Since the Supreme Court overturned Roe v. Wade in 2022, mifepristone has become the focal point of the next phase in the war on abortion, and now, the FDA itself is moving to restrict or eliminate access to this safe, widely used medication. The FDA, under influence from the US Health and Human Services Secretary RFK Jr., has ordered FDA Commissioner Marty Makary to fully review the abortion pill.
A full FDA review of mifepristone is not merely a scientific update. It may represent the start of politically motivated efforts to reinstate restrictions on the drug through administrative procedures. The FDA’s citizen petition process allows individuals or groups to formally request changes to a drug’s approval or regulation, and the agency is typically required to respond within 150 to 180 days.
In the past, petitions involving mifepristone have led to comprehensive evaluations of the drug’s safety and distribution guidelines. For instance, in 2016, the FDA reviewed its protocols after receiving a petition from anti-abortion physicians. A similar review took place in 2021, resulting in the removal of the in-person dispensing requirement during the COVID-19 public health emergency. Both decisions were based on scientific evidence and medical necessity. However, the current review, driven by RFK Jr. and shaped by lingering political pressure from the Trump administration, lacks the same scientific foundation and raises serious concerns about whether public health or political ideology is guiding the process.
Mifepristone, the generic form of Mifeprex, is a pill that halts an intrauterine pregnancy up to 10 weeks from developing by blocking progesterone and is taken along with misoprostol. It is regulated through the Mifepristone REMS Program, a safety system the FDA requires for its use in medication abortions up to 10 weeks of pregnancy. Under this program:
- Only certified healthcare providers can prescribe mifepristone, and only certified pharmacies or those providers can dispense it, either in person or by mail.
- Patients must review and sign a Patient Agreement Form and receive counseling about risks before getting the medication.
- Pharmacies must use tracked shipping and ensure timely delivery.
Originally approved in 2000 with strict safety controls, mifepristone’s REMS requirements were updated by the Biden Administration in 2021–2023 to improve access while maintaining safety. These updates allowed certified pharmacies to ship the drug by mail, reducing barriers for patients.
Recently, the democratic attorneys general from California, New York, Massachusetts, and New Jersey filed a petition requesting that the FDA remove or revisit the strict requirements from the Mifepristone REMS Program. The democratic Attorney General of New York argues that the REMS Program is putting healthcare providers and consumers at risk due to several barriers. For instance, prescriber and pharmacy certification has deterred local providers from carrying mifepristone in their pharmacy due to their names (patient, provider, and pharmacy) being added to national and local abortion provider lists. Even those who have experienced a miscarriage have to sign patient agreement forms admitting to “ending a pregnancy” which, in certain states, may violate HIPPA.
An analysis of public health insurance records conducted by the EECP found that more than one in ten women who use the abortion pill mifepristone to induce a medication abortion experience a serious health complication during the process. However, this claim is not backed by credible scientific evidence or data from the FDA. In fact, the FDA has tracked adverse events related to mifepristone since its approval in 2000 and, as of December 31, 2024, has reported only 36 deaths among the millions of people who have used the medication — a rate that is extraordinarily low. Importantly, the agency notes that these events cannot be directly attributed to mifepristone alone, as many involved other medications, unrelated medical conditions, or incomplete information.
Major medical organizations, including the National Academies of Sciences, have consistently affirmed that medication abortion is safe, with serious complications occurring in fewer than 0.4% of cases. The evidence overwhelmingly shows that mifepristone is a safe and essential part of reproductive healthcare — far from the danger some opponents claim it to be.
Removing access to mifepristone would not only set back abortion rights, it would also impede compassionate miscarriage care and worsen deep economic and racial inequities. Mifepristone is critical for effectively managing miscarriages, but limiting its use would result in more intrusive treatments, increased suffering, and greater expenses.
According to the Institution for Women’s Policy Research (IWPR), states with abortion restrictions lose tens of billions in labor-force participation and profits each year, ranging from $60 billion to $173 billion. These restrictions disproportionately affect low-income and rural women, resulting in poverty, eviction, and limited economic opportunities. Racial inequities exacerbate the harm. Maternal mortality rates for black women are already 2.6-3.4 times higher than for white women, and restrictive reproductive policies disproportionately affect them. In states with abortion bans, maternal mortality has increased by up to 56% in Texas, while newborn mortality has increased dramatically, disproportionately affecting Black mothers.
A new report from the Institute for Women’s Policy Research highlights how state abortion bans don’t just jeopardize reproductive rights—they actively harm economies and families. According to IWPR, eight of the ten states with the lowest GDP per capita have total bans or severe abortion restrictions, and ten of the 18 states with bans experienced below-average female employment growth between 2022 and 2023. This is a hard hit on Black women’s progress to end the wealth gap, since 59% of women live in states with strict abortion restrictions.
As the FDA considers its next steps under RFK Jr.’s directive and mounting political influence, it must remember that health policy isn’t decided in a vacuum: it’s decided on the ground, in the lives of millions who rely on these medications every day.
