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FDA Loses Major Case Testing its Enforcement Discretion Authority

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By Alexander Gaffney, RF News Editor

The US Food and Drug Administration (FDA) has a complicated history with sodium thiopental, a drug notoriously used as part of a multi-drug cocktail administered to prisoners condemned to death. And complicating the history further is a new ruling by the DC Court of Appeals, which today ruled that the agency may not exercise "enforcement discretion" to allow the drug into the country.

Background

In recent years, death penalty opponents have been using a deep understanding of FDA's regulatory process to go after the drugs used to put prisoners to death. Their mission: If they can't shut down the legal process used to execute some prisoners, they can remove all available and approved tools used to conduct the executions. Due to various legal rulings, only a small group of products may be used in the execution process. One of them is sodium thiopental, a fast-acting general anesthetic administered in a massive dose to immobilize a patient by causing unconsciousness. In some states, the drug is used as part of a three-drug cocktail, while in others it is the sole lethal injection agent. In both cases, it is an essential component.

It is also, as activists have found, a tempting target.

In February 2012, activists began the first of many challenges against FDA's authority to allow the import of sodium thiopental, which currently lacks approved status in the US. The only approved version of the drug, Abbott's Pentothal (#011679) has been discontinued, requiring it to be imported from abroad.

As states have turned to imports to meet their supply demands, legal teams have sued both states and FDA, claiming the drug samples were "wrongfully diverted," and are thus in violation of import restrictions.

The Case: Background

In March 2012, Judge Richard Leon – a regular thorn in the side of FDA – ruled against FDA's allowance of sodium thiopental imports, saying the agency "appears to be simply wrapping itself in the flag of law enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the executioner's needle.”

"How utterly disappointing," he exclaimed.

As Regulatory Focus explained at the time, the ruling could have pernicious effects in at least one respect: FDA uses similar authority to allow the temporary import of foreign drugs to ease drug shortages. For example, it has allowed unapproved variants of the drugs doxorubicin and methotrexate into the country. In theory, if FDA is not allowed to import a drug into the country without having first approved it, it would have one less tool available to confront drug shortages.

That decision was appealed soon thereafter by FDA, and eventually turned into the case Cook v. FDA, named after Daniel Wayne Cook, an Arizona inmate who was unsuccessful in his attempts to avoid his execution, which occurred in August 2012.

Despite Cook's demise, his case lives on, now joined by more than a dozen other defendants seeking similar relief.

New Case Developments

In FDA's appeal argument, which was filed in November 2012, the agency frequently referenced the Supreme Court precedent set by Heckler v. Chaney, which it maintained established the right of FDA to practice "enforcement discretion" in how it decides how to – or not to – practice its authority. In theory, this would allow the agency to not go after an importer of sodium thiopental, even if that entity was breaking the law. Such discretion is "unreviewable," FDA added.

Only that logic had failed to gain traction with the lower court and now, after a review by the DC Court of Appeals, FDA's Heckler argument is in even more trouble.

Writing for the majority of a three-judge panel, Judge Douglas Ginsburg wrote that it had found in favor of the plaintiffs – that is, against FDA – and that the agency would no longer be permitted to allow the importation of sodium thiopental into the country under its enforcement discretion practice.

The lower case, explained Ginsburg, found that FDA's enforcement discretion in this case was reviewable because it was contrary to the law—statute, not policy.  Ginsburg concurred with this analysis, saying no agency authority could overrule an "unambiguous" statute.

The court also addressed FDA's Heckler arguments, saying that despite the similarities of the two cases, the relevant statutory language in the Cook case is more precisely worded, giving FDA less room for discretion.

"The 'enforcement' discretion held unreviewable in Chaney, therefore, was whether to recommend prosecution," the court wrote. "Here, by contrast, the word 'shall' appears in both an antecedent ('shall request ... samples') and the consequent ('shall be refused admission')." By this reading, Ginsburg continued, "shall be refused admission" is a requirement, not an option for FDA to consider.

Perhaps anticipating the potential precedence of the decision, the court later hedged that this instruction should not be taken to apply to FDA-regulated facilities, but rather products from unregistered establishments. "Having found a drug that apparently violates the [Federal Food, Drug and Cosmetic Act], the FDA must 'refuse it admission,'" the court concluded.

Judge: Here are Workarounds for Drug Shortage Issues

The court also noted the argument first advanced by Regulatory Focus, and later FDA itself, that a change in discretion authority would potentially leave it unable to import drugs to solve shortages. Ginsburg wrote that it does not need such authority, and has "ways short of allowing importation of inadmissible drugs to counteract a drug shortage."

"The FDA may exercise enforcement discretion to allow the domestic distribution of a misbranded or unapproved new drug, as the Supreme Court recognized in Chaney, 470 U.S. at 837, and in some cases may invoke its express statutory authority to permit the importation of an unapproved new drug," he continued. "For example, the FDA may designate an unapproved foreign manufactured drug as an investigational new drug (IND), thereby allowing its lawful importation."

However, Ginsburg conceded that the revocation of authority would potentially deprive FDA of its authority to allow the import of unapproved drugs, but said that given the alternative options, "that is hardly an absurd result."

It was not clear at the time of publication whether FDA would appeal the ruling to the Supreme Court.


Cook v. FDA

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