- Nearly every state has picked sides in the legal battle over abortion pills, which continues as the U.S. District Court for the Northern District of Texas considers a major case that could overturn the Food and Drug Administration’s (FDA) approval of the drugs.
- Opponents to the pill argue that FDA lacks authority to authorize it, given that it was originally authorized in 2000 under accelerated approval regulations which forced the agency to categorize pregnancy as an “illness.”
- Other objections center on the drug’s negative impact on the health of women and a federal law that prohibits the mailing of abortion pills.
Dozens of organizations, companies and members of congress, along with nearly every state, have taken sides in the legal battle over abortion pills as the U.S. District Court for the Northern District of Texas considers the issue in a major case.
Over a dozen amicus briefs were filed in the Texas case, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA), on Feb. 10 alone, including one by a group of 22 Democratic attorneys general in support of the FDA and another filed by a group of 22 Republican attorney generals in support of the plaintiffs. Four medical organizations brought the original suit, which seeks to reverse the FDA’s 2000 approval of the drugs used in a chemical abortion, citing the FDA’s lack of authority to authorize the pill, the drug’s impact on the health of women and girls and a federal law that prohibits the mailing of abortion pills.
In 2000, when the FDA approved mifepristone, the first of two drugs used in a chemical abortion, it did so under accelerated approval regulations intended for drugs that “have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments,” forcing the agency to categorize pregnancy as an “illness,” according to the lawsuit.
“But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion,” the lawsuit contends. “In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs.”
The plaintiffs, and those who side with them, also raise concerns about impacts of the pill on the health and safety of women, taking issue with the FDA’s roll back of initial safety requirements, such as allowing prescriptions later in pregnancy in 2016 and ending in-person distribution requirements in 2021.
“Outside the regulated medical context, a person can obtain an abortion pill quite easily and then coerce a woman into taking it,” wrote GOP state attorneys general in their letter to CVS and Walgreens following the companies’ early January decision to start offering abortion pills.
In an effort to enforce the laws as written and protect women and children, I filed an amicus brief in a highly watched lawsuit against the FDA for their unlawful role in creating a regime of abortion by mail. pic.twitter.com/t9CWeZKkLD
— Attorney General Andrew Bailey (@AGAndrewBailey) February 13, 2023
Democratic attorneys general defended the drug’s safety in their own letter to CVS on Thursday, reassuring the company that their decision is “consistent with state and federal law.” Mifepristone and misoprostol have “extremely low” complication rates, and claims of coerced abortions resulting from their availability are “utterly false,” they wrote.
My office is leading a group of 22 AGs to defend and protect access to medication abortion in this country.
Medication abortion is safe and effective, and blocking access to it is a dangerous attack on reproductive freedom and public health.
— NY AG James (@NewYorkStateAG) February 10, 2023
Multiple amicus briefs supporting the plaintiffs also deal with safety concerns. The pro-life organization Human Coalition notes in its amicus brief filed Feb. 10 that there have been “1,048 hospitalizations, 604 blood transfusions, and 414 infections (including 71 severe infections)—with a total of 4,213 adverse events” reported since June 2022, adding that the reported data is “likely incomplete.”
“Despite the serious risks associated with mifepristone, the FDA only requires deaths to be reported,” the brief continues. “Physicians are not required to report other serious adverse events associated with the drug—reporting any other adverse event is voluntary.”
Another key issue highlighted in the case is a 1873 federal law, the Comstock Act, which prohibits the mailing of any “article or thing designed, adapted, or intended for producing abortion,” putting the FDA at risk of violating federal criminal statutes by authorizing mifepristone to be distributed via mail.
On Dec. 23, 2022, the Justice Department’s Office of Legal Counsel’s (OLC) issued an opinion interpreting the Comstock Act to allow the mailing of abortion pills, as long as the sender “does not intend that they be used unlawfully.”
In its amicus brief for the Texas case, the Ethics and Public Policy Center (EPPC) says the OLC has “no meaningful support” for this claim.
“OLC invokes rulings from a grand total of four circuit courts from the first half of the 20th century in support of its supposed ‘well-established, consensus interpretation,'” the EPPC brief states. “None of these cases that OLC cites stand for the proposition that the Comstock Act provisions bar the mailing of abortion drugs only when the sender intends that the drugs be used unlawfully.”
A Heritage Foundation report further explains that the OLC “never acknowledged its duty to adhere to Congress’ intended meaning.” Instead, it “started by searching outside the statute for a preferred meaning to impose upon it.”
Heritage Foundation Senior Legal Fellow Tom Jipping told the Daily Caller News Foundation that it’s “hard to tell” how many of these guidelines are actually intended as genuine policy steps.
The OFC opinion, he said, was “so badly reasoned” and ignored so many “of the basic rules of statutory interpretation” that it was hard to view as anything but a “political document.”
“I had a hard time believing that it was serious,” he said.
Alliance for Hippocratic Medicine v. FDA isn’t the only case taking up the abortion pill issue. Two other current cases also consider the FDA’s authority when it conflicts with state law.
Mifepristone manufacturer GenBioPro filed a federal lawsuit against West Virginia on Jan. 25 for the state’s abortion ban, which it says violates the Constitution’s Commerce Clause, according to Axios. The FDA’s regulations, the company argues, take precedence over the state’s law.
In North Carolina, a doctor filed a lawsuit against the state’s law mandating counseling and a 72-hour waiting period prior to receiving abortion pills, again citing the FDA regulations to argue that the state can not “impose additional controls.”
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