Jennifer Shutt, South Dakota Searchlight
The federal government on Monday asked the 5th Circuit Court of Appeals to place on hold a Texas judge’s ruling that would otherwise overturn U.S. Food and Drug Administration approval of the abortion pill.
The Department of Justice’s request for an administrative stay asks the New Orleans-based appeals court to decide before noon on Thursday whether the Texas ruling should take effect on Friday at midnight or if it should be placed on hold during the appeals process.
Meanwhile, on Monday, as the impact of the sweeping Texas decision reverberated:
More than 400 pharmaceutical companies, including Pfizer, wrote an open letter expressing concerns about the precedent that could be set if one U.S. district court judge can overturn the FDA’s scientific and medical judgment in approving pharmaceuticals. On Saturday, Democratic leaders in Congress voiced similar concerns.The U.S. Justice Department sought clarity in a different federal judge’s ruling on the abortion medication mifepristone, in Washington state, that was also released Friday evening. That ruling appears to conflict with the Texas ruling.
If a stay, or pause, is ordered on the Texas decision as the DOJ requested, that would keep mifepristone on the market and available to consumers throughout the appeals process that is likely to end at the U.S. Supreme Court. The Justice Department has also formally appealed the decision to the 5th Circuit.
If a stay isn’t granted, the Texas’s judge’s ruling would go into effect this weekend, likely creating immense confusion among health care providers about how exactly to implement a first-of-its-kind ruling overturning the FDA’s scientific and medical judgment. Some congressional Democrats, like Oregon Sen. Ron Wyden, have called for the FDA to defy or ignore the ruling, though administration officials don’t appear to be considering that proposal.
“Rather than preserving the status quo, as preliminary relief is meant to do, the district court upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety,” said the federal government’s request for a stay.
The request argued the Texas judge’s ruling on Friday evening was “especially unwarranted given the balance of harms.”
“If allowed to take effect, the court’s order would thwart FDA’s scientific judgment and severely harm women, particularly those for whom mifepristone is a medical or practical necessity,” it said. “This harm would be felt throughout the country, given that mifepristone has lawful uses in every State. The order would undermine healthcare systems and the reliance interests of businesses and medical providers.”
Medication abortion is typically a two-drug process that begins with mifepristone, which is approved for use up to 10 weeks into a pregnancy, and misoprostol. The second drug is not at issue in the legal fight.
Medication abortion is used in more than half of pregnancy terminations within the United States, according to the Guttmacher Institute.
U.S. District Court for the Northern District of Texas Judge Matthew Joseph Kacsmaryk’s ruling from Friday, April 7 would revoke the U.S. Food and Drug Administration’s 2000 approval of mifepristone, removing it from the market, in a case brought by the Alliance for Hippocratic Medicine and other anti-abortion organizations.
“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk wrote. “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.”
But Kacsmaryk put a seven-day delay in his ruling, giving the federal government through Friday, April 14, to appeal the decision and to seek a stay.
Separately on Monday, the U.S. Justice Department sought clarity on the Washington order.
The ruling, also from a U.S. District Court judge, ordered the FDA not to remove access to mifepristone in 17 states and Washington, D.C., following a lawsuit from their attorneys general.
In that request for clarification, the federal government says the Texas ruling to remove mifepristone from throughout the country “appears to be in significant tension” with the Washington state federal judge’s order that bars the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone” in those 17 states and the District of Columbia.
“The Court did not address the interaction between the two orders, presumably because they were issued less than 20 minutes apart,” the Justice Department’s clarification request says.
“To ensure that Defendants comply with all court orders in these unusual circumstances, Defendants respectfully request that this Court clarify their obligations under its preliminary injunction in the event that the Alliance order takes effect and stays the approval of mifepristone.”
‘Dangerous step’ seen
White House press secretary Karine Jean-Pierre addressed the Texas ruling during the press briefing Monday, calling the judge’s decision to try to remove medication abortion from the entire country a “dangerous step.”
“This court decision threatens access to this medication, which is used not only for abortion, but also for other critical purposes like helping women manage miscarriages,” Jean-Pierre said. “If the decision stands, it would put women’s health at risk and undermine the FDA’s ability to have access to safe and effective medications when they need them the most.”
Pharmaceutical companies made themselves heard as well.
“Judicial activism will not stop here,” the group of more than 400 companies wrote in their letter. “If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.”
Reproductive rights organizations also said Monday that the Texas judge’s ruling not only rejected decades of sound scientific evidence that mifepristone is safe and effective, but the FDA’s authority to approve pharmaceuticals.
Jessica Ellsworth, counsel at the law firm Hogan Lovells and counsel for Danco Laboratories, said on a press call the pharmaceutical company, which manufactures mifepristone, would likely ask the U.S. Supreme Court for a stay in the case if the 5th Circuit doesn’t grant a hold pending appeal.
“If the 5th Circuit does not grant a stay — or at least an administrative stay, which is sort of a short-term stay, so it has time to consider this request in an orderly fashion — I think it is likely that either Danco and/or the United States will ask the U.S. Supreme Court for a stay,” she said.
If neither the appeals court nor the U.S. Supreme Court grants a stay ahead of the current Friday deadline, Ellsworth said, “there will be some difficult questions Danco needs to address and some conversations that it will need to have with FDA around what happens next.”
Jennifer Dalven, director of the ACLU Reproductive Freedom Project, said the Texas judge set a dangerous precedent when he chose to ignore more than 100 studies spanning 30 years from 26 countries that concluded mifepristone is “a safe and effective means of ending an early pregnancy.”
Dalven said she expects the Texas case will quickly go before the U.S. Supreme Court, which will then decide on mifepristone access and FDA authority more broadly.
“As monumental as the effects will be for abortion and miscarriage care, the implications of this case go far beyond that,” Dalven said.
“If the courts allow this, it will radically alter the process for approving drugs and will chill innovation and bringing new drugs to market,” Dalven added.
“If the courts allow this decision to stand, they will be in essence telling every fringe group with an opposition to a medication or vaccine ‘Just go find a politically aligned judge,’ who can then with a stroke of a pen deny Americans the ability to get the critical, life-saving treatment they need. That possibility should have all of us very concerned.”
Kirsten Moore, director of the EMAA Project, said that it could potentially take years for the FDA to re-approve mifepristone if the judicial process ends with the Supreme Court overturning the FDA’s 2000 approval.
“The drugmaker would need to take some time to figure out what the new application would look like and have dialogue with FDA about that,” Moore said. “And then, FDA has typically 10 months to review that. So we could … in reality be facing a scenario where this medication is only available in a clinical trial setting and not available to patients in the real world for upwards of two, maybe three years. Even if everybody wants to move fast.”
Republicans in Congress, so far, have been relatively mum about the Texas or the Washington state judges’ decisions, though two key U.S. House GOP lawmakers weighed in Monday.
Energy and Commerce Committee Chair Cathy McMorris Rodgers, of Washington, and Subcommittee on Health Chair Brett Guthrie, of Kentucky, released a joint statement, saying “We must remain committed to the fundamental principle that every life is worth living.” The panel writes legislation on health care.
“The FDA‘s first and most important job is to ensure the safety of the American people,” they added. “As the courts review the cases at hand, we must not lose sight of this directive.”
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