Texas hearing in mifepristone FDA approval case
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A federal judge in Texas heard arguments Wednesday in a court case that could force a major abortion pill off the market nationwide.
U.S. District Judge Matthew Kacsmaryk gave both sides two hours to make their arguments in a case that could dramatically alter access to medication abortion, which makes up well over half of all abortions, by targeting the decadeslong FDA approval of the drug mifepristone.
Kacsmaryk did not make a decision during the hearing in Amarillo, Texas, but said a ruling would come “as soon as possible.”
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What does the lawsuit claim?
The lawsuit was filed in November by a coalition called the Alliance for Hippocratic Medicine, which is led by the conservative legal advocacy organization Alliance Defending Freedom. The coalition argues mifepristone comes with medical risks and should be pulled from the market.
The FDA approved mifepristone for medication abortion in 2000. The U.S. Department of Health and Human Services, the American Medical Association and the American College of Obstetricians and Gynecologists call mifepristone a safe and effective abortion medication and component of treatment and management for early pregnancy loss or miscarriage.
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Both sides of lawsuit make first arguments
During a 90-minute presentation to the court, attorneys for the Alliance Defending Freedom asked Kacsmaryk to issue an immediate order that would revoke mifepristone’s FDA approval.
The FDA reviewed mifepristone under its accelerated approval program, which has been used to expedite the approval process for drugs for cancer and other “serious or life-threatening diseases.” The plaintiffs argued pregnancy is not a disease and the drug should not have been considered for accelerated approval.
But attorneys representing the FDA countered by saying the definition of disease can include “medical conditions” like pregnancies, which can be serious and life-threatening in some cases.
When asked by Kacsmaryk about prior cases, the plaintiffs acknowledged there is no precedent of a court removing an FDA-approved drug after many years on the market.
In its argument, U.S. Department of Justice attorneys representing the FDA highlighted the long history of mifepristone as a safe and effective drug, saying 99.9% of people who take it experience no adverse effects. They also argued the FDA has the authority to regulate drugs and evaluate their safety. Granting the injunction, they said, would undermine the agency’s authority and the regulatory process.
Kacsmaryk seemed to consider options that would limit, but not completely bar, access to mifepristone. He asked the plaintiff’s lawyers if they were suggesting the court reverse the FDA’s original approval of mifepristone in 2000 or subsequent regulatory changes to the drug in 2016, 2019 and 2021.
For example, in 2021, the FDA lifted a rule requiring mifepristone be dispensed in person at certified clinics, allowing people to get the drug by mail or through telehealth services.
Ruling could devastate medication abortion access
If the judge rules in favor of the anti-abortion coalition, mifepristone could be effectively banned nationwide, creating what abortion access advocates have called severe consequences on people’s ability to access critical abortion and miscarriage care.
The ruling could bar healthcare providers from prescribing mifepristone even in states where abortion is legal. In-clinic, procedural abortion care would not be affected by the ruling.
“The stakes are very high and the impacts could be devastating, resulting in a nationwide ban of mifeprisone,” Jenny Ma, senior counsel at the Center for Reproductive Rights, said in a February interview. “That’s people in New York, in California, people who thought their abortion rights were protected in their states.”
The ruling will affect medication abortion access for about 64.5 million women of reproductive age nationwide, according to an analysis released Feb. 10 by NARAL Pro-Choice America. Low-income communities, rural communities and people of color will be disproportionately impacted by the reversal, experts say.
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Medication abortion lawsuit hearing made public
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The hearing became public knowledge Monday after media outlets raised concerns about the major court case proceeding without the level of openness typically expected of federal court proceedings.
The Washington Post first revealed the hearing was set for Wednesday, reporting Kacsmaryk delayed putting the date on the public docket to minimize possible threats and protests over the closely watched case. Kacsmaryk also asked attorneys not to publicly disclose details of the plans for the hearing, according to the newspaper.
Hearings are typically quickly placed on public court dockets, and delaying public notice is unusual. A coalition of media outlets, including the Amarillo Globe-News, part of the USA TODAY Network, filed a motion protesting the delay in public notice.
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Several legal experts have told USA TODAY the lawsuit lacks legal and scientific standing but have raised concerns that Judge Kacsmaryk may still rule on the side of the plaintiffs, striking down FDA approval of mifepristone. Typically, plaintiffs do not know who their judge will be when filing a lawsuit. But in this case, the complaint was filed in Amarillo, Texas, where the only judge is Kacsmaryk, an appointee of former President Donald Trump who has a history of conservative rulings.
Legal experts say this was no accident and part of a strategy to decimate medication abortion access.
“Clearly, overturning Roe v. Wade was not the end game for the anti-abortion movement,” Lorie Chaiten, senior staff attorney at the ACLU’s Reproductive Freedom Project, told USA Today in February.
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What happens next?
While the FDA may choose to restart the approval process, this could take years.
The case will likely be appealed, landing it in the right-leaning Fifth Circuit Court of Appeals. If the case is appealed again in federal circuit court, it may arrive before the U.S. Supreme Court.
If the judge rules on the side of the anti-abortion coalition, U.S. Department of Justice attorneys representing the FDA would also likely seek an emergency stay to stop the ruling from taking effect while the case proceeds.
Meanwhile, providers are rushing in preparation to shift to misoprostol-only protocols for medication abortions, and clinics have already begun ordering more misoprostol supplies.
Health experts say a misoprostol-only protocol for medication abortions is a safe and effective alternative to the two-step process using both mifepristone and misoprostol that is used in the U.S. While misoprostol has been used on its own for years for abortions around the world, studies show it is less effective than the two-step regimen.
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Texas lawsuit may have broader effect on FDA approval process
If the court rules for the plaintiffs some experts are concerned it could also inject a degree of uncertainty — and politics — into the FDA approval process.
Scott Lassman, an attorney who specializes in FDA regulation, said there have been times when courts have struck down drug approvals in cases where one company is seeking to market a generic drug over a brand name. But, he said, he isn’t aware of a situation in which a federal court has reversed an approval based on the FDA’s scientific analysis.
“I typically tell my clients, if you’re looking to sue the FDA, and the FDA is able to frame it as a scientific issue, you’re gonna lose,” Lassman said. “This is a special case, obviously, but anytime you get this kind of precedent it can have unintended consequences. So it’s something I would definitely be worried about.”
— John Fritze, USA TODAY
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Contact Christine Fernando at cfernando@usatoday.com or follow her on Twitter at @christinetfern.