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May 15, 2019

New opinion memo from DOJ concludes FDA lacks jurisdiction to regulate execution drugs

As long-time readers know, state execution efforts have sometimes been thwarted in recent years because of an inability to access needed drugs for lethal injections. This new Washington Post article, headlined "Justice Department says FDA ‘lacks jurisdiction’ over death-penalty drugs," reports on the possible start to a new chapter in this long-running saga. Here are the details:

The Justice Department says in a new legal opinion that the Food and Drug Administration does not have authority over drugs used in lethal injections, a stance sure to be challenged by death-penalty opponents. The department’s Office of Legal Counsel said that “articles intended for use in capital punishment by a state or the federal government cannot be regulated as ‘drugs’ or ‘devices.’ ”

The legal opinion, issued this month, comes as states have struggled in recent years to obtain drugs for lethal injections, which remain the country’s primary method of execution even as the number of executions has declined.

In 2015, the FDA blocked Texas from importing shipments of an anesthetic from an overseas distributor, finalizing the decision two years later. The agency argued the importation was illegal because the drug, sodium thiopental, was not approved in the United States and was improperly labeled. It also cited a 2012 federal injunction barring the agency from allowing the drug’s importation.

Texas responded to the FDA’s move by suing the agency in early 2017, claiming the agency was interfering with the state’s responsibility to carry out its law enforcement duties. The lawsuit was filed shortly before President Trump took office. Trump has long been a supporter of capital punishment. while his Senate-confirmed attorneys general — Jeff Sessions, who left the post last year, and William P. Barr, who assumed the job this year — have also backed the practice.

The legal opinion from the Justice Department this month sides against the FDA and with Texas. It says that drugs intended for executions are different from any others, noting that “they exclusively inflict harm” and “are not intended to produce any benefit for the end user.” It expressly highlights “the narrowness of our conclusion,” saying that it does not address whether the FDA “has jurisdiction over drugs intended for use in physician-assisted suicide.”

But it also takes a broad view of the issues at hand, arguing that if the FDA had jurisdiction over drugs meant for executions, it would have similar power over other areas — such as firearms — which the agency has not sought to regulate.

The Justice Department’s opinion is unlikely to have any immediate effect, however, because the FDA is still operating under the 2012 injunction. It is not clear whether the Justice Department will seek to have that injunction lifted, a move that could spark a long legal tussle.

The opinion seems aimed at “giving a green light” to corrections officials to look abroad for drugs needed for executions, said Deborah Denno, a law professor at Fordham University and a death-penalty expert. “I think this has very broad ramifications, unfortunately,” Denno said in an interview. “This is intended to allow departments of corrections to access drugs outside the country because they’re having so much difficulty doing so.”

While European companies have objected to their products being used in executions, corrections officials could have more luck turning to countries such as China or India, Denno said. “It has the potential to open the floodgates,” she said....

The FDA, in defending its efforts to block states from importing unapproved sodium thiopental has cited the 2012 injunction relating to the drug. That ruling came after death-row inmates filed a lawsuit against the Obama administration, saying the FDA was acting unlawfully by exercising “enforcement discretion” to allow states to import unapproved sodium thiopental from an unregistered foreign facility.

Despite the 2012 order, however, states continued to order sodium thiopental from overseas. BuzzFeed News found that at least three states — Nebraska, Texas and Arizona — had tried to import drugs from a supplier in India despite getting warnings from the FDA in 2015.

The Texas lawsuit, filed in the waning days of the Obama administration, says the state alerted federal officials in June 2015 that its Department of Criminal Justice — which is responsible for the state’s executions — planned to “import thiopental sodium intended for law enforcement purposes.” The lawsuit said the state’s “foreign distributor” shipped 1,000 vials of the drug to Houston in late July 2015, and not long after, the drugs were impounded. According to the FDA, the agency also impounded a shipment intended for Arizona that same year. Texas officials said they had obtained the drugs legally and referred to the government’s actions as an “unjustified seizure.”

The OLC opinion is titled "Whether the Food and Drug Administration Has Jurisdiction over Articles Intended for Use in Lawful Executions."  The opinion runs 26 pages and is available at this link.  Here is its concluding paragraph:

We conclude that articles intended for use in capital punishment by a State or the federal government cannot be regulated as “drugs” or “devices” under the FDCA. FDA accordingly lacks jurisdiction to regulate such articles for that intended use.

Chris Geidner, who did terrific reporting on these issues when at BuzzFeed News, has this lengthy tweet thread criticizing the substance of the OLC memo and concluding with just the right questions:

FINALLY: I'm not sure I get what the point of this OLC memo is.  To quote Madonna as Evita, "Where do we go from here?"  The injunction still exists.  This is OLC's opinion.  Is someone going to seek to have the injunction vacated?  Does DOJ think they can just ignore it?  What now?

May 15, 2019 at 10:01 AM | Permalink

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