Justice Department says FDA 'lacks jurisdiction' over death-penalty drugs

The Justice Department has issued a new legal opinion concluding that FDA does not have authority over drugs used in lethal injections.

The Justice Department has issued a new legal opinion concluding that FDA does not have authority over drugs used in lethal injections. 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.'" FDA in 2015 blocked Texas from importing shipments of an anesthetic from an overseas distributor, finalizing the decision 2 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 preventing the agency from allowing the drug's importation. Texas sued the agency in early 2017, claiming it was interfering with the state's responsibility to carry out its law enforcement duties. The legal opinion from the Justice Department 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 FDA "has jurisdiction over drugs intended for use in physician-assisted suicide." The opinion is unlikely to have any immediate effect, however, because FDA is still operating under the 2012 injunction. It is not clear whether the Justice Department will seek to have that injunction lifted.