In a filing released Tueday, the US Food and Drug Administration (FDA) argued before a federal judge in Amarillo, Texas that reversing the approval of medication abortion drug mifepristone would “dramatically harm” public interest.
The FDA argued that the drug was a “meaningful therapeutic benefit to patients” and had benefited thousands of women. The FDA further argued that patients who depend on mifepristone would seek legal access to abortion regardless of any injunction. Without mifepristone, patients would have to resort to invasive surgical methods that are “inaccessible” to some, risk patient health and cause increased wait times for an abortion.
Commenting on the effect the withdrawal of the drug would have on vulnerable populations, the FDA said:
As individual providers have explained, a substantial proportion of patients choose medication abortion for a variety of reasons including medical necessity, privacy, and avoiding further trauma, and its sudden absence would be expected to impose real and significant harms on such patients. The effects of a preliminary injunction would be particularly acute for patients for whom mifepristone is the medically indicated treatment because of the patient’s pre-existing health condition. For example, surgical abortion involves anesthesia, but people who are allergic to anesthesia can experience “a sudden drop in blood pressure with cardiorespiratory arrest, and death.”
The arguments were filed in opposition to a lawsuit in the US District Court for the Northern District Of Texas by anti-abortion groups like the Alliance for Hippocratic Medicine. The groups argued that the FDA did not follow due process while granting approval to the drug in 2000. The anti-abortion activists claim the FDA “chose politics over science” when giving authorization.
The groups remarked on the alleged adverse impact of the medication on adolescent girls and the federal agency’s lack of compliance with existing laws. Lawyers representing the groups stated in their filing:
The FDA needed to disavow science and the law because the FDA never studied the safety of the drugs under the labeled conditions of use despite being required to do so by the Federal Food, Drug, and Cosmetic Act (FFDCA). The agency also ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls in violation of the Pediatric Research and Equity Act (PREA). And the FDA disregarded the substantial evidence that chemical abortion drugs cause more complications than even surgical abortions.
According to the FDA, mifepristone facilitates medication abortion by blocking a hormone called progesterone. When used with another drug, misoprostol, it can be used to terminate a pregnancy within ten weeks of the last menstrual period. The FDA claims the drug has been used by approximately 5.6 million women with negligible adverse effects. On January 1, the Biden administration amended the rules governing the dispensing of mifepristone to include retail pharmacies for the first time.
