U.S. Reps. Chris Smith (R-NJ) and Diana Harshbarger (R-TN) led 175 House Republicans in a letter demanding the Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) undo the Biden administration’s “mail-order abortion scheme” and investigate the potential safety risks of abortion pills.
In 2021 under former President Joe Biden, the FDA removed the in-person dispensing requirement for abortion pills and allowed them to be sent via mail. That action, combined with shield laws in blue states, have allowed abortionists to mail abortion pills into red states with laws protecting the unborn. In their letter on Thursday, GOP lawmakers urged HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary to reverse course, especially in light of the FDA’s September approval of a generic version of mifepristone — the first drug used in a two-drug medication abortion regimen — and after a study was released in April suggesting abortion pill complications are 22 times higher than previously reported.
“As Members of Congress who share in the President’s vision for safeguarding life, protecting the health and wellbeing of American families, and ensuring that federal agencies act responsibly, we write to respectfully ask that the deleterious and grossly underreported effects on women of the drug mifepristone be aggressively investigated and decisive action taken to protect women from harm,” they wrote.
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“We also urge that immediate action be taken to, at a minimum, reinstate the in-person dispensing requirement for mifepristone,” they continued.
Lawmakers said the Biden administration’s actions created a “no-contact, mail-order abortion scheme.”
“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,” they wrote. “The previous administration claimed that these changes were in response to the COVID-19 pandemic, but in reality, COVID served as a smokescreen to accomplish its radical abortion agenda, which even now wreaks havoc across the nation.”
Lawmakers pointed to a study from the Ethics and Public Policy Center (EPPC) that found 10.93 percent of women who had mifepristone abortions experienced severe complications including sepsis, infection, hemorrhaging, or another serious adverse event within 45 days following the abortion. The percentage is significantly higher than the less than 0.5 percent in clinical trials reported on the FDA-approved drug label. The study is based on analysis of data from an all-payer insurance claims database that includes 865,727 prescribed mifepristone abortions from 2017 to 2023.
The study has led the FDA and HHS to conduct a safety review of the abortion pill, which the agencies said is ongoing.
“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,” lawmakers wrote.
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“The dangerous Biden mail-order scheme was designed to give abortion activists license to mail drugs everywhere, even into states…that have pro-life protections for pregnant mothers and their unborn babies,” they wrote. “These drugs are sent across state lines with no physician oversight, and without appropriate screening to ensure that bad actors are not secretly poisoning women without their knowledge or forcing women to take abortion drugs against their will—a clear indication that radical pro-abortion activists care more about protecting abortion access than about upholding women’s health and safety.”
In 2023, medication abortions accounted for 63 percent of all abortions within the formal U.S. healthcare system — meaning an estimated 642,700 unborn babies died in medication abortions, according to the pro-abortion Guttmacher Institute. The percentage was up from an estimated 53 percent in 2020 and 39 percent in 2017. The report did not account for abortion pills obtained through underground national and international networks, including those that send pills to women in states with abortion restrictions.
In a medication abortion, mifepristone blocks the action of progesterone, which the mother’s body produces to nourish the pregnancy. When progesterone is blocked, the lining of the mother’s uterus deteriorates, and blood and nourishment are cut off to the developing baby, who then dies inside the mother’s womb. The drug misoprostol (also called Cytotec) then causes contractions and bleeding to expel the baby from the mother’s uterus.
“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. 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,” they wrote.
“Under your leadership, HHS and FDA can reverse this wrong. 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,” they concluded.
The House Republicans’ letter comes after 51 GOP Senators sent a letter last month similarly urging FDA and HHS to expedite its review of mifepristone, revoke its approval of a generic version of the drug, and undo the Biden administration’s allowance of mail-order abortions.
Katherine Hamilton is a political reporter for Breitbart News. You can follow her on X @thekat_hamilton.
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