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The Justice Department says in a new legal opinion that the drug administration does not have authority over drugs used in injections injections, a stance sure to be challenged by death-penalty opponents.
The Department of Legal Counsel states that "articles intended for use in capital punishment by a state or federal government can not be regulated as 'drugs' or 'devices.'"
The legal opinion, issued earlier this month, has come into force in recent years to obtain drugs for lethal injections, which remain the country's primary method of execution.
In 2015, the FDA blocked Texas from importing shipments of an anesthetic from an overseas distributor, finalizing the decision two years later. The association was illegal because of 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 the drug's import.
Texas responded to the FDA's move by 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 – also backed the practice.
The legal opinion of the FDA and Texas. It says that it is intended to be used only for the purpose of making use of it. "It expressly highlights" the narrowness of our conclusion, "saying that it does not address 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 these situations, it would have had similar powers over other areas – such as firearms – which the agency has not sought to regulate.
The Justice Department's opinion is unlikely, however, because the FDA is still operating under the 2012 injunction. It is not clear that the law will be lifted, that it could have sparked a long legal tussle.
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 because they are having so much difficulty doing so."
While China, India, Denno said. "It has the potential to open the floodgates," she said.
The FDA declined to comment. The Texas attorney general's office did not immediately respond to a request for comment.
The legal opinion was issued after a protracted battle between the FDA and the Justice Department on the regulation of lethal injection drugs.
More than a year ago, then-FDA-Commissioner Scott Gottlieb and then-Attorney General Jeff Sessions had a heated argument in the House of White House.
Sessions wanted the FDA to allow drugs to be used. Gottlieb refused, saying that such a move could undermine the agency's authority. Gottlieb left the agency in April, six months after Sessions left the Justice Department. Neither Sessions nor Gottlieb was available for comment.
States 'difficulties in obtaining lethal injection drugs stem from drug companies' objections to having their products used in executions.
For many years, states of anesthetic, such as sodium thiopental; paralytic; and a product meant to stop the inmate's hearts. But Hospira, maker of sodium thiopental, said in 2011 that it would stop producing the product, a decision the company will be awarded for its use in executions.
In the years that followed, states began turning to new combinations and execution protocols. Nebraska last year became the first state of the art in the implementation of Omaha cabdrivers. Other states debated or adopted options including nitrogen gas or firing squads.
The FDA, in defending its efforts to block states of importing unapproved sodium thiopental has cited the 2012 injunction relating to the drug.
This ruling came into force after the death of the administration, saying that the FDA was acting unlawfully by exerting "enforcement discretion" to allow states to be unjustified.
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 – FDA in 2015.
The Texas lawsuit, filed in the waning days of the Obama administration, says the state alerted the 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 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 law and referred to the government's actions as "unjustified seizure."
In April 2017, the FDA wrote that the agency could not admit the drugs.
Texas quickly filed an amended complaint, but in December, 2017, a federal judge in Texas stayed in the case of a motion to lift it.
The case remains stayed. A status conference had been scheduled for September 2018, but the Trump administration asked for a 90-day continuity and for the case to remain stayed, adding that Texas officials did not oppose that motion. The Trump administration wrote that the federal government had "internal deliberations" that could resolve the lawsuit in a way that "could not provide further details.
Matt Zapotosky contributed to this story.
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