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| A win by his GenBioPro company, which manufactures mifepristone, could allow the pill to be prescribed, dispensed, and sold in other abortion-free states. Associated Press |
A company that makes abortion pills filed a lawsuit Wednesday morning challenging the constitutionality of a state ban on the drug.
This lawsuit was filed in federal court in West Virginia by his GenBioPro, one of its two manufacturers of mifepristone in the United States. Legal experts say other abortion bans could force the prescription, dispensing, and sale of drugs if they are ruled in favor of the company. If the court rejects the company's claims, some legal scholars say the decision could pave the way for states to ban or limit other approved drugs, such as the coronavirus vaccine and the morning-after pill. Says yes. I was told it was sexual.
The case is one of many that will test legal arguments after the Supreme Court ruled last June to overturn abortion rights. sued. I am discussing drug control. In November, an anti-abortion activist filed a lawsuit challenging his nearly 23-year-old FDA approval of mifepristone. They asked the court to ban the drug and her second drug, misoprostol, from use in abortions.
Taken together, these cases highlight how medical abortion has become pivotal in legal and political battles. The pill is now used for more than half of abortions in the United States. Recent FDA decisions allow patients to be prescribed telemedicine, obtain drugs by mail or retail pharmacies, and prohibit or limit abortions. It has been. it has been. It is increasingly targeting dosing regimens.
This duel echoes what some jurists predicted in a recent article. The aftermath of the Supreme Court ruling will lead to "a world of complex legal disputes in new jurisdictions over abortion." The authors — David S.
A recent article by legal scholars and experts on drug and health policy argues that the federal government has comprehensive powers to approve and regulate drugs.
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| The public watched as the West Virginia Senate debated the abortion bill in July. Associated Press |
These experts say states are permitted to adopt several laws and regulations that complement federal drug regulations and regulate medical practices within their jurisdictions. But they say conditions cannot interfere with the FDA or impose conflicting policies.
Law professor Patricia Zetler and medical professor Amit Sarpatwari wrote last year in an article in the New England Journal of Medicine that "Under the U.S. Constitution, when federal and state laws conflict, federal law takes precedence over state law." I will.” I do "I will take your place," he wrote.
Scholars point out that Massachusetts tried to ban the new opioid zohydro-ER in 2014. A federal judge has upheld drug company Zogenix. If states "can reverse FDA's decisions and substitute its requirements, it would undermine FDA's ability to make medicines available to promote and protect public health," the judge wrote. Subsequent State Restriction Attempts
Skye Perryman, an attorney at GenBioPro and president of the center-left legal advocacy group Democracy Forward, said Western Virginia's ban "was unwilling for the state to take her FDA's stance." No,' he said. It's gone too far," he said, making safety and efficacy decisions that contradict and interfere with the FDA's judgment.
The West Virginia sheriff passed an abortion ban against him in September. The lawsuit alleges that the ban violated a constitutional supremacy clause that provides for federal law.
West Virginia Attorney General Patrick Morrissey said in a statement Wednesday that he was "ready to defend West Virginia's new abortion law to the best of his ability, even if it may not work out with abortion drug makers." clarified that abortion regulation is a state matter. ”
His GenBioPro, which began manufacturing a generic version of mifepristone in 2019, says West He has 72 units of mifepristone for use in the state because of the Virginia ban and previously enforced abortion restrictions. I only have Hmm. Unable to ship and in 2022 he will not ship up to 8 units. march. Then go to zero. GenBioPro said he had zero sales in seven other states where abortion is banned and Wisconsin where abortion services have been suspended in light of unclear laws.
GenBioPro's medical director, Dr. DeShawn Taylor, said the ban "deprives people of their ability to access safe and effective medicines and puts the company at risk." "If people don't have access to mifepristone, of course, it will affect the company's bottom line," she added.
A notable aspect of the FDA's regulation of mifepristone is that for more than 12 years, the FDA has imposed an additional framework of restrictions and oversight on this drug. This methodology, called the Risk Evaluation and Mitigation Strategy (REMS), has only been used for about 300 other medicines, of which 60 are currently enabled in this framework. In recent years, the FDA has extensively reviewed new data on mifepristone and lifted some restrictions, including requiring patients to obtain the drug directly from their healthcare provider.
Some legal experts believe that the FDA imposed special restrictions on mifepristone. As evidence of its safety and efficacy grows, the FDA's decision to gradually ease restrictions is a matter of state discretion. Leading to a ban. Claim. Reinforces the need to affirm the federal government's ultimate liability and to withdraw restrictions. drug authority.
The North Carolina lawsuit was filed by Dr. Amy Bryant, an abortion provider at the University of North Carolina. North Carolina regulations require mifepristone to be taken under the supervision of a physician, who must first provide the patient with state-mandated counseling and then administer the drug. Yes, you have to wait 72 hours.
"Finally, the FDA has unequivocally concluded that requirements such as those imposed by the State of North Carolina are unnecessary to ensure patient safety and violate FDA.
A spokesman for North Carolina Attorney General Josh Stein said authorities were investigating the incident.
A Texas lawsuit filed by an anti-abortion advocate alleges that the FDA did not give due consideration to the scientific evidence and followed proper protocol when it approved his mifepristone in 2000. increase.
The lawsuit was filed in Amarillo, Texas, by the Hippocratic Medical Alliance, an organization of five anti-abortion groups, and Matthew North, Texas, who presided over the Kaksmalik trial in Amarillo. assigned to an officer. Given the. Before being nominated by President Trump, Judge Kaksmalik wrote articles critical of issues such as Roe v. Wade, marriage equality, and federal anti-discrimination protections for sexual orientation and gender identity. I was.
Dr. Christina Francis, chief executive officer of the American Association of Professional Obstetricians and Gynecologists, an alliance-affiliated group, said in the initial approval and recent decision to relax some restrictions on mifepristone: increase. FDA says: This is a study that doesn't give the full picture," she added.
Most medical organizations say vast amounts of data show the opposite. Unnecessarily restrictive, the ability to prescribe telemedicine and receive prescriptions by mail was a long-awaited change.
Her two public petitions against FDA action against mifepristone, filed by the same anti-abortion group in 2002 and her 2019, were dismissed by the FDA as baseless. was. Her 2008 review of her by the Government Accountability Office found no fraud in her FDA approval of mifepristone.
Because of the scientific evidence and rigor of the FDA's handling of mifepristone, many reproductive health law experts initially thought the Texas lawsuit was too baseless to win. Said. But some are starting to worry.
"This was a special case and should have been dropped immediately," said Jenny Ma, senior counsel at the Reproductive Rights Center.
“A single district judge in Texas, a state that already bans all abortions, could ban drug-induced abortions nationwide. One thing is clear,” he said. he said.
Erik Baptist, a senior attorney at Alliance Defending Freedom, a conservative Christian legal advocacy group representing the plaintiffs, expressed his confidence in the case, saying that reviewing the agency's actions would differ from the FDA. It may take perspective. ”
In response to the lawsuit filed this month, the FDA said the lawsuit was "unprecedented" and that the judge granted the plaintiff's request for an injunction to stop access to mifepristone.
