A group of doctors and medical associations are challenging the federal government’s decision to approve dangerous abortion drugs in a new lawsuit Friday, saying authorities skirted the process and put patients’ lives at risk.
In the lawsuit from the Alliance Defending Freedom, the doctors said the U.S. Food and Drug Administration “illegally” prioritized abortion politics over science and patients’ health when it approved the abortion drugs mifepristone and misoprostol in 2000.
These drugs now are used to abort more than half of all unborn babies in the U.S. every year, or nearly half a million, according to the Guttmacher Institute. More than two dozen women also have died and thousands more have suffered serious complications, according to FDA data.
The lawsuit accuses the FDA and U.S. Department of Health and Human Services of continuing to ignore safety issues, including by allowing the drugs to be sold through the mail without any direct medical supervision starting in 2021.
“Pregnancy is not an illness, and chemical abortion drugs don’t provide a therapeutic benefit—they end a baby’s life and they pose serious and life-threatening complications to the mother,” ADF Senior Counsel Julie Marie Blake said. “The FDA never had the authority to approve these dangerous drugs for sale.”
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Blake said the doctors know from personal experience and research how dangerous abortion drugs are, and they filed the lawsuit to protect their patients.
According to the lawsuit, the FDA never should have approved the drugs in the first place; but it did so by mischaracterizing pregnancy as an “illness” and arguing that the drugs provide a “meaningful therapeutic benefit.”
The lawsuit said the FDA didn’t have adequate data on mifepristone use by girls and some of the clinical studies the FDA relied on required more safeguards for patients, such as an ultrasound to confirm gestational age, than the agency later required.
The lawsuit also said rates of complications from using the drug—such as bleeding and infection, which are mentioned on the drug’s label—haven’t been adequately studied, and that emergency-room visits following use of the abortion pill are more common than following surgical abortion.
Dr. Ingrid Skop, an OB-GYN who has treated many abortion pill-related complications, thanked the doctors for taking action.
“I’ve performed at least a dozen surgeries on women who experienced complications when the abortion pills failed,” Skop said. “I’ve cared for several women who took mifepristone and misoprostol and required blood transfusions or treatment for severe infections, and I’ve counseled women who experienced significant emotional distress after viewing the body of their easily identifiable child in the toilet.”
She said the lawsuit comes at “a critical time, when the mainstream media and even the White House are willfully ignoring the known risks of abortion pills in pursuit of a pro-abortion political agenda.”
An FDA spokesperson responded to the lawsuit by insisting the abortion drugs are safe and its approval process was “thorough,” according to the Wall Street Journal.
However, the lawsuit asserts that the FDA continued to ignore safety problems when the agency expanded the use of mifepristone in 2021 under President Joe Biden’s administration.
This was “in direct violation of longstanding federal law,” according to ADF. “As the lawsuit points out, this decision puts girls and women at additional risk from chemical abortion drugs since mail-order, at-home abortions skip necessary medical examinations to ensure that girls and women do not have conditions that could lead to fatal outcomes.”
Those involved in the lawsuit include Drs. Shaun Jester, Regina Frost-Clark, Tyler Johnson and George Delgado, the Alliance for Hippocratic Medicine, the American Association of Pro-Life OB-GYNs, the American College of Pediatricians and the Christian Medical & Dental Associations.
Separately, the watchdog organization Judicial Watch also sued the Biden administration earlier this month for failing to respond to Freedom of Information Act requests about its 2021 decision to allow abortion drugs to be sold through the mail. The organization wants to see the research that the FDA used to determine that the abortion drug is safe.
Along with millions of unborn babies’ deaths, the FDA has linked mifepristone to at least 26 women’s deaths and 4,000 serious complications between 2000 and 2018. However, under President Barack Obama, the FDA stopped requiring that non-fatal complications from mifepristone be reported. So the numbers almost certainly are much higher.
Studies indicate the risks are more common than what abortion activists often claim, with as many as one in 17 women requiring hospital treatment. A recent study by the Charlotte Lozier Institute found that the rate of abortion-related emergency room visits by women taking the abortion drug increased more than 500 percent between 2002 and 2015.
In England, which began allowing mail-order abortion drugs around the same time as the U.S., new investigations show a huge increase in ambulance calls and reports of coercion and abuse. There also have been reports of late-term babies being born alive at home as a result of mail-order abortion drugs because their mothers did not realize how far along they were.
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