S-4066-119
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sponsored by Josh Hawley (R-MO)
What it does
This bill would deem the FDA's approval of mifepristone (Mifeprex/RU-486) for terminating pregnancy as withdrawn 14 days after enactment, making it illegal to ship or sell the drug in interstate commerce for that purpose. It would also make mifepristone "misbranded" if its labeling references use for pregnancy termination. Separately, starting 90 days after enactment, the bill would create a federal civil lawsuit right allowing any individual harmed — physically or mentally — by mifepristone to sue its manufacturer for compensatory damages, punitive damages, and attorney's fees.
Who benefits
Individuals who believe they were harmed by mifepristone and seek a federal legal remedy, including those who may have faced complications from medication abortion. Attorneys who specialize in pharmaceutical tort litigation. States that have restricted or banned abortion and whose policies would be reinforced by a federal ban on the drug. Anti-abortion advocacy organizations whose policy goals align with restricting medication abortion access.
Who is hurt
People who use mifepristone to terminate a pregnancy, who would lose access to the most commonly used medication abortion method in the U.S. (mifepristone is used in roughly 63% of all U.S. abortions, per the Guttmacher Institute). People who use mifepristone for non-abortion purposes, such as managing Cushing's syndrome (an FDA-approved use not addressed by this bill, though the misbranding provision is limited to pregnancy termination labeling). Pharmaceutical manufacturers of mifepristone and its generics, who would face both loss of market and expanded tort liability. Healthcare providers who prescribe mifepristone. Patients in states where abortion remains legal who would lose access to a medication abortion option. Pharmacies that currently dispense mifepristone under the FDA's REMS program.
Supporters argue
Supporters argue that the FDA's 2000 approval of mifepristone — and its subsequent loosening of safety restrictions in 2016 and 2021 — bypassed adequate safety review, pointing to studies they contend show elevated rates of emergency room visits and serious complications compared to surgical abortion. They contend that Congress, not an executive agency, should make the ultimate determination on whether a drug with this level of controversy and risk remains on the market, and that the federal tort provision fills a gap by giving harmed women a direct legal remedy against manufacturers who profited from the drug's distribution.
Opponents argue
Opponents argue that mifepristone has been used by more than 5 million people in the U.S. since 2000 and that the FDA's own data show a serious adverse event rate below 0.5%, making it one of the most studied drugs in the agency's history. They contend that Congress overriding a science-based FDA approval through legislation — rather than through the agency's established safety review process — sets a dangerous precedent for politicizing drug regulation, and that the broadly worded tort provision, which includes "harm to mental health" attributable "in whole or in part" to the drug, could expose manufacturers to virtually unlimited liability for any negative emotional experience following use.
Constitutional context
Congress has broad authority to regulate drugs in interstate commerce under the Commerce Clause (Art. I, §8, cl. 3) and to structure federal tort remedies. However, post-Dobbs (2022), abortion regulation has been returned to legislatures, and this bill operates in that space. The bill's direct legislative override of an FDA approval also raises questions under the major questions doctrine (West Virginia v. EPA, 2022), as courts may scrutinize whether Congress is acting within its own authority or improperly directing agency outcomes — though here Congress is acting directly, not delegating to an agency.
Checks and balances
Congress would gain direct authority over a specific FDA drug approval, bypassing the executive branch's normal drug safety review process; the primary check would be judicial review of the bill's constitutionality and the scope of the tort liability provisions.
Historical precedent
Congress has not previously legislated the withdrawal of a specific FDA drug approval by statute; the FDA's own administrative withdrawal process under 21 U.S.C. §355(e) has been used, but direct congressional override of an approved NDA has no direct modern precedent.