Safety, FDA approval of abortion pill being challenged in federal court

by Jacob Fuller

Vicky Arias, FISM News

A federal judge on Wednesday will hear arguments about the safety of the abortion drug, mifepristone, in what could prove to be the most important pro-life litigation since Roe v. Wade was overturned.

U.S. District Judge Matthew Kacsmaryk, a Trump-appointed judge, is due to hear arguments in Texas today and may issue a ruling soon after.

The Alliance for Hippocratic Medicine, along with four physicians and three pro-life medical organizations, filed a lawsuit in November 2022 against the Food and Drug Administration (FDA), stating that the agency didn’t properly study the safety of mifepristone prior to approving it.

The plaintiffs, therefore, seek to reverse the FDA’s approval of the abortion drug, potentially saving millions of unborn lives, as, according to the Guttmacher Institute, more than half of all U.S. abortions are carried out using abortion drugs.

Dr. Donna Harrison, former CEO of the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), said that the “use of [mifepristone] has been associated with massive hemorrhage” during an interview with CBN News.

“I’ve reviewed some of the adverse event reports sent to the FDA where women have lost over half of their blood volume, some have lost … their entire blood volume,” Harrison continued. “So, this is the kind of bleeding you see in major motor vehicle accidents and it’s one of the scariest parts of having a Mifeprex abortion — is that you have this uncontrolled bleeding that can happen afterward.”

The lawsuit states that “the FDA failed America’s women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States.”

According to the lawsuit, mifepristone was approved during the Clinton administration in 2000 after the Population Council applied for approval. Plaintiffs argue that “the only way the FDA could have approved chemical abortion drugs was to use its accelerated drug approval authority,” which would require the FDA “to call pregnancy an ‘illness,’” that needs therapeutic or drug management.

Plaintiffs in the case are referring to subpart H of the Code of Federal Regulations, which details the guidelines the FDA must follow under the protocol named “Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses.”

The lawsuit asserts that “pregnancy is not an illness” and claims that the FDA overstepped regulations by approving the life-ending drugs.

Additionally, attorneys for the plaintiffs from the Alliance Defending Freedom say that the FDA “never studied the safety of the drugs under the labeled conditions of use.”

The medication’s own information insert contains a “serious and sometimes fatal infections or bleeding” warning label to notify patients of potential risk.

A report from the Charlotte Lozier Institute states that “expanding abortion access has been a government priority since the 1970’s, largely driven by concerns regarding population control.” The report asserts that the Population Council created a company, called Danco, to manufacture mifepristone.

The FDA’s approval of abortion drugs in 2000 “was based on a single published trial that was non-blinded, non-randomized, and utilized only a historical, non-concurrent control,” the report continued. “For the sake of appearances, the FDA’s expedited approval … [and] stated that Danco would be required to conduct two post-marketing studies, but neither was ever completed.”

Dr. Christina Francis, an Ob-Gyn and CEO of AAPLOG, explained the dangers of mifepristone during a recent interview with Newsmax.

“Women and girls are being endangered and injured everyday … through these dangerous chemical abortion drugs,” Francis said.

“I personally, along with many of my colleagues, have seen women and girls come in through our emergency rooms with severe complications from these drugs,” Francis continued. “Complications that should be … addressed by the FDA … [such as] heavy bleeding and hemorrhage, the need for emergency surgery, [and] the need for admission to the hospital for blood transfusions and infections.”