MIKE PENCE: Supreme Court has chance to right historic wrong

[Valin]

The Washington Examiner

Mike Pence
March 26, 2024

The Food and Drug Administration was established to protect public health by ensuring the safety of medicine. Tragically, when the FDA illegally approved the dangerous abortion drug mifepristone, it abdicated this duty in the name of promoting abortion. 

This week, the Supreme Court will have the opportunity to right that historic wrong. 

In 2000, the FDA illegally approved mifepristone under rules that allow the agency to approve drugs that provide meaningful therapeutic benefits over existing treatments for serious and life-threatening illnesses, such as AIDS. Pregnancy, of course, is not an illness, and abortion is not a treatment. The FDA claimed otherwise, abusing its own regulation and illegally approving the abortion drug with tragic effects.

Chemical abortions are more dangerous to women than surgical abortions, as the FDA has known since it approved mifepristone. The rates of death from abortion pills are four times higher than that of surgical abortions. As of December 2022, 32 deaths have been reported as a direct result of mifepristone. Studies have shown that 10% of women who use mifepristone require follow-up medical treatment for a failed or incomplete abortion and 20% will experience adverse effects such as hemorrhaging or infections. 

Yet, in the intervening decades since mifepristone’s approval, the FDA has continually placed women’s health at greater risk by further loosening restrictions regarding the use of the drug.  

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[Valin]

Supreme Court appears skeptical on scope of abortion pill case

Kaelan Deese and Gabrielle M. Etzel
March 26, 2024

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Roberts tees up question on ‘standing’ theory

Chief Justice John Roberts asked Justice Department Solicitor General Elizabeth Prelogar about the theory of legal “standing,” which would allow some people to bring a lawsuit like the one at the center of the case if there is a statistical likelihood that they would face the requisite injury to bring the suit.

“Is there a number of which your argument would change the significant number of consequences — a higher likelihood of an emergency room visit? Doctors who spend more time in the emergency room at some point. Does this analysis lead to the other result?” Roberts asked Prelogar.

Prelogar argued that the government does not agree with the theory.

“Obviously the FDA is not requiring them to do or refrain from doing anything,” Prelogar said. “They aren’t required to treat women who take mifepristone. FDA is not directing the women who take the drug to go seek out care from these specific doctors, and so they stand at a far distance from the upstream regulatory action they’re challenging.”

Alito and Thomas invoke Comstock Act, ask who can sue the FDA

Justice Samuel Alito, the author of the Dobbs decision, raised concerns that the mail ordering of mifepristone may be linked to higher instances of emergency room visits, as prior studies have indicated.

Alito also questioned whether the government is arguing that no one can sue the FDA if it were to have violated the law.

“So your argument is that it doesn’t matter if the FDA flagrantly violated the law and didn’t do what it should have done, endangering the health of women? It’s just too bad — nobody can sue in court,” Alito suggested.

Prelogar responded that “drug sponsors themselves remain responsible at all times.”

“We have a tort system in this country, and that can help ensure that if there are safety problems that come to pass, the sponsors will take action in reaction to that,” Prelogar said. “So if the premise here is that unsafe drugs could somehow remain on the market, I think that that’s incorrect.”

Justice Clarence Thomas, another member who formed the Dobbs majority, bought up the Comstock Act of 1873, which disallows sending contraceptives through the mail, in questions for Danco: “How do you respond to an argument that mailing medication abortion is a crime under the Comstock Act?”

“We agree very much with the government that FDA’s charge under the Food, Drug, and Cosmetic Act is limited to looking at safety and efficacy considerations. That’s true for new drug approvals,” said Jessica Ellsworth, an attorney for Danco.

Jackson: Are there ‘concerns’ with judges parsing scientific studies?

*Justice Ketanji Brown Jackson, the newest justice appointed by President Joe Biden, asked Danco’s attorney if judges should be parsing medical and scientific studies.

Ellsworth responded that the pharmaceutical industry has expressed “significant concerns” over this sort of judicial review as it may threaten the FDA’s gold standard drug approval process.

Judges are “not experts in statistics,” Ellsworth added.

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* Who MAY be a Woman.