A federal judge allowed the abortion pill mifepristone to continue being distributed by mail nationwide for now, but warned the Biden-era policy could soon face major legal changes as a Food and Drug Administration (FDA) safety review of the drug unfolds.

The legal challenge to the U.S. Food and Drug Administration’s January 2023 Risk Evaluation and Mitigation Strategy (REMS) seeks to end the “certified pharmacies” regulation that allows for the drug to be mailed across state lines while the federal agency continues its review.

U.S. District Court Judge David C. Joseph, appointed by President Donald Trump, ruled against Louisiana Attorney General Liz Murrill on Tuesday, citing what he referred to as a “government by lawsuit.”

“…It is the completion of FDA’s promised good faith, evidence-based, and expeditious review of the mifepristone REMS, not “government by lawsuit,” that this Court finds to be in the public interest,” Joseph wrote in his ruling.

PLANNED PARENTHOOD ATTACKS HAWLEY EFFORT TO STRIP FDA APPROVAL OF MIFEPRISTONE

A federal judge Tuesday allowed the abortion pill mifepristone to continue being distributed by mail nationwide. (Evelyn Hockstein/Reuters, File)

Joseph also cited a letter from both Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary asking their respective agencies to “conduct a comprehensive safety review” of the 2023 mifepristone REMS.

Murrill told Fox News Digital she plans on taking Joseph’s ruling to the Fifth Circuit despite the ongoing mifepristone REMS review from both agencies.

“Judge Joseph concluded that Louisiana has standing to sue and is likely to succeed in showing that the 2023 REMS is unlawful,” Murrill said to Fox News Digital in a statement.

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Pro-life supporters rally outside the Supreme Court in Washington, D.C. (Olivier Douliery/AFP, File)

“He also concluded that Louisiana suffers irreparable harm every day that the 2023 REMS remains in effect,” she added. “Accordingly, under binding Fifth Circuit precedent, the only thing left to do is vacate the 2023 REMS pending the outcome of this litigation. We will ask the Fifth Circuit to do so.”

The ruling sets up a high-stakes legal fight over abortion pills, with a federal appeals court showdown looming and the FDA under pressure to justify rules that dramatically expanded access in recent years.

In the past year, many red states nationwide have taken the 2023 REMS mail-order regulation to the courts. 

In one notable incident last year, a Texas man who fathered an unborn child sued a California doctor who prescribed his ex-girlfriend mifepristone through the organization “Aid Access.” His case, Rodriguez v. Coeytaux, is still ongoing.

HAWLEY INTRODUCES BILL TO STRIP FDA APPROVAL FROM ‘INHERENTLY DANGEROUS’ ABORTION PILL

A federal judge ruled against Louisiana Attorney General Liz Murrill on Tuesday, citing what he referred to as a “government by lawsuit.” (Chris Graythen/Getty Images, File)

In the State of Louisiana v. U.S. Food and Drug Administration, Murrill seeks a full rollback of the REMS policy regardless of the findings of the review.

Joseph denied injunction without prejudice in the suit that Louisiana brought to the court, but also granted stay of the case. His ruling orders the FDA to complete their safety review, which had been postponed through the November midterm elections, and to report back in six months.

“Should the agency fail to complete its review and make any necessary revisions to the REMS within a reasonable timeframe, the Court’s analysis – and the weight accorded to these factors – will inevitably change,” Joseph wrote in his ruling.

Joseph did point to Louisiana’s standing in the suit, claiming the state is suffering “ongoing harm” after the Dobbs decision in 2022 allowed the state to ban abortion.

“Thus, in that post-Dobbs regulatory environment, there is evidence that the 2023 REMS was approved without adequate consideration, at least in part, as part of an effort to circumvent anti-abortion states’ ability to regulate abortion,” Joseph wrote. “Likewise, there is evidence that the consequences of this action were predictable – out-of-state providers and related entities would expand access to mifepristone in ways designed to reach into jurisdictions like Louisiana.”

PRO-LIFE ORGANIZATION CALLS ON HHS AND FDA TO SUSPEND ABORTION PILL APPROVAL, TIGHTEN SAFETY RULES

Mifepristone was first approved by the FDA in 2000 under strict guidelines. (Charlie Neibergall/AP, File)

However, Joseph pointed to the FDA as the ultimate decision maker on the issue, as a matter of “public health judgment.”

Mifepristone was first approved by the FDA in 2000 under strict guidelines, requiring a pregnancy at seven weeks’ gestation or fewer, and only administered in-person after being seen by a prescribing physician. 

The guidelines were first relaxed in 2016, where the gestational age of the proposed pregnancy was lengthened to 10 weeks, and required fewer in-person visits to obtain a prescription.

After the COVID-19 pandemic, where mifepristone was prescribed and sent via mail under unprecedented circumstances, the same rules were legalized under the FDA’s REMS in 2023.

Reuters reported that mifepristone is the single-most popular method of abortion in the U.S., representing about 60% of all abortions.

HAWLEY LAUNCHES INVESTIGATION INTO ABORTION DRUG MANUFACTURERS OVER ‘GRAVE RISKS’ TO WOMEN

A Kansas law requiring that patients be informed of reversal regimens for medication abortion is one of two being challenged in a lawsuit by abortion providers. (Charlie Riedel/AP)

Joseph’s ruling orders the FDA to finish their review, which may revise rules under the 2023 REMS guidelines. It also allows the court to act if the agency continues to delay its safety review more than six months.

“Should the agency fail… the Court’s analysis… will inevitably change,” Joseph concluded.

Joseph maintained mifepristone access in Louisiana for now, but signaled the legal and scientific basis for those rules may not hold.

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“This is one of the many reasons why the investigation into the FDA must be sped up so that states can begin to regulate abortions if the feds don’t,” 40 Days for Life President Shawn Carney told Fox News Digital. “This was one of the great promises by RFK that they initiated last year, because we now know how dangerous these abortion drugs are.”

“The investigation into the FDA must be sped up because every abortion pill sent through the mail is a huge, unregulated danger that has been a disaster since Biden deregulated it,” Carney added.

The FDA did not immediately respond to Fox News Digital’s request for comment.

Associations representing two health-care worker sectors given a central role in Saskatchewan’s newly-announced health care plan say they are optimistic about its prospects.

“We’re very excited about this announcement,” said Toni Giraudier, president of Saskatchewan Association of Nurse Practitioners.

Under the province’s new “patients first” health care plan announced Monday, nurse practitioners can take on enhanced roles in emergency rooms and long-term care centres to reduce wait times.

The plan also looks to increase opportunities for publicly-funded primary care by removing the limit on government contracts for nurse practitioners.

“It creates an opportunity where a nurse practitioner in a community can open a clinic. Or maybe there is a position but they have that interest to build their own team — this provides an avenue for them to do that,” Giraudier said.

Health Minister Jeremy Cockrill touted nurse practitioners as a key part of the government’s plan, noting that 26 new training seats would be added, split between the University of Saskatchewan and the University of Regina. He said this would increase nurse practitioner training capacity by 45 per cent.

The government also said it will invest $78,000 over two years to help registered nurses pursue training as nurse practitioners through a return-for-service contract.

2:08
Saskatchewan launches new health-care plan, says ‘standing still’ not an option

Greater responsibilities are also being afforded to pharmacists in the new plan.

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With an expanded scope, pharmacists will be able to order labs, perform point-of-care testing for conditions such as strep throat and ear infections, and broaden the range of prescriptions they can issue.

“It offers them an opportunity to use the skills and training that they got when they were at university,” said Michael Fougere, CEO of the Pharmacy Association of Saskatchewan.

“Dispensing is an integral part of the health-care system, but pharmacists and pharmacist technicians are trained to do much more,” he said.

Both the nurse practitioner and the pharmacy association say they’re receiving a lot of what they’ve been advocating for in the new plan, despite not being privy to its release.

However, both associations say they have questions about its scope and implementation.

“How is this actually gonna work?” said Giraudier, adding that she is excited to see the plan fully in action.

“We would like to see some direction on the recruitment and retention of pharmacists, as with other health care professionals,” said Fougere.

Improving recruitment, retention and training is one of the five pillars of the new plan.

The province said Monday it would streamline health-care recruitment, expand its recruitment incentives and increase training, including by adding more seats for medical training and residencies.

But for CUPE, which represents over 14,000 health care workers in the province, addressing the needs of front-line health care staff is missing from the new plan.

“They just realized that they want to put patients first. But for that to be done, we have to address the root cause of the problem, which is the short staffing,” said Bashir Jollah, president of CUPE Local 5430.

Health Minister Jeremy Cockrill told reporters Monday that retention goes hand in hand with recruitment and is currently being addressed with unions at the bargaining table.

“It really is about building the overall brand, the narrative of what a career in health care in Saskatchewan looks like,” Cockrill said.

But Jollah, who spoke to Global News during his bargaining lunch break, says he is not convinced that change will come fast enough.

“I am not optimistic with the pace that things are going,” Jollah said.

“We are putting processes in place, we are reaching out to our members, we’re consulting our members to see what’s going to be our next move, and that includes job action.”

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After hinting at it a week ago, Saskatchewan Premier Scott Moe has unveiled his plan to address health care, which focuses on improving access.

But the opposition NDP say the plan is a “recycle” of a health-care strategy from 14 years ago.

Moe said the “Patients First Health Care Plan” will ensure people get the “right care in the right place at the right time.”

“We have listened to people across the province, listened to patients, listened to families and listened to providers,” Moe said. “What we’ve heard is really reflected in the two commitments in the 2024 speech from the throne following the election: access to primary health-care providers for everyone in Saskatchewan was a commitment that we made and access to timely surgeries and diagnostics, also a commitment that we made.”

The premier touted the plan as having more than 50 actions being taken, including expanding access to virtual care, increasing the number of urgent care centres and access to them and continuing to recruit and train more doctors, nurses and nurse practitioners.

Moe said with the plan, they’re also setting new targets that include a three-month wait time for surgeries by 2028, have 90 per cent of patients waiting for a diagnostic to receive it within 60 days or less and complete 450,000 surgeries over the course of four years.

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The province said Monday it would streamline health-care recruitment, expand its recruitment incentives and increase training, including by adding more seats for medical training and residencies.

According to the plan, this also includes increasing nurse practitioner positions in emergency rooms and urgent care centres to reduce wait times.

Health Minister Jeremy Cockrill touted nurse practitioners as a big part of their plan, noting there would be 26 new seats split between the University of Saskatchewan and the University of Regina. He said this would increase training capacity for nurse practitioners by 45 per cent.

“As part of this plan, we are taking an all-in approach on the role of nurse practitioners in this province as a central part of improving that access to primary care,” Cockrill said Monday.

The government also said it will be investing $78,000 over two years for registered nurses to pursue training as a nurse practitioner with a return for service contract.

The minister told a news conference the plan also includes virtual care supports for unattached patients to start, providing them with basic primary care and the ability to renew prescriptions from home.

“We’ve heard you and standing still is no longer an option,” Cockrill said.

Health care has been an issue for both the government and the opposition in the legislature.

The government has stressed it’s working to tackle issues such as overcrowding and patient care, even after facing calls by health-care workers and the opposition for urgent improvements.

Plan a ‘recycle’ from the Brad Wall government: NDP

NDP MLA Keith Jorgensen criticized Moe during a news conference Monday, saying despite being premier since 2018, it was concerning that “just now, he wants to start a conversation with Saskatchewan people about the future of health care.”

“People, both patients and also front-line health-care workers, have been begging, begging for a seat at the table wanting to talk about their concerns about the crisis in health care and now, after eight or nine years, he wants to start a conversation,” Jorgensen said.

He also criticized the government over what he called routine closures of the urgent care centre in Regina.

Jorgensen told reporters the government’s plan resembled one from 14 years ago from former premier Brad Wall, which he said was called the “Patient First Transformative Act.”

“It is alarming that the government’s response, rather than coming up with new solutions to the problem, is to recycle something they tried 14 years ago and did not work,” he said.

Asked about the government’s focus on nurse practitioners, Jorgensen said the NDP have heard people “rave” about interactions but said it’s about the “execution.”

“It’s the execution, we still have to find those people, we need them in the right place and you still need them interacting with physicians,” Jorgensen said.

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As governments work to improve Canadians’ access to a family doctor, a new report shows the ability to access primary care varies depending on the province or territory.

The report, based on the Canadian Medical Association’s Our Care survey, shows about 5.8 million adults remain without primary care access. But when narrowing down, fewer Canadians in New Brunswick, Newfoundland, Prince Edward Island, Quebec, and two territories have access compared to others such as Ontario, British Columbia or Manitoba.

“I think the report findings really illustrate how we don’t have one national health-care system, instead we have 13 or more primary care systems,” said Dr. Tara Kiran, who worked with the CMA on the survey.

The survey gathered responses from 16,876 Canadian adults from across the country. They were asked if they had a regular family doctor or nurse practitioner, or a primary care setting to receive care.

New Brunswick ranked among the lowest, with 65.9 per cent of respondents reporting they had a primary care clinician — meaning if that number held true for the full population about an estimated 240,000 people are without.

“It’s not surprising to see that we’re lagging behind other provinces with regards to access to family physicians,” said Dr. Lise Babin, a family physician in New Brunswick.

“That’s what the numbers have been telling us for the last years and the fact there has not been much investment in primary care in New Brunswick like in the past years, that has definitely contributed to us lagging behind.”

By comparison, Alberta, Ontario and Manitoba saw the highest numbers of people reporting having a clinician at 87.4 per cent, 88.5 per cent and 88.8 per cent, respectively.

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Kiran said there could be multiple factors behind this including investments in team-based care, such as in Ontario and Alberta, or better pay that attracts doctors to those provinces.

Babin said in an interview with Global News the lack of a family doctor can lead to issues for Canadians’ health, especially those with chronic health problems.

2:28
Health Matters: 6M Canadians still do not have access to primary care, survey suggests

A recent study from Ontario backs up Babin’s assertions, with researchers finding Ontarians with multiple chronic conditions who went without a family doctor for two or more years had 12-fold higher odds of death, and a nearly 16-fold higher chance of premature death.

The report by the CMA also looked at whether those with a clinician could get care for an urgent concern the same or following day, with only 37 per cent nationally saying they could.

Ontario reported higher than the national average at 44.6 per cent, while Nova Scotia, Newfoundland and the Northwest Territories reported lower than average rates.

“It’s not that the doctor doesn’t want to do a good job and see the patient, it’s just that we haven’t designed our systems to be able to make that easy,” said Kiran.

She said one way to improve that is more investment in inter-professional teams to “grow the capacity” of family doctors and nurse practitioners to care for people.

After-hours care was also examined, with 31 per cent of Canadians reporting someone from their primary care clinic was able to help with urgent issues outside regular weekday hours.

B.C., Alberta, and Atlantic Canadian provinces all ranked “significantly” lower than the national average.

“So there are circumstances when patients could maybe get some advice late in the evening, and that’s where 811 comes in, and there are situations where patients don’t generally abuse the emergency department,” said Dr. Eddy Lang, an emergency room physician in Calgary.

“If they’re coming to see us, they genuinely feel they have an urgent problem that requires attention.”

Overall, the report found that among those with primary care access, about 67 per cent said their doctor or nurse practitioner supports their general well-being.

But it also found satisfaction by Canadians in the primary system was still low, with just 27.8 per cent nationally saying they were satisfied with how it is working.

“I think the conclusion is that we haven’t been doing OK for many years, but I think there is optimism,” said Babin. “We just have to go with it (investments) and then just try to do as much as we can with the investments we have now and I remain optimistic that we’re going to see a difference.”

Kiran adds that since the satisfaction rate is consistent regardless if a province or territory has more people with a family doctor or not, it shows primary care is about more than just having a clinician.

“People are looking not just for a family doctor, but being able to get in in a timely way, have access to their records, be treated with respect and feel empowered to be able to take care of themselves with the information that they need,” she said.

—with files from Global News’ Katherine Ward

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