Second Century Initiative Associate Professor and former attorney for the Food and Drug Administration Patricia J. Zettler was recently quoted by Regulatory Focus over a recent Justice Department memo asserting that the FDA does not have jurisdiction over drugs or devices intended for use in the death penalty, such as sodium thiopental.
Regulatory Focus writes:
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.”
Read the full article at https://www.raps.org/news-and-articles/news-articles/2019/5/fda-to-follow-doj-memo-on-limiting-its-regulation. For more about Zettler, visit https://nextgen.gsu.edu/2018/06/26/2ci-qa-patricia-j-zettler/.
– Jeremy Craig, Communications Manager, Office of the Provost