WASHINGTON — A group of 69 congressional Republicans is backing a federal judge’s ruling that would overturn the U.S. Food and Drug Administration’s two-decade-old approval of the abortion pill mifepristone.
The 11 GOP senators and 58 House lawmakers, who filed a brief in the appeals case, broke the relative silence from Republicans in Congress on the Friday ruling, though no members of leadership signed onto the brief.
“By approving and deregulating chemical abortion drugs, the FDA has not followed Congress’ statutorily prescribed drug approval process and has subverted Congress’ critical public policy interests in upholding patient welfare,” the GOP lawmakers wrote.
The Republicans expressed concern in their 34-page brief that people other than the pregnant woman — such as intimate partners, family members, or sex traffickers — “may be asserting reproductive control over the woman, which are ‘actions that interfere with a woman’s reproductive intentions.’”
“In the context of abortion, reproductive control not only produces coerced abortions or continued pregnancies, but it also affects whether the pregnancy was intended in the first place,” they wrote. “Reproductive control is a prevalent issue for women.”
The Republican lawmakers were among the dozens of organizations, both supporting and opposing abortion rights, that have filed briefs with the 5th Circuit Court of Appeals in New Orleans this week.
That court is now in charge of the case after the federal government appealed the Texas federal district court judge’s April 7 ruling that would overturn the FDA’s approval of mifepristone April 14 at midnight. The Department of Justice has also asked the appeals court to place the Texas ruling on hold amid the appeals process.
Anti-abortion groups argue against DOJ appeal
The anti-abortion organizations that filed the lawsuit seeking to overturn the FDA’s approval of the abortion medication mifepristone have filed briefs with the 5th Circuit opposing the federal government’s appeal of the Texas judge’s ruling.
The organizations are also opposed to the U.S. Justice Department asking for the appeals court to place the Texas ruling on hold past the Friday midnight deadline the Texas judge placed in his ruling.
In the 23-page brief rejecting the federal government’s appeal, they write that the 5th Circuit has no jurisdiction over the case since the federal district court judge issued a stay of the 2000 FDA approval and not an injunction.
In the 49-page brief opposing the federal government’s request for a stay of the Texas ruling, the anti-abortion organizations argue “the district court did not abuse its discretion in entering an administrative stay under Section 705 of the Administrative Procedure Act, and it is the government’s stay request that is ‘extraordinary and unprecedented,’ not the district court’s ruling.”
The anti-abortion organizations, in a brief filed by Alliance Defending Freedom, wrote that “because the district court granted an administrative stay, not a preliminary injunction, this Court lacks interlocutory appellate jurisdiction and should leave in place the district court’s ruling.”
The U.S. Department of Justice, in a 20-page response on Wednesday, said while the federal judge in Texas purported “to be acting in a restrained manner … there is nothing modest about upending the decades-long status quo by blocking access nationwide to a safe and effective drug.”
The federal government reasserted that mifepristone is safe and effective when used in line with the FDA approval, adding that there was no “basis in administrative law for the district court’s unprecedented overriding of FDA’s considered scientific judgment.”
The Justice Department also noted that “laws of every State allow patients to use mifepristone in some circumstances, reflecting the importance of a drug that millions of women have relied on to safely terminate their pregnancies.”
“States also have preserved access to mifepristone for other purposes, including to help women manage miscarriages,” the justice department attorneys wrote.
Democrats in Congress back FDA authority
Two hundred forty Democratic members of Congress filed their own brief supporting the FDA’s regulatory authority and the approval of mifepristone shortly ahead of the Republican lawmakers filing their brief.
Democratic attorneys general from 23 states and the District of Columbia have filed a brief supporting the approval of mifepristone, which is authorized for up to 10 weeks into a pregnancy as part of a two-drug regimen that includes misoprostol as the second pharmaceutical.
Republican attorneys general from 21 states have indicated they plan to file or have filed briefs in the case.
The GOP members of Congress who filed the brief opposing the FDA’s approval process for mifepristone represent 30 states.
Montana Sen. Steve Daines signed onto the letter.
Pharma companies argue against ruling
Pharmaceutical companies have also filed a brief with the 5th Circuit Court of Appeals, raising major warnings about the long-term effects of one federal judge overturning an FDA approval.
The companies, in a 46-page brief, argued the Texas district court “unreasonably found fault with FDA’s sound scientific judgments in order to stay approval of a drug that has been approved for nearly a quarter-century and used safely by millions of women.”
The argued that U.S. District Court for the Northern District of Texas Judge Matthew Kacsmaryk’s ruling “also badly misapplied governing drug-approval laws, and administrative law more generally.”
“Far from being limited to one drug, the logic of the district court’s order overturns the long-settled legal basis of FDA’s drug-approval process,” wrote the group of more than 20 companies that included Pfizer Inc. “Unless stayed, the district court’s lawless opinion will empower any plaintiff to grind drug approvals to a halt, disrupting patients’ access to critical medicines.”
If the federal district court judge’s ruling from Friday is allowed to take effect, they wrote, it would “result in a seismic shift in the clinical development and drug approval processes, erecting unnecessary and unscientific barriers to the approval of lifesaving medicines, chilling drug development and investment, threatening patient access, and destabilizing the pharmaceutical industry.”
