This story by Jennifer Shutt appeared on Colorado Newsline on February 12, 2023.
Attorneys general representing nearly two dozen Republican states are backing a lawsuit that would remove the abortion pill from throughout the United States after more than two decades, eliminating the option even in states where abortion access remains legal.
The state of Missouri filed its own brief in the case Friday, while Mississippi Attorney General Lynn Fitch filed a brief on behalf of her state as well as Alabama, Alaska, Arkansas, Florida, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Montana, Nebraska, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah and Wyoming.
“The serious nature of the FDA’s unlawful actions, and the agency’s decision to invite lawbreaking by private parties and government actors across the country, favors broad relief,” the 22 Republican attorneys general wrote in the multi-state brief.
“The FDA and the Administration as a whole have no intention to respect the Constitution, the Supreme Court, or the democratic process when it comes to abortion. This Court’s decisive action is warranted,” they added.
The case, Alliance for Hippocratic Medicine v U.S. Food and Drug Administration, was originally filed in the U.S. District Court for the North District of Texas in mid-November by Alliance Defending Freedom, an anti-abortion legal organization.
The lawsuit argues, on behalf of four anti-abortion medical organizations and four anti-abortion physicians, that the U.S. Food and Drug Administration exceeded its authority when it approved ‘mifepristone’ to end pregnancies in 2000.
The prescription medication was originally approved for up to seven weeks into a pregnancy but is now approved for up to 10. It is used as part of a two-drug regimen that includes ‘misoprostol’ as the second pharmaceutical.
The abortion pill, mifepristone, is legal at the federal level, though several GOP states have laws in place that restrict abortion to less than 10 weeks, setting up a dispute between state law and the federal government’s jurisdiction to approve pharmaceuticals.
If the judge doesn’t pull the abortion pill entirely, the anti-abortion organizations’ lawsuit argues to move the dosage and prescribing process back to how it worked before 2016, when the FDA made changes to its approval.
The U.S. Justice Department argued in its court filing the anti-abortion groups’ lawsuit “is extraordinary and unprecedented.”
“Plaintiffs have pointed to no case, and the government has been unable to locate any example, where a court has second-guessed FDA’s safety and efficacy determination and ordered a widely available FDA-approved drug to be removed from the market — much less an example that includes a two-decade delay,” wrote attorneys for the U.S. Justice Department.
The Republican attorneys general said in their Friday briefs that “while the FDA is authorized to evaluate new drugs for safety and effectiveness, States are primarily responsible for protecting the health and welfare of their citizens.”
“Many States, including several amici here, have thus enacted laws to regulate abortion-inducing drugs and account for their dangers,” they wrote.
“Such laws can include in-person examination and dispensing requirements, qualification requirements for prescribers, mandates for informed consent, bans on distribution by mailing, or some combination of these and other safety limitations.”
The 22 attorneys general argued in their brief that the FDA’s approval of the abortion bill has two legal flaws.
The first is that it “defies the agency’s own regulations” since the section the FDA first approved the drug under, Subpart H, “does not permit the agency to greenlight elective abortions on a wide scale.”
The second, they wrote, is that allowing abortion medication to be sent via the mail is in direct contrast to a federal law that prohibits “using the mail to send or receive abortion-inducing drugs such as mifepristone.”
Missouri Attorney General Andrew Bailey, in a separate brief, wrote that he agreed with the arguments made in the original lawsuit and by his fellow Republican attorneys general, but that he wanted to highlight facts “recently uncovered in litigation.”
Missouri’s brief alleges that medication abortions, which have been used for more than two decades, “are much riskier than surgical abortions” and that “there is a lack of substantial information that the drugs will have the effect they purport.”
Accessing abortions
Dr. Jamila Perritt, president & CEO for Physicians for Reproductive Health, said during a press briefing this week on the court case that abortion medication is safe and effective, and that “when abortion is more difficult to access, we know that this means abortion gets pushed later and later into pregnancy as folks try to navigate these barriers.”
If the judge in the case were to pull mifepristone, Perritt said, people in states where abortion is still legal would be able to access abortion using misoprostol alone since “there are approved regimens of managing medication abortion using only misoprostol.”
Perritt added that “while it is equally safe … dosage and timing to completion of the abortion varies if mifepristone is not added to the equation.”
Patients in legal states, such as Colorado, would also still have access to procedural abortion, Perritt noted.
Reproductive health experts have said the suit is based on flawed evidence, selected studies and anecdotes.
Dr. Iffath Abbasi Hoskins, president of the American College of Obstetricians and Gynecologists, said in a written statement in January that “restricting access to mifepristone interferes with the ability of obstetrician–gynecologists and other clinicians to deliver the highest-quality evidence-based care for their patients.”
“Since 2020, continued usage of mifepristone for abortion care without the in-person dispensing requirement has been shown to be safe and effective,” she wrote when the FDA announced it would allow commercial pharmacies to fill prescriptions for mifepristone.
The judge in the lawsuit, Trump appointee Matthew Joseph Kacsmaryk, could rule on whether to pull mifepristone from the market as soon as this month.
Any ruling is likely to be appealed to the conservative-leaning 5th U.S. Circuit Court of Appeals and could eventually find itself in the U.S. Supreme Court.