Monday, 04 March 2024
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“Mifepristone should have never been approved, the FDA overstepped" Towfiqu barbhuiya/Unsplash

“Mifepristone should have never been approved, the FDA overstepped"

The political ties to the expedient availability of the abortion pill were discussed earlier this year with representatives of the world’s largest network of pregnancy help. Christa Brown, senior director of Medical Impact for Heartbeat International and Heartbeat’s President Jor-El Godsey had the conversation on FDA regulations and chemical abortion on Pregnancy Help Podcast.

This past week, the issue was making headlines again as a federal judge in Texas suspended the Food and Drug Administration’s (FDA) approval of mifepristone, the first drug in the two-drug chemical abortion regimen, causing yet another political uproar. Judge Matthew Kacsmaryk put the FDA’s declaration of mifepristone as “safe,” on hold April 7. 

“There is no doubt the FDA overstepped,” Brown said in the days following the federal judge’s decision. “Mifepristone should have never been approved.” 

“The FDA approved mifepristone with caution and safety strategies 23 years ago,” Brown explained. “The agency exceeded its regulatory authority by using Accelerated Approval Program which permits speed to market of drugs. However, this program is limited to drugs that treat serious conditions which does not apply to an elective procedure that is used to end the life of a whole and separate individual.”

Godsey asked Brown in the Pregnancy Help Podcast for a timeline of events with the abortion pill and how the FDA has loosened its regulations during Democrat administrations. 

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Brown gave a brief background on the origins of the abortion pill from 1995 and the intent of the drug. 

“They wanted to make sure that while we might not have as many brick and mortar abortion facilities, abortion could still get to the women,” said Brown, “they could still manufacture this, they could still provide abortions.”

Brown then reminded listeners of the role of the FDA.

“Their primary existence, the primary reason that they exist is to protect public health by ensuring the safety of these drugs, both to humans and to animals,” she said.

Brown explained that the FDA had reported that they studied the pill very carefully. Other countries in the world had already made mifepristone available legally for abortions by the late 1990s. The United States made a decision on approval in 2000, Brown said.

Godsey pointed out the role of the Bill Clinton administration and the political push on the FDA to legalize the pill. Brown agreed this seemed to be the case and was unfortunate for the FDA to be put in this position.

“But the idea that politics would mix in with safety is concerning,” Brown said, “because their decision maybe wasn't made in an evaluation of the evidence and at hand it maybe was more about the politics involved and the profit possibly involved.”

Brown went on to say how the FDA was cautious with this approval and limited the use of the pill to seven weeks gestation as well as adding the very rare Risk Evaluation Mitigation Strategy known as REMS.

The FDA, Brown said, only puts the most dangerous drugs in the REMS category. Seventy drugs are in that section, including mifepristone.

In 2016, though, the FDA allowed the pill to be used up to 10 weeks gestation. 

“Let's look at the political timing of that as well,” Godsey said, noting the end of the Barack Obama administration. 

“Which again, the political timing of that is a little too obvious to suggest it's just agency activity moving at a certain pace,” he said. “It seems very politically motivated more than it is health motivated.”

The availability of the abortion pill then took center stage as the Covid-19 pandemic struck.

“The next step was in 2021, where they loosened the REMS even a little bit more, by no longer requiring in-person prescription,” Brown said. “This becomes even more dangerous as the ability to access the pill without face-to-face discussion with one’s medical provider makes room for error.”

Godsey asked about the reasoning for the FDA’s decision to put mifepristone on the REMS list.

Brown explained the main concern was making sure a pregnant woman’s gestation was not further than nine to 10 weeks and that the pregnancy was in fact in the uterus and not the fallopian tube. Ectopic pregnancies were a great concern, she said. 

However, after 2021, without a medical appointment, there is little to no chance a woman will have an ultrasound to ensure the pregnancy is where it should be before being given the chemical abortion drug. The risk for missing an ectopic pregnancy diagnosis while taking mifepristone is very high.

And that leads us to January 2023 where the safety of patients taking the pill was once again ignored by the FDA, Brown said, referencing the agency’s acting to allow dispensing of the abortion drug at retail pharmacies.

“(Pharmacies) could become the abortion facility and dispense these drugs,” she said. “They could also offer them through telehealth. So, the the pharmacies like Walgreens and CVS have already agreed that they would like to be certified and do this.” 

Brown and Godsey talked about the speed of this transaction and how quickly women can receive the pill in their mailbox. The process of the unravelling of abortion pill access has gone swiftly as well, they said, within the last 20 years as noted in this verbal timeline.

While some might assume the FDA is loosening up its measures based on research and findings that the pill is not as dangerous as previously assumed, that is further from the truth, Brown said. The FDA quit tracking non-fatal adverse events and act upon little data, she said.

Brown gave an example from an ER nurse in North Carolina who told her she rarely has a shift in her city hospital without a woman coming in with some reaction to a chemical abortion. 

“She's having extreme bleeding and hemorrhaging where she needs a blood transfusion or she needs medical attention, or she has infection,” Brown said. “These numerous incidents are not being tracked by the FDA.”

Another example came from APR doctor Brent Boles in Florida. Between December 2022 and January 2023, he had five critical patients who underwent chemical abortions.

Eight percent of chemical abortion clients will end up in the emergency room, Brown said.

Godsey said the marketing of the pill availability only makes the process much more appealing. Brown added that the pill has even been compared to Tylenol for safety, however, she said, the only common denominator with Tylenol is that they are pills taken orally.

“And I had two of the women that I served in pregnancy help had full hysterectomies after perforation,” Brown said. 

“So, we know that surgical abortion's very, very dangerous,” said Brown. “But these drugs, even though it may seem like it's just a pill, are four to five times more dangerous than surgical abortion.”

“Many people don't realize, because it's advertised as just a pill, how dangerous these drugs really are,” Brown said. 

Godsey noted the numbers of abortion pill patients among all women getting an abortion have increased significantly. 

Fifty percent of all abortions were chemical in 2020; 70 percent were chemical in 2022. 

“By the conclusion of 2023 the percentage will be even higher,” Brown said.

Tweet This: “There is no doubt the FDA overstepped. Mifepristone should have never been approved.”

Brown referred to the stats from the podcast, stressing safety concerns. 

“There is no longer the in-person requirement for dispensing mifepristone," she said, "eliminating the majority of the safeguards for women."

“The FDA reports that over five million have been prescribed this drug since its initial approval and the same agency that is charged with protecting the U.S. public from dangerous drugs like mifepristone openly admits that five percent have required medical treatment and surgery following its use,” she said.

Editor's note: Heartbeat International manages Pregnancy Help News. This articles has been updated.

Tabitha Goodling

Tabitha Goodling has been writing for media outlets for more than 20 years in her home state of Pennsylvania. She has served as a client services manager at her local pregnancy center since 2018. She and her husband are raising four teenage daughters, which include a set of triplets.

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