FILE - Mifepristone tablets sit on a table at a Planned Parenthood clinic in Ames, Iowa, Jul. 18, 2024. The courts are once again litigating distribution of the abortion pill by mail. (AP Photo/Charlie Neibergall, File)

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Courts in the United States are again litigating the distribution of the abortion pill, mifepristone, by mail. After a federal appeals court last week ruled that mifepristone can only be distributed in person and at clinics, the Supreme Court temporarily restored access yesterday while it reviews the case.

The abortion pill is once more in the crosshairs of American politics and the judicial system. Despite more than two decades of safe and effective use, politicians have been debating and courts litigating mifepristone since its regulatory approval in 2000. The intensity of the legal challenges has grown considerably in recent years, particularly in the wake of the Supreme Court’s decision to strike down Roe v. Wade.

The Fifth Circuit Court of Appeals ruled last week that mifepristone, known as the abortion pill, can be distributed only in person and at clinics. This reversed Food and Drug Administration regulations established under the Biden administration that allowed patients to obtain the medication through the mail.

Federal court judge Kyle Duncan sided with the argument put forward by Louisiana’s attorney general that mailing mifepristone undermines the state’s ban on abortion.

It’s expected that the case will ultimately get decided by the Supreme Court. In the meantime, the Court reinstated patient access to mifepristone by mail yesterday as part of a temporary order that will remain in effect for one week in order for it to more fully consider the issue.

The FDA approved mifepristone in 2000 for medication abortion. The medicine blocks progesterone, which is needed for a pregnancy to continue. When taken in conjunction with misoprostol, mifepristone ends early pregnancies (up to 10 weeks following conception).

It can be safely administered at home when prescribed by a healthcare provider, and the FDA has allowed people to take the drug outside of a clinic setting since 2021. That same year, the FDA further eased several conditions with respect to the prescribing and sale of mifepristone. Specifically, the regulatory authority allowed for prescriptions to be issued through telemedicine visits in for shipments of the product to be sent by mail.

Medication abortion currently accounts for over 60% of abortions in America. It appears that rising numbers of abortions using prescription drugs in the past five years may be linked to the changes instituted by the FDA. In addition, the use of medication to terminate pregnancies could have also been triggered by the Supreme Court decision to overturn Roe v. Wade in 2022, as a Journal of the American Medical Association study described.

Meanwhile, the political debate on the abortion pill has intensified since the Roe v. Wade reversal saying that the Constitution does not protect a right to abortion. State bans on abortion coupled with President Trump’s return to office for a second term have triggered heated arguments between pro-life and pro-choice advocates.

Mifepristone has been in use in Europe for nearly three decades with a minimal number of reported adverse events. And the drug has had a similar safety record in the U.S since its approval in 2000. Between September 2000 and December 2018, only 24 of the more than 3.7 million women who had undergone medicated abortions have died, according to the FDA. Overall, the adverse events rate is less than 1% and the drug is considered safer than, say, over-the-counter non-steroidal anti-inflammatory drugs and anti-histamines.

In more than 100 studies worldwide, researchers have examined the effectiveness and safety of mifepristone and misoprostol. All peer-reviewed studies concluded that the pills are a safe method for terminating a pregnancy.

Yet there appears to be a non-peer-reviewed study that’s at the center of a request for the FDA to assess mifepristone. It’s from the conservative think tank, the Ethics and Public Policy Center. This particular study makes claims about what it views as a high rate of serious adverse events following medication abortions.

Furthermore, Health and Human Services Secretary Robert F. Kennedy Jr. formally launched a review of mifepristone last autumn. The evaluation focuses on the drug’s Risk Evaluation and Mitigation Strategy, with the apparent aim of tightening prescribing rules or limiting telehealth and mail distribution. REMS are FDA-mandated drug safety programs for to ensure the benefits of certain medications outweigh risks.

Beth Schlachter, MSI Reproductive Choices’ senior director of U.S. external relations and advocacy stated that the “federal court [of appeals] ruling cutting off access to mifepristone by mail and pharmacy is a chilling attempt to restrict access to abortion across America."

She went on to say that “decades of international evidence, real‑world use in roughly 100 countries, and medical consensus all point to the same conclusion: Mifepristone is safe. Telemedicine abortion works. Abortion care should be governed by science and medical expertise – not politics.”

The FDA’s mandate is to review the safety and efficacy of drugs based on clinical evidence. As such, the FDA is the federal authority for all pharmaceuticals distributed throughout the U.S., including mifepristone and misoprostol. And so, the court cases along with requests for additional looks at mifepristone set a potentially unsettling precedent in which the FDA’s regulatory authority from past decisions is subverted.

And it’s not just mifepristone that’s currently under renewed scrutiny. Consider, for example, that HHS has been revisiting debunked theories of links between the measles, mumps and rubella vaccine and autism. The department also spearheaded significant changes in standard childhood immunizations that are inconsistent with prior guidance from the Centers for Disease Control and Prevention.