Amicus brief in US Supreme Court case by pharmacy, medicine, and health policy experts
A coalition of drug regulators and experts has filed a brief in the US Supreme Court warning that death rows’ efforts to obtain lethal injection drugs could end up causing a “public health crisis.”
The brief, filed in Bucklew v. Precythe in July 2018, was signed by 18 medicines experts, including a former FDA Commissioner and Deputy Commissioner.
The experts warn that drug makers’ restrictions on the sale of their drugs for capital punishment mean a small minority of states are now obtaining drugs through “overseas sellers, unlicensed middlemen, and secret compounding pharmacies…undermin(ing) federal laws that protect the public health.”
“States are willingly undermining the federal drug control regime; they are seeking execution drugs through unauthorized channels and importing unapproved products or ingredients from overseas suppliers who are not subject to U.S. inspection or oversight; they are relying on pharmacy compounding to produce a finished product even though compounding pharmacies are virtually unregulated in that regard; and they are actively violating the rules laid out in federal law for registration, importation, distribution, and security controls to prevent abuse and diversion. Each of these facts is problematic individually from a public health perspective. Collectively, they could lead to a public health crisis.”
The brief goes on to explain that the public health risks created are “not merely theoretical,” warning that “drugs obtained by States ostensibly for lethal injection have been diverted from that use and have reached the patient population.”
The document notes the tangible harm this has caused patients, who have “been exposed to substandard drugs compounded at pharmacies operating under the cover of ‘execution secrecy’ laws that effectively place the compounders beyond the scope of regulation by federal and state authorities.”
The submission draws from a recent study published in the Journal of the American Pharmacists Association (JAPhA), which warns that death penalty states could end up causing a public health emergency through their efforts to source lethal injection drugs. This research was authored by Dr Prashant Yadav, a globally recognized expert in healthcare supply chains from Harvard Medical School; Andy Stergachis, Editor in Chief of JAPhA and expert consultant to the Food and Drug Administration; and Dr Rebecca Weintraub, Director of the Global Health Delivery Project at Harvard University.
In filing the brief, the experts have made clear that they take no formal position on capital punishment, but simply “urge the Court to hold that the pursuit of execution by lethal injection does not permit a state to violate federal laws and regulations that protect the public health.”