On Tuesday, Democrats in the House and Senate and a coalition of pharmaceutical industry executives and companies filed separate amicus briefs arguing against a Texas federal judge’s ruling that would reverse 22-year-old federal approval of the most commonly used abortion pill.

Both briefs cited the widely held medical consensus that the drug, mifepristone, is safe and effective for abortions and miscarriage care. 

What You Need To Know

  • Democrats in the House and Senate and a coalition of pharmaceutical industry executives and companies filed separate amicus briefs arguing against a Texas federal judge’s ruling that would reverse 22-year-old federal approval of the most commonly used abortion pill

  • More broadly, the briefs argued the decision by U.S. District Judge Matthew Kacsmaryk would threaten the FDA's long-held mandate to approve medications, leaving an opening for judges to bar specific drugs based on political and personal views and not established medical science

  • For now the drug is still available as the case goes through the appeals process and is potentially heard before the Supreme Court, but Democratic governors have been stockpiling mifepristone and misoprostol, the other medication used for abortions
  • Millions of Americans have used the drug in the last two decades, according to federal data

“FDA has repeatedly demonstrated that its approval of mifepristone is based on a rigorous review of scientific data and literature supporting the safety and efficacy of the drug, which has been validated by the decades of experience of many Americans who, in consultation with their health care providers, have chosen to use mifepristone for a medication abortion,” the brief by congressional Democrats reads. 

Millions of Americans have used the drug in the last two decades, according to federal data.

While some progressive Democrats have called on the Food and Drug Administration to ignore the ruling, which the judge stayed through this week, others believe the dispute will play itself out in the courts and result in a favorable ruling for the FDA and Americans seeking to use the most common form of abortion.

“We are hoping that with this amicus briefing that this court, this decision, could stay,” Rep. Norma Torres, D-Calif., told Spectrum News Wednesday, calling the FDA approval process “world-renowned.” 

“For a court to say it’s not politically correct to be on the side of the scientists that study this drug, that said, ‘this drug is safe, not just for abortion, but for miscarriage care,’ it's really daunting to me as a woman what more we can expect from, you know, political hacks that are playing games with women's rights,” Torres added.

More broadly, the briefs argued the decision by U.S. District Judge Matthew Kacsmaryk would threaten the FDA's long-held mandate to approve medications, leaving an opening for judges to bar specific drugs based on political and personal views and not established medical science.

“With these dual requirements of safety and efficacy as the touchstone of FDA review, over the last sixty years, Congress has repeatedly expanded FDA’s authority and affirmed FDA’s role as the sole arbiter of whether and how a drug should be made publicly available,” the amicus brief signed by dozens of doctors, pharmaceutical companies, trade organizations and executives reads.

Pfizer, one of the largest pharmaceutical companies in the world, signed onto the brief. 

“The court substituted its own idiosyncratic views of clinical benefit and safety, replacing the gold-standard benefit-risk analysis and expert judgment of FDA’s medical and scientific professionals with anecdotes and conjecture,” the brief continued.

House and Senate Democrats made the same argument, saying the ruling could have wide implications for drug approvals and the FDA’s authority beyond mifepristone.

“The district court appears to have second-guessed FDA’s scientific determinations with cherry-picked anecdotes and studies, and on that basis, imposed a remedy that could significantly upend the status quo,” the brief filed by 190 House Democrats and 50 Senate Democrats reads. 

Sen. Joe Manchin, D-W.Va., was the lone Senate Democrat not to sign onto the brief, along with 23 House Democrats. 

“For the last century, a statutory scheme designed by Congress has assured the safety and effectiveness of the drugs available in the United States. At its core resides the application of scientific standards by agency experts,” the Democrats’ brief continued.

Amicus briefs are legal filings made by interested parties outside a court case to bolster the arguments of the side they support.

“What is the FDA going to be forced to do next?” Rep. Sydney Kamlager-Dove, D-Calif., asked in an interview with Spectrum News on Monday. “Are they going to take insulin off the shelves? You know, medicine that helps you if you have hypertension or high blood pressure or high cholesterol? If you are going through chemotherapy? What is next?” 

“If you are radicalizing and politicizing these approvals, we could be forced to have to throw all kinds of pharmaceuticals that are in our medicine cabinets, in the garbage,” Kamlager-Dove added. “Medicine that is saving people's lives.”

“This is incredibly ridiculous. And it is a slippery slope that will become increasingly dangerous to Americans who are sick and in need of medication,” the freshman Democrat said.

Mifepristone, first approved in 2000, is one of the most studied medications prescribed in the country and its safety is “on par with common painkillers like ibuprofen and acetaminophen,” the American Medical Association wrote in a separate amicus briefing filed earlier this week.

A letter signed by more than 300 current and former pharmaceutical executives released on Monday said the drug “has been proven by decades of data to be safer than Tylenol, nearly all antibiotics and insulin.”

But contrary to established science, Kacsmaryk wrote he believed the FDA was ignoring “thousands of adverse events” and the medical justifications for the drug were obscured by political pressure on the FDA the financial interests of “abortionists,” a term generally referring to illegal or underground abortion providers and used by anti-abortion activists to describe reproductive health professionals who provide abortion care.

“Many women also experience intense psychological trauma and post-traumatic stress from excessive bleeding and from seeing the remains of their aborted children,” Kacsmaryk wrote.

In contrast, the AMA wrote patients are “at least 14 times more likely to die of complications during childbirth than during any abortion procedure,” as well as experience hemorrhaging infection and injury during pregnancy and childbirth.

“And substantial evidence shows that denying abortion care puts patients at an increased risk for violence from intimate partners and it exacerbates patients’ economic hardships,” the AMA wrote in an article summarizing their brief.

For now the drug is still available as the case goes through the appeals process and is potentially heard before the Supreme Court, but Democratic governors have been stockpiling mifepristone and misoprostol, the other medication used for abortions.

But Torres said there’s more that can be done on a federal level. 

“President Biden should not squander off any opportunity to, you know, legislate through executive order, if he has to,” said Torres, the vice chair of the House Pro-Choice Caucus. “I know that that is not something that, you know, is a priority to him to legislate through executive orders. But you know, [former President Donald Trump] did that, and they did that very well. And I don't think that this president should shy away from protecting women's equal rights through this process.”

President Joe Biden has come out strongly against the ruling, calling it “out of bounds” in a press gaggle before heading to Belfast, Northern Ireland on Tuesday, and tweeting last week “we’re going to fight it.” 

The Department of Justice also filed an appeal, asking a higher court to implement a stay of the Texas judge’s ruling.

“Everything is on the table right now. And I want to encourage the president to utilize every tool that he has at his disposal to protect women's rights moving forward,” Torres added.