(Oregon Right to Life) — The U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee this week launched an investigation into whether manufacturers of chemical abortion drugs are operating in compliance with current FDA regulations. The committee is urging the FDA to crack down on illegal online sales and restore prior safety regulations on the drugs.
The HELP Committee announced its investigation in a Wednesday press statement, noting that it sent letters to the FDA and mifepristone manufacturers Danco, GenBioPro, and Evita calling for accountability.
“These manufacturers and websites have facilitated the explosion in online sales of these harmful drugs without regard for women’s health and safety while opening the door for coercion and abuse,” U.S. Senator Bill Cassidy, M.D. of Louisiana, chairman of the HELP Committee, said in a Wednesday press statement. “FDA should act within its existing authorities to curb this abuse and immediately reinstate safeguards such as the in-person dispensing requirement.”
In its press statement, the Senate committee spotlighted the removal of significant regulations on mifepristone that have vastly expanded access to the drugs and increased risks to women. In particular, they directed attention to the controversial 2016 elimination of the Risk Evaluation and Mitigation Strategy (REMS) program requirement to report adverse events that do not result in death, as well as the 2021 permission for mifepristone to be prescribed online and distributed through the mail.
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“Ending these requirements has led to horrific instances of coerced abortions and serious adverse events going untreated and undetected,” the committee said. Women who obtain abortion pills online, with no requirement to first obtain an ultrasound or undergo an in-person evaluation, are at increased risk of incorrect prescription – they may, for example, be further along in their pregnancy than believed, or have an undiagnosed ectopic pregnancy. Online prescription also places women at increased risk of coercion, as abusers may obtain the pills to cause forced abortions.
In addition to raising concerns about the inherent risks posed by online distribution with few safety regulations, the senators said some online sources appear to be selling and distributing the drugs illegally.
In the letter sent to the FDA, senators noted that “[n]on-U.S.-based online clinics sell unapproved and misbranded chemical abortion drugs to Americans and often market the drugs past the FDA-approved 10-week limit… The drugs being sold often come from a variety of manufacturers in India.”
The committee also warned the FDA that “many of these websites tell women that even if they are seeking care for a severe adverse event like heavy bleeding, incomplete abortion, or infection, they do not have to tell the medical staff that they took the chemical abortion drugs, but rather they can tell them that they had a spontaneous miscarriage. Giving this dangerous advice to lie to, or withhold information from, their doctors does not just put patients at greater risk of harm, but also prevents serious adverse events from chemical abortion drugs from being reported to drug manufacturers and FDA.”
“As it did under the first Trump administration, FDA must use all of the tools at its disposal to protect women and children,” the HELP committee said in its Wednesday statement.
Prominent pro-life groups have responded by praising the committee’s work and joining its call for a restoration of FDA regulations on chemical abortion drugs.
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“Abortion numbers are up, not down after Dobbs, driven by mail-order drugs flooding the states without regard for their laws,” said Marjorie Dannenfelser, President of Susan B. Anthony Pro-Life America. “We are now at over 1.1 million abortions per year. Companies whose sole source of revenue is abortion drugs—which carry a black box warning—are raking in millions while their inherently risky, abuse-prone drug sends thousands of women to emergency rooms, enables abusers, systematically kills countless unborn children, and brazenly undermines democratically enacted state protections. Their disregard for even the few remaining safety standards, and the lack of transparency around these secretive entities, is deeply troubling.”
“Senator Cassidy is right to hold the FDA accountable for the dangers of mifepristone,” said Lila Rose, Founder and President of Live Action. “Women and their children are being put at risk. The FDA must act immediately to restore protections and put their safety first.”
“Women deserve real medical care, not drugs dispensed through anonymous websites with little to no oversight,” said Carol Tobias, President of National Right to Life. “We commend the Senate HELP Committee for taking these concerns seriously and look forward to meaningful action that prioritizes women’s health and safety.”
Mifepristone is currently under a safety review by the U.S. Department of Health and Human Services (HHS). The review was triggered by a 2025 Ethics and Public Policy Center (EPPC) study suggesting the adverse reaction rate associated with the drug to be over one in ten (10.93%), twenty-two times the one currently listed on its official FDA label.
A recent national poll found that 69% of respondents across the political spectrum agreed that “it makes sense for the FDA to bring back” the requirement for in-person doctors’ visits removed under the Biden administration.
