FDA Put Women at Risk in 2016 by Removing Abortion Pill Safeguards, Now Thousands are Being Injured

The Supreme Court heard oral arguments Tuesday on the US Food and Drug Administration’s (FDA) sweeping deregulation of chemical abortion in 2016 and 2021. A coalition of doctors convinced “all six justices who weighed in on on the merits of this case” (FDA v. Alliance for Hippocratic Medicine) that “FDA’s 2016 Major Changes and 2021 actions are illegal,” according to respondents (the doctors’ alliance) short.

FDA Changes

When the FDA first approved chemical abortion in 2000, it required, among other precautions, that the drugs must be “administered personally by or under the supervision of a physician,” petitioners (the FDA ) recognized. Respondents mentioned that the approval of chemical abortion is conditioned on these safeguards “because the drug cannot safely be approved without restrictions.”

“These pills take a child’s life every time,” Senator James Lankford (R-Okla.) told The Washington Stand, “but they can also take a mother’s life or cause major side effects.”

However, in 2016, the FDA announced “major” changes to deregulate the abortion pill. Respondents taught that these changes were made “at the request of Danco.” Danco is the pharmaceutical company that makes the abortion pills and has been a party to a separate lawsuit, which the courts have consolidated into this one.

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In the 2016 revisions, the FDA made 10 changes to the administration of chemical abortions. These changes together:

  • “Increasing the maximum gestational age from seven weeks to ten,”
  • “Allowing non-physicians to prescribe and administer chemical abortions,”
  • “Removal of Day 3 in-person administration required for misoprostol,”
  • “Withdrawal at Day 14 in-person follow-up examination to identify complications,” and
  • “Removing the requirement that prescribers report nonfatal adverse events.”

“In 2016, the FDA removed many safeguards, failing to explain why it was appropriate to remove them all without studies showing their cumulative safety,” Respondents argued. “In 2021, the FDA eliminated the last doctor’s visit, allowing mail-order chemical abortions despite admitting that the safety studies it relied on were ‘inadequate’.

History of the Method

The coalition of doctors challenged this chemical abortion rule changes in 2022, as well as the FDA’s initial approval in 2000 and several other administrative actions. The district court ruled against the FDA on all counts, holding that their actions were “arbitrary and capricious” and declaring a “stay” against their approval of chemical abortion pills.

On appeal, a panel of the US Court of Appeals for the Fifth Circuit ruled that it was too late to challenge the initial approval of chemical abortion in 2000 but upheld the district court’s decision against the FDA’s recent actions. The FDA and Danco then appealed to the Supreme Court, which was interim put the district court’s order is on hold without writing an opinion.

However, “after further briefing and argument” in the Fifth Circuit, that appeals court again suspended the FDA’s actions in 2016 and 2021, leading to another appeal to the Supreme Court. The Supreme Court will hear arguments on Tuesday at three questionsrespectively examining 1) status, 2) the FDA’s actions, and 3) the district court’s order.

Context of Chemical Abortion

The chemical abortion method has expanded rapidly in recent years to the point that, “today, more than half of American women who … terminate their pregnancies rely on mifepristone to do so,” as the brief states. petitioned. put it.

The expansion of chemical abortion is “absolutely new” and “has nothing to do with Dobbs,” Lankford explained, but rather due to “its online promotion,” “its availability,” and “the fact that individuals are can receive these drugs to do. at home.”

Still, the Biden administration worked to aggressively expand chemical abortion after Dobbs, Lankford acknowledged, with forcing the Biden administration and pharmacies more than chemical abortion. “What the Biden administration is doing is saying, ‘We want to get these chemical drugs to as many people as possible. Even if they’re in states that don’t allow abortion, we still want the laws of state.’”

Risks of Chemical Abortion

Besides circumventing state laws, the FDA is also eliminating critical safety tests, Lankford argued. As evidenced by the drug’s conditional approval in 2000, “there is serious issue” with mifepristone “which only requires a basic check-in by the doctor, just a basic sonogram,” he said. For example, he said in an ectopic pregnancy or incorrect estimation of the gestational age, a woman taking chemical pills for abortion could have serious complications or possibly even die.

“The FDA’s own labeling for mifepristone and misoprostol says that about one in 25 women who take the drug will end up in the emergency room,” warned Alliance Defending Freedom attorney Erin Hawley, who represents the doctors’ coalition.

“If you take this pill, and you have an ectopic pregnancy, you’re going to have a lot of bleeding, and you’re going to end up in the emergency room. And if you don’t get there quickly, it could take your life,” Lankford warned. This is one reason to ask women to have a personal visit with a doctor before starting a chemical abortion, he argued. “If you don’t see a doctor, you can’t determine if you have an ectopic pregnancy.”

Additionally, “we need to know how far along the woman is,” Lankford said. The FDA previously approved mifepristone for a maximum gestational age of seven weeks, extended to 10 weeks in 2016, when the drug was deemed unsafe for the mother. Beyond this point, the unborn baby grows rapidly, increasing the risk of serious complications. “If she miscalculates the number of weeks she’s pregnant, and she’s actually further along than she thought, then there’s a dramatic increase in side effects, and … it can lead to death for him,” Lankford said.

Lankford also opposes the FDA changing the rules to no longer require reporting of adverse effects unless they are fatal. Adverse effects may include severe bleeding, requiring an emergency room visit or blood transfusion. “It is undisputed that complications result in emergency room visits for 2.9%–4.6% of women,” the respondents summarized. mentioned.

The FDA is charged in approving drugs that are safe and effective, the brief acknowledges this, but in this change it willfully ignores the evidence that chemical abortion drugs are unsafe, Lankford argued. “It allows the Biden administration, the FDA, to say, ‘We don’t have any record of any adverse effects from this,’ when really what the FDA is saying is, ‘Don’t tell us if there are any effects unless he dies, ‘” he says.

“It seems like the challenge now for the Biden administration is, how can they get abortions in states that don’t allow surgical abortions?” Lankford said. “They’re looking for ways to say, ‘We’ll just send you an abortion kit, and you can do it at home. And we won’t tell you about the possible side effects. We will not tell you about the risks. In fact, we don’t even track those things.’”

“This administration’s focus is very strongly on increasing the number of abortions in America,” Lankford said. “Whereas previous administrations — Republican and Democrat — talked about reducing the number of abortions, this administration is literally the opposite of that. … That’s scary in a million ways, but especially when it puts people at risk .”

LifeNews Note: Joshua Arnold is a staff writer at The Washington Stand, contributing both news and commentary from a biblical worldview. Originally published by The Washington Stand.

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