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In this photo illustration, packs of mifepristone tablets are on display at a family planning clinic in Rockville, Maryland on April 13, 2023.

Anna Moneymaker | Getty Images

The Biden administration and abortion pill distributor Danco Laboratories on Friday asked the Supreme Court to block an order threatening access to that drug, mifepristone, in an escalation of a legal battle that could make it harder to settle to undergo the process nationwide.

The U.S. 5th Circuit Court of Appeals late Wednesday blocked U.S. District Judge Matthew Kacsmaryk’s order to stay the Food and Drug Administration’s approval of mifepristone.

But the appeals court voted 2-1 to temporarily reinstate restrictions on mifepristone, which will severely limit access to the drug even in states where abortion is legal.

“If enacted, the lower court orders would upend the regulatory system for mifepristone, with far-reaching implications for the pharmaceutical industry, women who need access to the drug, and the FDA’s ability to implement its statutory authority ‘ US Attorney General Elizabeth Prelogar said.

The attorney general said this is the first time a court has overturned the terms of an FDA drug approval because of a disagreement over the agency’s judgment on safety. She emphasized that mifepristone has been on the market for more than 20 years.

Mifepristone, used in combination with another drug called misoprostol, is the most common method of abortion in the United States, accounting for about half of all abortions. Misoprostol, which is used as a standalone abortion drug in other parts of the world, is unaffected by the lower court’s rulings.

The Justice Department has said in previous filings that the ruling restricting access to mifepristone is scheduled to take effect at 12:00 a.m. CT Saturday.

Implications for access to abortion

Court of Appeal judges temporarily blocked mail delivery of mifepristone, reinstated doctor visits for patients and shortened the length of time patients can take the pill from 10 weeks earlier to the seventh week of pregnancy. Judges Kurt Engelhardt and Andrew Oldham, appointed by ex-President Donald Trump, voted in favor of the restrictions.

Prelogar said the lower court rulings would immediately mislabel all doses of mifepristone because its labeling would not match the original FDA approval. The generic version of mifepristone, made by a second company called GenBioPro, would also no longer be approved by the FDA at all, Prelogar said.

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Although the 5th Circuit maintained the FDA’s approval of mifepristone, attorneys for Danco said the company will not be able to market mifepristone unless the agency takes a series of regulatory actions to implement the Court of Appeals’ order.

“The direct consequence of the Fifth Circuit’s decision is that the FDA must obtain a comprehensive set of approvals in order to implement the Fifth Circuit’s retraction. Without these approvals, Danco cannot legally market and distribute mifepristone,” wrote Jessica Ellsworth, the company’s attorney.

The Justice Department said realigning mifepristone’s labeling could take months. The delay could deny women access to a drug the FDA has approved as a safe and effective alternative to surgical abortions, the Biden administration said.

DOJ criticizes court decisions

The Justice Department harshly criticized Kacsmaryk’s order and the Court of Appeal’s ruling. Kacsmaryk ruled against the FDA based on “a flimsy allegation” by the anti-abortionists who filed the lawsuit, the government said.

The Justice Department criticized the Court of Appeals for forcing the FDA to review virtually every action the agency had taken against mifepristone since it was originally approved in 2000 — with just 48 hours before Kacsmaryk’s ruling was due to go into effect.

“The course of this litigation has been troubling at every level,” Attorney General Prelogar wrote.

“This court should fully uphold the district court’s opinion and uphold the long-established status quo pending the completion of due appellate review,” she said.

Conflicting court decisions

The national legal landscape surrounding mifepristone has become confusing over the past week after Kacsmaryk of the US North District of Texas and Judge Thomas Rice of the US East District of Washington issued conflicting orders last Friday. The Supreme Court is likely to rule on the drug’s legal status.

While Kacsmaryk issued a sweeping order against mifepristone, Rice barred the FDA from taking any action restricting the drug’s availability in 17 states and the District of Columbia. Rice reiterated Thursday that Texas and the 5th District orders restricting access to mifepristone do not apply in states that have filed lawsuits in Washington state to protect the drug.

The Justice Department said the FDA risks contempt in those states if it allows mifepristone to be marketed in a manner consistent with the 5th Federal Court order.

Danco’s attorneys said the conflicting judgments created an “unsustainable limbo” for the company, providers, women and the healthcare system as they “try to navigate these uncharted waters.”

Rice’s order applies to Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Oregon, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania, Washington and Washington, DC

US suppliers of abortion pills are scrambling to make backup plans as the Supreme Court decides whether to keep restrictions on key drug mifepristone.

Some personal clinics in New York, California and Kansas will offer mifepristone for now, but are preparing to offer an alternative abortion pill if a later decision essentially bans the drug. Several personal providers in Ohio could stop offering mifepristone altogether. A telemedicine provider plans to shut down for up to two weeks to adjust to new surgeries.

All of these efforts are aimed at maintaining access to the most common type of abortion in the US, even as a major litigation over mifepristone escalates.

Access to mifepristone is on the brink and could change quickly depending on what the country’s highest court rules as soon as next week. Judge Samuel Alito on Friday temporarily stayed lower court rulings restricting access to mifepristone to allow judges more time to consider the case.

But for now, telemedicine and in-person clinics could be forced to deal with significant restrictions on the drug, which could come into effect after Alito’s order expires at 11:59 p.m. ET Wednesday.

In this photo illustration, packs of mifepristone tablets are on display at a family planning clinic in Rockville, Maryland on April 13, 2023.

Anna Moneymaker | Getty Images

The U.S. 5th Circuit Court of Circuit late Wednesday froze part of Judge Matthew Kacsmaryk’s order suspending the Food and Drug Administration’s approval of mifepristone. But the court temporarily blocked delivery of the pill in the mail, ordered abortion patients to see doctors again, and reduced the length of time the pill was taken to seven weeks of pregnancy, down from the previous 10 weeks.

These restrictions will limit access to mifepristone even in states where abortion is legal. But the appeals court ruling does not restrict access to abortion pills in 17 states and Washington DC, which were the subject of a separate court decision issued last week, a federal judge in Washington said Thursday.

Some in-person abortion clinics in states where the procedure is legal told CNBC the surgeries will remain largely the same. But they also highlighted their contingency plans in case the court battle leads to stricter restrictions on the pill.

Trust Women, a clinic in Wichita, Kansas, will continue to offer mifepristone even after the restrictions go into effect, according to Zack Gingrich-Gaylord, the clinic’s communications director.

“We are not greatly affected by this ruling,” Gingrich-Gaylord told CNBC, citing the appeals court’s decision. “But we are still prepared to pivot if there are further restrictions. We have the alternate protocol ready.”

The clinic is poised to offer misoprostol as a standalone treatment if a later decision overrules the FDA’s approval of mifepristone, Gingrich-Gaylord said. The drug is typically used in the US in combination with mifepristone in abortion patients

Misoprostol alone is recommended worldwide as a safe and effective treatment for women wishing to terminate their pregnancy. The appeals court’s decision does not affect access to the drug.

Choices Women’s Medical Center in Queens, New York, and the University of California San Francisco Center for Pregnancy Options will also continue to offer mifepristone and have misoprostol-only therapy as a backup plan, hospital officials said.

But some in-person abortion clinics in Ohio may stop dispensing mifepristone altogether when those restrictions go into effect, according to Jessie Hill, an attorney representing several independent providers in the state.

Hill, who is also a law professor at Case Western Reserve University, said Ohio law requires physicians to follow federal labeling guidelines when prescribing mifepristone. She noted that the law means clinics can’t prescribe a drug in a way that hasn’t been approved by the federal government, known as “off-label” prescribing.

Other clinics in states where abortion is legal can prescribe mifepristone outside of the first seven weeks of pregnancy, Hill said. She said this allows clinics to effectively circumvent a limitation in the appeals court order in a way that Ohio providers cannot.

“The regulation makes it particularly impractical for Ohio clinics to prescribe mifepristone, so they probably won’t do it.” We could be the only state in this strange situation,” Hill said.

She noted that some clinics may begin offering the misoprostol-only regimen once the restrictions take effect because it’s “actually a better option for most at this point”.

US-based telemedicine clinics may have to make more sudden changes than in-person providers due to mifepristone mail delivery restrictions.

Abortion Telemedicine will only offer misoprostol in states that allow it when restrictions go into effect Wednesday, according to provider founder Jayaram Brindala. The clinic looks after patients throughout the first trimester, i.e. the 13th week of pregnancy.

Just The Pill is also prepared to offer patients “the safe and effective pure misoprostol therapy when needed,” said Dr. Julie Amaon, the company’s medical director. Just The Pill supplies abortion drugs in Wyoming, Montana, Colorado and Minnesota.

Wisp, a company that offers telemedicine medical abortions in nine states, will also transition to offering only misoprostol when those restrictions are implemented, according to Monica Cepak, the company’s chief marketing officer.

But that change would require the company to close for up to two weeks starting Wednesday, she noted.

“Right now we are in our status quo mode and will remain so until we hear further developments,” Cepak said.

She emphasized the critical role of telemedicine in abortion care in the US, noting that the increasing demand for in-person services is making it difficult for patients to schedule appointments.

“It can sometimes take 20 to 40 days. That’s too long to wait for most people,” she said. “Telemedicine fills that gap.”

US Supreme Court Justice Samuel Alito on Friday temporarily blocked rulings by lower courts that imposed tighter restrictions on the abortion pill mifepristone.

US Judge Matthew Kacsmaryk of the US Northern District of Texas last week suspended the Food and Drug Administration’s approval of mifepristone.

The US 5th Circuit Court of Appeals blocked that part of Kacsmaryk’s order and allowed the FDA approval to stand. However, the Court of Appeals temporarily reinstated stricter restrictions on the use and distribution of mifepristone, which would make it more difficult for women to access the drug.

Alito blocked those decisions that limited access to mifepristone until 11:59 p.m. ET Wednesday. The Alliance Defending Freedom and Alliance for Hippocratic Medicine, the anti-abortion groups that have sued the FDA, have until noon Tuesday ET to submit their response.

The Supreme Court, which has a 6-3 Conservative majority, will next decide whether to keep mifepristone more widely available while the Biden administration’s appeal expires. But the court could also vote to reinstate the limits once the appeal is decided.

The final outcome of the national litigation over mifepristone could severely limit access to the drug, even in states where abortion remains legal. Mifepristone, used in combination with another drug called misoprostol, is the most common method of abortion in the United States, accounting for about half of all abortions.

US Attorney General Elizabeth Prelogar said the lawsuit against the FDA was “disturbing on every level.” She said the lower court rulings are the first time judges have overturned the terms of an FDA drug approval because of a disagreement over the agency’s ruling on safety.

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“If enacted, the lower court orders would upend the regulatory system for mifepristone, with far-reaching implications for the pharmaceutical industry, women who need access to the drug, and the FDA’s ability to implement its statutory authority ‘ said Prelogar.

5th Circuit Justices Kurt Engelhardt and Andrew Oldham, appointed by former President Donald Trump, have reversed virtually all regulatory action the FDA has taken against mifepristone over the past 20 years.

Court of Appeal judges blocked mail delivery of mifepristone, reinstated doctor visits as a condition of receiving the drug, and shortened the time frame that women can take it up to the seventh week of pregnancy. They also blocked approval of GenBioPro’s generic form of mifepristone in 2019.

The legal landscape surrounding mifepristone has become chaotic and uncertain over the past week. US Judge Thomas Rice in the Eastern District of Washington issued a competing order that the FDA maintains access to mifepristone in 17 states and Washington DC

The US government told the Supreme Court that complying with the 5th Circuit’s restrictions would violate the Washington State District Court’s order.

The Justice Department said the Texas and Circuit Court of Appeals rulings would mislabel all doses of mifepristone on the market because their labeling would not align with the 2000 FDA approval. The government said it would take months to realign labeling, which would deny women access to drugs approved by the FDA as safe and effective alternatives to surgical abortion.

Danco Laboratories, the distributor of the abortion pill, said it would not be able to commercialize mifepristone until the FDA took a series of actions to implement the lower court’s rulings.

“The direct consequence of the Fifth Circuit’s decision is that the FDA must obtain a comprehensive set of approvals in order to implement the Fifth Circuit’s retraction. Without these approvals, Danco cannot legally market and distribute mifepristone,” wrote Jessica Ellsworth, the company’s attorney.