The FDA banned shipments of execution drugs states have been trying to get for months. BuzzFeed News obtained the letter that shows why.
On Thursday, the federal government formally blocked 2 shipments of a massive amount of execution drugs on their way to Texas and Arizona.
The decision to block the shipments came after months of legal arguments back-and-forth between the states and the Food and Drug Administration. In announcing the conclusion, the FDA did not include its full decision or the reasons it came to its conclusion that the drugs can't enter the United States.
But the full decision shows the FDA said its hands were tied. BuzzFeed News obtained a redacted copy on Friday through an open records request.
In the decision, the FDA pointed to a 2012 court decision that requires the government block shipments of sodium thiopental, an outdated anesthetic, when the shipments appear to violate the law.
The states argued "that [the case] was 'wrongly decided,'" FDA importer Alexander Lopez wrote to Texas. "But FDA is bound by the terms of the order issued by the District Court in that case."
"We interpret the order to mean what it says: namely, that FDA is required to refuse entry to thiopental produced abroad when it appears that the thiopental is misbranded or an unapproved new drug."
There are no longer any FDA-approved manufacturers of sodium thiopental. Years ago, the sole supplier stopped making the drug because states were using it in lethal injections.
So in 2015, the states turned to a man in India who has made more than $100,000 selling execution drugs to states that have never been able to use his products. He placed a label on the vials that carries the disclaimer that they are "For law enforcement purpose only." Texas and Arizona argued the drugs should be allowed in due to a law enforcement exception.
The FDA responded that a law enforcement exception can't apply, because the drugs will still be used on humans.
"The law enforcement exemption could not have been intended to apply to lethal injection, because FDA issued the regulation ... in 1956, well before any state used lethal injection as a method of execution," Lopez wrote.
If states want to import the drug, they could attempt to have the drug approved - a process that could take years. They argued approving a drug for lethal injection would be absurd, as the approval process requires clinical trials and testing - something that has not been done for lethal injection.
"Here, it is not absurd to suggest that the [law] requires a drug to be shown to be safe and effective for use under the conditions suggested in its labeling," Lopez wrote.
"There are numerous situations where it is difficult to design appropriate clinical trials, such as testing a treatment for anthrax infection or plague. In such cases, FDA regulations may allow flexibility, or trials may differ from what scientists generally envision, but FDA's statutory authority remains the same."
If the states wanted to import the drugs, the FDA said they either needed to get the drug approved, or go to court to lift the 2012 order.
Litigation seems likely. Over the past year and a half, both states have indicated publicly that they would sue if the drugs were denied. Texas has requested the FDA give them time to seek a court order before the drugs are destroyed or returned to India. The FDA said the states have 90 days to export or destroy the drugs.
Source: buzzfeed.com, April 22, 2017
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