Causes.com
| 8.17.23
Appeals Court Restricts Access to Abortion Pill
Do you support keeping the abortion pill legal and accessible?
Updated August 17, 2023
- A federal appeals court panel ruled that the abortion pill should remain legal in the U.S. but imposed significant restrictions on its accessibility. The decision will prohibit the drug from being sent through the mail and prescribed by telemedicine, but keeps the FDA's 23-year-long approval of the pill in place.
- For now, the ruling will have no effect on mifepristone — in April, the Supreme Court declared it would remain available under the current rules. After the appeals court ruling, the Justice Department requested that the justices hear the case. The court will likely act in the next few months, either agreeing to restrict access to the pill or hearing the appeal.
- If the Supreme Court upholds the appeal court's decision, it will reverse changes made by the FDA in recent years to increase access to the pill.
- Judge James Ho, a Trump appointee on the panel, wrote:
"Scientists have contributed an enormous amount to improving our lives. But scientists are human beings just like the rest of us. They're not perfect. None of us are. We all make mistakes. And the F.D.A. has made plenty."
Updated - May 17, 2023 - 2:30pm EST
- Three conservative-leaning appeals court judges, Jennifer Walker Elrod, James Ho, and Cory Wilson, will hear arguments today on whether the abortion pill, mifepristone, is safe and should remain available.
- The three judges are from the highly conservative New Orleans 5th Circuit Court of Appeals and each has a history of supporting anti-abortion legislation. Ho has previously referred to abortion as a "moral tragedy." Jennifer Walker Elrod was appointed by George W. Bush and James Ho and Cory Wilson were both nominated by Donald Trump.
- Oral arguments began at 1 p.m. CT.
- It may take them months to issue a ruling and their decision on the safety of the abortion pill will likely be appealed to the U.S. Supreme Court.
- Access to the abortion pill will likely remain unchanged until the Supreme Court makes a final ruling or declines to hear the case.
What's happening with the abortion pill?
- While the U.S. Supreme Court decided not to limit access to the abortion pill mifepristone, the ultimate fate of the pill remains unclear as the lawsuit continues in the lower courts.
- The U.S. Justice Department and mifepristone manufacturers Danco Laboratories asked the Supreme Court to intervene and suspend the restrictions. They argued that changing the Food & Drug Administration's (FDA) twenty-three-year-old ruling would "create significant chaos for patients, prescribers, and the health care delivery system."
- Last Friday, the Supreme Court issued a decision allowing the drug to remain on the market without the restrictions imposed by the lower courts. The lawsuit continues in the lower New Orleans 5th Circuit Court of Appeals, where it is being reviewed.
What's the backstory?
Texas District Court
- The legal battle over the abortion pill was brought into focus by Texas Judge Matthew Kacsmaryk's ruling in favor of anti-abortion professionals in their suit against the FDA over the safety of mifepristone.
- Kacsmaryk suspended the FDA's approval of the drug, representing the first time in American history that a court challenged the FDA's approval. The abortion pill was approved in 2000, highlighting the unprecedented nature of Kacysmaryk's decision.
Washington State Court
- Immediately after the decision in Texas, Obama appointee District Judge Thomas Rice in Washington issued a contradictory ruling, ordering the FDA not to make any changes to mifepristone access across seventeen Democrat-led states.
The Biden administration's reaction
- The Biden administration and the manufacturer of mifepristone requested the high court to intervene and halt Kacsmaryk's ruling.
- Lawmakers like Sen. Ron Wyden (D-OR) and Rep. Alexandria Ocasio-Cortez (D-NY) urged Biden to protect the drug's availability through executive decree.
- In a tweet, Biden declared the White House's opposition to the suspension:
"We're going to fight it. The Attorney General has announced @TheJusticeDept will file an appeal and seek an immediate stay of the decision."
The New Orleans 5th Circut Court of Appeals
- With the two rulings in Texas and Washington contradicting each other, the Biden administration appealed to the New Orleans-based 5th Circuit Court of Appeals, requesting the federal judges to put Kacsmaryk's order on hold to keep the abortion pill available to women nationwide.
- The court agreed to keep mifepristone on the market but applied several restrictions: limiting the pill's use to seven weeks gestation, requiring that the medication be prescribed and dispensed by an in-person physician, and banning it from being accessible through the mail.
- The appeals court has revoked the FDA's 2019 approval of the generic, more affordable form of the drug.
What is next for the abortion pill?
- Access to the pill depends on what happens during the appeals process in the 5th Circuit Court of Appeals, where arguments will begin on May 17.
- The Supreme Court's stay on the ban is only valid until the appeals process ends and whether the appeals court rules in Texas's or Washington's favor.
- The ruling could create a new precedent in courts' abilities to challenge federal agencies. The Food, Drug, and Cosmetic Act of 1938 gives the FDA the authority to determine whether drugs are safe, and this ruling could directly impinge upon the FDA's long-standing authority.
Do you support keeping the abortion pill legal and accessible?
—Emma Kansiz
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These pills have been used safely for over 20 years.
Until we see evidence that it is vastly more unsafe than drugs like Tylenol and Viagra, it should remain legal.
Approving or rejecting drugs for OTC or prescribed use is the domain of the FDA, not some judge with an agenda.
The process of using the abortion pill to avoid the law in conservative states is encouraged by our federal government. The result is death to a child guaranteed the right to life, liberty, and the pursuit of happiness. Abortion no matter the process results in death. Sadly, women consenting to abortion risk death themselves, future health consequences, and depression. Many have had no counseling advising of options available. Abortion targets minority races. Abortion is a dark stain upon our country. We can never make restitution to those who have lost their lives to abortion, but we can protect mothers and the children on the battle line today. Stand for life!
Mifepristone was already approved in 17 countries before the US approved, so they had not only the US studies, but studies for other countries to consider for US approval, as well as 10 years of safety surveillance data from 17 countries which is far more data than most drug approvals.
7 US studies - 16,794 subjects
15 non-US studies - 18,425 subjects - 17 countries
11 studies self administered at home - 30,763 patients
Now in 2023 there is even more safety data to review and it's still 4X safer than penicillin and 10X safer than Viagra. Despite all the safety data available the recent court case couldn't even find 1 patient that was harmed to represent so had no standing.
100+ studies
5 systematic reviews (of all studies)
147 published research articles
124,000 1st trimester abortions
19,000 study patients
26 countries
30 years of data
5.4M safety data on abortions
"Serious side effects occur in less than 1% of patients, and major adverse events— significant infection, blood loss, or hospitalization—occur in less than 0.3% of patients," the brief states. "The risk of death is almost non-existent."
"a 2013 review of 87 different trials found that using mifepristone with misoprostol was "highly effective and safe." A 2015 study concluded that medication-induced abortions were less likely to cause "major complications" than procedural abortions."
"A 2001 study involving adolescents ages 14 to 17 who had abortions using mifepristone and misoprostol found that the drug was "highly effective and well tolerated," with no complications"
"Meanwhile, a systematic review of deaths associated with Viagra that was published in December found that it was tied to many more adverse events"
"In 2014, a study published in JAMA Internal Medicine found that men who used Viagra were 84 percent more likely to develop melanoma, the most dangerous form of skin cancer, over a period of 10 years."
"Viagra can cause some serious side effects. These can include an erection that will not go away (priapism), sudden vision loss in one or both eyes, and sudden hearing decrease or hearing loss. Some men have also experienced heart attack, stroke, irregular heartbeats and even death after taking Viagra."
https://www.drugwatch.com/viagra/#side-effects-of-viagra
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/1857095
https://www.causes.com/comments/71569
https://www.causes.com/comments/76932
https://www.newsweek.com/abortion-pill-mifepristone-safer-viagra-what-we-know-1788089?amp=1
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020MedR.pdf
This was settled a long time ago and it was working well. Leave it alone!
I am prolife. An abortion pill is just an easier way to kill a life.
With more and more states limiting abortion access now that Roe v Wade has been overturned, many women need alternative options for getting safe abortions. The abortion pill is just that. Claims conservatives have made about it being unsafe are unfounded. These claims are nothing more than conservatives' attempts to limit abortion access even more than they already have.
Much better to support the pill than make actual abortion part of your birth control approach
This pill should only be used with the direct supervision of a dr.
a woman can use this pill and not have a successful termination of their pregnancy therefore needing a physical abortion.
abortion at any cost or time during the pregnancy is wrong and MY TAX dollars should NOT cover it.
Pay for your abortions yourself then maybe you'll take life more seriously
You need to ensure women in Texas have the right to safe abortions. I request you vote to keep the anortion pill legal.
Abortion pills are unsafe for baby, resulting in death or maiming. The abortion pill is also unsafe for the mother, resulting in her death or health problems following use. The use of abortion pills is an unsafe practice.
BAN ABORTION PILL IMMEDIATELY PLEASE. BABIES LIVES MATTER. JAIL THE JUDGE IMMEDIATELY PLEASE
Needs to be for everyone!
Mifepristone is quite a bit safer than a full term pregnancy.
When combined with Misoprostol, together they are 97% effective as an abortifacient throughout the first 63 days of a pregnancy.
There is no justification for the Regressive U.S. 5th Circuit Court of Appeals should stay out of medical decisions and a woman's Right to Bodily Autonomy.
They literally know nothing about medical science!
The majority of Americans favor access to abortion. When are the Republicans, evangelicals and right wing conservatives going to wake up and smell the coffee?
It's time for these near-sighted people to get over trying to control what women do with their bodies.
The irony here is that these groups who rail against access to abortion saying that they are protecting the unborn - don't give a fig about these children once they are born.
Who gave any of these Circuit Court judges MD's.
Have you seen or heard about the crackpot Appelate judge who ruled on mifepristone?
Here's an article:
Ho Cites Doctor ‘Aesthetic’ Injuries in Abortion Pill Case (1)
https://news.bloomberglaw.com/us-law-week/judge-ho-cites-doctor-aesthetic-injuries-in-abortion-pill-case
I read the Judge's opinion and it is absolutely outrageous! Women are not zoo animals to be ogled at, we do not consider whether our pregnancy pleases the doctor, it's our body and our own responsibilities that matter.
Women's lives are at risk if they cannot have access to mifepristone. No governmental agency has the right to prevent a woman from her choice of healthcare! Politicians are NOT doctors!!
CAUSES ASKS: "Do you support keeping the abortion pill legal and accessible?" ME: Absolutely! 100% Keep politions and other non-medical people out of women's health care!
I support women's right to ownership of their own bodies. Why is it that there is an ungoing effort to take rights away from women, but no such efforts to take away men's rights to Viagra, erectile defunction treatments, etc? Seems only fair....
The abortion pill is a legitimate tool for women's health care. I am sick and tired of Republican white men and Republican privileged white women thinking they know best for all women and their health care choices. We will be better served to get rid of all the current Republicans most notably the ever-absent and unresponsive Kay Granger, CancunCruz, and say nothing do nothing what's his name. You know, the pasty white one? oh yeah, Cornyn.
It's time for Congress to stand up for a woman's right to body autonomy! Whether it's legalizing medical abortions by medical personnel or access to the abortion bill, it's time to separate the religious beliefs of some from national policy as outlined by the US Constitution!
It's every woman's RIGHT to choose! Nothing is as fundementally un-American as restricting a person's right to make a choice about something affecting their own body.
At my age, abortion is not a pressing matter. I do, however, believe that our government should keep their damn noses out of a woman's vagina and sex life. It is nothing more than a smoke screen to cover up the reality of what is really going on behind closed doors. How would they like it if there was a demand for ALL male pedifiles and rapists were forced to have a vascetomy? The perverts would fight such policy tooth and nail against it. As the old saying goes----"What's good for the goose is good for the gander". We might even see a drop in the demand for abortion because there wouldn't be some pervert forcing unwanted attentions on their prey. As I said, its all a "smoke screen" to coverup what is really going on.