REVIEWING REFUSAL: LETHAL INJECTION, THE FDA, AND THE COURTS.

• Author: Shi, Andrew

INTRODUCTION 246 I. REVIEW UNDER CURRENT LAW 249 A. The FDA Has Jurisdiction to Regulate Compounded 249 Lethal Drugs B. FDA Inaction Is Unreviewable Under Existing Law 258 II. REVIEW UNDER DISCRETE LOOK 262 A. Discrete Look Described 262 1. Discrete 263 2. Nonenforcement 264 3. Violation 265 4. Unitary Regulatory Scheme 266 B. Discrete Look Applied 268 1. Discrete 268 2. Nonenforcement 269 3. Violation 271 4. Unitary Regulatory Scheme 271 C. Discrete Look Justified 272 CONCLUSION 276 INTRODUCTION

Most death row inmates today face execution by lethal injection through a series of compounded lethal drugs. However, this lethal injection method has only become standard practice within the last decade. (1) Traditionally, state correctional facilities conducted executions using manufactured drugs, which national pharmaceutical companies produced at industry-grade standards. Starting in 2010, states began running out of manufactured drugs when pharmaceutical companies placed distribution restrictions on such drugs to ensure that states could not obtain the drugs for use in lethal injections. (2) Furthermore, a court order effectively blocked foreign imports of a misbranded drug that several state correctional departments had turned to for lethal injections. (3) This drug shortage crisis caused states to settle for a solution that would allow lethal injection to continue uninterrupted: sourcing drugs from local compounders. (4)

Compounded lethal drugs are mixed by individuals at local shops according to their own specifications and are widely regarded to be less safe than manufactured drugs. (5) These drugs receive little government oversight in their production. Although the Food and Drug Administration (FDA) has statutory authority to regulate compounded lethal drugs, it has consistently refused to do so. (6) Instead, the federal government has mostly left regulation of compounders to the states. (7) Despite being responsible for licensing and overseeing compounders, some states have passed laws that insulate these compounders from regulation by state boards of pharmacy, medicine, and health. (8) In fact, over twenty states have passed secrecy laws or engaged in practices that forbid public disclosure of their suppliers' identities in order to encourage compounders to enter into contracts to supply states compounded lethal drugs. (9)

Non-regulation of compounded lethal drugs has contributed to a disturbing series of botched executions. In 2012, a death-row inmate's heart continued to beat for at least twenty minutes after South Dakota officials injected him with compounded lethal drugs for execution. (10) In 2014, an Arizona death-row inmate died after two hours of "gasping and snorting." (11) Five of the eleven men executed in Texas in 2018 indicated in their final moments that they could feel the compounded drugs burning their bodies inside out. (12)

Non-regulation of compounded lethal drugs also poses profound dangers to the public. A 2018 article in the Journal of the American Pharmacists Association observed that an unregulated supply chain of these substandard drugs threatens the general public:

With states increasingly using compounded medicines in executions, there is a greater risk that non-pharmaceutical-grade, substandard or contaminated product will enter the United States market .... The secrecy surrounding the execution drug procurement practices of death-penalty states risks undermining channels for the importation of medicines that are otherwise safe and effective. Once an illicit supply channel is established with a supplier, it is extremely challenging to control which drug products move through it and which customers they reach, particularly in a context where the FDA, DEA [Drug Enforcement Administration], and state boards of pharmacy are prevented from performing their usual regulatory duties. These practices also create the risk that substandard execution drugs fall directly into the wider patient population. This has already happened in the manufactured drug context in several documented instances in which lethal injection drugs were diverted into the patient market. (13) Constitutional litigation is one strategy to urge state or federal governments to regulate compounded lethal drugs. However, if the Supreme Court's past rulings on the constitutionality of lethal injection provide any clue, it is unlikely the Court would find execution by these unregulated, compounded lethal drugs to be unconstitutional. (14) This Comment takes a different path of urging regulation by focusing on administrative litigation against the FDA. Compounded drugs used in lethal injection are, after all, drugs. A core component of the FDA's mission is to regulate drugs. It is the Food and Drug Administration. And yet the FDA refuses to regulate these drugs.

The FDA can refuse to regulate these drugs because the law insulates its inaction from judicial review. While courts regularly conduct arbitrary and capricious review of agency enforcement actions, they are far more reluctant to review agency inaction. In fact, the Supreme Court has created a presumption against judicial review of agency inaction. (15) The basic idea behind this principle is that agencies are far better positioned than courts to know how to allocate regulatory priorities against scarce resources to achieve their statutory duties. (16) So, the reasoning goes, courts should not be in the business of second-guessing agency inaction. This presumption is powerful because it closes the door to litigants at the outset of litigation regardless of how strong their claims are on the merits. Simply put, courts are foreclosed from reviewing FDA inaction.

The presumption against judicial review seems unreasonable when the stakes are so high for death row inmates and the public at large. Although the presumption against judicial review may be a sound principle generally, the FDA's refusal to regulate compounded lethal drugs is the kind of agency inaction that one might think necessitates at least some judicial scrutiny. I therefore propose creating a narrow avenue of judicial review for cases like these. My rule, what I will call "discrete look," identifies opportunities for judicial review that are sensible and manageable for the courts to engage in, while also keeping these avenues sufficiently narrow to respect the underlying policy rationales of the existing doctrine. Under discrete look, when death row inmates sue the FDA for its failure to regulate compounded lethal drugs, courts can no longer treat the FDA's inaction as an exercise of unreviewable enforcement discretion.

This Comment first establishes in Part I that the FDA has jurisdiction to regulate compounded lethal drugs. This is an important premise because an agency's duty to regulate presupposes that it has jurisdiction to regulate in the first place. Part I then moves on to show that under existing case law, the FDA is not subject to judicial review for refusing to regulate compounded lethal drugs. In Part II, I propose a rule, which I label "discrete look," that would allow judicial review in cases like these. My rule is broad in the sense that it is not bound to the context of lethal injection, but it is narrow in the sense that it requires plaintiffs to meet a test to qualify for judicial review. Part II then applies discrete look to the case of lethal injections to show that the FDA's inaction in that context would be subject to judicial review. Finally, I discuss the general benefits discrete look brings to administrative law.

1. REVIEW UNDER CURRENT LAW

   Section A of this Part shows that the FDA can regulate compounded lethal drugs. It first explains the statutory framework for FDA jurisdiction. Next, it discusses how two states have responded to claims about FDA jurisdiction. Finally, it addresses objections that Congress did not intend the FDA to have jurisdiction and that jurisdiction would produce an absurd outcome.

   Section B of first describes the Supreme Court case that created the presumption against judicial review of agency inaction. Then it discusses how the circuit courts have developed this doctrine. It concludes that under existing law, FDA inaction toward compounded lethal drugs is unreviewable.

   1. The FDA Has Jurisdiction to Regulate Compounded Lethal Drugs

      The FDA can regulate compounded lethal drugs because they are "new drugs." The Federal Food, Drug, and Cosmetic Act (FDCA) charges the FDA to regulate the interstate activity of new drugs, which the statute defines as any drug "the composition of which is such that such drug is not generally recognized ... as safe and effective . . . ." (17) For new drugs to enter the market, they must undergo an expensive and lengthy FDA clinical trial process to establish that they are "safe and effective." (18) Although the FDA's statutory framework never expressly says that compounded lethal drugs are new drugs, the statute's text requires this conclusion for two reasons.

      First, a compounded drug is a new drug because of the term's broad definition. Compounders create new drugs all the time when they compound because the act of compounding requires mixing existing drugs to achieve a unique composition as the end product. As the Fifth Circuit noted in a case turning on this very issue,

      If a compounder changes the composition of an approved drug--by mixing or combining an approved drug with something else to create a different substance or by creating special dosage or delivery forms of an approved drug inconsistent with a drug's labeling--the composition of the individualized concoction created by a compounding pharmacist will not have been previously approved for use. The resulting substance is therefore a 'new drug.' (19)

      Second, the structure of the FDA's statutory scheme assumes that compounded drugs are new drugs. The 1997 Food and Drug Administration Modernization Act (FDAMA) empowered the FDA to regulate...