{"id":320419,"date":"2024-10-19T15:34:32","date_gmt":"2024-10-19T20:34:32","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=320419"},"modified":"2024-10-23T02:11:21","modified_gmt":"2024-10-23T07:11:21","slug":"three-states-sue-fda-abortion-pill-expansion","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/three-states-sue-fda-abortion-pill-expansion\/","title":{"rendered":"Three states sue FDA for ‘disregarding the health and safety’ of women with abortion pill expansion"},"content":{"rendered":"
<\/div>

Missouri, Kansas, and Idaho have filed an amended lawsuit in federal court, claiming their “sovereign” interest in “protecting… citizens” was violated by the Food and Drug Administration’s (FDA) decision to expand access to the abortion pill to mail-order dispensing.<\/p>\n

The lawsuit, State of Missouri; State of Kansas; State of Idaho v. FDA<\/em>,<\/a> filed on October 14, 2024, in Amarillo, Texas, is “asking US District Judge Matthew Kacsmaryk to rollback efforts the Food and Drug Administration has taken over the past eight years to ease access to the drug, such as allowing it to be dispensed through the mail,” CNN reported<\/a>.<\/p>\n

The Plaintiff States allege that “Women face severe, even life-threatening, harm because the federal government has disregarded their health and safety. These dangerous drugs are now flooding states like Missouri and Idaho and sending women in these States to the emergency room.”<\/p>\n

As such, the lawsuit also alleged that “Defendant U.S. Food and Drug Administration (FDA) has the statutory responsibility to protect the health, safety, and welfare of all Americans by putting commonsense safeguards on high-risk drugs[;] the FDA has failed in this responsibility by removing many of the safety standards it once provided to women using abortion drugs.”<\/p>\n

\"Three

Three state Missouri Kansas Idaho v FDA lawsuit on abortion pill<\/p><\/div>\n

The State of Idaho, along with Missouri AG Andrew Bailey and Kansas AG Kris W. Kobach, brought the lawsuit to “vindicate [their] sovereign, quasi-sovereign, and proprietary interests, including its interests in protecting its citizens,” the court document read.<\/p>\n

States request preliminary injunction to reinstate prior safety regulations\u00a0<\/strong><\/p>\n

In their lawsuit,<\/a> the Plaintiff States request a “preliminary injunction” from the Court against the FDA, or “a stay of the effective dates” that “reinstates the REMS that were in place before 2016 insofar as they restore the Day 3 and Day 14 follow-up visits, restore the gestational age to 7 weeks from 10 weeks, restore the requirement that prescribers be physicians, and restore the requirement that prescribers must report all serious non-fatal adverse events to the agency; rescinds the 2019 generic approval; and restores the in-person dispensing requirement.”<\/p>\n

The three states are asking the court to “issues[] a permanent injunction ordering Defendants to withdraw Defendants\u2019 actions to deregulate these abortion drugs.”<\/p>\n

The abortion pill Mifeprex (mifepristone) was approved<\/a> by the FDA in September 2000 “for medical termination of pregnancy,\u201d the FDA website<\/a> states. \u201cFDA approved a generic version of Mifeprex, Mifepristone Tablets, 200 mg, in April 2019.\u201d<\/p>\n

In 2016, the Obama administration FDA weakened the safety requirements (REMS)<\/a> for the drug by removing<\/em> requirements that women take the first drug in front of a clinician in person, at the location of a certified prescriber. It also expanded use of the drug to abort preborn children up to 10 weeks (70 days)<\/a> of pregnancy from the previous seven weeks, and removed the requirement for the manufacturer (Danco, and now GenBioPro) report the drug\u2019s non-fatal adverse events\u00a0<\/em>(complications). Only deaths would be required for reporting.<\/p>\n

By December of 2021, the Biden-Harris FDA had further weakened<\/a>\u00a0the\u00a0REMS<\/a>\u00a0by eliminating the\u00a0in-person dispensing requirement<\/a>\u00a0and enabling the abortion pill to be permanently\u00a0shipped by mail<\/a>. Then in January 2023, the Biden-Harris FDA further gutted the REMS by announcing it would allow retail pharmacies to dispense the drug<\/a>.<\/p>\n

The Plaintiff States claim that the “FDA made [these changes] without any studies that evaluated the impact of removing all of these interrelated safeguards at once.” The suit adds that the undoing of the requirement to report “non-fatal complications” was “unreasonable” because it was “based on past data collected under the originally approved safety standards, not the new deregulated regime.”<\/p>\n

The Plaintiffs also noted:<\/p>\n

Women face severe bleeding, ruptured ectopic pregnancies, and life threatening infections because the FDA recklessly removed in-person safety standards that it once provided. Women should have the in-person care of a doctor when taking high-risk drugs.<\/em><\/p>\n

The States of Missouri, Kansas, and Idaho thus challenge the FDA\u2019s actions to remove commonsense safety measures for abortion drugs and ask that the Court hold these actions unlawful, stay their effective date, set them aside, and vacate them.<\/em><\/p>\n

In rolling back safeguard after safeguard, the FDA has turned a blind eye to the known harms of abortion drugs to the detriment of women and girls.<\/em><\/p>\n

States seek enforcement of Comstock Law, which prohibits mailing abortion drugs<\/strong><\/p>\n

In their complaint, the Kansas, Missouri, and Idaho are seeking to enforce a law (18 U.S.C. \u00a7 1461), known as the Federal Comstock Act, which prohibits<\/a> the mailing of \u201cany article, instrument, substance, drug, medicine, or thing [that] may, or can, be used or applied for producing abortion[.]\u201d<\/p>\n

They claim that “[t]he FDA\u2019s 2021\/2023 Removal of the In-Person Dispensing Protection violates the federal laws that expressly prohibit the mailing or delivery by any letter carrier, express company, or other common carrier, or by interactive computer service, of any substance or drug intended for producing abortion” by “impermissibly remov[ing] the in-person dispensing requirement for abortion drugs and, accordingly, authorized the downstream distribution of abortion drugs by mail, express company, other common carriers, and interactive computer service.”<\/p>\n

“Because a federal agency cannot permit what federal law expressly prohibits, the FDA lacked legal authority when issuing the 2021\/2023 Removal of the In-Person Dispensing Protection,” the lawsuit claimed. That decision “failed to account for or address the federal laws that prohibit the distribution of abortion drugs by postal mail, express company, or common carrier and by interactive computer service,” the lawsuit notes. “FDA permitted and sometimes even encouraged these illegal activities. But a federal agency cannot authorize unlawful actions.”<\/p>\n

States argue their standing to bring the lawsuit\u00a0<\/strong><\/p>\n

Kansas, Missouri, and Idaho are clear that the “FDA\u2019s actions interfere with Plaintiff States\u2019 “sovereign interest in \u2018the power to create and enforce a legal code.”<\/p>\n

State of Missouri; State of Kansas; State of Idaho v. FDA<\/em><\/a> follows a June 2024<\/a> ruling by the United States Supreme Court in a separate case, FDA vs. Alliance for Hippocratic Medicine (AHM)<\/em><\/a>. The latter challenged<\/a>\u00a0as\u00a0unsafe<\/a> the FDA\u2019s expansions of abortion pills in 2016 and 2021 \u2014\u00a0 from in-person visits with a lower gestational limit and more safeguards, to mail-order (and now pharmacy) dispensing. The doctors testified<\/a> to having treated women with severe complications \u2014 \u201cmany who presented to the emergency room.\u201d<\/p>\n

While Plaintiff doctors in AHM also requested that the Supreme Court reinstate the FDA\u2019s pre-2016 REMS safety requirements for mifepristone, calling<\/a> the recent expansions of the drug \u201carbitrary, capricious, an abuse of discretion, and otherwise unlawful,\u201d the Court’s decision in AHM<\/a> merely ruled<\/a> that the plaintiff doctors in the AHM lawsuit did not have standing to sue<\/em>.<\/p>\n

Referring to the new lawsuit, CNN wrote that “the states claim they have standing to sue because the FDA\u2019s actions facilitate violations of state abortion laws ‘by enabling an out-of-state abortion drug distribution network.’ The states also claimed the FDA\u2019s moves displaced state laws controlling abortions for girls in foster care.”<\/p>\n

The three states alleged in their lawsuit<\/a> that they have standing to sue “based on (1) federal assertions of authority to regulate matters they believe they control, (2) federal preemption of state law, and (3) federal interference with the enforcement of state law, at least where \u2018the state statute at issue regulates behavior or provides for the administration of a state program\u2019 and does not \u2018simply purport to immunize state citizens from federal law.’ They also claim to have “suffered\u00a0injury to their sovereign interests in enacting and enforcing their laws.”<\/p>\n

They say the FDA “intentionally facilitated widespread violations by third parties of state abortion laws..[,] unlawfully removed the backstop of federal law and federal law enforcement..[,] purport to preempt state abortion laws, and (4) seek to displace and nullify the States\u2019 state-law parental rights of notice and consent for abortions for teen girls in foster care.”<\/p>\n

States argue “abortion drugs are dangerous”<\/strong><\/p>\n

Before Roe v. Wade<\/em>, so-called self-administered abortions were portrayed<\/a>\u00a0by abortion advocates as\u00a0dangerous<\/a>. But once Big Abortion began\u00a0toying with the idea<\/a> of “no-test” abortion pill protocols and mail-order telabortion schemes (including an over-the-counter abortion pill push), suddenly, self-managed abortion became \u201csafe.\u201d<\/a><\/p>\n

Or so Big Abortion claims.<\/p>\n

The three Plaintiff states disagree, writing in their complaint, “Abortion drugs are dangerous\u2014the FDA\u2019s own label says that an estimated roughly one in 25 women who take abortion drugs will visit the emergency room.”<\/p>\n

According to the lawsuit, “[] the FDA has enabled online abortion providers<\/a> to mail<\/a> FDA approved abortion drugs to women in states that regulate abortion\u2014dispensing<\/a> abortion drugs with no doctor care, no exam, and no in-person follow-up care<\/a>. These dangerous drugs are now flooding states like Missouri and Idaho and sending women in these States to the emergency room.”<\/p>\n

Emergency visits as a result of the abortion pill<\/strong><\/p>\n

Live Action News has previously documented that mifepristone\u2019s 2023 label<\/a>\u00a0still contains a black box warning for sepsis, bleeding, and other life-threatening risks.<\/p>\n

In addition, published percentages for emergency room (ER) visits on the drug’s insert indicate that 2.9 to 4.6 percent of women who take abortion drugs end up in the emergency room, indicating<\/a>\u00a0that abortion pill ER visits could be in the\u00a0tens of thousands<\/em>\u00a0every year. In\u00a0addition<\/a>, the FDA\u2019s\u00a0medication guide<\/a>\u00a0acknowledges that as many as seven percent (7%) of women will need surgery after taking mifepristone \u201cto stop bleeding\u201d or to complete the abortion.<\/p>\n

\"Mifepristone

Mifepristone Jan 2023 label shows percentage of women taking abortion pill visit ER<\/p><\/div>\n

The data also is similar to findings from a\u00a0previously<\/a>-documented\u00a0Gynuity Health Projects (GHP)<\/a> telabortion study, which found that six percent (6%) of participants (70 out of 1,157) faced complications from the abortion pill, resulting in ER or urgent care visits<\/a>. Gynuity is a pro-abortion group, conducting clinical trials on the abortion pill, and funded<\/a>\u00a0by organizations with deep historic ties to the American\u00a0eugenics<\/a> movement.<\/p>\n

Abortion pill complications have been offloaded to emergency rooms instead of prescribers<\/strong><\/p>\n

Live Action News has\u00a0previously documented<\/a>\u00a0that the risks of the abortion pill triggered the FDA to place it under a safety system called REMS, where it has remained \u2014 even under multiple pro-abortion administrations.<\/p>\n

Under the REMS, prescribers of the drug are supposed to have provisions to handle abortion pill failures or complications<\/em>. Instead of abiding by the regulations, which are policed by those who profit from the drug (Danco and GenBioPro), abortion providers instead simply instruct women to present to the ER.<\/p>\n

In other words, they are offloading their abortion pill clients onto already potentially overcrowded emergency rooms.<\/p>\n

Live Action News previously documented<\/a> in detail how Danco and the FDA always understood<\/a>\u00a0that emergency rooms would be necessary<\/a> to treat abortion pill clients, even as the FDA allowed for the expansion of \u201cself-managed\u201d and \u201cmail-order\u201d abortion \u2014 something the Plaintiffs alluded to when they wrote: “The FDA has consistently identified emergency medical care<\/a>\u2014including State emergency medical care\u2014as the backstop for abortion drug complications. Its current label<\/a> directs women to emergency rooms if one of many adverse complications arise.”<\/p>\n

“The FDA has acted unlawfully,” the three states allege. “Now, the State Plaintiffs ask the Court to protect women by holding unlawful, staying the effective date of, setting aside, and vacating the FDA\u2019s actions to eviscerate crucial safeguards for those who undergo this dangerous drug regimen.”<\/p>\n

A “no-test protocol” can lead to increased rates of incomplete abortion<\/strong><\/p>\n

“The complications of abortion drugs increase as the baby\u2019s gestational age increases. One study found that, after nine weeks\u2019 gestation, almost four times as many women and girls experience an incomplete abortion<\/strong>, nearly twice as many suffer an infection, and over six times as many women and girls require surgical abortion after consuming the abortion drugs than at before nine weeks gestation,” reads the states’ complaint (emphasis added).<\/p>\n

Live Action News has\u00a0previously<\/a>\u00a0documented how the abortion industry\u00a0used<\/a> the COVID-19 pandemic to lift the in-person safety regulations on mifepristone, expanding access to it. In fact, well before<\/a>\u00a0the pandemic, the abortion industry\u00a0expanded<\/a>\u00a0its abortion pill clinical trials and then\u00a0rolled out<\/a>\u00a0a \u201cno test<\/a>\u201d abortion pill\u00a0protocol<\/a>\u00a0\u2014 eliminating important testing, bloodwork, and ultrasounds, which\u00a0some medical professionals assert<\/a>\u00a0endangers women.<\/p>\n

“The risks of harm to women are also exacerbated without follow-up visits, during which a doctor can assess whether a mother is suffering complications from the older gestational age of her baby,” the lawsuit added.<\/p>\n

Danco Laboratories, the drug’s manufacturer, claims online<\/a> that “Mifeprex*(mifepristone) is 93-98% effective for safely ending pregnancy (2-7% of women will need a surgical procedure to end the pregnancy or stop heavy bleeding).”<\/p>\n

In addition, Planned Parenthood’s national website<\/a> is clear<\/a> that \u201cAt 10-11 weeks pregnant” the abortion pill regimen only “works about 87% of the time.\u201d<\/p>\n

\"Danco

Danco abortion pill efficacy rates accessed 10182024<\/p><\/div>\n

Despite this fact, Big Abortion now prescribes<\/a> the abortion pill past the FDA approved<\/a> 10-week limit<\/a>.<\/p>\n

In addition, one Planned Parenthood facility admitted online<\/a> that \u201cAfter 11 weeks, there\u2019s a bigger chance that the abortion pills won\u2019t work and an increased chance of stronger bleeding or cramps.\u201d\u00a0Planned Parenthood\u2019s website says little about the effectiveness<\/a>\u00a0of the abortion pill at 12 weeks.<\/p>\n

\"Planned

Planned Parenthood New England warns abortion pills less likely to work after 11 weeks<\/p><\/div>\n

A “no-test” protocol also increases risks for Rh-negative women<\/strong><\/p>\n

“Abortion drugs present heightened risks for women with an Rh-negative blood type. If these women are not administered Rhogam at the time of their chemical abortion, they may experience isoimmunization, which threatens their ability to have future successful pregnancies,” the lawsuit claims.<\/p>\n

The American College of Obstetricians and Gynecologists (ACOG) changed<\/a> its recommendations to coincide exactly with the abortion industry\u2019s attempts to expand access to the abortion pill. Then, just weeks ago, ACOG once again co-signed with Big Abortion<\/a> against the health of women, regarding when to administer RhoGAM.<\/p>\n

OBGYN Dr. Ingrid Skop warned this move is dangerous, explaining<\/a> to Live Action News (emphasis added), \u201cEvaluation of Rh status and provision of Rhogam, if indicated, has long been the standard of care for early pregnancy loss, including elective induced abortion. This action will prevent a mother from mounting an immune response to her future unborn children<\/em><\/strong>. If Rhogam is\u00a0not<\/em>\u00a0given and isoimmunization occurs, 14% of untreated infants will be stillborn and half will suffer neonatal death or brain injury.\u201d<\/p>\n

The abortion industry is failing to care for women<\/strong><\/p>\n

The abortion industry has shifted responsibility<\/a> for abortion pill clients from abortion providers to overcrowded emergency rooms. In addition, bad actors<\/a> inside the abortion industry continue to flout the FDA\u2019s REMS by ignoring the approved gestational limits<\/a>\u00a0or\u00a0approved protocols<\/a>\u00a0for prescribing the abortion pill; leaving women to\u00a0deal with ectopic pregnancies<\/a>\u00a0by not ruling them out prior to prescribing the drug; promoting an\u00a0unapproved one-drug regimen<\/a>\u00a0of misoprostol only; dispensing\u00a0abortion drugs<\/a>\u00a0to women who are not yet pregnant; and\u00a0encouraging women<\/a>\u00a0to present to the emergency room and claim a natural miscarriage when experiencing abortion pill related complications.<\/p>\n

This flouting of the FDA REMS safety requirements may have prompted well-known late term abortionist Warren Hern to recently question<\/a> the care women receive when they are sold abortion pills by asking the obvious: Who is doing \u201cfollow-up exam[s]\u201d and \u201ctak[ing] care of\u2026 a complication?\u201d<\/p>\n

Due to a lack of care and the so-called ‘no-test<\/a>‘ abortion pill protocol which often fails to utilize ultrasounds, run labs<\/a>, or rule out potentially dangerous ectopic pregnancies<\/a>, medical doctors are now alerting ER professionals<\/a> that they may see undiagnosed ectopic pregnancies after abortion pill use. This is due to a reckless lack of concern<\/a> abortion providers have in relying on the woman, showing they remain pregnant after taking the deadly drug regimen rather than ruling ectopics out first.<\/p>\n

Today, Google Reviews<\/a> from clients purchasing abortion pills at various facilities suggest that some prescribers of the drug are failing to properly treat women, resulting in them seeking emergency medical assistance ERs.<\/p>\n

“The FDA\u2019s actions force States to divert resources to investigate and address the harms that this lawbreaking will inflict on women, children, and the public interest…The FDA\u2019s actions thus ‘intrude on state governmental functions[,]’…and hobble States\u2019 efforts to protect health and safety,” wrote Missouri, Kansas, and Idaho.<\/p>\n

Urge Walmart, Costco, Kroger, and other major chains to resist pressure to dispense the abortion pill<\/i><\/b><\/i><\/b><\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

Missouri, Kansas, and Idaho have filed an amended lawsuit in federal court, claiming their “sovereign” interest in “protecting… citizens” was violated by the Food and Drug Administration’s (FDA) decision to expand access to the abortion pill to mail-order dispensing. The lawsuit, State of Missouri; State of Kansas; State of Idaho v. FDA, filed on October […]<\/p>\n","protected":false},"author":303,"featured_media":315186,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false},"categories":[15,9459],"tags":[],"yoast_head":"\nThree states sue FDA for 'disregarding the health and safety' of women with abortion pill expansion<\/title>\n<meta name=\"description\" content=\"The FDA lacks legal authority to permit what federal law expressly prohibits, the states argue, referring to sending abortion drugs by mail.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/archive.liveaction.org\/news\/three-states-sue-fda-abortion-pill-expansion\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Three states sue FDA for 'disregarding the 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