FDA lacks jurisdiction to regulate lethal injection drugs, Justice Department argues
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The Food and Drug Administration has no jurisdiction to regulate drugs and devices used in executions, according to a legal opinion by the Department of Justice’s Office of Legal Counsel.
Articles intended for use in capital punishment aren’t covered by the federal Food, Drug and Cosmetic Act, according to the May 3 opinion that was posted online Tuesday. The New York Times, Politico and the Washington Post have coverage of the opinion, signed by Steven Engel, assistant attorney general for the Office of Legal Counsel.
The legal opinion appears intended to allow departments of corrections to access drugs from outside the country, according to Deborah Denno, a law professor at Fordham University and a death penalty expert. “I think this has very broad ramifications, unfortunately,” Denno told the Washington Post.
The OLC opinion relies on a 2000 Supreme Court ruling that held that Congress had not given the FDA authority to regulate tobacco products. The 2000 decision said tobacco didn’t fit within the agency’s regulatory scheme because it can’t safely be used for any therapeutic purpose, yet it can’t be banned under tobacco-specific legislation enacted by Congress.
Applying the Supreme Court decision, the FDA lacks jurisdiction to regulate execution drugs and devices, the OLC legal opinion says. On the one hand, the FDA would have to ban execution drugs and devices under the Food, Drug and Cosmetic Act. On the other hand, the Constitution and laws “presuppose the continued availability of capital punishment for the most heinous federal and state crimes,” the legal opinion says.
The OLC opinion notes that a federal judge issued a permanent injunction in 2012 that required the FDA to block importation of the death penalty drug sodium thiopental. A federal appeals court affirmed in 2012. The drug was being imported after the only U.S. manufacturer stopped making it in 2009.
Those rulings turned on whether the FDA could exercise enforcement discretion over sodium thiopental and did not address the broader question of FDA jurisdiction, the OLC opinion says. It’s not clear whether the DOJ will seek to lift the injunction, according to the Washington Post.
In 2015, the FDA impounded imported shipments of sodium thiopental that were on their way to Arizona and Texas. In January 2017, Texas sued the FDA for release of the shipment.
The OLC says its opinion was narrow, and it doesn’t reach the FDA’s regulation of products used for aesthetic purposes, such as breast augmentation or the regulation of recreational narcotics. “Nor do we address whether FDA has jurisdiction over drugs intended for use in physician-assisted suicide,” the legal opinion says.
