#fda v alliance for hippocratic medicine

[justinspoliticalcorner]

Joan McCarter at Daily Kos:

A group of women Democratic senators introduced a repeal of the 1873 Comstock Act Thursday, citing the threat of the Heritage Foundation’s Project 2025, a blueprint for the next Republican president. This archaic law needs to go, and talking about it—and the GOP’s plans—is an excellent way to get the word out to voters about Republicans’ radical agenda.

The Comstock Act banned the mailing of contraceptives, “lewd” writings, and any “instrument, substance, drug, medicine, or thing” that could be used in an abortion. It’s been more or less superseded by the Supreme Court and new laws in the past century and a half, but it remains on the books. Like a dormant volcano, it sits waiting for a shift in the political ground to erupt. Patty Murray of Washington, one of the co-sponsors, talked about the threat in a press conference Tuesday.  “Donald Trump and his allies are planning a detailed road map, they’ve given it out, to rip away a woman’s right to choose in every single state in America,” she said. Lead sponsor of the bill, Tina Smith of Minnesota, told The Washington Post that there is  “a very clear, well-organized plan afoot by the MAGA Republicans to use Comstock as a tool to ban medication abortion, and potentially all abortions.” “My job is to take that tool away,” Smith added.

The shift was presaged by the focus of Supreme Court Justices Clarence Thomas and Samuel Alito in their arguments in Food and Drug Administration v. Alliance for Hippocratic Medicine, in which the court unanimously preserved access to the abortion pill. The ruling wasn’t on the merits of the FDA’s decision to expand access to the drug, but rather on a technicality of whether the physicians’ group bringing the challenge could sufficiently claim that they were harmed by it. In that case, Thomas and Alito all but told future plaintiffs how to bring back this challenge: by invoking the Comstock Act. They specifically asked the attorneys arguing the case of the FDA’s pandemic-era decision—made permanent in 2023—to use the Comstock Act in their challenges.

Good to see the Senate Democrats take action to propose the repeal of the odious Comstock Act (even if the Republicans block it like usual). #RepealComstock

[thellawtoknow]

Alliance for Hippocratic Medicine v. FDA

Background of the Case: Alliance for Hippocratic Medicine v. FDAFDA’s Role in Drug ApprovalCore Issues in the Legal ChallengeBroader ImplicationsLegal Significance of Amicus Curiae BriefsPurpose and Function of Amicus Curiae BriefsThe Role of ACS and ACS CAN as AmiciImpact of Amicus Curiae Briefs on Judicial Decision-MakingKey Legal IssuesThe Role of ACS and ACS CAN Alliance for Hippocratic…

[rapeculturerealities]

Supreme Court will decide access to key abortion drug mifepristone - The Washington Post

https://www.washingtonpost.com/politics/2023/12/13/abortion-drug-supreme-court-mifepristone-fda/

The Supreme Court announced Wednesday that it will decide this term whether to limit access to a key abortion drug, returning the polarizing issue of reproductive rights to the high court for the first time since the conservative majority overturned Roe v. Wade last year.

The Biden administration and the manufacturer of mifepristone have asked the justices to overturn a lower-court ruling that would make it more difficult to obtain the medication, which is part of a two-drug regimen used in more than half of all abortions in the United States.

The conservative U.S. Court of Appeals for the 5th Circuit said the federal government acted unlawfully years ago when it began loosening regulations for obtaining the pill. The appeals court said the Food and Drug Administration did not follow proper procedures when it allowed the drug — which was first approved more than 20 years ago — to be taken later in pregnancy, to be mailed directly to patients and to be prescribed by a medical professional other than a doctor.

Medications to terminate pregnancy have increased in importance because more than a dozen states severely limited or banned abortions after the Supreme Court’s ruling last June in Dobbs v. Jackson Women’s Health Organization. That’s partly because the drugs can be sent by mail and taken at home.

If access to mifepristone was restricted, abortion providers and advocates say, pregnancies could still be terminated using only the second drug in the regimen, misoprostol. But using that drug alone causes more cramping and bleeding, and abortion opponents could move to restrict its use as well if they win limits on the use of mifepristone from the high court.

[ Faced with abortion bans, doctors beg hospitals for help with key decisions ]

The court’s decision to review the mifepristone case is not surprising. In April, after a District Court ruling to suspend FDA approval of the drug, the justices said existing rules for prescribing and distributing mifepristone would remain in place nationwide while the litigation continues.

In that order, only Justices Clarence Thomas and Samuel A. Alito Jr. said they would not have granted the Biden administration’s request for a stay of the District Court decision. Critics say the lower court’s ruling undermines the role of federal regulatory agencies.

Solicitor General Elizabeth B. Prelogar told the high court that mifepristone has been safely used by millions of people over more than two decades, and warned that allowing the lower court’s decision to stand would have “damaging consequences for women seeking lawful abortions and a healthcare system that relies on the availability of the drug under the current conditions of use.”

The challenge to mifepristone was initiated by the Alliance for Hippocratic Medicine, an association of antiabortion doctors and others. The group asserted that the FDA did not sufficiently consider safety concerns when it approved the drug in 2000 or when it removed some restrictions years later — allowing the use of mifepristone through 10 weeks of pregnancy, for instance, instead of seven.

The group filed its lawsuit in Amarillo, Tex., where U.S. District Judge Matthew J. Kacsmaryk — a Trump nominee with long-held antiabortion views — is the sole sitting judge. He sided with the challengers and suspended FDA approval of the medication.

The 5th Circuit reversed that part of Kacsmaryk’s order, but agreed with him in blocking the changes starting in 2016 for how the drug was prescribed and distributed, and at what point in a pregnancy it could be used.

[mariacallous]

On Tuesday, the Supreme Court of the United States will hear oral arguments in a challenge to abortion pill access across the country, including in states where abortion is legal. The stakes for abortion rights are sky-high, and the case is the most consequential battle over reproductive health care access since Roe v. Wade was overturned in 2022.

At the center of this fight is mifepristone, a pill that blocks a hormone needed for pregnancy. The drug has been approved by the US Food and Drug Administration for more than two decades, and it’s used to treat some patients with Cushing’s syndrome, as well as endometriosis and uterine fibroids. But its primary use is the one contested now—mifepristone is the first of two pills taken in the first 10 weeks of pregnancy for a standard medication abortion, along with the drug misoprostol.

If the justices side with the antiabortion activists seeking to limit access to mifepristone, it could upend nationwide access to the most common form of abortion care. A ruling that invalidates mifepristone’s approval would open the door for any judge to reverse the FDA approval of any drug, especially ones sometimes seen as controversial, such as HIV drugs and hormonal birth control. It could also have a chilling effect on the development of new drugs, making companies wary of investing research into medicines that could later be pulled from the market.

Pills are now the leading abortion method in the US, and their popularity has spiked in recent years. More than six in 10 abortions in 2023 were carried out via medication, according to new data from the Guttmacher Institute. Since rules around telehealth were relaxed during the Covid-19 pandemic, many patients seeking medication abortions have relied on virtual clinics, which send abortion pills by mail. And it keeps getting more popular: Hey Jane, a prominent telemedicine provider, saw demand increase 73 percent from 2022 to 2023. It recorded another 28 percent spike comparing data from January 2023 to January 2024.

“Telemedicine abortion is too effective to not be in the targets of antiabortion folks,” says Julie F. Kay, a longtime reproductive rights lawyer and director of the advocacy group Abortion Coalition for Telemedicine.

Tomorrow’s argument comes after a long, tangled series of legal disputes in lower courts. The Supreme Court will be hearing two cases consolidated together, including FDA v. Alliance for Hippocratic Medicine, in which a coalition of antiabortion activists filed a suit challenging the FDA’s approval of mifepristone, asking for it to be removed from the market. The Alliance for Hippocratic Medicine is represented by the Alliance Defending Freedom, a right-wing Christian law firm that often takes politically charged cases.

Despite decades of scientific consensus on the drug’s safety record, the Alliance for Hippocratic Medicine has alleged that mifepristone is dangerous to women and leads to emergency room visits. A 2021 study cited by the plaintiffs to back up their claims was retracted in February after an independent review found that its authors came to inaccurate conclusions.

In April 2023, the Trump-appointed judge Matthew Kacsmaryk of the Northern District of Texas issued a preliminary ruling on the FDA case invalidating the agency’s approval of mifepristone. The ruling sent shock waves far beyond the reproductive-rights world, as it had major implications for the entire pharmaceutical industry, as well as the FDA itself; the ruling suggested that the courts could revoke a drug’s approval even after decades on the market.

The US 5th Circuit Court of Appeals narrowed Kacsmaryk’s decision a week later, allowing the drug to remain on the market, but undid FDA decisions in recent years that made mifepristone easier to prescribe and obtain. That decision limited the time frame in which it can be taken to the first seven weeks of pregnancy and put telemedicine access, as well as access to the generic version of the drug in jeopardy.

Following the 5th Circuit ruling, the FDA and Danco Laboratories sought emergency relief from the Supreme Court, asking the justices to preserve access until it could hear the case. In its legal filing, Danco aptly described the situation as “regulatory chaos.”

SCOTUS issued a temporary stay, maintaining the status quo; the court ultimately decided to take up the case in December 2023.

As all this was unfolding, pro-abortion-rights states across the country were passing what are known as shield laws, which protect medical practitioners who offer abortion care to pregnant patients in states where abortion is banned. This has allowed some providers, including the longtime medication-abortion-advocacy group Aid Access, to mail abortion pills to people who requested them in states like Louisiana and Arkansas.

Though the oral arguments before the Supreme Court begin on Tuesday, it will likely be months before a ruling. Court watchers suspect a decision may be handed down in June. With the US presidential election in the fall, the ruling may become a major campaign issue, especially as abortion access helped galvanize voters in the 2022 midterms.

If the Supreme Court agrees with the plaintiffs that mifepristone should be taken off the market, some in the pharmaceutical industry worry that it will undermine the authority of the FDA, the agency tasked with reviewing and approving drugs based on their safety and efficacy.

“This case isn't about mifepristone,” says Elizabeth Jeffords, CEO of Iolyx Therapeutics, a company developing drugs for immune and eye diseases. Jeffords is a signatory on an amicus brief filed in April 2023 that brought together 350 pharmaceutical companies, executives, and investors to challenge the Texas district court’s ruling.

“This case could have easily been about minoxidil for hair loss. It could have been about Mylotarg for cancer. It could have been about measles vaccines,” Jeffords says. “This is about whether or not the FDA is allowed to be the scientific arbiter of what is good and safe for patients.”

Greer Donley, an associate professor of law at the University of Pittsburgh and an expert on abortion on the law, doesn’t think it’s likely that the court will revoke mifepristone’s approval entirely. Instead, she sees two possible outcomes. The Supreme Court could dismiss the case or could undo the FDA’s decision in 2023 to permanently remove the in-person dispensing requirement and allow abortion by telehealth. “This would be an even more narrow decision than what the 5th Circuit did, but it would still be pretty devastating to abortion access,” she says.

The Supreme Court could also decide that the plaintiffs lack a right to bring the case to court, says David Cohen, a professor of law at Drexel University whose expertise is in constitutional law and gender issues. “This case could get kicked out on standing, meaning that the plaintiffs aren't the right people to bring this case,” he says. “If most of the questions are about standing, that will give you a sense that that's what the justices are concerned about.”

As the current Supreme Court is considered virulently antiabortion, reproductive-health-care workers are already preparing for the worst. Some telehealth providers have already floated a backup plan: offering misoprostol-only medication abortions. This is less than ideal, as the combination of pills is the current standard of care and offers the best results; misoprostol on its own can cause additional cramping and nausea. For some providers who may have to choose between misoprostol-only or nothing, it’s better than nothing.

Abortion-rights activists have no plans to give up on telehealth abortions, regardless of the outcome of this particular case. “Let us be clear, Hey Jane will not stop delivering telemedicine abortion care, regardless of the outcome of this case,” says Hey Jane’s CEO and cofounder, Kiki Freedman.

“They’re not going to stuff the genie back in the bottle,” Kay says.

[appalachiananarchist]

I was so glad to see this, but infuriated it was ever up for debate in the first place.

[whenweallvote]

Today, the U.S. Supreme Court is hearing oral arguments in FDA v. Alliance for Hippocratic Medicine — a case that will decide national access to Mifepristone, a medication abortion pill used in over 60 percent of abortion procedures nationwide. In light of this case, we’re here to share an important reminder: Reproductive Care is Healthcare, and it’s on the ballot this year.

Across the country, elected officials are failing to protect Americans’ right to make decisions about their bodies, families, and lives. Attacks on reproductive rights restrict Americans’ access to standard pregnancy care and worsen maternal health overall.

In 2024, reproductive healthcare is on the ballot in as many as 15 states. Your vote is your voice. Make sure you’re registered NOW at weall.vote/register — then remind three friends to check their registration too.

[docmerry]

Health is on the Ballot in November-Reproductive Health

REPRODUCTIVE HEALTH

Perhaps you have been marooned on an uninhabited island for the past decade, in which case, let me catch you up. One of the promises that Trump fulfilled during his time in office, with an assist from Republican Senate Leader Mitch McConnell, was to appoint justices to the Supreme Court of the United States (SCOTUS) that would overturn Roe v Wade. The appointments of justices Gorsich, Kavenaugh, and Coney Barret gave conservatives a supermajority on the bench,

In Dobbs v. Jackson Women's Health Organization (2022), SCOTUS overturned Roe v. Wade (1973) and Planned Parenthood v. Casey (1992).decision in 2022 overturned what had been the law of the land for close to 50 years. Since then, 21 states have passed laws or reinstituted “trigger laws” that were on the books prior to 1973 that restricted or prohibitted abortion. Stick a pin in that.

Justices Gorsich, Kavanaugh, and Coney Barret were recommended by the Heritage Foundation (Heritage), which is a conservative think tank that began in 1973 and has been active in Republican politics since the Reagan administration.

Heritage is the publisher of "Mandate for Leakership: The Conservative Promise" aka Project 25, a conservative playbook for the next Republican administration. It includes utilizing the 1873 Comstock Act, an anti-vice law that specifically prohibits the mailing of items related to abortion or birth control. Project 2025 suggests that mifepristone, a drug used in medical abortions, should not be mailed to patients under any circumstances. Additionally, this law from the nineteenth century could prevent the mailing of devices used in surgical abortion.

SCOTUS heard two cases in the latest term on abortion. FDA vs Alliance for Hippocratic Medicine was a case brought by Texas physicians that challenged the approval of mifepristone. In a unanimous decision, that case was thrown out because the doctors were found to lack standing to bring the suit.

In the notable case of Moyle v. United States, consolidated with United States v Idaho, the central issue was whether the federal Emergency Medical Treatment and Labor Act (EMTALA), which mandates hospitals to provide stabilizing treatment, including but not limitted to emergency abortions, preempts state law in Idaho and five other states that restrict abortion. Once again the court decided not to decide and sent the case back to the lower courts. The justices were divided, with Justices Alito and Thomas suggesting that states may prioritize the fetus's health over the woman's. Currently, women in Idaho and five other states can obtain an emergency abortion.

Justices Alito and Thomas are both in their seventies. If Trump were to win the election in November, it is anticipated that they would retire during his term, potentially solidifying a conservative supermajority for an extended period.

Just as men’s health is about more than just erectile dysfunction, reproductive health is about more than just abortions. Bills have been introduced in the House and the Senate that address In-vitro fertilization (IVF) and access to contraception. The future actions of those who enforce moral standards remain uncertain.

Across the aisle, Democratic Vice-Presidential candidate Tim Walz signed a law that "codified Roe," granting the right to abortion access in Minnesota's constitution. President Biden and VP Harris have considered similar national measures, but without eliminating the Senate filibuster, that would be a heavy lift in Congress.

Regarding the broader strategy, it may not be detrimental. Ruth Bader Ginsburg posited that if Roe v. Wade hadn't made abortion legal nationwide in one sweeping decision, states might have individually repealed anti-abortion laws gradually, similar to the recent trend of states legalizing recreational marijuana.

We don’t live in that universe. We live in this one where reproductive health is on the ballot in November.

[dreaminginthedeepsouth]

Sanity prevails!  ::  April 22, 2023

ROBERT B. HUBBELL

APR 22, 2023

         In a 7-2 ruling, the Supreme Court stayed Judge Kacsmaryk’s ruling revoking the FDA’s approval of mifepristone. As a result, mifepristone will remain available until the Fifth Circuit and Supreme Court consider Judge Kacsmaryk’s ruling on the merits. That process will likely take two years.

         The Supreme Court’s order and Alito’s dissent are here: Danco Laboratories LLC v. Alliance for Hippocratic Medicine.

         In granting the stay, the Supreme Court pulled back from the precipice of chaos that would have been created by a nationwide ban on mifepristone. There was a palpable sigh of relief among court watchers and reproductive rights advocates that the Court did not accept the invitation to depart the realm of sanity. As Ian Millhiser tweeted,

The Supreme Court did not do the most hackish, credibility-destroying thing it could possibly do.

         Millhiser offers a more sober analysis in his article in Vox, The Supreme Court’s new abortion pill ruling, explained. Per Millhiser,

The plaintiffs’ arguments in this case are laughably weak. They ask the Court to defy longstanding legal principles establishing that judges may not second-guess the FDA’s scientific judgments about which drugs are safe enough to be prescribed in the United States. Moreover, no federal court has jurisdiction to even hear this case in the first place.

[¶]

That said, the Court’s decision to temporarily keep mifepristone legal is a hopeful sign that the justices will ultimately decide not to ban mifepristone. And there are other reasons to believe that a majority of the Court might reject this entirely meritless attack on abortion rights.

         Justice Alito continued his descent into terminal crankiness with a three-page diatribe that belittles the medical necessity of mifepristone and women’s rights to healthcare. Alito would have denied the stay because he believes that a several-month period of restrictions on mifepristone would not “likely [impose] irreparable harm.” Tell that to a woman suffering through a protracted and dangerous miscarriage.

         It is tough to make predictions—especially about the future. But the fact that seven justices refused to allow Kacsmaryk’s ruling to remain in effect bodes well for the ultimate decision on the merits in favor of reproductive liberty.

         That is a good place to come to rest before the weekend. Sanity prevailed (for once), perhaps because the Court realized Dobbs inflicted irremediable damage to its legitimacy.

[pro-birth]

From AAPLOG on Facebook:

Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration

"Description: By illegally approving chemical abortion drugs, the U.S. Food and Drug Administration failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women. The FDA never studied the safety of the drugs under the labeled conditions of use, ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions, and eliminated necessary safeguards for pregnant girls and women who undergo this dangerous drug regimen."

On November 18, AAPLOG, alongside other plaintiffs, filed a lawsuit against the U.S. Food & Drug Administration (FDA) for illegally approving mifepristone (also known as “Mifeprex” and “RU-486”) and misoprostol for chemical abortion, as these dangerous drugs harm women and girls. The plaintiffs are represented by Alliance Defending Freedom, the law firm that worked with Mississippi in the US Supreme Court Case Dobbs v Jackson Women’s Health Center, the ruling for which overturned Roe v Wade. As the lawsuit explains, the FDA illegally approved mifepristone and has repeatedly removed the few safeguards governing it's use over the past two decades. The agency did not study the danger mifepristone posed to minors despite approving mifepristone for use by young girls. The FDA also has never required an ultrasound prior to a chemical abortion. An ultrasound is the best way to confirm the baby’s age and to rule out an ectopic pregnancy, which occurs in 1 in every 50 pregnancies. Without an ultrasound, the risks from a chemical abortion are significantly increased.

The FDA has not worked to correct, or even mitigate, the dangers intrinsic to chemical abortions. Instead, in 2016, the FDA dangerously expanded the approval of chemical abortion drugs from 7 weeks of pregnancy up to 10 weeks of pregnancy, changed the dosing regimen, reduced the number of in-person doctor visits from three to one, expanded who could prescribe and administer chemical abortion drugs beyond medical doctors, and eliminated the requirement for prescribers to report non-lethal complications from chemical abortion drugs. And in 2021, based on incomplete and unreliable data, the FDA removed the requirement that an abortionist physically meet with the woman and give her the chemical abortion drugs, thus allowing for chemical abortions by mail and telemedicine. This will only increase the danger to women, not to mention the children whose lives will be ended. As many as one out of five women who undergo a chemical abortion will suffer a complication. Women can face severe bleeding, life-threatening infections, and the inability to have future successful pregnancies—requiring emergency medical treatment, surgeries, blood transfusions, and hysterectomies. In addition, chemical abortion has a complication rate four times higher than surgical abortions.

AAPLOG has long fought against efforts by the FDA and pro-abortion advocates to prioritize abortion access over the health and safety of women and their preborn children. We are proud to be a part of this effort to hold the FDA accountable to its obligation to protect the health, safety, and welfare of women and girls. You can see the full press release about this lawsuit here. https://adfmedia.org/case/alliance-hippocratic-medicine-v-us-food-and-drug-administration .

[beardedmrbean]

The Supreme Court just upheld full access to mifepristone, a widely used abortion drug. In a unanimous ruling issued on Thursday, the justices decided that the challengers who brought the case did not have standing, or a right to bring the lawsuit.

Justice Brett Kavanaugh, who was appointed by former President Donald Trump, wrote the opinion.

"Under Article III of the Constitution, a plaintiff's desire to make a drug less available for others does not establish standing to sue. Nor do the plaintiffs' other standing theories suffice," Kavanaugh wrote. He also added that "federal courts are the wrong forum for addressing the plaintiffs' concerns about FDA's actions."

🔎 What the ruling means

If the Supreme Court would have ruled against the Food and Drug Administration, restrictions on mifepristone would have reverted back to what they were when the drug was approved in 2000.

But since the court tossed the case, prescriptions will still be allowed during the first 10 weeks of pregnancy and the medication can still be prescribed over telehealth visits and be delivered by mail in states that allow it.

The ruling comes nearly two years after the Supreme Court overturned the federal right to an abortion established by Roe v. Wade. As a result of that historic decision, over a dozen states now have total abortion bans in place.

🗣️ Reactions to the ruling

While many abortion rights supporters were relieved by the SCOTUS decision, they aren't necessarily celebrating because of the absence of the federal right to an abortion.

"We are relieved by this outcome, but we are not celebrating," Destiny Lopez, acting co-CEO of the Guttmacher Institute, said in a statement. "In the face of relentless attacks, policymakers at all levels need to keep pushing forward expansive and protective policies that ensure everyone can access abortion care using the method that best suits their needs.”

President Biden said the ruling "does not change the fact that the fight for reproductive freedom continues – the right for a woman to get the care she needs is imperiled if not impossible in many states."

Meanwhile, anti-abortion groups condemned the ruling.

“It is a sad day for all who value women’s health and unborn children’s lives, but the fight to stop dangerous mail-order abortion drugs is not over,” said Kate Daniel, state policy director for SBA Pro-Life America.

Kristan Hawkins, president of Students for Life of America, called the decision “disappointing but not surprising” and also expressed concern for the “conscience rights of the pro-life doctors.”

💊 What is mifepristone?

The widely used abortion drug has been used by more than 6 million people since 2000, according to the Associated Press.

Mifepristone is one of two pills in a two-step drug regimen to induce an abortion during the early stages of a pregnancy.

"Mifepristone blocks the hormone progesterone and primes the uterus to respond to the contraction-causing effect of a second drug, misoprostol," the AP reports.

Mifepristone is also used to help with the treatment of miscarriages.

In 2020, more than half of abortions in the U.S. (51%) were induced using medication, according to data from the Centers for Disease Control and Prevention.

⬅️ How we got here

The Supreme Court heard two cases consolidated together back in March: FDA v. Alliance for Hippocratic Medicine and Danco Laboratories v. Alliance for Hippocratic Medicine.

The Alliance for Hippocratic Medicine is a group of anti-abortion-rights physicians and organizations who originally challenged the FDA's 2000 approval of mifepristone, claiming the FDA didn't study it enough and the drug isn't safe. The case ultimately worked its way through the courts, where their challenge is now focused on actions taken by the FDA in 2016 and 2021 to make the drug more accessible.

➡️ What's next?

The Supreme Court still has to decide on another abortion-related case, Moyle v. United States. The justices will have to decide whether a federal law that requires emergency rooms to provide stabilizing care, including abortions, in certain medical emergencies overrides state law in places that impose a near-total ban on abortion, like Idaho.

[thepro-lifemovement]

Senator Cindy Hyde-Smith (R-Miss.) and U.S. Representative August Pfluger (R-Texas-11) today led 13 Senators and 54 Representatives in signing an amicus brief supporting a lawsuit challenging the Food and Drug Administration’s approval and deregulation of chemical abortion drugs.

The brief, authored by Americans United for Life, has been filed in the case of Alliance for Hippocratic Medicine v. FDA, which is pending before the Northern District of Texas. The brief spotlights how the FDA’s actions have disregarded the law and put the lives and health of women and girls in danger. It follows a Jan. 26 letter to the FDA led by Hyde-Smith that was signed by 77 Senators and Members of Congress.

“The FDA’s reckless decisions to approve and deregulate chemical abortion drugs put the profits and political agenda of the abortion industry over the law and abundant evidence that abortion drugs present harm to women, girls, and their unborn babies,” Senator Hyde-Smith said.

The amicus brief makes three primary arguments that demonstrate how the FDA exceeded its authority by subverting the law and public policy with its approval and deregulation of harmful chemical abortion drugs. The brief contends the FDA endangered the health of women and girls when it:

Failed to adhere to the drug approval process in the Federal Food, Drug, and Cosmetic Act (FFDCA)

Unlawfully waived the pediatric study requirement under the Pediatric Research Equity Act

Violated federal law by permitting mail-order chemical abortion pills

[justinspoliticalcorner]

Andra Watkins at How Project 2025 Will Ruin YOUR Life:

Regarding mifepristone:

[Reverse its approval of chemical abortion drugs because the politicized approval process was illegal from the start. The FDA failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women. It never studied the safety of the drugs under the labeled conditions of use, ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions, and eliminated necessary safeguards for pregnant girls and women who undergo this dangerous drug regimen. Furthermore, at no point in the past two decades has the FDA ever acknowledged or addressed federal laws that prohibit the distribution of abortion drugs by postal mail; to the contrary, the FDA has permitted and actively encouraged such activity. Project 2025, page 458]

Pay attention to the highlighted language. Republicans have made no secret of their goal to use the Comstock Act to outlaw the shipment of chemical abortion pills and abortion supplies. Both Clarence Thomas and Samuel Alito name-checked Comstock during oral arguments in the recent mifepristone case.

[...] Republicans WILL define hormonal birth control as an abortifacient (“abortion drugs”) using the methodology outlined by Human Life International above. They WILL use the Comstock Act to ban the shipment of oral contraceptives by calling them “abortion drugs.” I’m not making a stretch for shock value. It is impossible to follow these breadcrumbs without arriving at this conclusion.

Be aware: Project 2025 planners seek to ban mifepristone, birth control, and contraception under the broad redefinition of the term “abortifacient”. Their goals also include the enforcement of the mostly-dormant Comstock Act.

[fantabulisticity]

Alliance for Hippocratic Medicine v. FDA Court Case

Access to mifepristone could be eradicated in every single state in the country, including in states where the right to abortion is protected—amounting to a backdoor nationwide ban on medication abortion.

Last updated: 2/7/23. This is an ongoing case—we’ll periodically update this page with the latest updates.

The Case Anti-choice groups filed a federal lawsuit in a Texas district court challenging the U.S. Food and Drug Administration (FDA) in its decades-old approval of mifepristone, one of the two medications typically used to provide medication abortion care. The lawsuit seeks to revoke the FDA’s approval of mifepristone in an attempt to effectively ban medication abortion nationwide.

Timeline The Trump-appointed federal judge could issue his ruling as early as Friday, February 10.

Why does this court case in Texas matter? The judge could grant an emergency injunction that would force the FDA to withdraw its approval of mifepristone—which would pull it off the market and, in effect, ban it nationwide. Medication abortion is the most commonly used method of abortion. Banning mifepristone nationwide would have severe consequences on people’s ability to access critical abortion and miscarriage care. Abortion access in our country is already in crisis after the Supreme Court overturned Roe v. Wade. If this judge takes medication abortion off the market, even more people will lose the freedom to make their own decisions about their lives, bodies, and futures.

Frequently Asked Questions

What is mifepristone? Mifepristone is one of two pills typically used in medication abortion care. For over 20 years, medication abortion has been a safe and effective FDA-approved option for ending an early pregnancy. It’s also used for miscarriage management.

I live in a state where abortion is legal. Will this affect me? Yes. A federal ruling means health care providers would be banned from prescribing mifepristone for medication abortion and miscarriage treatment, no matter where you live.

Will I still be able to access abortion care? Yes. In-clinic care for procedural abortion access will not be affected by this ruling. It is likely that with the removal of medication abortion options, the availability of clinic appointments will be impacted and make it much harder to obtain one. To learn more about where to find abortion care, visit https://www.ineedana.com/.

What’s the difference between medication abortion and birth control pills or emergency contraception? Birth control and emergency contraception (such as Plan B) prevent pregnancy in different ways, while medication abortion ends an early pregnancy. Medication abortion (also known as abortion pills): Medication that is taken to end a pregnancy. The two medications typically used in the U.S. are mifepristone and misoprostol. Birth control: There are many different birth control methods to prevent pregnancy. The most common include condoms, birth control pills, IUDs, and diaphragms. Emergency contraception (also known as Plan B and the morning-after pill): The morning-after pill is an effective emergency form of birth control that is used to prevent pregnancy after sex.

[usalatestwebstories]

Supreme Court preserves access to abortion pill

OPINION ANALYSIS By Amy Howe on Jun 13, 2024 at 11:13 am The court ruled against a group of anti-abortion doctors suing the FDA in Food and Drug Administration v. Alliance for Hippocratic Medicine on Thursday. (Timothy Neesam via Flickr) This article was updated on June 13 at 2:20 p.m. The Supreme Court on Thursday threw out a lawsuit seeking to roll back access to mifepristone, one of the…