United States: Texas's Challenge To The FDA's Authority

Last Updated: May 11 2017
Article by John Sullivan

Executions by lethal injection are in the news. Arkansas recently executed four inmates in just eight days. One of the drugs that it uses for its three-drug lethal injection protocol was set to move beyond its expiration date. And, apparently, Arkansas wanted to use them before that happened.  It seems that states are finding it more and more difficult to get the drugs that they need for lethal-injection executions.

In fact, Texas so badly needs to get access to one of those drugs that it is now suing the FDA to get it. The drug—thiopental sodium—is used to render inmates unconscious before the lethal drugs are administered. But Texas can't get thiopental sodium anymore because the FDA, as of five years ago, bans its importation. It did so after a group of inmates successfully sued the FDA in federal court to stop it from allowing thiopental sodium into the country. The inmates claimed that thiopental sodium (i) was "misbranded" and (ii) an unapproved new drug. Interestingly, the FDA conceded both points. It argued that it could still allow thiopental sodium into the country, however, by exercising its enforcement discretion. The federal court disagreed. See Beaty v. FDA, 853 F. Supp. 2d 30 (D.D.C. 2012), aff'd in part, rev'd in part sub nom., Cook v. FDA, 733 F.2d 1 (D.C. Cir. 2013). The court held that the language of the Food, Drug and Cosmetic Act, in particular its repeated use of the word "shall," gave the FDA no such discretion. We wrote about that decision here.

Since then, the FDA has banned the importation of thiopental sodium. And that's where Texas comes in. Texas needs thiopental sodium for its lethal injection program. In 2015, Texas attempted to import thiopental sodium to be used in its lethal injection protocol, and the FDA detained it. On April 20, 2017, after a lengthy administrative process, the FDA reached (what Texas calls) a final decision, holding firm to its determination that it must follow the Beaty decision and ban the importation of thiopental sodium.

And so, just over a week ago, the Texas Department of Criminal Justice filed an amended complaint in federal court in Texas challenging the FDA's determination. Texas, however, does not claim that the FDA does in fact have the enforcement discretion necessary to allow thiopental sodium into the country. Instead, it tries to shift the focus of the dispute, claiming that thiopental sodium is not misbranded and that its distribution does not require FDA approval.

In particular, Texas claims that thiopental sodium does not meet the FDCA's definition of a "new drug" and therefore does not require FDA approval. Under the FDCA, a drug is a "new drug" requiring approval if it is not generally recognized by experts "as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling." 21 U.S.C § 321(p). Texas claims that the labeling of the thiopental sodium it imported makes no statements about its use at all and, therefore, it does not qualify as a new drug that requires approval. Texas also claims that its proposed use of thiopental sodium falls under a "law enforcement" exception (21 C.F.R. § 201.125) to the statutory requirement that a drug come with instructions for use and, therefore, the thiopental sodium was not "misbranded" for failure to come with such instructions.

Well, these are certainly interesting claims, ones that we are quite sure that the FDA will fight. In fact, the FDA's administrative decision states that it doesn't buy this arguments. The FDA believes that the statements made on the thiopental sodium packaging, as limited as they are, suggest its use for lethal injections and therefore constitute labeling requiring its approval as a new drug. It also believes that the "law enforcement" exception does not apply when the drug is to be administered to humans.

From our point of view, we know that a regulatory agency like the FDA is not going to accept a claim that limits it authority or jurisdiction without a fight—particularly when, as here, it addresses whether the FDA must approve a "new drug," one of the most important roles that the FDA plays. Accordingly, this litigation will address important issues related to labeling and "new drugs," and we will follow it.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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