Senators urge FDA to 'combat illegal sale of unapproved... abortion pills'

U.S. Senator Bill Cassidy, M.D. (R-La.), Chairman of the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee, is leading a coalition of Senators urging the FDA to "leverage its authorities to combat the illegal sale of unapproved and misbranded chemical abortion drugs into the U.S. by online entities."

Key Takeaways:

• Several U.S. senators are urging the FDA to take action against entities that are illegally selling "unapproved and misbranded" abortion drugs online.

• They note that abortion pills sold online and without in-person oversight make it difficult to "ensure that prescribers and pharmacies comply with the few remaining REMS [safety] requirements" for the abortion pill.

• They note that many of these abortion drugs are shipped from India, and purchasers are told that "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."

• This encouragement to lie "prevents serious adverse events from chemical abortion drugs from being reported to drug manufacturers and FDA," the senators note.

• The senators list multiple online sellers as well as unapproved abortion pill "kits" that are sold online, many of which are not approved for sale in the U.S.

The Details:

The press release noted that the Committee "began an investigation into chemical abortion drug manufacturer compliance with U.S. Food and Drug Administration (FDA)-mandated safeguards associated with marketing their drugs."

It noted (emphasis added):

... [I]t is unclear how the three FDA-approved chemical abortion drug manufacturers, Danco, GenBioPro, and Evita, ensure that prescribers and pharmacies comply with the few remaining REMS requirements, especially when pills are sold online and without the in-person oversight of a medical professional.

... [V]arious types of domestic and international websites appear to illegally sell unapproved and misbranded chemical abortion drugs directly to U.S. consumers, often with no prescription, no medical oversight, and no assurances on whether the drug is actually what the seller claims it is.

As it did under the first Trump administration, FDA must use all of the tools at its disposal to protect women and children.

The Senators are asking the FDA to answer the following questions and to provide the Committee "with an update on FDA’s plans to implement these actions, no later than April 8, 2026."

Zoom In:

Senate Committee Demands Explanations from Abortion Pill Manufacturers

The March 25 letters sent by the Senate Committee to abortion pill manufacturers Danco Laboratories, GenBioPro (GBP) and Evita Solutions list similar demands for documents and information as those issued by Senator Josh Hawley on March 18, 2026, in reference to his investigation.

These include:

• Number of prescribers/pharmacies

• Number of drugs sold by quarter

• List of certified pharmacies

• List of decertified prescribers or pharmacies

The letters also ask Danco and GBP to explain why they direct "consumers on [their websites] to online prescribers that advertise prescribing Mifeprex after 10 weeks gestation when FDA only approves Mifeprex for use within the first 10 weeks of pregnancy." It also asks how they ensure the safety requirements of the REMS are enforced.

Live Action News has also posed these questions in our "Dear FDA" series.

Senate Committee Asks FDA to Take Immediate Action

The letter to Martin A. Makary, M.D. urges the FDA to take immediate action to "prevent misbranded and unapproved versions of the chemical abortion drugs, mifepristone and misoprostol, from being marketed in the U.S. by online retailers in violation of federal law."

Illegal abortion drugs...

• are sold by "foreign-based" online pharmacies "directly to customers in the U.S. with no restrictions."

• pose "serious risks to women’s health"

• increase "risk of forced and coerced abortions"

• are prohibited under "federal law."

The letter continued (emphases added):

The drugs being sold often come from a variety of manufacturers in India. Further, 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.

READ: FALLOUT: How dumping patients and pushing a lie misled everyone about the abortion pill

The letter also identified several U.S.-based websites, including:

• Texas: Abortionpills247.com and Daynighthealthcare247.com selling "unapproved and misbranded chemical abortion drugs despite claiming its drugs are 'FDA Approved.'"

• Virginia and Nevada: Lifeeasyonpills.com: sells "three unapproved and misbranded chemical abortion drugs."

• California: Pillpulse.org claims sells "three unapproved and misbranded chemical abortion drugs."

• New York: Ybycmeds.com claims sells "three unapproved and misbranded chemical abortion drugs."

Unapproved drugs/abortion pill kits sold included internationally and within the U.S. include:

• “Abortion Kit” (containing both “mifewomem” manufactured by Thuoc Biet Duoc in Vietnam and “Misoprostol STELLA 200 mcg” manufactured by Stella in Vietnam).

• “AntiPREG Kit” (manufactured by Intas Pharmaceuticals Ltd. in India).

• “Combipack kits” (a “CENOFI AMFY Kit” manufactured by Cenofi Healthcare Pvt Ltd in India).

• “Contrakit” (manufactured by Cadila Pharmaceuticals in India).

• “Cytotec” (actually “Misoprost-200” manufactured by Cipla Ltd. in India and not brand name “Cytotec” manufactured by Pfizer).

• "Cytolog” (misoprostol manufactured by Zydus Cadila in India).

• “Divabort Kit” manufactured by Jagsonpal Pharmaceuticals Ltd in India.

• “Killpreg Kit” manufactured by Synokem Pharmaceuticals Ltd. in India.

• “Medoz Kit” manufactured by Medoz Pharmaceuticals in India.

• “Mifegest Kit” manufactured by Zydus Healthcare Ltd in India.

• “Mifegyne” manufactured by Exelgyn in France.

• “Mifeprex” (actually “Mifeprin” manufactured by Sun Pharmaceutical Industries Ltd in India and not brand name “Mifeprex” manufactured by Danco).

• “Mifekit” manufactured by Naman Pharma Drugs in India.

• “Mifepristone Linepharma 200 mg” manufactured by Linepharma International Ltd. in England.

• “MTP Kit” manufactured by Cipla Ltd.

• “MTP Kit Combo + Misoprostol” (actually a “Medoz Kit” and “Cytoheal 200mcg” misoprostol pills manufactured by Healing Pharma in India).

• “Pregnancy Kit” (includes a “CENOFI AMFY Kit” and “Cytoheal 200mcg” misoprostol pills).

Marketing Abortion Pill Past FDA Gestational Limits

While "[a] group of seemingly U.S.-based online clinics at least purport to sell the FDA-approved versions of mifepristone and misoprostol," the letter stated that "many openly market the chemical abortion drugs for use after the FDA-approved limit of 10 weeks gestation...."

The letter specified:

If these clinics prescribe the drugs based on self-reported gestational age at the time of the drug is purchased, it can be a week or more before the drugs actually arrive, and women purchasing these drugs may be at risk of taking them long after FDA has approved them for safe and effective use.

In addition, the U.S.-based online clinics lack transparency into whether and how they abide by the Mifepristone REMS Program requirements, including whether they use a certified prescriber to prescribe the drugs, whether the drugs are dispensed from a certified pharmacy, or whether patients are required to sign the Patient Agreement Form.

Furthermore, there is no transparency into how online clinics comply with other REMS requirements like ensuring prescribers can “assess the duration of pregnancy accurately,” “diagnose ectopic pregnancies,” and “provide surgical intervention in cases of incomplete abortion or severe bleeding, or . . . have made plans to provide such care through others.

It is also unclear how the “providers” prescribing the chemical abortion drugs online, often without even a call or telehealth appointment, and who determine eligibility by reviewing a cursory (and often anonymous) online form submitted to them, could possibly meet the REMS requirement to ensure any deaths associated with the use of the drug are reported to the manufacturer.

Clinics said to "openly market unapproved and misbranded chemical abortion drug for use beyond 10 weeks gestation" included:

• Women on Web: up to 14 weeks gestation

• Abortion Pills in Private: up to 11 weeks gestation.

• Aid Access: up to 14 weeks.

• Pills by Post, Roxy, Abuzz, OPTIO Women’s Health, 199 Abortion Telemedicine, Southern Woven, and We Take Care of Us: up to 13 weeks.

• Maitri Wellness, Choices Rising, carafem, Serenity Choice Health, Whole Woman’s Health Virtual Care, and Juniper Midwifery: up to 12 weeks.

• Sunny, All Our Bodies, The MAP, and Atlanta Comprehensive Wellness Clinic: Up to 11 weeks.

As Live Action News has noted, Planned Parenthood also advertises the abortion pill well past the FDA-approved limits.

Reports from the Centers for Disease Control and Prevention (CDC) have indicated that the abortion pill is being prescribed well into the second trimester — and lawsuits filed against Planned Parenthood have revealed that preborn babies were killed very late in pregnancy after the corporation prescribed the regimen.

Community Networks

The letter to the FDA referenced "community networks" that are "made up of loosely organized groups" which "distribute unapproved and misbranded chemical abortion drugs, often for free, that are illegally imported from foreign countries, including Mexico and India, and then repackaged before distribution to customers..."

The letter added:

These networks usually have no gestational age limit and often advertise that customers can have the drugs delivered as “loose, unidentifiable pills” or “foil, blister packs.” There is no medical consultation provided to screen for contraindications and no prescription is needed.

Further, nearly every community network only requires someone to send them an anonymous email to request the chemical abortion drugs with not even a cursory online intake form.

Taking Action:

The letter highlights three methods of enforcement the Senators are urging the FDA to utilize:

• Reinstate REMS: "... especially the in-person dispensing requirement and the requirement for manufacturers to report non-fatal adverse events to FDA."

• Abuse complaints: These can be filed by FDA’s Office of Regulatory Affairs Health Fraud Branch (HFB).

• Warning Letters: Sent to entities violating federal law.

• Interdiction: Enforced by U.S. Customs and Border Protection (CBP) and U.S. Postal Inspection Service (USPIS): to "improve the interdiction of unapproved and misbranded chemical abortion drugs that sellers attempt to illegally mail into the U.S."

• Investigation and Prosecution: "FDA through its Office of Criminal Investigations, can prioritize working alongside the U.S. Department of Justice (DOJ) to investigate and prosecute individuals who illegally sell unapproved and misbranded chemical abortion drugs into the U.S....There are reports that some illegal chemical abortion drug shipments from online clinics and community networks have been confiscated both at the border and within the U.S., and this work must be prioritized."

The letter claimed that "federal law permits FDA to debar an individual from importing any drug into the U.S. if that individual has been convicted of a felony for conduct relating to the importation of any drug into the U.S."