Two new lawsuits from an abortion pill manufacturer and an abortionist aim to frustrate attempts by state legislatures in West Virginia and North Carolina to regulate the sale of the abortion pill within their states. The lawsuits claim that federal approval of the pill by the Food and Drug Administration (FDA) preempts state attempts to restrict it.
If successful, states will be helpless to regulate the ever-increasing growth of chemical abortions, now estimated at over 50% of all abortions in the U.S. The lawsuits have major implications for the ongoing fight to save preborn lives and protect women’s health from the dangerous risks and side effects of the abortion pill.
The lawsuits pit the rights of states to determine whether and how to protect its most vulnerable members – preborn babies – against the actions of a federal agency that has dedicated much of its efforts in the last several years to promoting abortion.
In the first lawsuit, Genbiopro, Inc., a manufacturer of the abortion drug mifepristone, is suing West Virginia claiming the state’s abortion law banning most abortions must yield to the FDA’s approval of the drug for abortion use.
In this case, just follow the money.
Genbiopro manufactures only two products, mifepristone and misoprostol, the two drugs that make up the two-pill abortion regimen that comprise a chemical abortion. Since 2019, when it first received FDA approval to sell generic mifepristone, the company has sold approximately 850,000 units of the drug.
How many of those 850,000 units ended up killing a preborn baby? How much did the company earn in sales due to this drug that ends life, rather than extends it?
West Virginia, in the wake of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization last June overturning Roe v. Wade, enacted the Unborn Child Protection Act (HB 302), which prohibits abortion except in the cases of rape, a nonmedically viable fetus, an ectopic pregnancy, or in a medical emergency, which is strictly defined.
Genbiopro, in an effort to preserve its market in West Virginia and elsewhere, sued West Virginia in the U.S. District Court for the Southern District of West Virginia. The company alleges that Congress, in enacting the Food and Drug Administration Amendments Act of 2007, authorized the FDA to “design and implement risk evaluation and mitigation strategies for drugs moving forward.”
One of those drugs that Congress authorized the FDA to assess is mifepristone, according to the lawsuit. When the FDA approved mifepristone for chemical abortions, Genbiopro argues, that approval became a mandate from Congress that mifepristone be exempted from any state regulation affecting its sale or use for abortion.
In legal terms, the argument is that federal law preempts state law on this subject, making state laws on the subject irrelevant.
“West Virginia cannot override FDA’s determinations about the appropriate restrictions on a medication that FDA approved for use and Congress subjected to this enhanced regulatory regime,” the Genbiopro lawsuit asserts.
That last conclusion is by no means an undisputed one, and likely will the legal ground where much of the case will be fought.
West Virginia’s attorney general, Patrick Morrisey, welcomes the legal challenge. In a statement, he said:
“We are prepared to defend West Virginia’s new abortion law to the fullest. While it may not sit well with manufacturers of abortion drugs, the U.S. Supreme Court has made it clear that regulating abortion is a state issue. I will stand strong for the life of the unborn and will not relent in our defense of this clearly constitutional law.”
Meanwhile, in North Carolina, which permits abortions only up to 20 weeks gestation, an abortionist named Dr. Amy Bryant is suing the Tar Heel State using the same legal theory of FDA preemption of state law to invalidate that state’s abortion restrictions, which apply to the sale of the abortion pill.
North Carolina law requires all abortions, including chemical, to be provided only in person, only by a physician, and only in a specially certified facility after state-mandate counseling, a 72-hour waiting period, and in certain circumstances, an ultrasound.
That is apparently too much for the abortion industry, which wants to rush women through the process.
“As part of its congressionally mandated regulatory balancing, FDA specifically considered and rejected the idea that mifepristone must be provided in person by a physician in a particular type of facility,” Dr. Bryant’s lawsuit alleges.
“FDA instead concluded that mifepristone can be safely prescribed by any certified healthcare provider either in person or via telehealth, obtained by the patient directly from or under the supervision of the healthcare provider or from a certified pharmacy, and taken by the patient in her home or other place of her choosing.”
And there it is.
The abortion industry wants to make abortion as quick and accessible as possible – and lucrative, of course – and rejects the notion that states have the right to protect women and preborn babies in any way.
After Dobbs, it’s clear that chemical abortion will be the next legislative, legal and cultural flashpoint in the battle to save preborn lives. According to the Guttmacher Institute, 29 states currently require chemical abortions to be administered by physicians, two states prohibit chemical abortion starting at a specific point in the pregnancy, and 18 states require the abortionist to be physically present when the medication is administered.
Another lawsuit to watch is one that claims the FDA is the one breaking the law, not the states. Filed in November 2022 by Alliance Defending Freedom (ADF) on behalf of four medical associations and four doctors, it asserts the FDA violated its own regulations when it authorized the use of mifepristone for chemical abortions.
For starters, the ADF lawsuit alleges, the FDA had to twist the meaning of the term “illness” to include “pregnancy” in order to claim authority to authorize the drug for use in abortions.
More state legislation on the subject of chemical abortions is inevitable. That’s why these lawsuits will be watched carefully by those on both sides of the abortion issue. Dobbs returned the abortion issue back to the people. Please pray that the people, through their elected representatives in pro-life states, can indeed carry out their delegated mission to protect women and save lives.
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