Industry leaders warn the Trump administration that ignoring decades of evidence on mifepristone’s safety would jeopardize public trust and the entire U.S. drug approval process.
Fifty-three biotechnology industry leaders and investors representing dozens of companies and organizations issued a letter late last month advising the U.S. Food and Drug Administration: Follow the science on mifepristone, not political ideology.
The Biotech CEO Sisterhood initiated the letter, with Grace Colón as lead author and dozens of senior biotechnology leaders signed on in support.
“We are urging the agency and the department to continue to follow the science,” said Colón, who warned that political interference in drug regulation undermines both public trust and the FDA’s authority.
The FDA first approved mifepristone in 2000 for use with misoprostol for early abortion care. The agency expanded access to the medication in 2016 and again in 2021 — decisions based on years of clinical evidence showing the medication is safe, effective and essential to reproductive healthcare.
The letter followed FDA commissioner Marty Makary’s recent pledge to “review” the agency’s regulation of mifepristone, in response to a letter from Sen. Josh Hawley (R-Ark.) citing a methodologically flawed report written by the Ethics and Public Policy Center (EPPC). The EPPC report falsely claimed nearly 11 percent of mifepristone patients experienced a “serious adverse event.” Hawley demanded Makary prohibit clinicians from prescribing mifepristone at telehealth appointments, despite overwhelming peer-reviewed research proving telehealth abortion is safe, effective and widely used. Today, nearly two-thirds of all abortions in the United States involve mifepristone.
In their letter, biotechnology leaders urged the FDA to uphold the agency’s “gold standard regulatory environment,” warning that “our industries’ investment in the lengthy process of scientific discovery relies on this regulatory predictability.” They emphasized that the FDA conducted a rigorous scientific review when it originally approved mifepristone in 2000, and when expanding its approved use in 2016 and 2023.
Biotech leaders warned that undermining the FDA’s scientific authority threatens not just mifepristone, but the entire foundation of drug approval in the United States.
“At each point, the FDA relied on numerous high-quality, peer reviewed studies, analyzing tens of thousands of patient experiences that conclusively demonstrated the safety and effectiveness of these actions,” stated the letter, noting decades of mifepristone’s safe use by millions of women.
They describe the medication as “among the most studied medications” with risks “similar to the risks of taking commonly prescribed antibiotics and over-the-counter pain relievers” such as Tylenol.
We were already quite alarmed … We didn’t want too much time to pass before we spoke out and made it clear that this is not the direction we would like FDA to go.
Grace E. Colón, Ph.D.
The biotech leaders firmly opposed the FDA relying on the EPPC report in any assessment of mifepristone’s safety and efficacy, calling the report “fundamentally, fatally flawed.” They emphasized the report was self-published and not peer-reviewed and that the authors have not made their data publicly available — leaving other researchers unable to verify the findings.
As misinformation has increasingly influenced the conversation around mifepristone, Colón and other biotech leaders felt compelled to step in to challenge the political misuse of unverified data.
“We were already quite alarmed with this study. It was just really preposterous,” said Colón. “We noticed that it was getting a lot of attention. It was being quoted. It was being talked about as part of the rationale for looking at mifepristone more closely. We didn’t want too much time to pass before we spoke out and made it clear that this is not the direction we would like FDA to go. We feel very strongly that it would greatly harm patients.”
The biotech letter outlines critical methodological flaws that undermine the report’s reliability, including the conflation of emergency room visits with serious adverse events, a move that contradicts FDA guidance, and inflated estimates of complications linked to mifepristone. The authors also failed to define key terms and phrases, leaving vague language that weakens regulatory standards and invites political misuse.
The letter warns that legitimizing the EPPC report would set a dangerous precedent for drug regulation.
“The FDA has never relied on publications with such unreliable methodologies,” it states. “Doing so would pave the way for any political or interest group to undermine well-grounded FDA decisions with baseless claims. The resulting regulatory uncertainty could destabilize the drug-approval process, chill drug development and innovation, and compromise patient health.”
The leaders stressed that billion-dollar investments in research and development rely on an FDA approval process grounded in scientific rigor. “If high quality evidence is disregarded and treatment protocols can be threatened by a single, low-quality, unverified report, our system of scientific oversight of discovery, development, and delivery is compromised.”
ACOG Citizen Petition to Remove Mifepristone Restrictions
The biotech letter supports a citizen petition filed to the FDA in January by the American College of Obstetricians and Gynecologists, the Society for Family Planning and the Society for Maternal-Fetal Medicine, urging the agency not only to maintain access to mifepristone, but to remove the agency’s remaining restrictions on mifepristone.
In their petition, these three professional associations representing abortion care providers urged the FDA to lift unnecessary and politically motivated restrictions on mifepristone. “The scientific evidence is overwhelming: major adverse events occur in less than 0.32% of patients. The risk of death is almost non-existent. Few drugs have been so extensively studied after their approval by FDA and few can boast such a clear and compelling record of safe use.”
The citizen petition objects to the FDA’s placement of mifepristone into the Risk and Evaluation Mitigation System drug safety program. REMS impose three additional requirements restricting access:
- clinicians prescribing mifepristone must be certified by registering with the drug maker;
- pharmacies dispensing the medication must be certified; and
- patients must sign an additional agreement form.
The petition argues that these barriers are medically unnecessary and should be removed.
In addition to the biotech letter, the FDA received letters of support from leading reproductive health organizations, including the National Abortion Federation, Planned Parenthood Federation of America, the Guttmacher Institute, Reproductive Freedom for All and researchers at the UCSF’s Bixby Center for Global Reproductive Health. These letters strongly support the FDA’s 2021 decision to no longer require in-person dispensing of mifepristone, which expanded clinicians’ ability to offer telehealth abortion to patients. By 2024, telehealth provided one quarter of all abortions in the United States.
In their letter, the UCSF Bixby Center, which represents over 200 physicians, nurses, advanced practice clinicians, social scientists, clinical researchers and staff, stress that telehealth has been critical to expanding abortion care. The researchers also criticize the REMS, arguing it has “been a barrier for qualified family physicians to integrate medication abortion care in their practices.”
Bixby researcher Ushma Upadhyay in a separate letter details 10 flaws in the EPPC report, including:
- the report assumes emergency room visits are serious adverse events in direct contradiction to FDA guidance, noting many are not admitted;
- subsequent treatment to complete the abortion is not a serious adverse event;
- conflation of abortion with miscarriage and other uses of mifepristone;
- “other abortion-specific complications” are not clearly defined;
- lack of a standardized definition of hemorrhage;
- ectopic pregnancy is not a complication of medication abortion;
- “other life-threatening adverse events” are not necessarily abortion-related;
- over-reliance on diagnosis codes rather than treatment;
- the policy implications not supported by the findings; and
- these analyses cannot be verified.
Guttmacher Institute’s letter of support argued, “the medication’s inherent safety illustrates that mifepristone should not be governed by a REMS program, as Congress intended these regulations only meant for medications that carry serious health risks.” The institute emphasized that telehealth access to abortion pills is critical to expanding access to care, especially for “patients who face barriers reaching a brick-and-mortar clinic, such as patients living in rural or medically underserved communities, patients with disabilities, and those facing other financial or logistical barriers to travel.” They underscore that telehealth abortion reduces the financial costs of seeking care, including transportation, child care and lost wages from taking time off work.
Another letter was submitted by Legal Voice, which advocates for gender equity in the Pacific Northwest, joined by Family Violence Appellate Project, the Sexual Violence Law Center and the Washington State Coalition Against Domestic Violence. It argues that restricting mifepristone will cause particularly grave harm to survivors of intimate partner violence. The letter states, “Limiting [survivors] ability to access abortion care, [increases] their risk of health complications, violence, and homicide.” They highlight that abusers often control their partners’ reproductive choices by forcing pregnancy and restricting prenatal care.
The National Abortion Federation’s letter writes that “after more than 25 years of high-quality medical research and real-world clinical data from 7.5 million patient uses in the United States alone, mifepristone’s safety is incontrovertible.” They argue that mifepristone “does not fit the safety profile for a REMS program at all.” They reject the prescriber certification requirement as unnecessary, noting that professional medical licensure requirements and ethical guidelines already govern abortion care. The patient agreement form is also not “necessary or appropriate” since the FDA itself acknowledges that clinicians strongly adhere to evidence-based guidelines requiring patients to be provided with accurate information about abortion.
In its letter, PPFA argues the FDA had not met the legal threshold for imposing a REMS on mifepristone. Under federal law, a REMS is only allowed to ensure that the benefits of a drug outweigh its risks. “Given the enormous benefits of access to mifepristone for patients who need abortion or miscarriage care and mifepristone’s minimal risks, mifepristone does not meet the statutory requirements for a REMS,” argues PPFA. They also add that the extra safety measures may only be imposed when necessary to ensure safe use of a drug with “inherent toxicity or potential harmfulness,” which mifepristone does not have, and they cannot place undue burdens on patient access.
Reproductive Freedom for All, formerly NARAL, argues in their letter that the REMS restrictions on mifepristone reflect a “harmful double standard and highlight how reproductive health care is singled out and treated differently from other types of medical care.” They note mifepristone has a “profile equal to or better than widely-used medications like Tylenol, Viagra, and penicillin – some of which are available over the counter, and none of which are subject to REMS.” They say that mifepristone is “significantly safer than opioid painkillers, which are regulated with fewer safety restrictions despite contributing to a national public health crisis.”
They also challenge the pharmacy certification requirement, which means “prescribers cannot issue a prescription to a patient’s preferred pharmacy, as with virtually all other medications,” a restriction lacking any scientific support. They further note the FDA requires patients to sign a form stating they “have decided … to end [their] pregnancy,” even when mifepristone is prescribed for miscarriage treatment.
Fighting Mifepristone Restrictions on All Fronts
Kirsten Moore, director of the EMAA Project, which advocates for expanding medication abortion access, doesn’t believe the FDA will reverse its previous decisions on mifepristone, “It’s not at all clear that Makary cares about mifepristone. I have no doubt that if Trump or Secretary Kennedy said you have to reinstate the in-person distribution requirement, he would do it. But I don’t think that’s happening. I think Trump obviously has 800,000 other things to do right now. And this is not a priority for Secretary Kennedy himself. There’s just no impetus inside the agency to go back on its own scientific evaluation.”
Still, Moore warns that antiabortion forces are fighting on multiple fronts to eliminate access to mifepristone. “The opposition, as we know funded by Leonard Leo, is not going to stop trying to put mifepristone back under lock and key, and they will try that through legislation, through litigation and through regulation.”
Moore notes that several bills introduced in Congress aim to restrict mifepristone and although the Supreme Court dismissed the Texas lawsuit to restrict mifepristone in 2024, the case has since been revived by attorneys general of Kansas, Missouri and Idaho.
EMAA’s Mife in All 50 campaign is organizing people to write to Donald Trump and urge him not to fall for “junk science, bogus policies and privacy invasions” by imposing a national ban on telehealth abortion.
“Rolling back access to an FDA approved medication that’s used at 10 weeks or less of pregnancy to me seems politically unwise,” said Moore. “I hope Trump actually is smart enough to know that.”
Editor’s note: Carrie Baker’s latest book, Abortion Pills: US History and Politics, is the first to offer a comprehensive history of abortion pills in the United States. In it, she shows how courageous activists waged a decades-long campaign to establish, expand and maintain access to abortion pills. Weaving their voices throughout her book, Baker recounts both dramatic and everyday acts of their resistance. The book is available via open access.
