Declaration of Independence

We hold these truths to be self-evident, that all men are created equal, that they are endowed by their Creator with certain unalienable Rights, that among these are Life, Liberty and the pursuit of Happiness. - That to secure these rights, Governments are instituted among Men, deriving their just powers from the consent of the governed.

Tuesday, March 26, 2024

Will the New Chemical Abortion Pill Be Dangerous for Women?

Today the U.S. Supreme Court heard oral arguments in two combined cases regarding the regulation of abortion drugs by the Food and Drug Administration (FDA). In the first case of Alliance for Hippocratic Medicine v. Food and Drug Administration, the 5th U.S. Circuit Court of Appeals ruled that it was unlawful for the FDA to decide “in 2016 and 2021 to drop the safety rules for obtaining and using mifepristone.”

According to an article by Thomas Jipping and Sarah Parshall Perry, Danco Labs is the maker of a generic version of the drug, and the Supreme Court combined the appeals from the FDA and Danco Laws. The high court will announce its decision before ending its term in June. The article continued. 

The FDS approved mifepristone, under the brand name Mifeprex, in 2000 under strict safety restrictions. It could be prescribed only by physicians with the requisite training to handle potential complications, and women had to obtain it in person. Doctors were also required to report all medical complications from its use. These were unusual restrictions, but they reflected the FDA’s concern about the risks of using this drug.

Medical associations first challenged the FDA’s decision by way of a “citizen petition,” bringing their concerns to the FDA itself and arguing that the evidence did not justify concluding that mifepristone was safe and effective.

Not only did the FDA refuse to reconsider its original approval, but in 2016 and 2021 it actually dropped two sets of original safety restrictions. As a result, doctors no longer have to report any nonfatal complications arising from use of mifepristone, women can use the drug during the first 10 weeks of pregnancy (an increase from the previous seven-week limit), and women never have to see a doctor for an ultrasound or examination before obtaining the drug.

Four medical associations and four individual doctors filed a lawsuit in federal court in November 2020. They challenged both the original approval of mifepristone and both decisions to drop its safety restrictions.

A U.S. District Court in Texas agreed with them that the FDA did not have a sufficient basis for either approving mifepristone or for dropping its safety rules.

On appeal, the 5th Circuit said that the lawsuit was filed too late to challenge the original approval of mifepristone, but that the decisions to drop the safety rules were unlawful. The original plaintiffs, the FDA, and Danco Labs each appealed the part of the 5th Circuit’s decision that they lost.

The Supreme Court agreed to consider only whether the FDA had made its 2016 and 2021 decisions to drop mifepristone’s safety restrictions properly, and in accordance with federal law.

There are questions about whether women are in more danger with the decisions of the FDA. Will doctors in emergency rooms be faced with cleaning up the mess when the pills do not cause complete abortions? Will emergency doctors who oppose abortions be forced to complete a botched chemical abortion? Will the chemical abortion pill cause more health problems or even death for women? The authors voiced my thoughts about the case before the justices.

Now, the Supreme Court must weigh the evidence, and decide whether every federal agency is bound to follow the law, or whether the FDA gets a pass simply because it thinks its choices were justified.

           For the sake – and safety – of American women and girls, let’s hope they decide correctly. 

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