Federal Judge Halts FDA’s Abortion Pill Approval

Federal Judge Halts FDA’s Abortion Pill Approval

— But competing ruling orders agency not to alter status quo

by
Shannon Firth, Washington Correspondent, MedPage Today

A federal judge in Texas on Friday suspended the FDA’s 2000 approval of mifepristone (Mifeprex) — the most commonly used drug for medication abortion nationwide.

Importantly, Judge Matthew Kacsmaryk, of the U.S. District Court for the Northern District of Texas, also stayed the effective date of his order for 7 days to allow the federal government time to appeal the ruling.

Meanwhile, in the Pacific Northwest, Judge Thomas Rice of the U.S. District Court for the Eastern District of Washington, who was nominated by President Obama, issued a competing decision nearly at the same time granting — in part — a preliminary injunction in another case that would prevent the FDA from “altering the status quo and rights as it relates to the availability of mifepristone.”

Conflicting decisions on such issues often end up at the Supreme Court.

In Kacsmaryk’s decision, he also stayed “all subsequent challenged actions” by the FDA, including the agency’s April 2019 approval of a generic version of mifepristone; the March 2016 removal of certain post-approval safety restrictions; and the April 2021 decision to “exercise enforcement discretion” and allow mifepristone to be dispensed by mail.

The decision, if enacted, amounts to a nationwide ban that would block access to those seeking medication abortion even in Democratic-led states, where abortion is still broadly legal.

Mifepristone, used in more than half of all abortions nationally, is one half of a two-drug regimen approved by the FDA to end a pregnancy without surgery. Misoprostol, the other drug in the regimen, carries other indications and was not targeted in the Texas lawsuit. Mifepristone first received FDA approval in September 2000 for terminating a pregnancy through 7 weeks’ gestation, which was later expanded to 10 weeks’ gestation in 2016, according to the agency’s website.

Physician Groups Weigh In

Iffath Abbasi Hoskins, MD, president of the American College of Obstetricians and Gynecologists (ACOG), and Maureen Phipps, MD, MPH, chief executive officer of ACOG, condemned the Texas judge’s actions as “decidedly misrepresent[ing] medication abortion care.”

“Mifepristone has been used safely and effectively for medication abortion for more than two decades. That safety and efficacy is backed up by robust, evidence-based, clinical data and its observed use by millions of people with support from clinicians, including obstetrician–gynecologists. Regardless of the opinion of one judge on this matter, mifepristone is a safe, effective part of comprehensive health care,” Hoskins and Phipps said in a press release.

“Today’s decision is clearly a transparent effort to make it harder for people to access medication abortion. It will force people to turn to other means of accessing abortion care; it will force clinicians to prescribe less safe, less effective regimens for medication abortion; and it will impose greater harm on those who already struggle to access needed reproductive health care, thus increasing health inequities,” they added.

Jamila Perritt, MD, MPH, president and CEO of Physicians for Reproductive Health, also expressed her concern. “The decision attempting to stay the approval of an FDA-approved medication that is safe and effective from the market two decades after its approval is politically based, not grounded in medicine or science,” she said in a statement. “This would have far-reaching implications for access to other medications people rely on. We should all be alarmed.”

“Should Judge Kacsmaryk have his way and mifepristone is removed from the market entirely, it will have many consequences for the provision of abortion care and for the lives of those that need it. Many people will be forced to carry pregnancies to term — whether they want to or not. This is particularly harmful given the clear evidence showing that when an individual is denied an abortion that they seek, their mental health, emotional health and financial health all suffer. Moreover, the health and wellbeing of the children that individuals already have is negatively impacted. These consequences will impact generations to come.”

The American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), an anti-abortion group, praised the decision, calling it “a victory for all our patients.”

“The FDA began a pattern of prioritizing the interests of the abortion industry over the health and safety of our nation’s women and girls 23 years ago by illegally and recklessly approving dangerous drugs for use in chemical abortions, and then continuing to remove safeguards for women,” the group said in a statement. “Today’s ruling places women’s welfare back at the forefront of the conversation on this issue. Our patients deserve excellent healthcare and fully informed consent; this decision helps ensure they receive that.”

Background on the Texas Case

In the Texas case, Alliance for Hippocratic Medicine et al v. U.S. Food and Drug Administration et al, the plaintiffs requested a preliminary injunction of the FDA’s approval of mifepristone, arguing that the drug’s safety had never been appropriately vetted and that the medication should not have been made available via telehealth during the pandemic.

The Alliance for Hippocratic Medicine, a newly formed anti-abortion advocacy group, argued that the FDA approved the drug “illegally.”

“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,” the group noted on the Alliance Defending Freedom website. (The Alliance Defending Freedom represents the Alliance for Hippocratic Medicine.)

During a 4-hour hearing in March, Justice Department attorney Julie Straus Harris argued that “[a]n injunction would cause significant public harm.” She stressed that a ruling in support of the Alliance for Hippocratic Medicine would undermine the public’s trust in the FDA and worsen the pressures on surgical abortion clinics, which are already over-burdened due to an influx of patients from states that have closed their clinics following Roe v. Wade‘s reversal last year by the Supreme Court, noted Reuters.

Kacsmaryk, a conservative federal judge, was nominated by President Trump and has ties to the religious right. Prior to his role on the federal bench, he worked for First Liberty Institute, a conservative legal group.

On June 24, 2022, the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization overturned Roe v. Wade, returning the decision over abortion access to the states and thrusting the issue of access to medication abortion further into the spotlight.

As a direct result of the Dobbs decision, 12 states now have a “near-total” ban abortion, according to the Guttmacher Institute, while clinicians in Wisconsin are unable to provide abortion due to legal uncertainties. In addition, 15 states restrict access to medication abortion, including North Dakota, where there are currently no abortion providers, according to the institute.

“The FDA approved Mifeprex more than 20 years ago based on a thorough and comprehensive review of the scientific evidence presented and determined that it was safe and effective for its indicated use. As of 2016, it can be used for medical termination of pregnancy up to 70 days of gestation,” according to the FDA’s website.

The agency also noted that it has completed “periodic reviews” of postmarketing data on mifepristone and its approved generics and “have not identified any new safety concerns with the use of mifepristone for medical termination of pregnancy through 70 days’ gestation.”

The medication protocol of mifepristone followed by misoprostol successfully terminates pregnancies 99.6% of the time, according to the Kaiser Family Foundation, with major complications occurring in 0.4% of cases and deaths in 0.00064% of cases.

Misoprostol alone has been deemed in studies “safe and effective” for terminating a pregnancy; however, it is somewhat less effective and the two-drug regimen has become standard of care.

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    Shannon Firth has been reporting on health policy as MedPage Today’s Washington correspondent since 2014. She is also a member of the site’s Enterprise & Investigative Reporting team. Follow

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