- Nearly every state has taken a side in legal battles over abortion pills.
- Opponents of the pill say the FDA does not have the authority to approve it, given that it was approved in 2000 under accelerated approval rules that forced the FDA to classify pregnancy as a “disease.” claim.
- Other counterarguments center on the drug’s adverse effects on women’s health and federal laws banning the mailing of abortion pills.
Nearly every state, plus dozens of organizations, businesses, and legislators We’re on both sides of the legal battle over abortion drugs as the United States District Court for the Northern District of Texas considers the issue in a major lawsuit.
Dozens of Amicus Briefs Filed in Texas caseAlliance for Hippocratic Medicine v. U.S. Food and Drug Administration (FDA), Feb. 10 alone, including by a group of 22 Democratic Party Attorney General Supporting FDA and Another Attorney General Filed by Group of 22 Republican Party Attorney General supporting plaintiff. Four medical organizations filed the first lawsuit in 2000 seeking to overturn FDA approval of drugs used in chemical abortion, banning the mailing of abortion pills.
When the FDA approved mifepristone in 2000, it was the first of two drugs used for chemical abortion and was declared “safe and effective in treating serious or life-threatening illnesses. have been studied and offer significant therapeutic benefits to patients over existing treatments,” forcing government agencies to classify pregnancy as a “disease.” lawsuit.
“However, pregnancy is not a disease, and abortion drugs do not provide any therapeutic benefit over surgical abortion,” the lawsuit asserts. “By insisting on these patently erroneous conclusions, the FDA has approved the drug beyond regulatory agencies.”
Plaintiffs and those who stand by them allowed prescriptions in the third trimester in 2016 and eventually – a person distribution requirement in 2021.
“Outside of regulated medical settings, a person can very easily obtain abortion pills and coerce women into taking them,” said the Republican state attorney general. letter To CVS and Walgreens following the companies’ decision in early January to start offering abortion pills.
I have filed an Amicus Brief in a highly publicized lawsuit against the FDA over its illegitimate role in creating a mail-in abortion system to enforce written legislation and protect women and children. pic.twitter.com/t9CWeZKkLD
— Attorney General Andrew Bailey (@AGAndrewBailey) February 13, 2023
Democratic attorney general defended drug safety independently letter It reassured the company to CVS on Thursday that their decision was “consistent with state and federal law.” Mifepristone and misoprostol have “very low” complication rates, they write, and claims of forced abortion due to their availability are “completely false.”
My office leads a group of 22 AGs to defend and protect access to medical abortion in this country.
Medical 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 plaintiffs also address safety concerns.The Human Coalition of Pro-Life Organizations wrote in its Amicus simply Since June 2022, “1,048 hospitalizations, 604 blood transfusions, and 414 infections (including 71 severe infections) – a total of 4,213 adverse events” have been reported, and the data reported ”may be incomplete.” high,” was filed on February 10.
“Despite the serious risks associated with mifepristone, the FDA only requires reporting of deaths,” the summary continues. “Physicians are not required to report other serious adverse events related to this drug. Reporting of other adverse events is voluntary.”
Another important issue highlighted in this case is the federal law of 1873. lawthe Comstock Act puts FDA at risk of violating federal criminal law by permitting the mail distribution of mifepristone, “any article or thing designed, modified, or intended for the purpose of abortion.” are prohibited from being sent by mail.
On December 23, 2022, the Department of Justice’s Office of General Counsel (OLC) opinion Interpreting the Comstock Act to allow the mailing of abortion pills so long as the sender “not intended to be used illegally.”
in that amicus simply Regarding the Texas case, the Ethics and Public Policy Center (EPPC) said the OLC “has no meaningful support” for this claim.
“The OLC invokes judgments from four circuit courts from the first half of the 20th century to uphold its supposed ‘well-established consensus interpretation,'” the EPPC brief states. “None of these cases cited by the OLC support the proposition that Comstock Act provisions prohibit the mailing of abortion pills only if the sender intends to use the drug illegally. It’s nothing.”
heritage foundation report Further, the OLC explained that it “never acknowledged any obligation to abide by the intended meaning of Congress.” Instead, it “started by looking outside the law for favorable meanings to impose on it.”
Tom Jipping, Senior Legal Fellow at the Heritage Foundation, told the Daily Caller News Foundation it was “difficult to judge” how much of these guidelines were actually intended as true policy steps. .
The OFC’s opinion was “so irrational” and ignored so many “basic rules of law interpretation” that it was difficult to consider it anything but a “political document.” he said.
“I couldn’t believe it was serious,” he said.
The Alliance for Hippocratic Medicine v. FDA is not alone in addressing the issue of abortion drugs. Two other current cases are also being considered where FDA’s authority conflicts with state law.
GenBioPro, the manufacturer of mifepristone, submitted to the federal government lawsuit On January 25, he called on the state of West Virginia to ban abortion, saying it violated the Constitution’s Commerce Clause. AxiosFDA regulations supersede state laws, the company said.
In North Carolina, doctors lawsuit Opposing state laws requiring counseling and a 72-hour waiting period before receiving abortion pills, he argued that states “cannot impose additional regulations,” again citing FDA regulations.
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