Preemption Exemption: FDA-Approved Abortion Drugs After Dobbs

Dobbs v. Jackson Women’s Health Organization held that no constitutional right to abortion exists, overruling Roe v. Wade and Planned Parenthood of Southeastern Pennsylvania v. Casey. After Dobbs, states are free to regulate abortion as they see fit. 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. The Court handed down many cases which attempted to bring clarity to the murky standard. 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. 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. 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. 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. 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