A Texas judge will rule on mifepristone soon. Here’s what can happen
The Hippocratic Medicine Alliance wants Judge Kachmari to revoke the FDA’s medical approval of mifepristone, which would effectively ban abortion pills in the US.
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A court in Texas is about to make a key ruling in a closely watched case challenging the Food and Drug Administration’s approval of mifepristone in abortion pills.
The lawsuit, filed by a group of anti-abortion doctors called the Hippocratic Medicine Alliance, is an unprecedented case, and Judge Matthew Kachsmarik of the US Northern District of Texas may decide differently.
He could have ordered the FDA to completely remove mifepristone from the US market. It is also possible that Kachmari may have ordered the agency to impose tighter restrictions on access to mifepristone, but not completely stop sales. The judge could also have ruled in favor of the FDA, but anti-abortion groups would have filed an appeal.
Kaczmarik told lawyers involved in the case during oral arguments in Amarillo on Wednesday that he would make his decision “as soon as possible.”
Abortion rights groups and lawyers expect the judge to rule in some form against the FDA. Kachmari joined the court in 2019 after being appointed by the former president Donald Trump. His nomination was unanimously opposed by Senate Democrats as well as Republican Susan Collins of Maine due to concerns about his views on abortion and LGBTQ rights.
Wendy Davis, senior adviser to Planned Parenthood Texas Votes, told reporters at a press conference on Wednesday that abortion rights activists are preparing for the worst.
A court ruling blocking the sale of mifepristone will have the most impact in states where abortion remains legal, said Carrie Flaxman, who leads the Planned Parenthood Federation’s litigation.
Rachel Rebush, a reproductive health law expert at Temple University, said the blocking sales order would create confusion because there would be further litigation over whether such an order is legal.
If Kachmari issues an order to withdraw mifepristone from the market, such an order can be drafted in several ways. The impact of its decision will depend on the language of the order and how the FDA decides to respond.
“There are many ways a court can rule in our favor,” said Eric Baptist, who represents the Hippocratic Medicine Alliance in the case and is a senior adviser to the Freedom Alliance, another anti-abortion group.
Baptiste told reporters during a press conference on Thursday that a judge could immediately revoke the FDA’s approval or order the agency to initiate a process to withdraw mifepristone from the US market.
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“But how the court will be affected in terms of timing — whether it will take effect immediately, whether it will take effect in 30 days, again, that is up to the court,” Baptiste said.
Rebouche said it is possible that the judge will issue a ruling that directs the FDA to begin the process of recalling mifepristone while also suspending the drug from the market as the agency goes through the process.
If Kachmari issues an immediate recall order for mifepristone, the Biden administration will ask him to stay the decision pending appeal, said Glenn Cohen, a health law expert at Harvard. If Kachmari refuses, the administration will refer the case to the US 5th Circuit Court of Appeals.
“I assume that the suspension papers have already been drawn up. Someone will take them to court within hours of the decision being made,” said Cohen, who previously worked as a lawyer in the Justice Department’s civil division.
Cohen, Rebush and 17 other drug law experts, in a court filing in support of the FDA, told Kasmari that ordering mifepristone to stop immediately would be contrary to federal law.
According to them, the right to withdraw a drug belongs to the FDA commissioner, who makes this decision based on scientific data on the safety and effectiveness of the drug. The manufacturer, in this case Danco Laboratories, also needs to be heard during the process.
“The FDA will argue that the court cannot revoke the drug — the FDA must revoke the drug, and federal law does not allow the court to revoke the drug,” Rebusch said.
The FDA may delay the process
If Kachmari refuses to immediately recall mifepristone and instead orders the FDA to initiate a formal process to withdraw the drug from the market. Assuming he does not withhold approval during this time, the agency may use this process to shield him from retaliation.
“Removing a drug from the market when the FDA follows these procedures takes months, if not years, so the FDA may try to delay the process a bit to keep the drug on the market in the meantime,” said Allison Whelan. , an FDA regulatory expert at Georgia State University.
“The FDA doesn’t want its scientific expertise and legitimacy to be questioned,” said Whelan, who also signed the lawsuit in support of the FDA.
mifepristone off label
The agency also has enforcement powers, Whelan said, under which it may not prosecute companies that sell unapproved drugs. Mifepristone is also approved for the treatment of Cushing’s syndrome. Some clinics may decide to prescribe off-label abortion pills, she said.
And mifepristone is used in a two-drug regimen with another drug called misoprostol. A Baptist from the Liberty Alliance told reporters during a press conference on Thursday that the lawsuit is only seeking approval for mifepristone.
The World Health Organization recommends misoprostol as a standalone method of terminating a pregnancy. Although the Food and Drug Administration (FDA) has not approved misoprostol as a standalone abortion, clinics plan to use the pill as an alternative to mifepristone.
The American College of Obstetricians and Gynecologists recommends misoprostol as an alternative to early abortion if mifepristone is not available, although it is not as effective as the two-component regimen. according to the organization.
Kachmari also may not suspend the sale of mifepristone and instead order the FDA to impose tighter restrictions on the distribution of the drug.
In January, the FDA finally removed the requirement that patients receive mifepristone in person from a certified health care provider. This allowed for telemedicine appointments and mail delivery of mifepristone.
The Hippocratic Medicine Alliance has petitioned the judge to reintroduce FDA restrictions that had been lifted over the years, arguing that an 1873 federal law called the Comstock Act prohibited the mailing of abortion drugs.
Rebush said the Comstock Act hadn’t been enforced in decades, but there’s a chance a judge could try to revive the statue to force the FDA to re-impose requirements for patients to receive mifepristone in person.