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A biker rolls past the U.S. Capitol on Tuesday, March 21, 2023. Photo by Jennifer Shutt/States Newsroom.

A group of 69 congressional Republicans is backing a federal judges ruling that would overturn the U.S. Food and Drug Administrations 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 their34-page briefthat 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 womans 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 governmentappealedthe Texas federal district court judges Friday, April 7 ruling that would overturn the FDAs approval of mifepristone Friday, April 14 at midnight. The Department of Justice has also asked the appeals courtto place the Texas ruling on holdamid the appeals process.

Anti-abortion groups argue against DOJ appeal

The anti-abortion organizations that filed the lawsuit seeking to overturn the FDAs approval of the abortion medication mifepristone have filed briefs with the 5th Circuit opposing the federal governments appeal of the Texas judges 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 the23-page brief rejecting the federal governments 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 the49-page brief opposing the federal governments request for a stayof 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 governments stay request that is extraordinary and unprecedented, not the district courts 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 courts ruling.

The U.S. Department of Justice, in a20-page responseon 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 courts unprecedented overriding of FDAs 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 Congressfiled their own brief supporting the FDAs regulatory authority and the approval of mifepristone. Maryland Rep. Kweisi Mfume (D-7th) was the only Maryland Democrat who did not sign on.

Democratic attorneys general from 23 states, including Maryland, 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 FDAs approval process for mifepristone represent 30 states. Rep. Andy Harris (R-1st) was among the House Republicans to support the brief.

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 a46-page brief, argued the Texas district court unreasonably found fault with FDAs 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 Kacsmaryks 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 courts order overturns the long-settled legal basis of FDAs drug-approval process, wrote the group of more than 20 companies that included Pfizer Inc. Unless stayed, the district courts lawless opinion will empower any plaintiff to grind drug approvals to a halt, disrupting patients access to critical medicines.

If the federal district court judges 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.

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Texas judges abortion pill ruling supported by 69 Republicans in ... - Maryland Matters