Mifepristone comes under scrutiny

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MYRNA BROWN, HOST: Coming up next on The World and Everything in It: fair warning.

Federal regulators are taking a closer look at the abortion drug mifepristone. The review comes after new data that raises questions about its alleged safety for women. WORLD’s Lauren Canterberry has the story.

LAUREN CANTERBERRY: In a recent hearing, Health and Human Services Secretary Robert F. Kennedy Jr. said he would direct the Food and Drug Administration to investigate mifepristone. He had this exchange with Missouri Senator Josh Hawley.

HAWLEY: You’ve previously testified to the committee that you would do a top to bottom review of mifepristone. Do you continue to stand by that? And don’t you think that this new data shows that the need to do a review is in fact very pressing?

ROBERT F. KENNEDY: It is alarming and clearly it indicates that at the very least the label should be changed.

Abortion advocates have long claimed mifepristone is safe for women and rarely has adverse effects. But a new data analysis shows the pill is far more dangerous than its supporters admit.

Mifepristone was first approved in 2000. Clinical trials appeared to show it was safe for women when used alongside the other abortion drug misoprostol. And studies claimed that serious side effects were rare. Mifepristone now accounts for more than half of all abortions in the United States.

But since its approval, the dispensing standards for the drug have fallen dramatically.

At first, the FDA only permitted certified medical professionals to prescribe mifepristone to women up to seven weeks pregnant, and only during an in-person visit. Patients had to have three appointments—one to determine the gestational age of their unborn child and to rule out ectopic pregnancy, another to take the pill, and a follow-up appointment to check for complications. Abortionists also had to report any adverse effects to the FDA, as is standard practice with many drugs and vaccines.

Then the restrictions started loosening. The FDA went from requiring three to only two in-office visits with a medical professional. And women could now take mifepristone in up to 10 weeks of pregnancy.

They went further in 2021, completely removing the requirement to attend any in-person visit with a medical professional. Two years later, the Biden administration allowed retail pharmacies to dispense mifepristone directly to patients.

Officials are gradually chipping away regulations surrounding the drug and pro-life advocates are worried that the current warning label for the pill is no longer accurate. Ryan Anderson is one of them. He’s president of the Ethics and Public Policy Center.

ANDERSON: And we had been hearing stories from pro-life doctors in the ER and OB-GYNs saying the abortion pill is much more dangerous to women. Obviously, we know that when the abortion pill works, it’s deadly for children, but the concern here is that it’s also much more dangerous for women than the FDA has ever admitted.

In April, Anderson and colleague Jamie Bryan Hall published an analysis of data from public and private insurance claims. The data ranges across 5 years, from 2017 to 2023.

The results of the analysis are at sharp odds with previous studies which said only 1 in 200 women experience adverse side effects from the drug.

But according to the Ethics and Public Policy Center, the number is much higher. Their analysis reveals almost 11% of women experienced a serious adverse event within 45 days of taking the drug. That’s one in nine women.

Almost half of the women who experienced an adverse event visited the emergency room. The most common serious outcomes were: hemorrhage, infection, and needing surgery to finish the abortion. And there were other abortion-related complications, such as damage to a woman’s internal organs or life-threatening mental health diagnoses that occurred later.

ANDERSON: Real world insurance data shows you, well, how is this drug being used in reality, not under ideal circumstances.

Pro-abortion groups have claimed Anderson and Hall manipulated the data to support their position. The drugmaker Danco says cramping and bleeding are known side effects, and abortion advocates say there have not been any new studies to show the drug is unsafe.

But Anderson says he believes their findings will hold up to scrutiny, and calls on federal officials to do their own review.

ANDERSON: This should make the FDA think twice about whether the current regime of mail order telehealth is really in the best interests of the safety and the protection of these women.

Many others agree. Dr. Donna Harrison is the director of research at the American Association of Pro-Life Obstetricians and Gynecologists. She says that abortionists dispensing mifepristone without listing complications could amount to medical malpractice.

HARRISON: What we have right now is a willy-nilly distribution of mifeprex, which does cause significant side effects. Women are really, actually not able to get informed consent, because you can't tell a woman what her rate of complications will be unless you know exactly how far along she is in her pregnancy.

Harrison and Anderson advocate for pulling mifepristone from the market entirely, but both recognize that convincing federal officials to do so is unlikely.

HARRISON: It’s not real medical care. What it is is an attempt at a chemical solution to a social problem.

Other pro-life doctors agree that the study should push regulators to scrutinize mifepristone much more closely.

ERIC HUSSAR: If the solution to that is just finding a quote, unquote, safer abortion pill, then we’ve also still neglected the baby in the process.

Dr. Eric Hussar is the Pennsylvania state director for the American Academy of Medical Ethics. He says it’s critical that patients know the truth about the risks of any medication they take. And while mifepristone poses significant risks to women, it is almost always fatal for unborn babies.

HUSSAR: Ultimately, it’s the enemy that’s behind it all and he’s a deceiver and a liar and he’s going to do whatever he can to try to destroy life.

Reporting for WORLD, I’m Lauren Canterberry.

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