Doctors, politicians, pro-life leaders, and women’s health advocates rallied outside the United States Supreme Court Tuesday, calling for the overturning of the U.S. Food and Drug Administration’s reckless abandonment of care standards for women and girls with the deregulation of the chemical abortion drug mifepristone.
Alliance Defending Freedom Senior Counsel Erin Hawley, American Association of Pro-Life Obstetricians and Gynecologists CEO Dr. Christina Francis, and Kansas Attorney General Kris Kobach spoke outside of the capitol building alongside more than 50 speakers demanding the return of basic safety standards on the high-risk drug as oral arguments opened for U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine.
'Recklessly Betraying Women'
A documented high-risk drug resulting in emergent care for 1 in 25 women, mifepristone was first approved for market use in 2000. At that time, a prescriber was required to provide ongoing medical care, an initial in-person visit to screen for complication-inducing conditions, and follow-up care to treat infection, internal bleeding, and other possible side effects. Since then, the FDA has removed those basic safeguards.
The FDA’s action in this case is unprecedented, said ADF senior counsel Julie Marie Blake.
“The FDA’s job is to ensure health and safety, especially when high-risk drugs are involved,” Blake said. “The FDA has failed in that duty; recklessly betraying women who have been taking chemical abortion drugs. We are unaware of any situation in which the FDA has approved any drug with this level of high risk, knowing that 1 in 25 women will go to the ER and simply saying, ‘We know we don’t have enough adequate data about its safety.’”
Lower courts have already found the FDA guilty of failing to protect public health and safety in the case of mail-order abortion drugs. The agency continues to defend its actions in supporting the multi-billion dollar abortion industry.
Americans United for Life, Susan B. Anthony Pro-Life America, Catholic Medical Association, American College of Pediatricians, and numerous other organizations issued called the FDA’s abandonment of standards “reckless,” ahead of Tuesday's oral arguments.
Restoration of Standards
Dr. Karen Poehailos, a family physician with experience providing care for women suffering a chemical abortion, spoke outside the court, calling for the restoration and re-evaluation of safety standards on mifepristone.
“I am here for my patient who called me crying that she could still see her nine-week baby alive in the gestational sac and wondering how long it would take for her child to die,” Poehailos said. “I am here for my patients who went into labor at home and delivered the embryo or fetus into the toilet and didn’t know what to do next,” she said.
She recounted the stories of patients who were given these drugs to take at over 12 weeks gestation, which can cause life-threatening complications and even require surgical intervention.
“She had to be treated in an emergency room due to excessive bleeding from an incomplete abortion. I am here for my patient with a history of ectopic pregnancy who was not aware that she should have had an ultrasound due to her higher risk of another life-threatening ectopic,” she said.
Democrats for Life of America Executive Director Kristen Day called out the FDA for sending women to the bathroom alone to perform abortions with no support.
“The Democratic position sacrifices key ideals on an altar of unrestricted abortion. It represents the transformation of a party once dedicated to regulation balanced in the interests of society to a wholesale surrender to both Big Abortion and Big Pharma,” she said.
Eroded Confidence
Dr. Tim Millea, CMA Health Care Policy Committee and Conscience Rights Protection Task Force chair, attended the rally in defense of women, children, and future generations directly effected by the FDA’s malfeasance.
In his nearly 40 years of practice, Millea has seen a dramatic erosion of confidence in the FDA, an agency he previously considered a thorough and honest arbiter of medications and their safety.
“The FDA is now determining ‘standards’ based on ideology rather than science,” Millea said. “Personally, I am here to protect my children and grandchildren from health care that is driven by politics and not evidence. If the FDA's laxity in protecting us is not corrected, they need to know that Americans will be harmed and will not tolerate their mistakes.”
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