A group of pro-life doctors called the Alliance for Hippocratic Medicine sued the Food and Drug Administration last November to ensure the federal agency follows its mandate to “protect the health, safety, and welfare of all Americans by rejecting or limiting the use of dangerous drugs.”
The dangerous drug in question is the chemical abortion drug known as “the abortion pill” or RU-486, which is marketed as Mifeprex by the secretive single-product pharmaceutical company, Danco Laboratories.
Roughly half of the abortions committed in the United States are now carried out using these lethal chemicals.
The Biden administration has continued to deregulate the prescription and distribution of these drugs using a combination of administrative agency actions and executive orders in the hopes of circumventing pro-life protections. Pro-life Americans have responded with citizen petitions, promises by state attorney generals to enforce state laws, peaceful protests and lawsuits.
Politics Over Health and Safety
In this latest lawsuit, the association of pro-life doctors, represented by Alliance Defending Freedom, makes the case for how, from the very beginning of the review process, the FDA put politics over safety considerations. As the lawsuit alleges in the initial complaint the FDA has failed to protect America’s women and children from the dangerous abortion pills.
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. And it has continued to fail them by repeatedly removing even the most basic precautionary requirements associated with their use.Complaint in Alliance for Hippocratic Medicine v. FDA
Initially, the FDA used an “accelerated” drug approval authority that required them to call pregnancy an “illness” and argued that the drugs offered important therapeutic benefits over other abortion alternatives.
Gross Media Manipulation
While American mainstream outlets initially regularly reported the deaths of young women who ingested the abortion pills, the increasingly radicalized media is now ignoring the deaths of women and the well-known complications from the drugs in their effort to promote the expanding use of the abortion pill.
In 2004, NBCNews published a story titled “Are abortion pill safety warnings enough?” The story described the grief suffered the family of women killed by the abortion pill and suggested more regulation, not less, was needed. Now, although a teenage woman died less than three months ago in Canada from the abortion pill, the radicalized media covers the issue exclusively in pro-abortion political terms; terms that completely ignore the pregnant victims of the abortion pill just like they do their unborn children.
Most of the coverage from the pro-abortion mainstream media has been limited to pro-abortion talking points and the fact that the judge who is hearing the case was appointed by Trump and worked many years before that for a Christian non-profit law firm. The media’s concern for judicial neutrality in abortion cases seems to depend on who is bringing the case, as media criticism was noticeably absent when Planned Parenthood brought a case in Michigan before Judge Elizabeth Gleicher to strike down the state’s pre-Roe abortion ban. Judge Gleicher had not only previously represented Planned Parenthood as an attorney in private practice but was also a donor to the abortion giant. Nevertheless, she refused to recuse herself, ruled in favor of her previous client. Predictably, the media ignored the gross conflict of interest in that case.
FDA’s Growing Deregulation of the Abortion Pill
The complaint also explains that 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).” Instead, they have systematically “removed the few safeguards that were in place.”
In March of 2016, towards the end of the Obama administration, the FDA not only rejected a citizen petition filed fourteen years earlier requesting that the abortion pill lose its FDA approval for violations of the FFDCA, but they doubled down on their promotion of the drugs, extending the gestational age of the babies that could be killed by chemical abortion from seven weeks to ten weeks.
The FDA also rushed to “change the dosage and route of administration for the chemical abortion drugs, reduced the number of required in-person office visits from three to one, expanded who could prescribe and administer chemical abortion drugs beyond medical doctors, and eliminated the requirement for abortionists to report non-fatal complications from chemical abortion drugs.”
In effect the FDA was making it easier to dispense the abortion pill and nearly impossible to document any complications and serious health issues, short of death, arising from the abortion pill.
Even during the Trump administration, the FDA continued on its march towards deregulation of chemical abortion, approving a generic version of the abortion pill to be sold by other pharmaceutical companies. Again, the government agency in charge of protecting America’s women and children neglected to carry out the safety studies required by laws such as the Pediatric Research and Equity Act and the FFDCA.
In 2021, in the midst of the COVID pandemic, President Biden issued an executive order allowing the abortion pill to forego the in-person dispensing of the abortion pill, opening up the dangerous drug to mail order dispensing with a simple “tele-health” consultation. The executive order was supposed to be temporary due to the pandemic, but within six months the FDA moved to make the COVID “emergency” changes permanent.
The Deadly Abortion Pill
The dangers of the politically driven deregulation of the abortion pill is explained by Dr. William Lile, a board certified OB/Gyn who reviewed a recent case of a 26 year old woman who died after taking the abortion pill while suffering from an ectopic pregnancy.
The lawsuit explains that the use of chemical abortion drugs “causes significant injuries and harms to pregnant women and girls,” the complaint continues by citing evidence proving that “upwards of ten percent (10%) of women who take chemical abortion drugs will need follow-up medical treatment for an incomplete or failed chemical abortion, with an average of thirty-nine percent (39%) of women requiring surgery if taken in the second trimester.”
Meanwhile, a common myth based upon faulty studies is being promoted by the abortion industry and its allies in the mainstream media that chemical abortion is safer than Tylenol.
Reality, is, of course, very different.
The real data shows that the abortion pill has serious life-threatening consequences for the women who ingest it and almost always cause the death of the baby she is carrying.
The lawsuit explains that “twenty percent (20%) of females will have an adverse event after taking chemical abortion drugs—a rate four times higher than with surgical abortion. This includes over fifteen percent (15%) of females experiencing hemorrhaging and two percent (2%) having an infection during or after taking chemical abortion drugs. Chemical abortions are over fifty percent (50%) more likely than surgical abortions to result in an emergency department visit within thirty days, affecting one in twenty females.”
The fact that the abortion pill is more dangerous to the mothers than surgical abortion is an important factor in the litigation, as it negates one of the alleged reasons the FDA originally approved the drug.
The Decision Could Come as Early as Monday, Feb. 27
The initial question that the court will decide will be whether to allow an injunction that would prohibit the sale of the drug while the case is litigated.
To win an injunction, a plaintiff has to prove that they are “likely to prevail on their claims that the
U.S. Food and Drug Administration (FDA) acted unlawfully” and that failure to grant the injunction will result in irreparable harm to the parties.
On February 10th, the court ruled that Danco Laboratories (the original US licensee of the abortion pill drug) could intervene in the case, and gave the parties two more weeks to file responsive pleadings.
The pro-life plaintiffs then filed their brief in which they laid out why it is appropriate to issue a preliminary injunction.
Stay tuned to American Pro-Lifer as we cover this case and all of the ongoing battles for and against legalized child-killing in America.