A federal appeals court pressed attorneys for the federal government and the manufacturer of chemical abortion pill mifepristone Wednesday about the FDA’s assessment of the drug’s safety and the issue of standing during oral arguments in the case that could mean the abortion drug’s removal from the market.
A three-judge panel from the Fifth Circuit Court of Appeals also scrutinized the arguments of pro-life doctors challenging the FDA’s approval of mifepristone and subsequent removal of safety standards for the drug.
The Alliance for Hippocratic Medicine - a coalition of medical associations and physicians with experience providing caring for pregnant and post-abortive women – sued in November contesting the FDA’s approval of mifepristone in 2000 owing to the FDA’s rushed and reckless approval process for the drug and politics behind it.
Mifepristone is the first pill in the two-drug chemical abortion regimen. It blocks progesterone in the pregnant woman’s system, starving her unborn child of nutrients necessary for survival. Misoprostol is the second drug, and is taken about a day after the first, prompting the mother to go into labor and deliver her deceased child.
Chemical abortion makes up more than half of all the abortions committed in the U.S. and that number continues to grow. Pro-life and pregnancy help advocates continually advocate for the women's safety related to abortion pills.
While the panel pressed attorneys from both sides in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration there was skepticism for arguments put forth by the U.S. Department of Justice and Danco Laboratories, which manufactures the abortion drug.
The head of the world’s largest network of pregnancy help said the case is bringing the dark reality of abortion and the political approval of mifepristone to light.
“Abortion politics distorts everything it touches,” Jor-El Godsey said. “Through the insights of actual judges rather than purchased politicians and pundits, we see how terribly the 'abortion distortion' infected the FDA in its original approval and since.”
The pro-life doctors say the FDA never studied mifepristone’s safety under the labeled conditions of use, overstepping its authority in doing so. They take issue with the FDA’s approval of mifepristone hinging on defining pregnancy as an “illness” and the accompanying claim that the drug provides a “meaningful therapeutic benefit.”
They say too that the FDA disregarded substantial evidence that chemical abortion drugs cause more complications than surgical abortions, and that the FDA ignored the potential impact of the hormone-blocking chemical abortion regimen on the developing bodies of adolescent girls.
The doctors argue as well that to expand access to the abortion pill the FDA also eliminated necessary safeguards for pregnant girls and women.
Along with the safety concerns Wednesday’s hearing touched on whether the pro-life doctors have standing to sue, attorneys for the DOJ and Danco Laboratories arguing not, and legal counsel from Alliance Defending Freedom (ADF), representing the doctors, countering that the physicians have been compelled to complete chemical abortions that failed, raising the issue of conscience.
The Alliance for Hippocratic Medicine is also saying that the FDA has stonewalled attempts to hold the federal agency accountable for its handling of the approval of the abortion pill for the last two decades, refuting pro-abortion claims that arguments made against mifepristone’s approval were not made in timely fashion.
U.S. District Judge Matthew Kacsmaryk had agreed with this and found that the initial approval of mifepristone in 2000, along with the more recent FDA decisions permitting the drug to be dispensed through telemedicine, via mail, and at retail pharmacies, were unlawful. Kacsmaryk suspended the abortion drug’s approval April 7 with a seven-day stay allowing for Biden administration attorneys to appeal.
A Washington State federal judge swiftly issued a ruling contradicting Kacsmaryk’s, prohibiting the FDA from removing approval, prompting speculation that case is being primed for the Supreme Court.
On April 12 the Fifth Circuit Court of Appeals restored access to the abortion pill, though ordering the FDA changes to loosen regulations and increase access be put on hold.
The Biden administration appealed to the Supreme Court April 14 asking for an administrative stay pending its appeal to the Fifth Circuit. The Supreme Court granted a five-day stay April 14, followed by a two-day extension, after which it upheld access to the abortion pill while litigation proceeds, with Justices Clarence Thomas and Samuel Alito dissenting from the Court’s 7-2 decision.
The roughly two-hour hearing on Wednesday before the 5th Circuit panel in New Orleans had its tense moments and was widely read as the three-judge panel being open to the pro-life plaintiffs’ arguments.
At one point Judge James Ho expressed doubt over the FDA’s hurried approval of mifepristone, the expediting of approval typically limited to drugs used to treat serious or life-threatening illness.
“Pregnancy is not a serious illness,” Ho said to the lawyer for Danco.
Ho later added, “When we celebrated Mother’s Day, were we celebrating illness?”
Tweet This: “When we celebrated Mother’s Day, were we celebrating illness?” - Fifth Circuit Court of Appeals Judge James Ho
Judge Cory Wilson remarked on the risk to women related to the FDA’s loosening of safety standards.
"It just strikes me that what the FDA has done in making this more available," he said, "is you've made it much more likely that patients are going to go to emergency care or a medical clinic where one of these doctors are a member."
Judge Jennifer Walker Elrod challenged Danco attorney Jessica Ellsworth about the language used by Danco in its court filings criticizing Kacsmaryk’s ruling.
Elrod quoted the Danco briefs back to Ellsworth, Danco calling Kacsmaryk’s decision a “judicial assault” from a “non-expert court” that advanced a “relentless one-sided narrative” about the chemical abortion drug. Elrod asked if this rhetoric could be ascribed to Danco attorneys being “in a rush” and “exhausted from this whole process.”
When Ellsworth went to defend Danco’s remarks, Elrod interrupted and questioned, “Do you think it’s appropriate to attack the district court personally?”
Ho also questioned the abnormal language coming from Danco on the case.
The attack on the district court and other notable portions of the hearing were listed in a Students for Life of America blogpost.
This included challenging the idea that the FDA could not be held accountable for its decisions in a lawsuit concerning happens to women when a company sells the drugs and women use them, and disputing the argument that “the FDA can do no wrong.”
The lack of appropriate testing and study of mifepristone was the highlighted by SFLA, along with the questioning about safety and assessment of conditions such ectopic pregnancy, considering the absence of data on adverse events, because the FDA does not require reporting of non-fatal complications from mifepristone, and the absence of required testing, like an ultrasound.
Legacy media framed the 5th Circuit Court as “extremely conservative,” and “one of the most conservative courts in the country,” and seemed to concede the hearing did not go well for the pro-abortion side. This coverage also assumed the argument made by the pro-abortion defendants that mifepristone is safe and effective.
The appeals court judges “appeared to express support for opponents of the abortion pill mifepristone to pursue their challenge to its U.S. approval,” Reuters reported.
The judges “appeared open to limiting access” to mifepristone, a report from ABC News said.
The hearing’s outcome “suggested that the judges were not buying the Biden administration’s arguments for why courts should not second guess how the government has regulated a medication abortion drug,” CNN’s report said.
The court “appeared prepared to rule that the availability” of mifepristone “should be curtailed,” the New York Times report said, “showing skepticism of the decisions that the Food and Drug Administration has made about” the drug.
The panel “appeared sympathetic to arguments by an anti-abortion group and anti-abortion doctors who want to unwind FDA policies that have expanded access to mifepristone since 2016,” Politico’s report said.
Godsey expressed gratitude for the 5th Circuit judges’ rigorous examination of the pro-abortion claim of safety with the chemical abortion drug, and further decried the apparent politics surrounding mifepristone’s approval.
“Clearly the FDA was, and is once again, acting at the behest of Big Abortion in the guise of Big Pharma,” he said. “Grateful for judges who recognize the law is for the protection of the people and cannot be so easily dismissed by abortion profiteers.”
The Fifth Circuit Court of Appeals has not indicated when it will rule in the case.
Editor's note: Heartbeat International manages Pregnancy Help News.