Women's Health Care: Post-Roe Assault on Medically Approved Abortion Pill

Left is Backup to Current Rx “Mifepristone”

Major update on the following abortion pill story below – this update raises serious legal and public interest question based on this main part of the story from CNET here with this headline:

“Medication Abortion Remains a Battleground, this Time over FDA Authority”

The future of medication abortion is teetering in lawsuits over the availability and legality of mifepristone, the first of two drugs used in the procedure. 

Attorneys General from about a dozen Democratic-led states sued the FDA over regulations they say are medically unnecessary and are meant to make it harder for people to get mifepristone.

The background is in the post below at the heart of this update:

Whether the drug is even able to stay on the market could depend on the ruling of one judge in Texas, which could come in any day. The judge is ruling on a lawsuit that claims, in part, that the FDA never had the right to approve mifepristone in the first place and questions the safety of the drug despite medical organizations continuing to uphold it as safe. 

If the judge agrees, the case has the potential to ban mifepristone even in states where abortion is legal, though a cascade of other legal steps and appeals are expected to follow immediately.

Medication abortions are typically limited to the first trimester of pregnancy and account for a growing number of the total number of abortions — currently more than half.

Medical organizations including the American Medical Association (AMA) and the American College of Obstetricians of Gynecologists (ACOG) both say the pill for abortion is safe.

Patients may choose medication abortion because it's done in the privacy of their home and can be more accessible or less expensive than the in-clinic procedure. After the Supreme Court overturned Roe. v. Wade last spring, restricting abortion pills became a priority for lawmakers trying to ban or limit abortion.

Whatever the judge in Texas rules, a stream of appeals and other court moves are expected to follow, which makes it difficult to say for certain what will happen to mifepristone. Health care providers and legal experts alike say this is par for the course post-Roe v. Wade, when the future and legality of medication used in pregnancy and abortion is up to state actors and the courts.

But in the Texas case, specifically, the FDA's approval process is called into question. If the judge revokes the agency's 20-plus year approval stamp of a drug, it would be overriding the FDA's own calculations on a drug's benefits and risks — and according to an article in The New England Journal of Medicine would be an unprecedented move in U.S medicine regulation.

Even if mifepristone stays on the market, the case has opened the door for the potential removal of other drugs and medications from the market, regardless of what medical consensus is. 

My Notes on this latest: Of course this is centered in Texas just like Florida in other cases impacting the whole country. Both of them are GOP-run states that seem to want to be independent and “divorced” from the Union as Rep. Taylor Greene (R-GA) rants about along with a few other like-minded looney Republicans in Congress advocate for more and more these days so it seems.

Texas seems to be just against anything that is not from Texas. So, I guess they want Gov. Abbott or AG Paxton or Sen. Ted Cruz to run the state, nation, and hell the whole planet regarding our health care or just about anything else in our individual lives? It sure seems that way to me.

Thanks for stopping by.

ORIGINAL POST FOLLOWS FROM HERE:

This headline court case story is all over the news from a lot of networks – NPR’s coverage headline for this post and an excellent article from Planned Parenthood that follows:

“A Trump-appointed Texas judge could force a major abortion pill off the market”

First, NPR’s article coverage (formatted to fit the blog):

A case before a federal judge in Texas could dramatically alter abortion access in the United States – at least as much, some experts say, as the U.S. Supreme Court's Dobbs v. Jackson Women's Health Organization decision last year, which overturned Roe v. Wade – the 50-year old abortion-rights precedent.

A decision is expected soon challenging the FDA’s approval more than 20 years ago of the abortion drug “Mifepristone,” which a growing number of patients use to terminate pregnancies.

Jenny Ma, senior counsel with the Center for Reproductive Rights, says: “The outcome of the suit brought by a coalition of individuals and groups opposed to abortion could amount to a nationwide ban on medication abortion with a greater impact than even Dobbs.”

Ms. Ma continued: “That decision left the decision about abortion up to the states, but this would be one court in Texas deciding whether or not medication abortion could be allowed across this country, even in states that have protected abortion since the Dobbs decision.”

Ms. Ma further said: “Because this is a federal case, the impact could be felt nationwide, not only in states with abortion bans. After Dobbs, it almost seemed like there were two Americas – where abortion access was allowed in some states and not in others. This would amount to a nationwide ban on medication abortion, and patients who seek this care would not be able to get this care from any pharmacy, or any prescriber or any provider.” 

Tiny pill, big impact: Medication abortion (taking the pill) — as opposed to a surgical procedure — is now the most common way that people terminate pregnancies. That's especially true in the first trimester when the vast majority of abortions occur. Abortion pills are increasingly relied on by people who live in places where access to clinics is limited by state laws or geography.

While various regimens exist for terminating pregnancies with pills, the gold standard for medication abortion in the United States is a two-drug protocol that includes “Mifepristone” and another, less-regulated drug, “Misoprostol.”

But now, a coalition led by the anti-abortion rights group Alliance Defending Freedom (ADF) (with ultra-Conservative links) has filed a lawsuit in federal court in Texas asking a judge to reverse that approval.

Revisiting a decades-old drug approval: The anti-abortion group is raising questions about the FDA's approval process in 2000 and some of the rule changes that have been made since then. They note that under President Biden, the FDA now allows mifepristone to be mailed or dispensed by retail pharmacies, while it used to be subject to more layers of restriction.

Denise Harle, senior counsel with the ADF says: “They've loosened the requirements again, and again, and again. So now, Mifepristone is being given to women who have never even seen a physician in person.”

Under the recent rule changes, it's now possible for patients to receive a prescription through telehealth in states where that's legal, an option that major medical groups support.

Critical of story is one judge, national implications: Normally, as the FDA has noted in its defense of its approval process, it would be unusual to pull a drug from the market after more than two decades of widespread safe and effective use.

That decision is now up to Matthew Kacsmaryk, a Federal Judge in Texas, and a Trump appointee with longstanding affiliations with the religious right, including work as an attorney with a conservative Christian legal group based in the state.

Elizabeth Sepper, a University of Texas at Austin law professor said: “It's no accident that the complaint was filed in Amarillo. The way the district courts in Texas dole out cases makes it so that there are a few places where you pretty much know which judge you're going to get. So they know they have a very sympathetic ear.”

Then any appeals in the case would go to the U.S. Court of Appeals for the Fifth Circuit – also widely known as a conservative jurisdiction – and then to the U.S. Supreme Court.

Not just red states: If Judge Kacsmaryk sides with the anti-abortion group, Mifepristone would have to be pulled from the market, at least temporarily. The FDA could choose to restart the approval process, which could take years. The judge has allowed additional time for the plaintiffs to respond to a brief filed by the drug's manufacturer. Sometime after that deadline, February 24, the judge is expected to issue a decision or schedule a hearing.

Three related stories in the NPR story:

1. Meeting abortion patient needs: Providers turn to mobile units

2. As medication abortion becomes dominant: RED states restrict pills

3. Abortion pills should be easier to get: But doesn't mean they will be

Now the article from Planned Parenthood – also worth reading with their story headline (also formatted to fit the blog):

“What You Need to Know About the Latest Attack on Abortion Care: the Mifepristone Abortion Pill”

As discussed above, this is another attack on abortion care and more seen below:

“Mife” (the common short title name for Mifepristone) has been approved by the FDA for more than 20 years, and has been used by more than 5 million people in the U.S. to safely end their early pregnancies. This lawsuit is not about the safety of a pill — it’s a political attack on people’s ability to control their own bodies and lives, and will affect people across the country.

FYI: The court’s ruling in this case, Alliance for Hippocratic Medicine v. FDA, won’t end medication abortion. In states where abortion is legal, medication abortions are still a safe and effective way to end an early pregnancy. The supportive, expert staff at Planned Parenthood health centers are dedicated to providing the education and health care patients need, including abortion. Contact the nearest Planned Parenthood health center to learn more and book an appointment or a virtual visit. 

What this lawsuit is really about: This case is about controlling the medical decisions of women, Trans and non-binary people. Not satisfied with ending the federal right to an abortion in June 2022, a group of anti-abortion activists and organizations asked the court to order the FDA to end its 22-year approval of Mife. If the judge rules in their favor, Mife will no longer be available, even in states where abortion is accessible. 

This case is not about safety. 

§  Medication abortion is safer than other common medicines like penicillin, Tylenol, and Viagra. 

§  Medication abortion has a strong safety record — serious complications happen in less than ⅓ of 1% of cases, whether a patient gets their abortion pills in person, at a doctor’s office, or remotely through a virtual visit.

§  In 2021, more than half of all documented abortions were medication abortions. 

Medication abortions are safe and available where abortion is legal.  

Lots of people refer to medication abortions as the abortion pill, although medication abortion in the U.S. most commonly involves taking two pills: Mifepristone and Misoprostol. Both drugs are safe and effective and have been used for decades by millions of people to end early pregnancies. If mifepristone is taken off the market, misoprostol will still be available as an option to end an early pregnancy. Misoprostol by itself is a safe and effective way to end an early pregnancy. Local Planned Parenthood office will discuss options and what kind of care is best.

Medication abortions without mifepristone are common around the world. In the U.S. most people have relied on a combination of mifepristone and misoprostol for medication abortions. But for decades, all around the world, many people have used just misoprostol to safely end early pregnancies when mifepristone isn’t available.

Misoprostol works on its own to empty your uterus. Visit your nearest Planned Parenthood health center to discuss your options. And get fast facts on misoprostol-only medication abortion.

 A few facts about misoprostol: 

• Misoprostol is, on its own, a safe way to end an early pregnancy. 
• Respected medical organizations like The American College of Obstetricians and Gynecologists, Ipas, and the World Health Organization agree that misoprostol-only abortions are a safe alternative if mifepristone isn’t available. 

• Using misoprostol pills to have an abortion is legal in states where abortion is legal.

• Misoprostol has been around for more than 30 years. Besides abortion, misoprostol has other medical uses — like miscarriage management and preventing and treating ulcers.

My 2 Cents: This story has one simple topic: A woman’s right to choose her own health and pregnancy decisions and care whether she is single, married, divorced, or widowed matters not – it’s her choice.

Just a side note sure to tick off some readers. I am not pro-abortion. Unless an abortion is a medical emergency or medically needed, etc. I say the choice is up the women, her doctor, and possibly her family, too – not to anyone else. Thus I am strongly pro-choice.

Another note: How about a movement to stop vasectomies and uses for Viagra and or any ED drugs for men? Oops – I hit a sore spot didn’t I? Thought so … a pregnancy of any sort is two steps as we all know. I suspect in most cases the women wants the baby and again, that is up to her. In cases of rape or incest – a whole new topic. Or when the Ob-Gyn says the fetus is not viable – still the woman’s choice.

I say to the courts when we have a legal, safe, medically proven effective medicine for any purpose – then keep legal hands and views and opinion away. We can’t sell and peddle rights about the globe and punish women the way we have and now again it seems again in this medical choice question – and yes, my view and opinion, too.

Long post but a very critical issue. More after the decision on this case I am sure. Stay tuned.

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