WASHINGTON—Republicans are calling on the Department of Health and Human Services to take &#8220;immediate action&#8221; to reinstate safety requirements on abortion drugs, highlighting a growing body of evidence showing that the drugs are causing severe and underreported harm to women.
In a letter first obtained by The Daily Wire, New Jersey Rep. Christopher Smith and Tennessee Rep. Diana Harshbarger call on Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary to &#8220;at a minimum, reinstate the in-person dispensing requirement for mifepristone.&#8221; Until 2023, the FDA required abortion drugs to be administered to women under a doctor&#8217;s supervision.
&#8220;The need for urgent investigation and review of this drug comes in the wake of the Biden-Harris administration’s egregious action to remove critical safeguards that once applied to abortion drugs, and the FDA’s approval of a new abortion drug generic in September 2025,&#8221; write the 175 lawmakers, including House Speaker Mike Johnson (R-LA), Majority Leader Steve Scalise (R-LA), and Majority Whip Tom Emmer (R-MN).
&#8220;Under your leadership, HHS and FDA can reverse this wrong,&#8221; they conclude. &#8220;We urge you to immediately reinstate the REMS requiring in-person dispensing of mifepristone and to expedite the promised review by the FDA into the dangers of abortion drugs.&#8221;
The move is significant since President Joe Biden&#8217;s administration green-lit the removal of safety standards on the drugs during the COVID-19 pandemic, allowing women to easily obtain the drugs at home. Pro-life advocates have long argued that women are being put in danger simply from taking the abortion drugs, but they are even more anxious about women taking the drugs on their own.
New studies are showing that complications are &#8220;astonishingly higher than what is reported on the drug’s label,&#8221; the lawmakers say: &#8220;Even the current Obama FDA-approved label for mifepristone — which the data show understates the dangers to women — says that roughly 1 in 25 women who use mifepristone as directed will end up in the emergency room.&#8221;
“We join House and Senate Republicans in calling on the FDA to – at a minimum – immediately end Joe Biden’s legacy of mail-order abortion and restore the in-person doctor requirement that existed during President Trump’s first administration,&#8221; said SBA Pro-Life America&#8217;s head, Marjorie Dannenfelser. &#8220;<a href="https://sbaprolife.org/newsroom/press-releases/breaking-7-in-10-voters-want-to-roll-back-biden-covid-abortion-drug-policy-reinstate-in-person-doctor-visits">Seven in 10</a> voters agree. We are deeply grateful to Reps. Chris Smith and Diana Harshbarger for leading this important letter, and to House leadership and every member of Congress who joined in standing for women and their unborn children.&#8221;
Meanwhile, abortion proponents and legacy media insist the drugs are safer than Tylenol. President Donald Trump&#8217;s administration has weighed the issue carefully, cognizant of how electorally delicate abortion is. And in early October, the FDA approved a new abortion pill, shocking the president&#8217;s <a href="https://www.dailywire.com/news/pro-lifers-demand-answers-from-trump-admin-after-shocking-abortion-pill-approval">pro-life supporters.</a>
At the time, Kennedy put out a statement clarifying that he understood that the Biden administration had removed mifepristone&#8217;s safety standards &#8220;without studying the safety risks.&#8221;
&#8220;We are filling that gap,&#8221; he promised, sharing that he and Makary wrote to state attorneys general and promised to &#8220;review all the evidence — including real-world outcomes — on the safety of this drug.&#8221;
<blockquote class="twitter-tweet">
The Biden administration removed mifepristone’s in-person dispensing rule without studying the safety risks. We are filling that gap. Last month, I joined <a href="https://twitter.com/DrMakaryFDA?ref_src=twsrc%5Etfw">@DrMakaryFDA</a> in writing to state attorneys general, pledging to review all the evidence — including real-world outcomes — on… <a href="https://t.co/G0eE4H4y42">pic.twitter.com/G0eE4H4y42</a>
— Secretary Kennedy (@SecKennedy) <a href="https://twitter.com/SecKennedy/status/1973866621245567344?ref_src=twsrc%5Etfw">October 2, 2025</a></blockquote>
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&#8220;Recent studies already point to serious risks when mifepristone is used without proper medical oversight,&#8221; he said, and he clarified of the new abortion pill that that the FDA just approved: &#8220;[The FDA] only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug.&#8221;
In their appeal, the Republican lawmakers express gratitude to Kennedy and Makary for serving the most pro-life president in American history, saying that Trump has &#8220;done more to advance a culture of life and the protection of women and children from the violence of abortion than any president before him.&#8221; But they also cite polling from McLaughlin and Associates that found that 7 in 10 voters agree that it &#8220;makes sense&#8221; to bring the former FDA safety standards back, arguing that &#8220;clear majorities of Americans recognize the extreme overreach of the previous administration’s actions.&#8221;
The lawmakers also dive into how the abortion drugs affect mothers, citing an Ethics and Public Policy Center study showing the adverse events from mifepristone are about 22 times more frequent than the FDA recognizes. That study found that almost 11% of women experience sepsis, infection, hemorrhaging, or other life-threatening events after aborting their unborn baby with mifepristone.
&#8220;While we have long known that mifepristone causes the death by starvation of children alive in the womb — it is baby poison — we now know with greater certitude that their mothers are also being seriously harmed. Despite the mainstream media and the Biden-Harris administration perpetuating the lie that these drugs are &#8216;safer than taking a Tylenol,&#8217; science and women’s lived experiences clearly say otherwise.&#8221;
And while the Biden administration claimed that the removal of safety standards was in response to the COVID pandemic, to help women receive &#8220;medically necessary&#8221; care, the lawmakers argue that the former administration was really just using COVID as a &#8220;smokescreen&#8221; to &#8220;accomplish its radical abortion agenda, which even now wreaks havoc across the nation.&#8221;
&#8220;Even the current Obama FDA-approved label for mifepristone — which the data show understates the dangers to women — says that roughly 1 in 25 women who use mifepristone as directed will end up in the emergency room,&#8221; they write.
They also say that the Biden FDA ignored warning signs from the studies on which it had already relied, including data showing that 3% of the women who took the drugs need to be hospitalized, &#8220;a 330% increase over the rate on the approved drug label,&#8221; data showing that 6% of participants had unplanned visits to emergency rooms, surgery was required to complete the abortions for 4.1% of the women, and, in the telemedicine group, 5.8% of women had emergency room visits.
&#8220;Beyond the studies, women tell us how they have suffered harm from mifepristone, and stories of coercion and abuse involving abortion drugs now run rampant,&#8221; they continue. &#8220;Real women like Rosalie Markezich — who is just one example of many — felt coerced by her boyfriend to take abortion drugs that he ordered from an out-of-state prescriber in her name and had delivered to her home through the U.S. Postal Service.&#8221;
&#8220;Rosalie did not want to have an abortion, but Biden’s egregious weakening of mifepristone’s safety standards let her boyfriend obtain abortion drugs and force her to take them,&#8221; they argue. &#8220;The dangerous Biden mail-order scheme was designed to give abortion activists license to mail drugs everywhere, even into states like Markezich’s home state of Louisiana that have pro-life protections for pregnant mothers and their unborn babies.&#8221;
&#8220;Today, abortion drugs account for nearly two-thirds of all abortions in the United States; there are over six hundred thousand abortions committed using these drugs each year,&#8221; the lawmakers write. &#8220;The Biden FDA’s reckless, no-contact, mail-order abortion scheme is to blame. Abortion providers are reaping increased profits, while women and their unborn children suffer irreparable harm.&#8221;

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‘Reverse This Wrong’: Republicans Push RFK To Fix Biden’s Abortion Drug Mistakes