WASHINGTON, D.C. (LifeSiteNews) — Lawmakers on Capitol Hill joined their voices with the Alliance Defending Freedom (ADF) and numerous OB-GYN’s urging the U.S. Supreme Court to protect women and children from the dangers of the now widely available chemical abortion drugs mifepristone and misoprostol.
The court is set to hear oral arguments in the high-profile abortion pill case that could see the practice curtailed pursuant to federal law.
Reps. Chris Smith (R-NJ) and August Pfluger (R-TX), in a press conference at the Capitol on March 21, called for the FDA to be held accountable for not following federal law in its initial approval of the abortion drug and in all subsequent restriction rollbacks. They were joined by senior counsel at Alliance Defending Freedom, Erik Baptist, and CEO of the American Association of Pro-Life Obstetricians & Gynecologists, Dr. Christina Francis.
The Supreme Court will hear oral arguments in the case, FDA v. Alliance for Hippocratic Medicine, on Tuesday, March 26. Plaintiffs have been joined by 25 states, 145 members of Congress, women harmed by chemical abortion, and a broad coalition of doctors and advocacy groups who filed friend-of-the-court briefs.
READ: EXCLUSIVE: Attorney describes what’s at stake when Supreme Court hears abortion drug case
In the summary of the case the Alliance Defending Freedom, which will be making the pro-life arguments in court, highlighted the fact that in addition to killing the baby in the womb, the abortion drug poses “severe, even life-threatening, harm” to women.
Detailing the more than two-decades long history of the FDA’s blatant ignoring of federal law, ADF stated:
In 2000, the FDA approved high-risk abortion drugs for use in the United States with specific safety standards in place. The FDA required doctors to provide ongoing care to women and girls using the drugs, including in-person visits to check for ectopic pregnancies, severe bleeding, and life-threatening infections. Since its initial approval, the FDA has removed nearly every safety standard it once determined essential for women’s health and safety.
By eliminating the requirement that doctors provide in-person care, the FDA has left young girls to take these high-risk drugs alone at home or in their dorm room. It also removed the requirement for prescribers to report all serious complications from these drugs.
In 2022, ADF attorneys – representing the Alliance for Hippocratic Medicine, three other national medical associations, and individual doctors – sued the FDA to hold it accountable for endangering the health and safety of women and girls. In 2023, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted unlawfully in removing these important safety standards. The Supreme Court has agreed to review the case. Oral arguments will be held on March 26, 2024.
Among the key points of the case, ADF will be arguing that:
- Women face severe, even life-threatening, harm because the FDA disregarded their health and safety.
- The FDA must be held accountable for violating its duty to protect women and girls.
- The doctors ADF represents have witnessed firsthand the harm to women and girls caused by the FDA’s reckless actions.
- The FDA’s own label for these abortion drugs says that roughly one in 25 women who take the drugs will end up in the emergency room.
READ: US bishops call for nationwide prayer to St. Joseph for end to abortion ahead of Supreme Court case
In their original judicial complaint, ADF argued that the original approval of the abortion drugs was illegal because it required the FDA to grossly and falsely designate pregnancy an “illness” and the chemical abortion drugs, designed to kill the baby in the womb, “medication” providing “meaningful therapeutic benefit.”
The FDA detailed:
Beginning in January 1993, on his second full day in office, President Bill Clinton directed his cabinet to legalize chemical abortion drugs in the United States. President Clinton and his agency officials then pressured the French manufacturer of the key chemical abortion drug, mifepristone (also known as ‘RUUmbrasaetus.1486’ and ‘Mifeprex’), to donate for free the U.S. patent rights of the drug to the Population Council – as its name suggests, an entity focused on population control.
After receiving the patent rights to mifepristone, the Population Council submitted a new drug application, worked closely with the Clinton FDA during the review process, and, not surprisingly, obtained the agency’s approval on September 28, 2000 – just over one month before the closely contested 2000 U.S. presidential election.
The only way the FDA could have approved chemical abortion drugs was to use its accelerated drug approval authority, necessitating the FDA to call pregnancy an ‘illness’ and argue that these dangerous drugs provide a ‘meaningful therapeutic benefit’ over existing treatments.
But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion. In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs.
What’s more, 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.
READ: Why won’t the Supreme Court grant legal status to the unborn in FDA abortion pill case?
ADF also alleged the FDA has criminally not only “not followed the science, reversed course, or fixed its mistakes – all to the detriment of women and girls,” but instead, “has doubled down on its actions and removed the few safeguards that were in place.”
The FDA’s more recent steady rollback of restrictions began in 2016, when the agency “extended the permissible gestational age of the baby for which a pregnant woman or girl may take chemical abortion drugs – from seven weeks to ten weeks.”
ADF argued in the court filing that “numerous studies have demonstrated that there is an increased risk from chemical abortion drugs to pregnant women and girls as the baby’s age advances from seven weeks to ten weeks because the surface area of the placenta as well as the size of the baby significantly grow during these three weeks.”
The court filing drew attention to the fact that, additionally, “in 2016, the FDA changed 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 – without requiring any objective clinical investigations or studies that evaluated the safety and effectiveness of this new chemical abortion regimen or any safety assessment of its effects on the developing bodies of girls under 18 years of age.”
Continuing the report noted:
Realizing a profit-making opportunity in the rapidly growing chemical abortion business, another entity sought the FDA’s approval to market and distribute a generic version of mifepristone. In 2019, the FDA obliged and approved the generic drug – without requiring any new clinical investigations or studies that evaluated the drug’s safety and effectiveness under the requirements of the FFDCA, nor any specific safety assessments on girls as set forth under PREA.
A couple of years later, in April of 2021, shortly after President Joe Biden took office, the FDA’s new management issued a ‘Non-Enforcement Decision’ by which the agency would stop enforcing its requirement that abortionists provide in-person dispensing of mifepristone and instead would temporarily allow mail order chemical abortions during the COVID-19 public health emergency.
On the same day that it rejected the citizen petition, the Biden FDA also announced that it would permanently allow abortionists to send chemical abortion drugs through the mail.
ADF further argued that the rollback of restrictions uniquely places women and girls at risk of sex-trafficking, as it facilitates sexual abusers forcing victims to obtain an abortion without anyone’s knowledge.
ADF stated that allowing mail-in chemical abortions “not only harms women and girls who voluntarily undergo chemical abortions, but it also further helps sex traffickers and sexual abusers to force their victims into getting abortions while preventing the authorities from identifying these victims.”
In support of their argument, ADF documented the fact that “the State of Texas has recognized that ‘[d]ue to the potentially high number of trafficking victims who undergo abortion procedures, abortion facility employees are uniquely situated to identify and assist victims of sex trafficking.’”
READ: Pro-life group to submit thousands of abortion pill horror stories for Supreme Court case
ADF argued further that “all of the FDA’s actions on chemical abortion drugs – the 2000 approval, the 2016 major changes, the 2019 generic drug approval, and the two 2021 actions to eliminate the in-person dispensing requirement – failed to acknowledge and address the federal laws that prohibit the distribution of chemical abortion drugs by postal mail, express company, or common carrier. See 18 U.S.C. §§ 1461, 1462. Instead, the FDA’s actions permitted and sometimes even encouraged these illegal activities.”
The arguments the Supreme Court has agreed to hear on Tuesday are limited to the harms for women incurred by the lifting of restrictions that have taken place since 2016. ADF has told LifeSiteNews it is hopeful the Court will acknowledge the need for reinstating the safeguards for women and girls that the FDA has disregarded.
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