This article was originally published in Pregnancy Help News on Feb 9th, 2023, and was written by Kim Hayes. It is reprinted here with permission.

The U.S. Food & Drug Administration (FDA) attempted a distraction from safety issues in its initial response to the lawsuit against its approval of chemical abortion drugs. 

The FDA is being sued by a group of physicians and doctors’ associations represented by Alliance Defending Freedom (ADF) for failing to fulfill its mission of keeping Americans safe and putting women at risk over the last 20 years via its rushed approval of the abortion pill.

The FDA’s mission includes being “responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products and medical devices,” and ADF’s argument in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration centers on the federal agency’s failure to do so with chemical abortion.

The FDA acknowledged it gave at best minimal attention to the safety of women using the drug in the approval process in its opposition brief, according to ADF Senior Counsel Julie Marie Blake.

“The government’s brief conceded that it has never studied the labeled conditions of use for chemical abortion drugs,” Blake said. “So, the harms to women that our frontline doctors have been treating firsthand are heartbreaking and yet not surprising.”

ADF filed its complaint against the FDA on November 18, 2022, along with a preliminary injunction asking the court for expedited review. The government’s opposition brief was due January 13, 2023, and ADF then had until February 10 to reply.

ADF contends in the case that the FDA approved chemical abortion drugs without basis in 2000 and has continued to remove the few protections initially in place since. At issue as well is the FDA’s defining pregnancy as an illness to justify the abortion pill’s approval. Proper legal channels were not followed with the approval, the plaintiffs argue, and politics came before science.

Instead of patient safety, the FDA’s response focused on the fact the drug has been on the market for a long time, (albeit via its own approval of the drug amid the safety issues at hand) and how inconvenient it would be to the drug manufacturer to have it removed from the market. Abortion drug manufacturer Danco Laboratories has, unsurprisingly, filed a motion for leave to intervene in the case in defense of its abortion pill business.

FDA attorneys also argued concern over the economic effects of removing the availability of the drug for the supposed sake of the financial good of the broader public. 

Despite the possible dangerous side effects of these drugs, the FDA stated in its response that, “More than twenty-two years ago, the U.S. Food and Drug Administration (FDA) approved the drug mifepristone as safe and effective for the medical termination of intrauterine pregnancy under certain conditions.”

It goes on to declare that the plaintiff’s motions to remove the drug from the market should be denied, arguing that the statute of limitations for raising complaints has expired.

The FDA touches on complaints filed on this issue in 2002, which the FDA finally addressed in 2016 with a denial of the petition, demonstrating its own stonewalling on the matter. 

The FDA’s approval for the abortion pill stated outright that its use was for “under certain conditions,” conditions which have been summarily rendered moot by the agency itself over the years as restrictions for the distribution of the drug have been removed and reduced.

The FDA permitted use of these drugs by mail order since the end of 2021, more recently allowing distribution through pharmacies without a physician’s oversight.

The FDA’s own Risk Evaluation and Mitigation Strategy” (REMS) previously required the abortion drugs only be dispensed in person by a certified healthcare provider in a clinic, hospital, or medical office. An in-person exam by a physician is necessary to properly determine the gestation of a woman’s pregnancy and to also screen for ectopic pregnancy, as well as for other conditions, which are all significant factors in ensuring the woman’s safety.

“The FDA, by approving chemical abortion drugs for home use, puts a woman or girl’s life at risk,” Blake said.

The FDA in its opposition brief argued that certifying pharmacies for abortion pill distribution equates to ensuring women’s safety, stating, “mifepristone will remain safe and effective if the in-person dispensing requirement is removed, provided all the other requirements of the REMS are met and pharmacy certification is added.”

The FDA argued as well that the plaintiffs do not have standing, having not shown that they – medical providers, because they are not the patients – have not personally been harmed.

As the case progresses, Blake aptly stated, “The FDA must protect the health, safety, and welfare of women and girls by rejecting the dangerous chemical abortion drugs.”

+ posts

The views and opinions expressed in these articles are those of the author and do not necessarily reflect the official position of Human Defense Initiative.