Saturday, April 08, 2023

ITS ABOUT BANNING CONTRACEPTION

Access to abortion pill in limbo after competing rulings

ANTI ABORTION IS ANTI CONTRACEPTION 

By PAUL J. WEBER, MATTHEW PERRONE and LINDSAY WHITEHURST
TODAY

Boxes of the drug mifepristone sit on a shelf at the West Alabama Women's Center in Tuscaloosa, Ala., March 16, 2022. A federal judge in Texas on Friday, April 7, 2023, ordered a hold on the U.S. approval of the abortion medication mifepristone, throwing into question access to the nation’s most common method of abortion in a ruling that waved aside decades of scientific approval. Federal lawyers representing the FDA are expected to swiftly appeal the ruling. (AP Photo/Allen G. Breed, File)

AUSTIN, Texas (AP) — Access to the most commonly used method of abortion in the U.S. plunged into uncertainty Friday following conflicting court rulings over the legality of the abortion medication mifepristone that has been widely available for more than 20 years.

For now, the drug the Food and Drug Administration approved in 2000 appeared to remain at least immediately available in the wake of two separate rulings that were issued in quick succession by federal judges in Texas and Washington.

U.S. District Judge Matthew Kacsmaryk, a Trump appointee, ordered a hold on federal approval of mifepristone in a decision that overruled decades of scientific approval. But that decision came at nearly the same time that U.S. District Judge Thomas O. Rice, an Obama appointee, essentially ordered the opposite and directed U.S. authorities not to make any changes that would restrict access to the drug in at least 17 states where Democrats sued in an effort to protect availability.

The extraordinary timing of the competing orders revealed the high stakes surrounding the drug nearly a year after the U.S. Supreme Court overturned Roe v. Wade and curtailed access to abortion across the country. President Joe Biden said his administration would fight the Texas ruling.

The whiplash of the conflicting decisions is likely to put the issue on an accelerated path to the Supreme Court.

“FDA is under one order that says you can do nothing and another that says in seven days I’m going to require you to vacate the approval of mifepristone,” said Glenn Cohen of Harvard Law School.

Abortion providers slammed the Texas ruling, including Whole Woman’s Health, which operates six clinics in five states and said it would continue to dispense mifepristone in person and by mail over the next week as they review the rulings.

The abortion drug has been widely used in the U.S. since securing FDA approval and there is essentially no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration. Mifepristone is one of two drugs used for medication abortion in the United States, along with misoprostol, which is also used to treat other medical conditions.

Kacsmaryk signed an injunction directing the FDA to stay mifepristone’s approval while a lawsuit challenging the safety and approval of the drug continues. His 67-page order gave the government seven days to appeal.

“The Court in this case has substituted its judgment for FDA, the expert agency that approves drugs,” Biden said. “If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.”

Clinics and doctors that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but it is widely used in countries where mifepristone is illegal or unavailable.

The lawsuit in the Texas case was filed by the Alliance Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because it did not adequately review its safety risks.

Courts have long deferred to the FDA on issues of drug safety and effectiveness. But the agency’s authority faces new challenges in a post-Roe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications.

Since the Texas lawsuit was filed in November, legal experts have warned of questionable arguments and factual inaccuracies in the Christian group’s filing. Kacsmaryk essentially agreed with the plaintiffs on all of their major points, including that the FDA didn’t adequately review mifepristone’s safety.

“The Court does not second-guess FDA’s decision-making lightly.” Kacsmaryk wrote. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”

Mifepristone has been used by millions of women over the past 23 years, and complications from mifepristone occur at a lower rate than that seen with wisdom teeth removal, colonoscopies and other routine medical procedures, medical groups have recently noted.

Elsewhere, Kacsmaryk sided with plaintiffs in stating that the FDA overstepped its authority in approving mifepristone, in part, by using a specialized review process reserved for drugs to treat “serious or life-threatening illnesses.” The judge brushed aside FDA arguments that its own regulations make clear that pregnancy is a medical condition that can sometimes be serious and life-threatening, instead calling it a “natural process essential to perpetuating human life.”

His order also agreed with plaintiffs in invoking a controversial 19th century law that anti-abortion groups are now trying to revive to block sending abortion medications through the mail. Originally passed in 1873 and named for an “anti-vice crusader,” the Comstock Act was used to prohibit the mailing of contraceptives, “lewd” writings and “instruments” that could be used in an abortion. The law was seldom invoked in the 50 years after Roe established a federal right to abortion.

Kacsmaryk, though, agreed with plaintiffs that the law — as literally interpreted — prohibits mailing mifepristone.

His order, if upheld, would also dismantle a number of recent FDA actions intended to ease access to the drug.

In late 2021 the FDA — under the Biden administration — dropped a requirement that women pick up the drug in person, opening the door to delivery by mail-order pharmacies. In January the agency dropped another requirement that prevented most brick-and-mortar pharmacies from dispensing the pill.

Anti-abortion groups, which are newly encouraged about their ability to further restrict abortion and prevail in court since last’s year’s reversal of Roe v. Wade, embraced the Texas ruling.

“The court’s decision today is a major step forward for women and girls whose health and safety have been jeopardized for decades by the FDA’s rushed, flawed and politicized approval of these dangerous drugs,” said March for Life President Jeanne Mancini.

Legal experts warned that the ruling could upend decades of precedent, setting the stage for political groups to overturn other FDA approvals of controversial drugs and vaccines.

“This has never happened before in history — it’s a huge deal,” said Greer Donley, a professor specializing in reproductive health care at the University of Pittsburgh Law School. “You have a federal judge who has zero scientific background second guessing every scientific decision that the FDA made.”

Still, because of the contradictory nature of the rulings, Donley and other experts said there would be little immediate impact.

“In the short term, nothing’s going to change,” Donley said. “This is the time to be preparing for the fact that in a week, potentially, mifepristone becomes an unapproved drug in this country.”

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Perrone and Whitehurst reported from Washington. Associated Press reporter Gene Johnson in Seattle and Claire Rush in Portland, Oregon, contributed.


Trump-appointed judge strikes down FDA approval of abortion pill mifepristone

Matthew Chapman
April 07, 2023

(Shutterstock.com)

A far-right judge in Texas has issued a long-awaited ruling, striking down the Food and Drug Administration's approval of mifepristone for abortions.

Judge Matthew Kacsmaryk, an appointee of President Donald Trump, has stayed his ruling for seven days to give the federal government time to appeal the decision to the Fifth Circuit.

The case was brought by right-wing groups arguing that the approval process for the drug did not fully evaluate the safety and effectiveness of the drug. Among other things, Kacsmaryk ruled that the FDA failed to evaluate the "psychological trauma" that medication abortion could cause to women.

Doctors have broadly disputed any claims that the drug is not safe or effective.

The ruling, if allowed to go into effect, would suspend the ability of mifepristone to be prescribed for abortions, even in states where abortion and specifically medication abortion are legal. Women seeking abortions through this method would now have to use surgical abortion instead, or else rely solely on misoprostol, another drug generally used in tandem with the drug.

The Justice Department broadly expected the ruling, and will almost certainly move forward with appeal.

Legal reporter: Trump judge's claim about abortion drug is 'dumbest' thing I've ever seen

Matthew Chapman
April 07, 2023

Matthew Kacsmaryk

On Friday, a Trump-appointed federal judge in Texas voided the Food and Drug Administration's more than two-decades-old approval for mifepristone as an abortion medication — ruling in favor of a coalition of anti-abortion groups that argued the FDA did not consider things like the psychological anguish of women who have abortions when issuing the approval.

This widely-anticipated ruling, from U.S. District Judge Matthew Kacsmaryk in Amarillo, outraged legal reporter Elie Mystal, who called the decision "risible" and "dumb."

"As expected, the Republican judge hand picked by forced-birthers has issued a nationwide ban on the abortion pill. Stayed for a week. FDA will certainly appeal," wrote Mystal.

In particular, Mystal focused on the argument made by these groups, who would normally not have any standing to bring a suit, why they can represent the legal interests of women. "The argument, made here, that third party plaintiffs have standing because 'women who have had abortions' might experience too much 'shame… or regret' to bring suit against the government… is one of the dumbest and risible things I’ve read in a minute."

There is no medical evidence that mifepristone as it is used for abortion is unsafe or causes undue anguish to women; doctors have found the procedure of medication abortion is safer than Viagra and penicillin.

This comes at the same time as another federal judge in Washington state issued a ruling that would actually order the FDA to ease access to mifepristone in several states — setting up a conflict in federal courts and dramatically increasing the odds the Supreme Court may have to step in and resolve the issue. The Texas ruling is certain to be appealed by the Justice Department in the next few days.

Federal judges issue conflicting rulings in a pill used for medication abortion

Shefali Luthra, The 19th
April 07, 2023
Originally published by The 19th

Federal judges have issued contradicting orders about whether mifepristone — one of two drugs used to induce a medication abortion — can be legally distributed.

A judge in Texas ruled Friday in a much-watched case, saying that the federal government’s approval of the drug must be blocked; his decision, he wrote, takes effect in one week, giving the Department of Justice time to appeal the decision.

But another federal judge, in Washington state, found the opposite in a separate case concerning the drug’s approval. That judge, who also ruled Friday, held that a nationwide injunction blocking mifepristone’s distribution would be “inappropriate.”

The conflicting federal rulings increase the likelihood that mifepristone’s legality will ultimately be decided by the Supreme Court. The stakes for people seeking abortions are significant.

If the Texas-based judge’s decision takes effect, people seeking a pill-based option would be forced to use a less effective, at times more painful medical regimen for medication abortions, which is the most common method to terminate a pregnancy. Some clinics told The 19th they will stop providing medication abortions altogether following the ruling. The decision is expected to be quickly appealed.

Medication abortions typically involve two medications: mifepristone, which is administered to stop a pregnancy from progressing, and then misoprostol, which is taken 24 to 48 hours later to empty the uterus. The protocol is only recommended for the first trimester of pregnancy, and has somewhere between a 95 and 99 percent effectiveness rate. The risk of complications is less than 1 percent.

With mifepristone potentially unavailable soon, some abortion providers have been preparing to offer medication abortions using only misoprostol. That regimen — which is used in most other countries, where mifepristone is often unavailable — is safe and effective, but research shows it has a higher failure rate than the two-drug option. (A recent study found misoprostol-only medications had an 88 percent effectiveness rate.) Patients who take only misoprostol also can experience heightened side effects, including greater pain and vomiting. Other providers have said they will distribute mifepristone for as long as they have the drug in stock.

Adjusting to the one-drug regimen would not be easy. Clinicians across the country told The 19th it would take time to adjust to a misoprostol-only protocol. Many clinicians have only ever provided mifepristone-misoprostol regimens up until now, and experts told The 19th that switching to misoprostol only could mean reduced capacity at clinics.

If mifepristone’s distribution is blocked, some providers will now only provide surgical abortions, which are also safe and effective. But surgical abortions can only be offered in clinics, and take more time and resources for abortion clinics to provide.

For patients traveling across state lines to get an abortion, a misoprostol-only abortion presents particular challenges. The higher failure rate means greater odds of needing follow-up care when people have already returned to their home state.

Mifepristone has been on the market since 2000, when it was first approved by the Food & Drug Administration to help induce abortions. Since Roe v. Wade was overturned last summer, allowing states to ban abortion, the mifepristone-misoprostol combination has become even more significant.

Health care providers in states that allow abortion, especially those that have seen a surge in out-of-state patients as states restrict or ban the procedure, have leveraged medication abortion as a way to serve more patients quickly. Medication abortions are cheaper to administer, and patients can safely take the pills from home. Some people who have been unable to leave their home states have ordered mifepristone and misoprostol online to perform medication abortions at home, a practice that is potentially legally risky but is medically safe. (The World Health Organization recommends people taking medications have access to professional medical support if needed.)

The ruling in Texas, issued by Judge Matthew J. Kacsmaryk from the Northern District of Texas, comes in an unusual case. Filed by an anti-abortion group, the lawsuit argues that the government should revoke the FDA’s approval of mifepristone, claiming that the drug was improperly approved. Legal experts have robustly criticized the substance of those arguments.

There is no precedent for a district judge effectively undoing the FDA’s approval of a drug, and it’s not clear if this ruling will spur similar lawsuits. Some reproductive rights advocates worry that Kaczmaryk’s ruling could open the door for challenges to the FDA’s approval of intrauterine devices or emergency contraception pills — methods of birth control that some influential anti-abortion groups also oppose.

Recent polling found that 62 percent of voters disapprove of efforts to block access to medication abortion, including the majority of independents and of women voters.



THEY'RE BACK

Abortion pill plan clears Kansas Legislature; veto expected

By JOHN HANNA
yesterday

Kansas state Reps. Susan Concannon, left, R-Beloit, and Fred Patton, right, R-Topeka, confer during a session of the House, Thursday, April 6, 2023, at the Statehouse in Topeka, Kan. Both Concannon and Patton supported a bill approved by lawmakers that would require abortion providers to tell patients that medication abortions can be "reversed" once they are started, something experts dispute. 
(AP Photo/John Hanna)

TOPEKA, Kan. (AP) — Abortion opponents pushed a bill through the Kansas Legislature early Friday to require providers to tell patients that a medication abortion can be “reversed” once it’s started — a measure that could face a state court challenge if its supporters can overcome the governor’s expected veto.

Republican lawmakers pursued the bill even though experts dispute abortion opponents’ claims about medication abortions. Democrats argue the measure defies a decisive statewide vote in August affirming abortion rights. Democratic Gov. Laura Kelly vetoed a similar measure in 2019.

Kansas has been an outlier on abortion among states with GOP-controlled legislatures because its legal and political climate won’t allow a ban on abortion, despite the U.S. Supreme Court’s ruling in June 2022 that states can outlaw abortion. The Kansas Supreme Court ruled in 2019 that access to abortion is a matter of bodily autonomy and a “fundamental” right under the state constitution, and last year’s vote was to reject stripping out that protection.

“The people of Kansas have spoken,” state Rep. Christina Haswood, a Democrat from the liberal northeastern Kansas community of Lawrence, home to the main University of Kansas campus, said during Friday’s brief debate. “They do not want us touching anything on abortion.”

HEALTH


Republican lawmakers and anti-abortion groups contend the vote last year doesn’t preclude “reasonable” restrictions. They contend that the “abortion pill reversal” measure only ensures that patients have information.

“They need to be knowledgeable about what can happen,” Republican state Rep. Susan Humphries, of Wichita, during a debate on the issue last week.

The votes for the final version of the bill were 80-38 in the House and 26-11 in the Senate. In both chambers, abortion opponents were short of the two-thirds majorities needed to override a veto but enough absent lawmakers might have voted “yes” for an override to be possible.

But even then, the measure still could be challenged in court by providers who believe it would force them to give patients inaccurate information. Lawsuits have prevented Kansas from enforcing a 2015 ban on a common second-trimester abortion procedure and a 2011 law imposing extra health and safety rules for abortion providers.

Meanwhile, legislators this week also approved a bill dealing with live deliveries during certain types of abortion procedures. Doctors could face criminal charges or lawsuits for monetary damages if they are accused of not providing reasonable care to an infant delivered alive during certain types of abortion procedures.

And lawmakers have included $2 million in state tax dollars in the next state budget for centers that provide free prenatal and post-birth counseling and other services as they seek to discourage women from having abortions. Abortion opponents also are pursuing creation of an income tax credit for donors to those centers, allowing up to $10 million total a year.

“This is not about abortion and it’s not about a ban. We heard the vote. We get that,” House health committee Chair Brenda Landwehr, a Wichita Republican, told colleagues during a debate on the issue last week. “We also heard you say we don’t care and now we’re trying to step up to the plate.”

The American College of Obstetrics and Gynecology says there is no scientific evidence that the “reversal” method, involving using the hormone progesterone in place of the second abortion medication, is safe or effective.

Two physicians started using the “reversal” method more than 15 years ago, and abortion opponents note that progesterone is often used to try to prevent women from miscarrying a pregnancy. One of the doctors who participated in a 2018 study said doctors followed more than 750 women who’d sought to reverse medication abortions and said a sizeable majority were successful.

Critics have said the study was flawed and couldn’t show whether the women would have carried their pregnancies to term without progesterone.

“Kansas deserves providers who are free to stick to fact-based health care and not forced to spread scientific myths,” Democratic state Rep. Melissa Oropeza, a Kansas City nurse practioner, said during Friday’s debate.

But abortion opponents said it’s not improper to promote what is essentially an off-label use for progesterone.

“Heck, we use a lot of things off label,” state Rep. John Eplee, a northeastern Kansas doctor, said during last week’s debate. “Viagra — sildenafil — was used as a medication for pulmonary hypertension for five years until they found all the male patients woke up with complications, quote-unquote, from it.”

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Follow John Hanna on Twitter: https://twitter.com/apjdhanna

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