PREEMPTION EXEMPTION: FDA-APPROVED ABORTION DRUGS AFTER DOBBS.

• Author: Huber, Jared C.

INTRODUCTION

Dobbs v. Jackson Women's Health Organization held that no constitutional right to abortion exists, (1) overruling Roe v. Wade and Planned Parenthood of Southeastern Pennsylvania v. Casey. (2) After Dobbs, states are free to regulate abortion as they see fit. (3) Under Roe and Casey's old regime, a state could not regulate abortion in a way that presented an "undue burden on a woman's ability" to decide to abort. (4) The Court handed down many cases which attempted to bring clarity to the murky standard. (5) But the conglomeration of interpretation is now wiped away.

In Dobbs's wake, states and the federal government are left with a host of questions that they could not approach under Roe and Casey. (6) One is whether states have the authority to prohibit the use of abortion-inducing drugs within their borders--regardless of whether the Food and Drug Administration (FDA) approves them as safe and effective for use. (7) Immediately following Dobbs, the Biden administration anticipatorily issued statements claiming the FDA's regulatory determination of the safety and efficacy of mifepristone (Mifeprex), the only currently approved abortion-inducing drug, preempted state regulations or bans based on contrary state safety and efficacy determinations. (8) While these proclamations evidence the administration's stance, they do not resolve the underlying question of whether state mifepristone bans are preempted by FDA approval. (9)

To assess this novel question, Part I surveys the birth of the FDA, Congress's purposes in instituting it, and its approval of mifepristone. Part II examines the current preemption doctrine and uncovers the particularities of its application for federal agency actions and regulations. Part III will look at express, impossibility, obstacle, and field preemption and demonstrate how under current precedent and Congress's discernable purposes, none of them would preempt a state ban on the use of FDA-approved mifepristone. Congress has never expressed a clear intent to expressly preempt any state drug regulations through its grant of power to the FDA. Nor has it shown any clear purpose to equate FDA approval with ensuring approved drugs remain freely accessible to the public; approving a product to be used by the public does not necessarily require that that product is freely available on the marketplace. Rather, Congress intended the FDA to prevent unsafe or inefficacious drugs from reaching the market without demanding that those drugs remain easily and freely accessible to the entire market. State bans on FDA-approved drugs do not rise as an obstruction to this congressional objective. Finally, Congress has never granted the FDA the entire field of drug regulation but has instead recognized the existence of concurrent state action in the field. This recognition precludes any possibility that Congress intended the FDA to have exclusive, comprehensive domain over drug regulations. Thus, a state ban on FDA-approved mifepristone would not be preempted by current federal law or regulation.

1. CONGRESS'S PURPOSE, FDA HISTORY AND APPROVAL PROCESS

   To understand how that is so, the FDA's history, purpose, and scope of power provide the starting place to analyze its preemptory power over the drugs it approves. This Part examines the creation of the FDA and how its function has evolved over its lifetime so that Congress's express and nonexpress purposes for the FDA can be understood. Understanding Congress's purpose for the FDA--and the authority Congress granted to carry out its objectives for the FDA--are critical to understanding the extent of the agency's preemptory power, especially over drugs it approves for use as safe and effective. This Part continues by examining the approval process the FDA uses for its drugs is necessary to uncover exactly how state laws and regulations may conflict with FDA requirements, especially ones that arise from the approval and labeling process. Finally, this Part looks specifically to the FDA's approval of mifepristone, what elements of it are vital to determining the contours of FDA preemption of state abortion bans, and how the shift Dobbs wrought blows open the realm of reasons a state can point to that do not inevitably contradict FDA determinations.

   1. Background & Function of the FDA

      Congress gave birth to the FDA in the Pure Food and Drug Act of 1906. (10) The Act prohibited the manufacture, sale, or transportation of "adulterated or misbranded" foods and drugs. (11) Congress fashioned the legislation to carry out its purpose to supplement--and not displace--"the protection for consumers already provided by state regulation and common-law liability." (12) Rather, the Act allowed the federal government to add a layer of "complementary" (13) protection over drug and medical regulations, recognizing that those were fields "which the States have traditionally occupied." (14) In 1938, Congress passed the Federal Food, Drug, and Cosmetic Act (FDCA), in part to allow the FDA to further regulate food and drugs by granting the authority to prohibit the distribution of new drugs until the FDA approved them. (15) Initially, the FDA simply had to prove that the drug was unsafe for distribution, but Congress amended the FDCA in 1962 to require the manufacturer to prove that the drug was safe for distribution. (16) Continuing the complementary relationship between state and federal law in drug regulation, Congress's 1962 amendments expressly stated that "[n]othing in the amendments... shall be construed as invalidating any provision of State law... unless there is a direct and positive conflict." (17) Despite Congress's incremental expansion of the FDA's complementary power over drug regulation, it "took care to preserve state law." (18) In the history giving rise to the FDA, Congress made clear that its purpose and authority were oriented toward consumer protection and allowing concurrent state and federal regulation in that field advanced, and did not impede, that purpose. Never does that consumer protection purpose seem orientated toward the distinguishable purpose of ensuring public access to approved products.

      To that end, one of the FDA's primary functions today is to approve new drugs for use. The FDA's current approval process for new drugs requires manufacturers to submit a new drug application (NDA) that demonstrates the drug is safe and effective for use, proven with extensive documentation about the drug's composition and effects. (19) The manufacturer must include the proposed labeling for the new drug (20) along with a detailed "discussion of why the [drug's] benefits exceed the risks under the conditions stated in the labeling." (21) The FDA takes in all of the submitted evidence and decides whether the drug is "safe for use" under the conditions the manufacturer laid out in the proposed label. (22) The FDA will deem the drug safe and effective if its "probable therapeutic benefits... outweigh its risk of harm." (23) Once approved, a manufacturer is expressly prohibited from changing the drug product in any "major" way. (24) Major changes include the "qualitative or quantitative formulation of the drug product," inactive ingredients, or "specifications provided in the approved NDA." (25) Compiling and submitting an NDA is a daunting task as each typically "spans thousands of pages and is based on clinical trials conducted over several years." (26) If approved, the approval represents the agency's determination that the drug is safe and effective for marketing and distribution. But a mere determination of safety and efficacy at one point in time by one agency "has never been regarded as a final stamp of approval of the drug's safety." (27) Neither has the FDA's determination of a drug as merely safe and effective ever been equated to safe, effective, and required to be sold. (28)

      The FDA's drug approval process can occur in two different ways. After one version of a new drug gains FDA approval, other manufacturers who produce the same drug may seek approval under an expedited process. (29) Oftentimes, manufacturers of a generic version of a name-brand drug will use this secondary process. (30) Congress created this secondary path to FDA approval in 1984 to help smooth the approval process for drugs that substantively had already undergone rigorous evaluation. (31) Drugs approved by this secondary path must be equivalent to the one previously approved. (32) The generic drug must have the same active ingredient(s) and methods of administration as the brand-name drug. (33) Just as with name-brand drugs, the FDA permits no major changes unless they are pre-approved. (34) Importantly, the second drug must also almost always have the same labeling as the previous drug. (35) Its approval can be revoked if the label or any other major change deviates from the brand-name drug. (36)

      Beyond mere approval of a drug as safe and effective, the FDA may impose a Risk Evaluation and Mitigation System (REMS). (37) A REMS is a safety program that the FDA requires for certain drugs that have "serious safety concerns" so that the drug's benefits can be sure to outweigh its inherent risks. (38) The imposition of a REMS is rare (39)--"only a few medications [even] require a REMS." (40) One such example is mifepristone, the only FDA-approved drug for terminating a pregnancy. (41) Mifepristone's REMS provides that it must be dispensed under the supervision of a qualified healthcare provider who only dispenses it after requiring a patient to sign a Patient Agreement Form. (42) The FDA implements and revises these requirements in light of "specific scientific findings" about the drug's safety and efficacy. (43)

   2. Mifepristone Approval History

      The FDA first approved Mifeprex, the name-brand version of mifepristone, in 2000 under suspicious circumstances. (44) In 2016, the FDA approved a supplemental application based on further data submitted by the...