California Stockpiles Emergency Supply of Abortion Drugs After Judge’s Ruling

California Stockpiles Emergency Supply of Abortion Drugs After Judge’s Ruling
California Gov. Gavin Newsom speaks during a press conference in San Francisco on Oct. 6, 2022. (Justin Sullivan/Getty Images)
Caden Pearson

California has secured an emergency stockpile of up to 2 million abortion pills after a federal judge blocked the federal regulator’s approval of mifepristone, Gov. Gavin Newsom announced on Monday.

The unprecedented ruling by U.S. District Judge Matthew Kacsmaryk in the northern district of Texas halted the Food and Drug Administration’s (FDA) approval of mifepristone while the lawsuit that challenges the safety and approval of the drug plays out.

California has already received more than 250,000 misoprostol pills and the ability to purchase up to 2 million more as needed through CalRx, according to Newsom’s office. CalRx is a program in California that negotiates and purchases pharmaceuticals in bulk, helping to lower the cost of drugs and making them more accessible to people in the state.

“In response to this extremist ban on a medication abortion drug, our state has secured a stockpile of an alternative medication abortion drug to ensure that Californians continue to have access to safe reproductive health treatments,” Newsom said in a statement. “We will not cave to extremists who are trying to outlaw these critical abortion services. Medication abortion remains legal in California.”

Two concurrent court rulings are contributing to uncertainty surrounding the fate of mifepristone in the U.S. market.

On Friday, two different federal judges, one from Washington state and the other from northern Texas, issued contradictory rulings on mifepristone.

First, Kacsmaryk, an appointee of former President Donald Trump, issued his nationwide injunction suspending the FDA’s approval of the drug on Friday.

Shortly thereafter, Judge Thomas Rice, an appointee of former President Barrack Obama, issued a ruling preventing the FDA from removing mifepristone from the market in 17 states plus the District of Columbia.

The split rulings may mean the cases end up in the U.S. Supreme Court.

Texas Ruling

In his ruling on Friday, Kacsmaryk said the FDA had ignored risks in approving the drug.
“The Court does not second-guess FDA’s decision-making lightly,” he said in his ruling (pdf). “But here, FDA acquiesced on its legitimate safety concerns—in violation of its statutory duty—based on plainly unsound reasoning and studies that did not support its conclusions.

“There is also evidence indicating FDA faced significant political pressure to forego its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion—which was the ‘whole idea of mifepristone.'”

Immediately following the decision, the U.S. Justice Department and a manufacturer of mifepristone, Danco Laboratories, announced their intention to file lawsuits challenging the ruling.

In response to the ruling, the FDA insisted that the abortion drug was “safe and effective.”

“FDA approved Mifeprex more than 20 years ago based on a comprehensive review of the scientific evidence available and determined that it was safe and effective,” the agency said in a statement. “FDA stands behind its determination.”
The agency said it had appealed the ruling.

How Mifepristone Works

Mifepristone works by blocking progesterone, which is essential for providing nutrients needed for the growth and development of the unborn child. The drug stops this process and leads to the termination of the pregnancy.

The drug misoprostol is then used to induce labor and expel the unborn child’s remains.

Since 2000, mifepristone has been frequently used in the United States to terminate pregnancies of up to 10 weeks using this chemical abortion process. It is also sometimes used for women who experience miscarriages.

Chemical abortion is the most commonly used method of abortion in the United States and accounts for more than half of all abortions performed in the country. It is also known by various other names, such as “abortion by medication.”

While Newsom’s office claimed the misoprostol-only regimen is safe, the World Health Organization provides a caution, advising that it is “less effective” alone and recommending a clinic follow-up. It is widely used in countries where mifepristone is illegal or unavailable.
Mifepristone is available as a generic drug and also available under the brand name Mifeprex. In January, the FDA said the Biden administration is allowing mifepristone to be dispensed at retail pharmacies. The move faced criticisms from attorney generals from 22 U.S. states, who called it illegal and dangerous.

Newsom last year committed $200 million to his agenda to support and expand abortion access to make it easier for women to get abortions.

Mimi Nguyen-Ly contributed to this report.
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