diversion. Once a such a supply channel is established it can be difficult to control what happens to the drugs coming through that channel. For example, when states bought unapproved sodium thiopental from Dream Pharma in 2010, some of it went missing from San Quentin and at least one shipment ended up at a pharmacy in Georgia.”

DOJ Memo


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