Abortion Drugs and the FDA: What Every American Should Know

On June 24, 2022, the U.S. Supreme Court issued one of the most consequential rulings in American history.

In Dobbs v. Jackson Women’s Health Organization, the Court overturned Roe v. Wade and returned to the people and their elected representatives the ability to pass laws protecting unborn life at all stages. For the millions of Americans who had spent decades fighting for that moment, it was cathartic. States like Louisiana and Texas had already decided to protect unborn life, and their laws became effective immediately.

Unfortunately, the Biden FDA had other plans. Mere days after oral argument in Dobbs, the FDA concluded that it would remove the in-person dispensing requirement for the abortion drug mifepristone. By January 2023, the FDA made that decision permanent, making abortion drugs available by mail to anyone, anywhere, in any state, regardless of what that state’s laws said. The result—and the express goal of the Biden administration—was a federal end-run around the will of the people and the ruling of the Supreme Court.

Today, abortion drugs account for more than 60 percent of all abortions in the United States. In Louisiana—a state that protects life from conception with narrow exceptions—nearly 1,000 unlawful mail-order abortions are now occurring every month.

Unless this changes, the Dobbs decision is nothing more than a hollow gesture. And the story of how the Biden FDA made that possible begins long before anyone was talking about mail-order abortion drugs.

How did mifepristone come to the U.S.?

To understand how mifepristone became the most common form of abortion in the U.S., you actually have to go back to France.

A French pharmaceutical company called Roussel Uclaf S.A. first developed mifepristone, then known as RU-486, and France approved it as an abortion drug in 1988. What happened next deserves far more attention than it has received.

A nonprofit called the Population Council acquired the American patent rights and conducted the clinical trials necessary to bring the drug to the U.S. market. Notably, this came at the strong-arm lobbying efforts of the Clinton administration.

The Population Council is no ordinary nonprofit. It was founded in 1952 by John D. Rockefeller III explicitly to address what he viewed as the problem of world “overpopulation.” The Council filed its new drug application with the FDA in March 1996 and licensed the exclusive rights to manufacture and distribute mifepristone in the United States to Danco Laboratories—a company that was incorporated not in America, but in the Cayman Islands, and whose sole business is distributing abortion drugs. And that business has been extremely profitable. To this day, no one knows much about Danco or the other mifepristone manufacturers, GenBioPro and Evita.

The ideological underpinning of the Population Council’s efforts and the importance of mifepristone in that scheme have never been hidden. Ruth B. Merkatz served as Director of the FDA’s Office of Women’s Health from 1994 to 1996—the same years the Population Council was conducting U.S. clinical trials and ultimately filed its new drug application with the FDA on March 18, 1996—before later becoming a director at the Population Council herself. In an FDA interview, she was candid: “We knew [mifepristone] was going to be very important especially in states where surgical abortions are not permitted. And if they overturn Roe v. Wade, it’s going to be really important.” That legacy echoed earlier sentiments by her Population Council predecessor, who acknowledged that “[b]irth control and abortion are turning out to be the great eugenic advances of our time.”

The FDA approved mifepristone in September 2000 with strict safety requirements, such as three required in-person doctor visits, licensed physician dispensing, and mandatory adverse event reporting, acknowledging that “restrictions…on the distribution and use of mifepristone are needed to assure safe use of this product.” The drug was even deemed unsafe for women who did not have convenient access to a medical facility equipped to provide emergency blood transfusions and resuscitation. Unfortunately, those safety standards would not last.

The sordid history of the FDA and abortion drugs

The original safeguards for mifepristone went something like this:

The drug could only be prescribed up to seven weeks’ gestation by a licensed physician capable of diagnosing ectopic pregnancies and accurately determining gestational age. That physician was required to see the patient three separate times in person, with serious complications reported through the manufacturer to the FDA. These were basic, commonsense protections for women taking a high-risk drug. The FDA knew it. And for a time, it acted like it.

Then Danco Laboratories, the drug’s manufacturer, got involved.

In 2016, at Danco’s explicit request, the FDA began dismantling those standards. The gestational limit was extended from seven to ten weeks. Required in-person visits were reduced from three to one initial visit to screen for complications and dispense the drug. The licensed physician requirement was eliminated. And the FDA stopped requiring providers to report serious non-fatal complications except for deaths—effectively ensuring that the consequences of weakening these standards would be nearly impossible to track.

That last point is especially important. By eliminating the reporting requirement—and thus removing safety oversight—the FDA guaranteed its own adverse event data would show fewer complications. Then it turned around and cited the absence of such adverse event data to justify removing another safeguard. The U.S. Court of Appeals for the 5th Circuit called this out directly in April 2023: “[i]t’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision.” The FDA’s math, in other words, amounts to zero plus zero equals one.

In April 2021, under the cover of COVID-19, the FDA temporarily eliminated the requirement that a woman have an initial in-person office visit before being dispensed mifepristone. This made abortion drugs available by mail. By 2023, that change was made permanent. To justify that decision, the FDA cited studies it admitted were “not adequate on their own” to establish the drug’s safety and the data it had earlier gutted.

Today, women are taking high-risk, life-ending drugs they received in the mail without so much as a conversation with a medical professional to rule out complications like ectopic pregnancy and screen for abuse and coercion. That is not healthcare. And many women and their children have suffered because of it.

Just how dangerous are abortion drugs?

Abortion activists have spent years insisting that mifepristone is safe. Danco Laboratories calls it “the safe and effective abortion pill,” and organizations like Planned Parenthood claim it is safer than Tylenol—though they’ve since admitted the Tylenol quip is “mere puffery,” despite their and many women’s firm reliance on it. A host of media outlets have repeated these claims, particularly in the years following Dobbs. The data tell a very different story.

The FDA’s own drug label—the one attached to the very drug the industry calls safe—states that roughly one in 25 women who take mifepristone as directed will end up in the emergency room, and that up to seven percent will require surgery. Those numbers were calculated when there was still an in-person dispensing requirement, and the FDA itself admits that removing that requirement likely increases those risks. That alone should give anyone pause.

But a 2025 review of large-claims insurance data by the Ethics and Public Policy Center (EPPC) indicates that the FDA’s own figures look like woeful underestimations. Analyzing nearly 866,000 mifepristone prescriptions from 2017 to 2023, the EPPC found that nearly 11 percent of women suffered serious complications, which is approximately 22 times higher than the less than 0.5 percent figure the FDA cites.

How have women been harmed by abortion drugs?

The statistics above are staggering enough on their own. But even more tragically, behind every data point is a woman who has been forced to live it.

Elizabeth Gillette

Elizabeth Gillette was 24 years old when she found herself unexpectedly pregnant, pressured by an unsupportive boyfriend, and sitting in an abortion facility where staff handed her papers to sign without time to read them, offered no counseling, and made no mention of what she was about to experience. She was told she would feel a great sense of relief. She was told it would feel like a heavy period. After they got her money, her case was closed.

Her abortion was anything but what was promised. For hours, her body was wracked with pain that no heating pad or Advil could relieve.

“I was so scared—I thought I was going to die,” Elizabeth said. “But that wasn’t even the worst part. The worst part was that nobody told me that I would actually pass the entire amniotic sac whole—that I would hold my dead baby. That I would see his eyes and his fingers. They told me I would just see clotting and heavy period blood. They lied to me.”

“When the FDA took away its original safeguards, it betrayed every woman—not just me.”

Elizabeth’s story is a painful glimpse at what many women suffer alone in their own private spaces when they take abortion drugs.

Rosalie Markezich

Rosalie Markezich did not want an abortion. But her boyfriend ordered abortion drugs online and coerced her to take them. An in-person office visit would have given Rosalie a chance to ask for help.  

When Rosalie unexpectedly found out she was pregnant in October 2023, all she could do was smile at the positive pregnancy test. Her boyfriend had other ideas. After initially supporting the pregnancy, he did what the Biden FDA made possible—he ordered abortion drugs through the mail from a California doctor and had them delivered directly to Rosalie’s house in Louisiana, despite the fact that she had never spoken to this doctor and despite the fact that they were unlawful in her state.

When Rosalie initially refused, her boyfriend grew livid. Trapped in a car with a man she knew had a criminal record and history of anger issues, with no one aware of her whereabouts (and with her own tragic history of being a domestic violence victim), Rosalie made a calculated decision. Terrified, she pleaded: “Don’t make me do this.” Those pleas fell on deaf ears.

“I was scared, and I felt pressured to take the pills,” Rosalie said. “So I did.”

“I planned to throw up the drugs as soon as I could.”

Rosalie was unable to throw up the drugs in time. She tragically lost her baby.

She spent the days that followed bleeding and crying, utterly devastated. But Rosalie’s closing words leave little room for ambiguity about what—and who—was responsible.

“Had the FDA required an in-person visit with a doctor before dispensing the drugs, my boyfriend would never been able to obtain the drugs that he made me take. I also would have told the doctor that I did not want to take them.

“And I would have told the doctor that I wanted to keep my baby.”

Catherine Herring

In March 2022, Catherine’s husband brought her breakfast in bed—and a cup of water. But it wasn’t just water. He had spiked her drink with abortion drugs in an attempt to kill their baby without her knowledge. The effects were severe enough to send Catherine to the emergency room, and she almost lost her child. That was the first of seven total poisoning attempts.

Miraculously, Catherine’s baby girl survived. But Catherine’s story is not unique. As mail-order abortion drugs have become easier to obtain, the window for this kind of reproductive coercion has only grown wider. The FDA has now recklessly facilitated this kind of harm.

ADF is standing up for women harmed by the FDA’s reckless actions

Women like Elizabeth, Rosalie, and Catherine are not alone. The FDA must be held accountable.

The fight for women’s safety—and for life—is far from over. ADF has been at the forefront of challenging the FDA’s dismantling of abortion drug safety standards, first in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine and now alongside the state of Louisiana and Rosalie in State of Louisiana v. U.S. Food and Drug Administration.

In FDA v. Alliance for Hippocratic Medicine, ADF represented doctors and medical organizations who sued the FDA over its reckless removal of abortion drug safety standards. The case made it all the way to the U.S. Supreme Court, where the Court ultimately ruled that the doctors and medical associations did not have the legal right to bring this challenge—not because the FDA was right, but because of a legal technicality. While the Court did hand down a notable win for the conscience rights of medical professionals, the FDA’s conduct ultimately went unexamined by the Court. And so the harm to women and their children continued.

Enter State of Louisiana v. U.S. Food and Drug Administration. Louisiana, one of the most pro-life states in the country, has nearly 1,000 unlawful mail-order abortions occurring within its borders every single month despite its strong pro-life laws. Alongside Rosalie, ADF and Louisiana Attorney General Liz Murrill filed suit against the FDA in October 2025. The case has already produced significant wins: a federal district court upheld Louisiana’s standing and found it likely to succeed on the merits. In May 2026, the 5th Circuit temporarily halted the abortion drug scheme entirely—only for the Supreme Court to allow it to continue thirteen days later while the appeal is fully litigated.

The fight is ongoing, the stakes are real, and ADF is not finished.

The Biden FDA utterly failed women—and it’s time for accountability

Stepping away from the intricacies of legal procedure, the story of the FDA and abortion drugs is ultimately one about women and their unborn children. Elizabeth still closes her eyes and sees her baby. Rosalie still mourns the child she thought she was going to have.

None of this was inevitable. The FDA chose to make high-risk drugs available by mail. The FDA chose to remove safeguards that reduced complications. The FDA chose to eliminate the reporting requirements that provided oversight. And the FDA chose to do all this despite the immeasurable harm it would bring to women and their unborn children.

The FDA has been entrusted with protecting the health of all Americans. But when it comes to women and their unborn children, the FDA has betrayed that trust at an enormous human cost.

Despite the recent Supreme Court action, ADF’s fight to hold the FDA accountable is far from over. The 5th Circuit appeal is still active, and the coalition supporting it continues to strengthen. The Biden FDA’s scheme continues for now. But the fight for life is far from over.