Crockett Leads Letter Calling on White House To Aggressively Act To Protect Reproductive Care And FDA’s Drug Approval Authority
WASHINGTON – Congresswoman Jasmine Crockett (TX-30) released the following statement following the decision in Alliance for Hippocratic Medicine v. FDA.
“While conservatives love to talk-the-talk on protecting individuals’ constitutional rights, they continue to use backdoor, coordinated legal strategies to try and rip away those rights when they pertain to women. This decision will not only impact millions of Texas women living under our oppressive and harmful state government, but countless other women across our country.
“The medication at the center of this case, Mifepristone, was approved by the Federal Drug Administration (FDA) in 2000 and has been available for safe use longer than some of my staff have been alive. Now, following the Supreme Court’s decision in Dobbs v. Jackson Women's Health Org., extremists have taken up the mantle to tell women what medication they can and cannot take as a further attack on reproductive healthcare. Have we lost faith in women, doctors, nurses, healthcare professionals, the FDA, and others whose counsel is contrary to this decision? Or have political priorities and inflammatory legal rhetoric taken the front seat over the health and well-being of our nation’s people? While this legally dubious decision remains under a seven-day stay, I fear for the larger implications this decision will have in bringing mifepristone before this radical conservative Supreme Court.
"Given the stakes arising from this misguided decision, I have drafted a letter to President Biden signed by forty of my fellow House Democrats calling on the administration to (i) aggressively act to protect women’s access to medication abortion, (ii) defend the authority of the FDA, (iii) meet with the pharmaceutical industry to discuss the possible ramifications of an unfavorable decision regarding market access to medication abortions and the implications it will have on the U.S. Food and Drug Administration (“FDA”) drug review process at large and (iv) continue fighting these baseless legal challenges to reproductive rights.
"This decision serves as a reminder of the necessity for Congress to act to restore our hard-won reproductive rights in all 50 states. This fight is far from over - and we will not stop until our reproductive freedoms are enshrined in law."
A copy of Rep. Crockett's letter to the Biden Administration can be found in the attachment to this email, with text appearing below.
Dear President Biden:
As you know, last year the U.S. Supreme Court made the unprecedented move overturning the constitutional right to an abortion established in Roe v. Wade.[1] Now, recent federal lawsuits[2] threaten to further turn back the clock and restrict access to abortion and life-saving reproductive health care in states where it remains legal. Of significant concern is the pending decision arising from Alliance for Hippocratic Medicine v. FDA.[3] The plaintiff organization in the case, a collection of staunch anti-abortion groups, established itself two months after the Dobbs decision and located its place of incorporation in Amarillo, Texas.[4] Three months after incorporating, and using a coordinated national strategy, the organization deliberately forum shopped the case in order to argue before a judge who has previously ruled against women’s rights in the Northern District of Texas in Amarillo—all with the goal of stripping away women’s bodily autonomy.
Given the grave threat this decision now poses on abortion-access nationwide, we call on your administration (i) to continue taking action to protect access to medication abortion, (ii) to defend the authority of the FDA, (iii) to meet with the pharmaceutical industry to discuss the possible ramifications of an unfavorable decision regarding market access to medication abortions and the implications it will have on the U.S. Food and Drug Administration (“FDA”) drug review process at large and (iv) continue fighting these baseless legal challenges to reproductive rights.
Unsurprisingly, the plaintiffs in Alliance for Hippocratic Medicine v. FDA grossly understated the severe health risks posed by pregnancy in their brief. They argue that pregnant individuals rarely face life-threatening complications and that nearly all go back to a normal routine without any kind of disability thereafter. [5] This lie stands contrary to scientific evidence and data.
Last month, the World Health Organization reported that “every day in 2020, almost 800 women died from preventable causes related to pregnancy and childbirth.”[6] More appalling is the maternal mortality rates in the United States—23.8 deaths per 100,000 live births.[7] To put this in perspective, the U.S. mortality rate was three times that of individual countries’ rates like France, Canada, United Kingdom, Australia, Switzerland, Sweden, Germany, Netherlands, Norway, and New Zealand.[8] Moreover, U.S. maternal mortality rates disproportionately impact minority women. In October 2022, the U.S. Government Accountability Office reported pregnancy-related deaths for Black and Hispanic women increased over 50% between 2019 to 2021, while white women’s pregnancy-related deaths increased by 45% during that same period.[9] Leading medical organizations like the American College of Obstetricians and Gynecologists and the American Medical Association have repeatedly expressed concern that lack of access to medication abortion will only worsen the country’s unacceptable maternal mortality crisis.[10] In the state where the case is being adjudicated, a report authored by Texas’s own Department of Health Services stated that severe medical complications from pregnancy, like obstetric hemorrhage, non-cerebral thrombotic embolisms, cardiovascular conditions, and infection have led to an increase in maternal mortality rates in the state.[11]
For over two decades, women have used mifepristone—the drug at the center of the Texas case—to safely end a pregnancy and treat early pregnancy loss and miscarriage.[12] Use of mifepristone, or medication abortions, account for over 50% of all abortions performed in the United States.[13] FDA conducted a thorough and comprehensive review of this drug when it was approved in 2000,[14] and also updated the Risk Evaluation and Mitigation Strategy (“REMS”)[15] in 2011, 2016, 2019, and 2021—with each review having been based on new science and established data—which overwhelmingly dispels these unfounded anti-abortion groups’ concerns regarding the safety of this medication. Indeed, even a robust audit by the Government Accountability Office found that the FDA’s initial approval of mifepristone was consistent with other medication reviews and approvals.[16]
Nevertheless, the consequences at risk from the decision in this case also pose significant threats to the broader FDA drug approval process. For instance, should the judge wrongfully rule that FDA acted beyond its authority, the case would then open the floodgates for actors to sue to block the approval of new or even existing drugs, particularly those which Republican-led states are beginning to deem “controversial.”[17] Indeed, as law scholars stated in their amicus brief, “overriding FDA’s safety and efficacy determination and forcing FDA to withdraw a longstanding drug approval would profoundly undermine the statutory and regulatory framework underpinning the approval of new drugs, thereby threatening patient access to therapeutics and chilling industry research and development.”[18] This may include, for example, contraception as well as hormone therapies for gender-affirming care.[19] Such concerns are not unfounded. Due to the various state-led legislation aim at restricting access to medication abortion across the country, at least one company initially stated it would not dispense medication abortion prescriptions in certain states “out of an abundance of caution amid a shifting policy landscape.”[20] Although it later clarified that it would continue dispersing the medication “in any jurisdiction where it is legally permissible to do so,”[21] we in Congress are deeply concerned that the country’s legal patchwork of abortion restrictions—as well as the potential decision likely to arise from Alliance for Hippocratic Medicine—will have a landslide effect on other pharmaceutical companies in decreasing access to medication abortion, contraceptive care, and other medications nationwide, in addition to a chill in investments in pharmaceutical research.[22] Thus, it is imperative that your administration tackle this lack of access with the same level of urgency as seen with other supply chain crises. Indeed, the result of such decisions by pharmacies and the pharmaceutical industry at large would have catastrophic effects not only on women’s health but also the economy.
Accordingly, as President of the United States, it is vital that you direct your administration to use all the tools at your disposal to protect access to abortion and reproductive healthcare. This includes federal agencies providing guidance on federal rights of women to access out-of-state abortions without threat of criminal and civil penalties, as well as examining the use of federal resources unavailable in women’s home states for transportation, medical treatment, and other resources related to accessing legal abortions and reproductive care.
Moreover, we urge your administration to meet with pharmaceutical stakeholders as soon as possible to mitigate both the politicization of lawsuits regarding medication access and healthcare and the threats that cases like this pose to pharmaceutical business decisions nationwide.
Thank you for your attention to this important matter.
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Congresswoman Jasmine Crockett represents portions of Dallas and Tarrant Counties, with the cities of Dallas, Grand Prairie, DeSoto, Cedar Hill, Lancaster, Duncanville, Glenn Heights, Hutchins, Wilmer, Arlington, Ovilla, and Seagoville.