Abortion pill challenge goes before federal judge in Texas

AP Photo/Jacquelyn Martin

A Trump-appointed federal judge in Texas gave lawyers on both sides of the argument over abortion pills two hours each to make their case on Wednesday. U.S. District Judge Matthew Kacsmaryk is considering the request by a Christian conservative group, The Alliance for Defending Freedom, to overturn the Food and Drug Administration’s (FDA) approval of mifepristone, an abortion pill. The FDA approved mifepristone more than 20 years ago.

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Mifepristone was approved by the FDA in combination with a second pill as a safe and effective alternative to traditionally performed surgical abortions in 2000. Abortions via pills are often referred to as medical abortions or medication abortions. Lawyers or the FDA are expected to argue that taking mifepristone off the market would disrupt reproductive care for American women as well as undermine the government’s oversight of prescription drugs. Mifepristone manufacturer, Dance Laboratories, will join the FDA in arguing in favor of keeping the pill available.

The judge in Amarillo can rule at any time after listening to the arguments. The hearing is being closely watched by people on both sides of the abortion issue because this is the first one in this case.

The Alliance for Defending Freedom was also involved in the Dobbs v. Jackson Women’s Health Organization. It wrote the model legislation for Mississippi’s pro-life legislation. Removal of mifepristone would curtail access to abortion even in states where it is legal. It is unclear how quickly mifepristone can be curtailed or how the process would work. The process used by the FDA to revoke drug approval can take months or years. It involves public hearings and scientific deliberations.

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What will clinics and doctors do if mifepristone is taken off the market? They say that they will use the second drug, misoprostol as a single-drug approach. This lowers the rate of effectiveness but it is widely used in countries where mifepristone is illegal or unavailable.

The Alliance for Defending Freedom’s argument is that the FDA’s approval of mifepristone was flawed in 2000. The reasons include an inadequate review of the pill’s safety risks. It also challenges several later decisions by the FDA that ease restrictions on the pill. One example of that is eliminating a requirement that women pick up the drug in person.

Serious side effects can happen from the use of mifepristone, though lawyers for the FDA say they are rare. The most serious include bacterial infections and prolonged, heavy menstrual bleeding. If the drug is pulled, the FDA says it would be “extraordinary and unprecedented.’ If the judge rules against the FDA, the ruling will be swiftly appealed by the Department of Justice attorneys who represent the FDA. They would seek an emergency stay to stop the ruling from going into effect, too.

The Biden administration is the most pro-abortion administration in U.S. history. There is little doubt that it will do all it can to keep abortion options available to as many women as possible. Kamala Harris is making a last-minute trip to Des Moines, Iowa on Thursday to convene a roundtable with local leaders about the fight to protect reproductive rights. It will be her first trip to Iowa since she became vice president. Priorities. It’s no coincidence – the administration is trying to counter the potential and declared Republican candidates for president who have been visiting Iowa recently. As I have mentioned many times, the Biden administration is a reactive one, not a proactive administration. In this case, they are scrambling on behalf of Joe Biden’s re-election, though he has not formally declared himself a candidate for re-election yet. It’s coming.

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