{"id":290711,"date":"2023-05-11T12:39:18","date_gmt":"2023-05-11T17:39:18","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=290711"},"modified":"2023-05-10T14:30:35","modified_gmt":"2023-05-10T19:30:35","slug":"whole-womans-health-alliance-lawsuit-fda","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/whole-womans-health-alliance-lawsuit-fda\/","title":{"rendered":"Whole Woman’s Health Alliance files lawsuit against FDA’s abortion pill safety requirements"},"content":{"rendered":"
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Whole Woman’s Health Alliance (WWHA) has filed a lawsuit<\/a> against the U.S. Food and Drug Administration (FDA) requesting “declaratory and injunctive relief” and asking the District Court for the Western District of Virginia to order the FDA to remove the abortion pill from under REMS safety requirements due to “chaos surrounding mifepristone.”<\/p>\n

The lawsuit also asked the court to enjoin the government agency from “altering the availability of mifepristone under the January 2023 REMS, to ensure some modicum of certainty and continued patient access to a safe, effective medication that has been repeatedly targeted simply because of its association with abortion.” In addition, the lawsuit is asking the Court to “[e]njoin Defendants… from taking any action under the REMS against any providers in Virginia, Montana, or Kansas.”<\/p>\n

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Whole Woman’s Health Alliance (WWHA) v FDA mifepristone abortion pill lawsuit<\/p><\/div>\n

WWH lawsuit follows additional court cases<\/strong><\/p>\n

Whole Woman’s Health Alliance’s (WWHA) lawsuit follows a case filed<\/a> by GenBioPro (GBP)<\/a>, the generic abortion pill manufacturer, before the U.S. District Court for Maryland. GenBioPro is asking the court to preemptively block the FDA from \u2018upending\u2019 the generic abortion pill company\u2019s 2019 approval to distribute mifepristone.<\/p>\n

It also follows\u00a0Alliance for Hippocratic Medicine (AHM) v. FDA<\/a>\u00a0<\/em>as well as\u00a0Washington State v. FDA<\/a>\u00a0\u2014 <\/em>surrounding legitimacy of the FDA’s approval process of the drug.<\/p>\n

The AHM lawsuit<\/a>\u00a0centers on\u00a0a\u00a0ruling<\/a>\u00a0by U.S. District Court Judge Matthew J. Kacsmaryk which\u00a0suspended<\/a>\u00a0the FDA\u2019s 2000 approval of the abortion pill mifepristone, and all decisions made thereafter. The case was appealed but a temporary stay<\/a> has been\u00a0issued<\/a> by the Supreme Court until the case can be heard before the full Fifth Circuit Court later this month.<\/p>\n

The Washington State lawsuit<\/a>,\u00a0filed\u00a0by pro-abortion plaintiffs and\u00a0impacting<\/a>\u00a0a handful of states, is also requesting that the Court remove the abortion pill from the FDA\u2019s REMS safety system. However, before hearing the merits of the full request, U.S. District Judge Thomas O. Rice granted a preliminary injunction to\u00a0bar the FDA<\/a>\u00a0from \u201caltering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. \u00a7 355-1 in Plaintiff States.\u201d<\/p>\n

The conflicting lawsuits prompted WWHA to write, “Plaintiffs\u2014independent abortion providers with limited resources in hostile states\u2014are caught in the middle of this maelstrom. They provide care in states that are party to neither case and are thus in a particularly precarious and uncertain position.”<\/p>\n

“There is no reason that providers at Plaintiffs\u2019 clinics, who are not party to the Washington case, should have to be subject to these same risks from being certified prescribers,” WWHA added.<\/p>\n

WWHA targets the FDA REMS<\/strong><\/p>\n

Whole Woman’s Health Alliance (WWHA) claimed that the FDA “has overregulated mifepristone in ways that are unjustified and discriminatory.” They called the FDA’s decision to place the dangerous drug under its REMS safety requirement “irrational” despite the fact that the REMS is used on a limited number of drugs which need additional monitoring.<\/p>\n

“From the very beginning, FDA has overregulated mifepristone in ways that are unjustified and discriminatory… These restrictions are already irrational, but in light of the recent chaos surrounding mifepristone, they have also become intolerable and incompatible with Plaintiffs\u2019 ability to meet the needs of their patients,” the lawsuit claimed.<\/p>\n

“A ‘Risk Evaluation and Mitigation Strategy’ (‘REMS’) is an unusual overlay of requirements, far outside of the norm, that FDA can choose to impose only when ‘necessary to ensure that the benefits of the drug outweigh the risks of the drug,'” WWHA wrote, failing to mention that the drug was placed under the REMS<\/a> following a number of deaths.<\/p>\n

“The most burdensome type of REMS is ‘Elements to Assure Safe Use’ (‘ETASU’), which FDA imposes only if medically necessary due to a drug\u2019s ‘inherent toxicity or potential harmfulness,'” the lawsuit added.<\/p>\n

“FDA reevaluated<\/a> the provisions of the mifepristone REMS in 2016, and again in 2019, 2021, and 2023, but it has continually decided to reimpose the REMS despite longstanding objections from the medical community and its own review of the data showing mifepristone\u2019s safety and efficacy,” WWHA claimed.<\/p>\n

The lawsuit bemoans the possibility that the REMS could be returned to a pre-2016<\/a> status should the decision in the AHM lawsuit be upheld in full or in part. This would allow for only in-person dispensing of the deadly drug regimen and eliminate the profitable<\/a> virtual, mail order and pharmacy dispensing of the drug.<\/p>\n

“First, reinstating the physician-only requirement for certified prescribers retracts the pool of qualified mifepristone providers. And it does so after years of incremental progress to build a network of advanced practice clinicians (including nurse practitioners, nurse midwives, and physician assistants) with the training and experience to provide this critical care,” WWHA wrote in its lawsuit.<\/p>\n

“Second, reinstating the REMS requirement that mifepristone be dispensed only in a clinic, medical office, or hospital\u2014and not via mail order pharmacy\u2014will eliminate abortion access for the large number of patients who have come to rely on direct to patient telehealth services, and destroy Plaintiffs\u2019 virtual care models for mifepristone,” the lawsuit added.<\/p>\n

WWHA then called the required patient agreement<\/a> “useless,” suggesting that signing the form\u00a0harmed women experiencing a miscarriage by “requiring them to make a false and potentially traumatizing attestation that they are ‘decid[ing]’ to ‘end [their] pregnancy’ when they are experiencing a pregnancy loss.” And yet, the abortion industry has made multiple efforts to conflate abortion (direct and intentional killing) and miscarriage (accidental and unintentional death) as no different.<\/p>\n

WWHA also claimed the patient agreement<\/a>, which has never had a privacy breach, would put abortion providers at potential risk by identifying “the provider to people who have access to the patient record, potentially including, for example, a patient\u2019s spouse, partner, or parent,” which could expose “providers and patients to threats of reprisal, especially in today\u2019s climate of hostility to abortion.”<\/p>\n

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Mifepristone Patient Agreement Form for abortion pill<\/p><\/div>\n

WWHA’s lawsuit makes it clear that the goal is to demedicalize and expand access to abortion: “Simply put, the 2023 REMS retains unnecessary and harmful dispensing and prescribing requirements that threaten patient and provider privacy and continue to put mifepristone out of reach despite its exemplary safety record. As one recent study of clinicians and administrators put it, although mifepristone is safe and effective, the REMS are the ‘linchpin of a cycle of stigmatization that continues to keep mifepristone out of primary care practice.'”<\/p>\n

WWHA claims abortion is ‘safe’ but pregnancy isn’t<\/strong><\/p>\n

Whole Woman’s Health Alliance (WWHA) and the other abortion plaintiffs extolled the alleged “safety” of mifepristone but pointed to pregnancy in general as stressful and often dangerous.<\/p>\n

“Each day a person remains pregnant means they continue to experience the symptoms, risks, and potential complications of pregnancy. Pregnancy\u2014even when uncomplicated\u2014stresses the body, causes physiological and anatomical changes, and affects every organ system,” WWHA lawsuit stated.<\/p>\n

“People who continue their pregnancies and give birth face significant risk in the United States\u2014in large part as a result of systemic discrimination and inequitable access to healthcare.\u00a0Pregnancy also has potentially long-term physical, emotional, and mental effects on a person who goes through childbirth, sometimes persisting well after birth,” the lawsuit added.<\/p>\n

The lawsuit then went on to cite the debunked<\/a> Turnaway Study: “Forced pregnancy and childbearing also have long-term impacts on a person\u2019s educational and economic futures, and their ability to shape their lives. People who are denied a wanted abortion are more likely to experience economic insecurity and raise their existing children in poverty. The financial impacts of being denied an abortion are as large as or larger than being evicted, losing health insurance, or being hospitalized.”<\/p>\n