Congress Moves to Override FDA Drug Approval Process
Senator Josh Hawley introduced legislation on March 13, 2026, that would revoke FDA approval for mifepristone, the abortion medication that has been available in the United States since 2000. The bill, co-sponsored by Representative Diana Harshbarger in the House, bypasses the standard pharmaceutical safety review process by using congressional action to ban a drug that the FDA has repeatedly evaluated and maintained on the market for 25 years.
The move represents an unusual reversal of how drug regulation typically works in America. The FDA has established procedures for withdrawing approval from medications that prove unsafe after reaching the market. Those procedures involve post-market surveillance, adverse event reporting systems, and scientific review panels that evaluate emerging safety data. This bill, titled the Safeguarding Women from Chemical Abortion Act, sidesteps that entire architecture.
How Drug Approval Is Designed to Work
When a pharmaceutical company seeks FDA approval, it must demonstrate safety and efficacy through clinical trials. After approval, the agency continues monitoring through its adverse event reporting system, where doctors, patients, and manufacturers report complications. If safety signals emerge that suggest a drug causes more harm than benefit, the FDA can restrict its use or withdraw approval entirely.
That system has operated for mifepristone since 2000. The FDA initially required the medication to be dispensed in person at clinics or hospitals. In 2023, after reviewing additional safety data, the agency eliminated that requirement and allowed pharmacies to dispense mifepristone directly to patients with a prescription. That regulatory change followed the standard process: the FDA reviewed evidence, consulted medical experts, and adjusted the drug's risk management strategy.
The Hawley bill would override all of that. Under the proposed legislation, distributing or labeling mifepristone for pregnancy termination would become a violation of the Federal Food, Drug, and Cosmetic Act. The bill would also create a private right of action, allowing women who experience complications to sue manufacturers for damages.
The Evidence Being Used to Justify the Ban
At a press conference accompanying the bill's introduction, Hawley cited a study finding that nearly 11% of women who use mifepristone experience sepsis, infection, hemorrhaging, an emergency room visit, or another serious adverse event within 45 days. That study was compiled by the Ethics and Public Policy Center, a conservative think tank, and has not been peer-reviewed.
Elizabeth Gillette, an advocate from Oregon who spoke at the press conference, described her experience taking mifepristone. She reported developing post-traumatic stress disorder after experiencing shaking, vomiting, sweating, and profuse bleeding. Her testimony illustrates why some women want the FDA's approval reversed: the drug caused them severe physical and psychological harm.
The American College of Obstetricians and Gynecologists, the leading professional organization for reproductive health physicians, maintains that mifepristone is safe and effective. The organization has supported the medication's use throughout its 25-year history on the U.S. market.
This creates an evidentiary standoff. On one side: an unpublished study from an advocacy organization and individual accounts of serious complications. On the other: the FDA's ongoing safety monitoring, ACOG's professional consensus, and millions of uses without reported adverse events. Normally, the FDA would be responsible for weighing that evidence and determining whether the drug's benefits outweigh its risks. The Hawley bill removes the agency from that role.
What Makes This Approach Unusual
Congress rarely intervenes in individual drug approvals. Lawmakers set broad policy for how the FDA operates, but they typically leave specific approval and withdrawal decisions to the agency's scientific staff. The reason for that division of labor is straightforward: evaluating pharmaceutical safety requires specialized expertise in pharmacology, epidemiology, and clinical medicine. Legislative bodies aren't designed to perform that kind of technical analysis.
When drugs have been withdrawn from the U.S. market in the past, the FDA has led that process. The agency identifies safety problems through its surveillance systems, convenes advisory committees to review the evidence, and makes a determination about whether the drug should remain available. Political pressure can influence that process, but the formal mechanism runs through the FDA's scientific review structure.
The Safeguarding Women from Chemical Abortion Act would establish a different mechanism: Congress declares a drug unsafe and bans it through legislation. Hawley stated that mifepristone was approved during the Clinton administration, framing a regulatory decision as a political one. That framing matters because it suggests the drug's approval was ideological rather than scientific, which then justifies a political reversal.
The bill has support from a coalition of pro-life organizations, including Susan B. Anthony Pro-Life America, Family Research Council, Alliance Defending Freedom, Concerned Women for America, Live Action, Students for Life of America, the Ethics and Public Policy Center, and the American Association of Pro-Life OBGYNs. The breadth of that coalition indicates this is a coordinated legislative strategy, not a spontaneous response to newly discovered safety data.
The Precedent This Would Set
If Congress can revoke approval for a drug that has survived 25 years of FDA review, the implications extend beyond mifepristone. The pharmaceutical approval system is designed to insulate medical decisions from political pressure. Drug companies invest billions in developing medications because they believe approval depends on demonstrating safety and efficacy, not on maintaining political support.
That insulation breaks down if congressional majorities can ban drugs they find objectionable. Mifepristone is politically controversial because it terminates pregnancies, which makes it an obvious target. But the mechanism the Hawley bill would create, a legislative override of FDA approval, could theoretically apply to any medication that becomes politically unpopular.
The private right of action provision adds another layer. By allowing individual lawsuits against manufacturers, the bill creates legal liability that exists outside the FDA's regulatory framework. Pharmaceutical companies currently face product liability suits, but those suits operate within a legal structure that accounts for FDA approval. A drug that has been properly approved and marketed according to FDA requirements receives some legal protection. This bill would remove that protection for mifepristone, even though the FDA has never withdrawn its approval.
What This Reveals About Regulatory Authority
The bill exposes a tension that has always existed in American drug regulation: the FDA operates with authority delegated by Congress. That delegation has historically been stable because both parties benefited from having a scientific agency make difficult decisions about pharmaceutical safety. When a drug caused unexpected harm, the FDA took the blame. When a drug saved lives, the FDA received credit. Politicians could avoid the technical complexity and political risk.
That arrangement worked as long as both parties accepted the FDA's legitimacy as a neutral arbiter of safety. The Hawley bill suggests that acceptance may be eroding, at least for drugs that intersect with contentious social issues. By framing mifepristone's approval as a Clinton administration decision rather than an FDA scientific determination, the bill treats regulatory choices as political acts that can be reversed through political power.
The result is a system where pharmaceutical regulation operates on two tracks: the scientific review process for most drugs, and legislative override for drugs that become politically salient. That dual system creates uncertainty for everyone involved. Patients don't know whether a drug's availability depends on medical evidence or political majorities. Doctors don't know whether their prescribing decisions will be criminalized by future legislation. Pharmaceutical companies don't know whether their FDA-approved products will remain legal.
Elizabeth Gillette's traumatic experience with mifepristone is real. The American College of Obstetricians and Gynecologists' safety data is also real. The FDA has a process for reconciling those competing realities, weighing individual adverse events against population-level benefits, and making a determination about whether a drug should remain on the market. The Safeguarding Women from Chemical Abortion Act would replace that process with a congressional vote. Whether that represents better pharmaceutical regulation or the politicization of medical decisions depends on whether you trust scientific review or legislative majorities to determine what belongs in American medicine cabinets.