Happy Monday! Congress is back in session this week. Tell us what we need to know: rachel.roubein@washpost.com.
This court case is putting one of two abortion medications in jeopardy
In calls with small private clinics and large abortion providers, Melissa Grant has increasingly found herself talking about a different regimen for medication abortion: using the drug misoprostol alone to terminate a pregnancy.
That’s different from the standard protocol in the United States of taking two drugs together, both mifepristone and misoprostol. But as soon as this week, a federal judge in Texas could rule on a lawsuit seeking to revoke the Food and Drug Administration’s approval of mifepristone — a decision that could be the most consequential ruling on abortion since the Supreme Court overturned Roe v. Wade in June.
Medication abortion accounted for more than half of all abortions in the nation even before the Supreme Court’s ruling, leaving abortion providers scrambling to determine if there are legal pathways to blunt the impact of a decision that doesn’t go their way. That’s where a misoprostol-only regimen could potentially come in.
Abortion providers and the World Health Organization say misoprostol pills can be used effectively on their own to end a pregnancy, though the method is generally considered slightly less effective than the two-step regimen and can cause longer discomfort and cramping. Since 2020, Carafem, a network of abortion clinics and telehealth services, has offered misoprostol-only as one option for ending pregnancies.
- “We’re having people reach out to us saying, ‘Can you tell us the real-life experiences of your patients who’ve used this, and how can we learn to provide it with the most comfort and the most efficacy,’” said Grant, Carafem’s chief operations officer.
Stat’s Sarah Owermohle:
A looming court decision could take abortion pills off the market, even in legal states.
— Sarah Owermohle (@owermohle) February 24, 2023
The Biden administration says it's fighting the possibility, but there aren't many actual levers to pull:https://t.co/cE8uO8OAYB
The details
The case boils down to this: In 2000, the FDA approved mifepristone for medication abortion, and the drug is used with misoprostol to induce what’s essentially a miscarriage. In November, abortion opponents sued the agency in an effort to reverse the more than two-decades-old approval of mifepristone. Were the courts to ultimately take their side, it would be what some experts say appears to be an unprecedented situation: ordering the FDA to remove a medication from the market.
Alliance Defending Freedom (ADF), a conservative legal group, filed the lawsuit on behalf of four antiabortion medical organizations and four doctors. The suit contends the FDA lacked the authority to approve the drug, didn’t adequately study the mediation and that the pills are unsafe.
Such claims have received fierce pushback from Biden officials, providers and some legal experts. The American Medical Association and the American College of Obstetricians and Gynecologists say “robust evidence” accumulated over years shows the drug is safe and effective. And Biden’s Department of Justice has called the allegations “cursory and baseless” with the potential to undermine the country’s process for regulating pharmaceuticals.
The timing: The final brief in the case was due Friday, meaning a ruling could come at any moment from U.S. District Court Judge Matthew Kacsmaryk (more on him later). Biden officials have indicated they will fight any ruling that restricts the medication.
- “We are vigorously defending FDA’s evidence-based decisions,” a spokesperson at the Department of Health and Human Services said in a statement to The Health 202. “The bottom line is that mifepristone went through a rigorous and evidence-based approval process — and we will continue to use every tool we have available to protect access to reproductive health care.”
An appeal would go to the right-leaning U.S. Court of Appeals for the 5th Circuit, before next landing at the Supreme Court. Erik Baptist, senior counsel for ADF, said the group doesn’t believe the case should go all the way to the nation’s highest court because “the facts and the law very much support our side.”
More from ADF:
By illegally approving and continuing to remove safety requirements for chemical abortion drugs, the FDA has proven it places politics above protecting women's health.https://t.co/uS1xYlgDGu
— Alliance Defending Freedom (@ADFLegal) February 26, 2023
The response
Groups supporting abortion rights say it’s difficult to prepare for the upcoming decision.
“People are trying to think creatively based on potential scenarios,” said Lorie Chaiten, a senior staff attorney at ACLU, adding, “they’re looking at ways to make that happen within the law. But again, without knowing what the ruling will be … it’s really hard to plan.”
As we mentioned earlier, providers are discussing whether they could switch to a misoprostol-only protocol. Misoprostol is widely used to perform medication abortions on its own around the world, though in the United States, it’s technically only approved to treat gastric ulcers.
- Using the misoprostol regimen is “certainly one of the things that’s on the table, and every affiliate is in a different position,” said Carrie Flaxman, the senior director of public policy litigation and law at Planned Parenthood.
But again, there are caveats. “That’s going to be dependent on how the judge rules,” said Kirsten Moore, the director of the advocacy organization Expanding Medication Abortion Access Project, adding the plaintiffs also mention misoprostol.
Another option is ramping up surgical abortions — something providers have already done in the wake of the ruling overturning Roe. Many providers likely won’t have the capacity to increase such services much more than they already have.
In other medication abortion news …
The Post’s Caroline Kitchener and Ann E. Marimow had a deep dive out this weekend into Matthew Kacsmaryk, the Texas judge nominated by former president Donald Trump who could take down the abortion pill mifepristone. What emerged from their reporting was a portrait of a religious conservative who is widely regarded as a thorough and analytical legal thinker, but who also comes to his judicial work with a long history of activism rooted in his religious beliefs.
A quick snapshot: When he was 22 years old, he spent a day with his teenage sister’s baby before the infant was given up for adoption. Kacsmaryk’s sister, Jennifer Griffith, says that helped solidify his belief that every pregnancy should be treasured. In college, he wrote a letter to the editor of the student newspaper on abortion, and he has previously shared with friends that he thinks the Supreme Court’s Roe decision was an overreach. Read the full story here.
🧵 A thread from Caroline:
NEW: Matthew Kacsmaryk, the Texas judge who could soon halt the abortion pill, has deep antiabortion beliefs that go back decades.
— Caroline Kitchener (@CAKitchener) February 25, 2023
We spent time in west TX, read his college paper, and interviewed 20 people who know him. Some big finds, w/ @amarimow
(🧵) https://t.co/cRe5LNeFOp
Also of note …
Twelve Democratic state attorneys general sued the FDA in an attempt to loosen restrictions on the distribution of mifepristone, arguing the agency has imposed “particularly burdensome” limitations on the drug, The Post’s Kelsey Ables reports. In a statement to The Health 202, the agency said it doesn’t comment on litigation.
Industry Rx
Doctors who touted ivermectin for covid-19 are now pushing it for flu, RSV
The Front Line Covid-19 Critical Care Alliance first championed ivermectin as a coronavirus treatment. It didn’t live up to the hype, and prescriptions for the drug nosedived.
Now, the group that was formed in 2020 is promoting the anti-parasitic to prevent and treat the flu and RSV, The Post’s Lauren Weber reports. There isn’t clinical data in humans to support using ivermectin for either one, according to the Centers for Disease Control and Prevention and other medical experts, which strongly advise against such protocols.
“And yet, the alliance publishes ‘treatment protocols’ promoting the use of ivermectin for flu, RSV and covid that it says have been downloaded more than a million times,” Lauren writes. “It also recommends a network of hundreds of medical providers and pharmacies that can provide prescriptions for ivermectin, often through virtual visits that can run hundreds of dollars.”
The view from the alliance: One of the alliance’s co-founders, Pierre Kory, a Wisconsin critical care doctor, responded through a spokesman to questions about the group’s recommendations despite the lack of scientific evidence and accusations of profiteering from medical misinformation.
- “He said doctors and medical scientists associated with the alliance began exploring how ‘covid-like’ respiratory infections ‘might respond to novel treatments’ and developed the protocol for RSV and flu ‘using medical and scientific research (including over 80 references to peer reviewed studies) as well as clinical data from doctors currently treating patients,’” Lauren writes.
Coronavirus
Energy Department: Lab leak most likely origin of covid pandemic
A laboratory leak in China most likely caused the coronavirus pandemic, the Energy Department concluded in a classified intelligence report recently shared with the White House and key lawmakers, the Wall Street Journal reports.
Federal agencies as a whole, though, remain divided over the origins of the virus. The updated assessment by the department, which was previously undecided on how the virus emerged, comes in light of new intelligence not yet disclosed by officials. The department made its judgment with “low confidence,” according to people who have read the classified report.
The department joins the FBI in backing the lab-leak theory. Meanwhile, four other agencies and a national intelligence panel believe that the virus likely emerged through natural transmission. The CIA and another agency that officials wouldn’t name remain undecided, WSJ’s Michael R. Gordon and Warren P. Strobel report.
In other health news
- The FDA on Friday authorized the first combination test for the flu and the coronavirus that is fully performed at home, our colleague Laurie McGinley reports.
- The CDC is warning about a sharp rise in people infected with strains of Shigella bacteria that are highly resistant to available drugs, our colleague Lena H. Sun reports.
- The Drug Enforcement Administration is planning to reinstate the requirement that patients see a doctor in person first before being prescribed attention-deficit disorder medication or addictive painkillers, the Associated Press reports.
Daybook
📅 Welcome back, Congress. The House and Senate are both in session this week. Here’s what we’re watching over the next few days:
On Tuesday: The House select subcommittee on the coronavirus pandemic is holding a roundtable to examine the federal government’s policy decisions throughout the public health crisis; the House Financial Services Committee is marking up several pieces of legislation to prepare for future public health emergencies, among other measures.
Also on Tuesday … President Biden will deliver a speech on protecting Americans’ access to affordable health care at an event in Virginia Beach, where he is expected to repeat his frequent criticism of Republicans, alleging they would raise costs.
On Wednesday: A House Judiciary subcommittee will discuss the fentanyl crisis.
On Thursday: The Senate HELP Committee is holding a hearing to examine community health centers. Our colleague Frances Stead Sellers will interview Mark Suzman, CEO of the Bill and Melinda Gates Foundation, on lessons from covid-19, pandemic preparedness and the global health system.
Health reads
Sugar rush
Thanks for reading! See y'all tomorrow.