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Three appeals judges appear skeptical of retaining full access to mifepristone

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Happy Thursday, everyone. This morning we’re reading why it’s okay to ignore food expiration dates. Send your rules and tips to rachel.roubein@washpost.com. Not a subscriber? Sign up here.

Today’s edition: What antiabortion groups told former president and GOP presidential candidate Donald Trump. Progressives re-introduce Medicare-for-all legislation. But first … 

The hearing over mifepristone’s FDA approval didn’t bode well for the Biden administration

A federal appeals court seems prepared to limit access to an abortion pill approved over two decades ago.

That was our colleagues’ key takeaway from oral arguments yesterday in New Orleans. A panel of three judges quizzed the lawyers for the federal government and the drug manufacturer about why the Food and Drug Administration has let the drug be sent directly to patients by mail, as well as why medical professionals other than doctors can prescribe mifepristone, The Post’s Ann E. Marimow, Caroline Kitchener and Perry Stein report.

The hearing was part of a high-stakes case brought by several antiabortion doctors and groups seeking to revoke the FDA’s approval of mifepristone. The fight over the medication has escalated in recent weeks, with the outcome having the potential to restrict a drug used in more than half of all abortions in the United States.

How we got here: Last month, U.S. District Judge Matthew Kacsmaryk blocked the federal government’s decades-old approval of mifepristone. Then, the U.S. Court of Appeals for the 5th Circuit temporarily blocked Kacsmaryk’s suspension, but reinstated strict regulations around the pill from before 2016. In response, the Supreme Court maintained full access to mifepristone — at least for now — while the lawsuit went back to the 5th Circuit to review the merits of the case. 

That brings us to yesterday’s oral arguments — and what you need to know about the two-hour hearing. 

More on the case’s backstory from KFF:

The 5th Circuit Court is hearing an appeal of a district court’s decision to temporarily block approval of mifepristone. No matter the ruling, mifepristone will remain available while litigation continues through the final decision of the Supreme Court. https://t.co/T50K5msMQE

— KFF (@KFF) May 17, 2023

1. The judges who heard the case have previously backed abortion restrictions. 

Two of the 5th Circuit judges — Judges James C. Ho and Cory T. Wilson — randomly selected to hear the case were nominated by former president Donald Trump. The other judge, Jennifer Walker Elrod, was a nominee of former president George W. Bush. 

Going into the hearing, abortion rights groups expressed concern that this panel of judges wouldn’t support retaining full access to mifepristone. In previous legal briefs and writings, each of the three judges has supported restrictions on abortion, per Ann. For instance, Ho referred to abortion as a “moral tragedy” in an 2018 opinion, and Elrod upheld a 2017 Texas law banning a common second-trimester abortion procedure. 

Bear in mind: No matter how the judges rule, mifepristone — one of two drugs commonly used in a medication abortion — will remain available under existing regulations until the case is resolved, likely by the Supreme Court.

2. The judges aggressively questioned the government’s lawyers and the drug company — and challenged some of their arguments. 

One of the Biden administration’s central arguments has been that the court shouldn’t second-guess the FDA’s scientific expertise. But Ho made it clear that he rejected that thinking. 

“I don’t understand this theme that FDA can do no wrong,” he said. “We are allowed to look at the FDA just like we’re allowed to look at any agency. That’s the role of the courts.”

The judges also quizzed the federal government’s lawyers on how obtaining the medication works since the pill can be prescribed via telehealth, Perry notes. They asked whether a medical professional can remotely instruct patients on how to potentially evade strict state abortion bans.

  • Sarah Harrington, the Justice Department’s lawyer, said there isn’t any evidence that’s occurring. But she also contended the question isn’t relevant to the case, emphasizing the lawsuit is about whether the FDA properly determined that the pill is safe and effective. 

Meanwhile … Erin Hawley, the lawyer representing the antiabortion groups (who is married to Republican Sen. Josh Hawley of Missouri) was questioned much less aggressively by the judges than the attorneys on the other side, Caroline notes. At the end of her arguments, the judges didn’t have any further questions, so she didn’t even use the full time allotted to her.

3. The question of whether the challengers have standing to sue got a lot of attention. 

The Justice Department and the drugmaker contend the challengers don’t have legal standing to file the lawsuit.

Their argument? That the antiabortion groups and medical professionals haven’t been directly harmed by the FDA’s approval of the abortion pill. The antiabortion doctors’ “carefully worded” affidavits do not actually allege they have provided care violating their religious beliefs or consciences, Harrington said. 

But the judges appeared to refute this claim, with one saying Harrington was trying to “split words” to get the lawsuit tossed. It appears unlikely the panel will agree the challengers don’t have standing, meaning the judges would instead rule on the merits of the arguments against FDA approval, our colleagues note. 

Read the full story from Ann, Caroline and Perry here.

Mary Ziegler, a professor of law at the University of California at Davis:

So very much looking like full steam ahead for now, the SCOTUS stay notwithstanding. This looks like the 5th Circuit panel trying to overcome what are likely to be SCOTUS doubts on standing. https://t.co/KzujoRbXlX

— Mary Ziegler (@maryrziegler) May 17, 2023

Antiabortion leaders push for messaging unity among GOP presidential hopefuls

Antiabortion advocates are using the early days of the 2024 presidential contest to coach GOP candidates on the need to find a common voice on the issue, arguing that any effort to shy away from federal restrictions could jeopardize Republicans, The Post’s Michael Scherer and Josh Dawsey report.

Their influence was on full display during a CNN town hall with former president Donald Trump last week. Before the event, SBA Pro-Life America President Marjorie Dannenfelser and others gathered in Trump’s Mar-a-Lago office to conduct damage control, after his reelection campaign told The Post last month that abortion restrictions “should be decided at the state level.”

  • Trump’s guests insisted that the federal government must have a role and showed him polling from a GOP firm suggesting a majority of Americans support restricting the procedure after 15 weeks of pregnancy.
  • They also reminded Trump of his performance at the 2016 Las Vegas presidential debate, when he described Democratic support for abortions later in pregnancy, which are rare and usually occur in cases of fetal anomalies or threats to the life of the mother, this way: “If you go with what Hillary is saying, in the ninth month, you can take the baby and rip the baby out of the womb of the mother just prior to the birth of the baby.”

Two days later, during the town hall, Trump repeated almost word for word what they had discussed in his office, reframing the debate away from Republican plans and onto misleading claims of Democratic extremism. The moment was a win in a behind-the-scenes battle being waged by antiabortion activists and senior Republican officials to corral the party’s presidential candidates on an issue that has been widely viewed as kryptonite for the GOP since the Supreme Court overturned Roe v. Wade last year, Michael and Josh write.

If you are running for POTUS and say you have no role wirh Congress in establishing at least a 15 week consensus/minimum standard that puts us in line with the rest of the civilized world, you really don’t care about the children and the needs of mothers in states like CA and NY.

— MarjorieDannenfelser (@marjoriesba) April 18, 2023

Drug overdose deaths in the United States plateaued in 2022 but still topped 105,000 — a staggering figure that’s expected to increase because of the lag time in reporting by state agencies, The Post’s David Ovalle reports, citing provisional data released yesterday by the Centers for Disease Control and Prevention.

The CDC is estimating that the final number of overdose deaths last year could surpass 109,000. That would set a record high for the nation, eclipsing 2021, when drugs such as illicit fentanyl, cocaine and methamphetamine killed more than 107,000 people.  

Sen. Bernie Sanders renews Medicare-for-all push

Sen. Bernie Sanders (I-Vt.) is launching his latest effort to transform Medicare into a universal health program. Joined by Democratic Reps. Pramila Jayapal (Wash.) and Debbie Dingell (Mich.), the progressive lawmakers reintroduced a Medicare-for-all bill in both the House and Senate yesterday.

While the effort faces long odds to become law, the notion of a single-payer system has received more support among Democratic lawmakers over the last decade. When Sanders introduced a similar bill back in 2013, he didn’t garner a single co-sponsor. This year’s proposal, however, amassed 14 co-sponsors in the Senate and more than 110 in the House, including several key lawmakers.

Rep. Pramila Jayapal (D-Wash.), who introduced the bill in the House:

White House prescriptions

White House looks to strengthen mental health services in schools

New this a.m.: The Biden administration is announcing a slate of actions this morning aimed at tackling the nation’s mental health crisis, with a focus on increasing access to behavioral health services in schools.  

The details: The Education Department is proposing a new rule to streamline the Medicaid billing process for schools under the Individuals with Disabilities Education Act. The proposal would streamline consent that schools need to bill for Medicaid services, with the goal of making it easier for schools to provide health care to students enrolled in the safety net program, according to senior administration officials.  

The administration is also announcing new funding opportunities to recruit and train behavioral health specialists for children and adolescents; launching a technical assistance program to support mental health programs in schools; and is announcing the availability of $200 million to states, territories and tribal organizations to strengthen the nation’s 988 Suicide and Crisis Lifeline, among other actions.

  • In South Carolina: Lawmakers in the House passed a ban on most abortion after fetal cardiac activity is detected at roughly six weeks, sending an amended version of the bill back to the Senate, the 19th reports.
  • In Florida: Republican Gov. Ron DeSantis signed a bill into law yesterday banning gender transition care for minors in the state. The bill also enacts barriers for transgender adults to access such treatment, such as barring the use of telehealth to begin care, Brandon Girod reports for the Pensacola News Journal.
  • Easy Healthcare, owner of the fertility app Premom, has reached a settlement agreement with the Federal Trade Commission and attorneys general in Connecticut, D.C. and Oregon for allegedly sharing users’ sensitive health information with third parties without receiving consent. The company denied the allegations and any wrongdoing, The Post’s Tatum Hunter reports.
  • Private health insurance companies expect to pay $1.1 billion in rebates this year under an Affordable Care Act provision requiring insurers to spend at least 80 percent of customers’ premium payments on care, rather than administrative costs, marketing expenses and profits, according to new estimates from KFF.

Bogus nurses, fake diplomas: Officials search for unqualified health workers (By Lenny Bernstein l The Washington Pst)

House panel takes first steps toward reining in hospitals with ‘site-neutral’ changes (By Rachel Cohrs l Stat)

Drug Shortages Near an All-Time High, Leading to Rationing (By Christina Jewett | The New York Times)

State Lawmakers Eye Forced Treatment to Address Overlap in Homelessness and Mental Illness (By April Dembosky, Amelia Templeton and Carrie Feibel | KQED, Oregon Public Broadcasting and NPR)

Today’s second @washingtonpost TikTok features seven possible scenarios if we hit the debt ceiling, including:

-People on Social Security & Medicare missing payments

-Federal workers in limbo

-Stocks crashing

-Worldwide economic problems pic.twitter.com/GEcEKfsQ7o

— Chris Vazquez (@ByChrisVazquez) May 17, 2023

Thanks for reading! See y’all tomorrow.

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