The latest on judge’s decision to suspend FDA rule protecting women undergoing chemical abortions

By Dave Andrusko

Here’s today’s update in the ongoing pro-abortion campaign to force the FDA to cease requirements that protect women who are undergoing chemical (“medication”) abortions.

The campaign is part and parcel of the Abortion Industry’s end game: Do It Yourself abortions performed at home. The issue took on immediacy with District Judge Theodore Chuang ’s July 14 decision to suspend an FDA rule, which among other things, requires a woman to have an in-person doctor’s visit before undergoing a chemical abortion during the COVID-19 pandemic. Of course, the objective is not merely to win relaxation during the pandemic but to establish that such abortions are “safe” and should be routinely allowed to go forward once the pandemic is tamed.

Writing for Vox today, Ian Millhiser warns his readers that “The Supreme Court is already considering another threat to abortion rights: The Trump administration could force abortion patients to have unnecessary surgeries.”

After the usual huffing and puffing, Millhiser summarizes the immediate situation:

The case turns on whether the courts should relax long-standing FDA-imposed restrictions on the drug mifepristone, which is commonly used in medication abortions, in order to make the drug easier to obtain during the Covid-19 pandemic.

Then

Although patients may take mifepristone at home, the FDA only permits this drug to be distributed at hospitals, clinics, or medical offices — meaning that it cannot be dispensed by a retail or mail-order pharmacy.

And therein lies at the heart of what pro-abortionists so desire—mifepristone “dispensed by a retail or mail-order pharmacy.”

This has long been opposed by the FDA and by the Trump Administration, and by pro-life organizations, including, of course, National Right to Life.

Opposition to Judge Chuang’s very questionable decision includes an amicus brief from 11 states in support of the FDA’s motion for a stay of the district court’s ruling.

Rules such as the requirement that mifepristone be dispensed only in a clinic, medical office, or hospital protect women’s health and “are not unduly burdensome even in the current public health emergency,” according to the brief filed in the 4th U.S. Court of Appeals.

“When a woman ingests mifepristone for the purpose of aborting a fetus, she not only ends the life of her unborn child, but also undergoes significant risks to her own body,” Indiana Attorney General Curtis Hill said. “Federal and state laws require physical examinations and in-person dispensing of mifepristone to ensure that physicians check for contraindications and that women fully understand the risks.”

Writing for Law360, Kevin Stawicki explained

The lower court misapplied the Supreme Court’s ruling in June Medical Services v. Russo, which struck down a Louisiana law requiring abortion providers to have admitting privileges at nearby hospitals, by relying on a cost-benefit test for abortion laws, the states said.

U.S. District Judge Theodore D. Chuang improperly used the cost-benefit balancing test rejected by Chief Justice John Roberts when he should have adhered to the test that considers whether the law imposed an “undue burden” on abortion access, the states said.

“A balancing test that would invalidate laws without a substantial obstacle lies outside common ground shared with the chief justice, and therefore does not control,” Texas and the other states wrote in the brief.

In addition to the issue of which test Judge Chuang should have used, the amicus brief also argued that “Plaintiffs’ claim is also legally barred because Plaintiffs failed to exhaust their administrative remedies, ignoring the ordinary requirement that they submit scientific evidence for expert review by FDA regulators”; “Nor does evidence establish a uniform nationwide burden that justifies a national injunction, which forecloses evidence-based, local responses”; and before raising a challenge in federal court, “Plaintiffs were required to file a formal petition for relief with FDA based on science justifying the relief they seek,” which “they failed to do.”

In addition, more than 20 pro-life leaders, including NRL President Carol Tobias, have written to the head of the FDA urging Dr. Stephen Hahn “to protect American women and preborn children by removing the abortion pill (mifepristone) from the US market.”

The letter thoroughly and systematically disputed the conclusion that such self-administered abortions are safe, an assertion Judge Chuang, an Obama appointee, agreed with wholeheartedly

For example,

This lethal drug that the FDA permits for killing innocent preborn children during the first 10 weeks of pregnancy is also highly dangerous for women. According to the FDA’s adverse event reporting system, the abortion pill has resulted in over 4,000 reported adverse events since 2000, including 24 maternal deaths. Adverse events are notoriously underreported to the FDA, and as of 2016, the FDA only requires abortion pill manufacturers to report maternal deaths. Manufacturers gather this information from the prescribers, such as Planned Parenthood facilities. Yet, women who experience side effects like heavy bleeding, abdominal pain, or severe infections are likely to seek care at emergency rooms, not the abortion facilities where they received the pills. Since emergency rooms are not required to report abortion pill adverse events to the FDA, the true number of adverse events is impossible to assess.

Most importantly, the Trump Administration has asked the Supreme Court to reinstate the FDA protective measures as it appeals. In commenting on the 4th Circuit’s one-sentence decision not to stay Judge Chung’s decision, the Trump Administration wrote that “The Fourth Circuit necessarily would have rejected two settled principles in this Court’s precedents:

first, that a regulatory requirement imposed on one abortion method is not unconstitutional when another safe abortion method remains readily available; and second, that merely incidental effects on abortion access do not render an otherwise valid law unconstitutional, especially when those effects are not caused by the government. Apart from the merits, the nationwide scope of the injunction independently warrants review. The circumstances here — in which a single district court, presented with a suit by a single physician and a handful of organizations, displaced the FDA’s scientific judgment with respect to every medication abortion provider in the country — illustrate the problems with allowing district courts to award relief untethered to the established injuries of the specific plaintiffs before them.

NRL News Today will continue to update you as the case proceeds.