Senator’s Legislation Shakes Up FDA Authority

FDA logo under a magnifying glass.

Senator Josh Hawley has introduced legislation that would strip FDA approval from the abortion pill mifepristone and ban its distribution nationwide, directly challenging federal regulatory authority in a move that could eliminate the method used in 63% of all abortions.

Story Snapshot

  • The Safeguarding Women from Chemical Abortion Act would revoke mifepristone’s FDA approval and classify its distribution for abortion as a federal violation
  • Bill creates private right of action allowing women to sue manufacturers for damages, targeting companies like Danco Laboratories
  • Legislation cites research claiming complication rates 22 times higher than FDA-approved label indications
  • Trump administration’s position remains unclear despite conducting its own review of Biden-era mifepristone policies

Hawley Escalates Fight Against Abortion Pill

Senator Josh Hawley introduced the Safeguarding Women from Chemical Abortion Act on March 11, 2026, representing a significant escalation in conservative efforts to restrict abortion access through federal legislation. The Missouri Republican’s bill would revoke FDA approval granted during the Clinton administration in 2000 and classify mifepristone distribution for pregnancy termination as a violation of federal law. Hawley argues only Congress possesses authority to withdraw the approval, directly challenging regulatory agencies’ power over pharmaceutical decisions. The legislation includes a private litigation mechanism enabling women to sue manufacturers for damages.

Bill Targets Drug Dominating Abortion Access

Mifepristone has become the dominant abortion method in America, accounting for 63% of all abortions in 2023. The Biden administration implemented policies easing restrictions on mail-order abortion pills, which pro-life organizations estimate facilitate approximately 500 abortions daily. Hawley’s legislation would eliminate this telehealth access entirely, reversing what conservatives view as dangerous regulatory overreach. The bill positions itself as protecting women’s health rather than restricting abortion rights, framing the pharmaceutical companies as profit-driven entities endangering women. This represents a marked departure from Hawley’s previous May 2025 legislation, which sought FDA safeguards rather than outright prohibition.

Safety Claims Challenge FDA Approval

The bill relies heavily on Ethics and Public Policy Center research claiming mifepristone’s side effect rate is 22 times higher than FDA-approved label indications. The analysis of 865,727 insurance claims between 2017 and 2023 asserts more than one in ten women experienced infection, hemorrhaging, or another serious or life-threatening adverse event. At a Capitol press conference, Hawley featured testimonies from women who reported adverse effects from mifepristone, emphasizing manufacturer profits over patient safety. FDA Commissioner Marty Makary pledged to conduct a safety review, though no timeline or methodology has been specified. This data dispute highlights fundamental disagreements over pharmaceutical regulation and women’s health protection.

Uncertain Path Forward in Trump Era

The legislation faces significant obstacles despite Republican congressional control. President Trump indicated as a 2024 candidate he would veto a national abortion ban, creating uncertainty about administration support for Hawley’s bill. The Trump Justice Department has requested judges pause state lawsuits challenging Biden-era mifepristone policies, suggesting the administration prefers conducting its own review rather than supporting immediate federal prohibition. Abortion restrictions have consistently failed to gain legislative traction since the 2022 Dobbs decision returned regulation to states. The Supreme Court unanimously rejected a 2024 challenge to mifepristone’s FDA approval, though the ruling addressed legal standing rather than drug safety merits, leaving the substantive debate unresolved.

West Virginia’s Senate passed a state-level abortion pill ban in February 2026, demonstrating momentum at the state level that federal legislation has yet to match. The bill remains in early legislative stages with no committee assignment or co-sponsor information publicly available. If enacted, the legislation would eliminate mail-order abortion pill access, expose manufacturers to civil litigation, and restrict healthcare providers from prescribing mifepristone even for off-label medical uses. The economic impact would eliminate a significant pharmaceutical market while creating substantial litigation costs. For women seeking abortion services, particularly in rural and underserved areas, the bill would eliminate the most accessible abortion method and compound restrictions already in place across multiple states.

Sources:

Hawley introduces bill to strip FDA approval from ‘inherently dangerous’ abortion pill – Fox News

Sen. Hawley introduces bill to revoke FDA approval of abortion pill – OSV News

Hawley Introduces Bill to Ban Chemical Abortion Drug – Hawley Senate

Abortion Pill Ban Clears Senate – WV Legislature Blog

Hawley unveils bill to ban abortion pill, strip FDA approval – Courthouse News