National

The U.S. faces a range of health care flashpoints — unaffordable drugs, opioids, vaping — as we debate whether to adopt universal care. For now, the Affordable Care Act is the law of the land, but Republicans want to issue it a final death blow.

Health

Wyoming became the first state to ban abortion pills this week after Gov. Mark Gordon (R) signed the controversial bill into law on Friday.

Why it matters: The demand for abortion pills has surged since the Supreme Court overturned Roe v. Wade. The new law also comes as the nation awaits a ruling from a federal judge in Texas who could suspend the FDA's approval of a widely-used abortion pill.

Medication abortion accounted for more than half of all U.S. abortions in 2020, according to the reproductive policy nonprofit Guttmacher Institute.

Abortion pills are frequently prescribed via telehealth and mailed to patients, allowing abortion seekers to circumvent state restrictions on the procedure.

Driving the news: The new law bans the use of abortion medication with a few exceptions, including in the treatment of a "natural miscarriage according to currently accepted medical guidelines," according to the text of the legislation.

Any physician or person who prescribes, distributes or otherwise provides abortion medication could face prison for a maximum of six months and a fine of up to $9,000.

Women who attempt chemical abortions would not be criminally prosecuted.

Gordon has said that legal challenges are expected and that "this question needs to be decided as soon as possible so that the issue of abortion in Wyoming can be finally resolved," AP reports.

The new law will have "no practical impact on abortion in the state of Wyoming, as all abortions were already outlawed by a bill that the Governor signed last year," Michael Pearlman, Gordon’s communications director, said in a statement to Axios. 

Pearlman noted that the abortion ban is currently being challenged in court and that this new law "only establishes new penalties for physicians who provide chemical abortion."

What they're saying: Gordon's decision to sign the bill is "disappointing," Antonio Serrano, ACLU of Wyoming advocacy director, said in a statement. 

Deeply private, personal and unique decisions about abortion should be "made by pregnant people in consultation with their doctors – who should be able to treat their patients according to their best medical judgment."

"A person’s health, not politics, should guide important medical decisions – including the decision to have an abortion," Serrano added.

Don't forget: Wyoming's trigger abortion ban is currently tied up in courts after health providers filed a lawsuit last July challenging the law's constitutionality.

The big picture: Wyoming isn't the only state moving to outlaw or restrict abortion pills. 

Fifteen states already restrict access to medication abortion, including six that require an in-person visit with a physician, per the Guttmacher Institute.

What to watch: In Texas, District Judge Matthew Kacsmaryk, a Trump appointee who openly opposed Roe v. Wade, is poised to order the FDA to temporarily withdraw its approval of mifepristone, one of two drugs used to end pregnancies, after holding a closely watched hearing this week.

Doing so would effectively lead to a nationwide ban on medication abortions.

Wyoming becomes first state to ban abortion pills

It's one of several red states that have moved to restrict access to abortion medication in recent months.

Photo of a set of pills lying next to a box of Mifeprex

Mifepristone and misoprostol pills as displayed at a Carafem clinic for medication abortions in Skokie, Ill. Photo: Erin Hooley/Chicago Tribune/Tribune News Service via Getty Images

Abortion

Public health

A company in Oregon is recalling frozen fruit distributed to major food retailers such as Costco and Trader Joe's following an outbreak of Hepatitis A illnesses.

Driving the news: The recalled products are frozen organic strawberries sold at grocery stores in certain states and a frozen organic tropical fruit blend sold at Trader Joe’s nationwide.

Details: On Friday, the Food and Drug Administration shared an announcement from the Scenic Fruit Company in Gresham, Oregon, saying it had stopped producing and distributing the fruit. 

"Although Hepatitis A has not been detected on this product, out of an abundance of caution, consumers should stop consuming the product and return it to their local store for a refund," the announcement says.

Trader Joe's said in a statement Friday that "no illnesses have been reported to date, and all potentially affected product has been removed from sale and destroyed."

A full list of the recalled products can be found on the FDA website.

Threat level: As of Mar. 13, the Centers for Disease Control and Prevention had received five reports of Hepatitis A cases from the state of Washington.

Two people were hospitalized and no deaths have been reported.

Evidence has pointed to frozen organic strawberries as the likely source of the outbreak, per the CDC.

Another company, California Splendor, Inc., has also issued a recall for frozen organic strawberries sold at some Costco stores on the West Coast. 

Company recalls frozen fruit sold nationwide due to Hepatitis A risk

Organic frozen strawberries are the "likely source" of the Hepatitis A outbreak, the CDC says.

An employee restocks shelves at a Trader Joe's in New York on Dec. 2, 2021. Photo: Jeenah Moon/Bloomberg via Getty Images

Product recalls

Officials in Texas have released a transcript of this week's hearing in a major federal case that could limit access to abortion pills for millions of people across the country. 

Why it matters: The legal challenge was brought by a coalition of anti-abortion groups that argued the FDA did not properly authorize the pill for terminating pregnancies — and a decision in their favor could reverse the agency's authority on drug regulation for the first time.

The groups are asking the judge to grant a preliminary injunction on the FDA's approval of mifepristone, used alongside misoprostol for medication abortion.

The FDA first approved mifepristone in 2000. Now, medication abortion accounts for the majority of abortions in the U.S., according to the Guttmacher Institute.

What happened: District Judge Matthew Kacsmaryk, a Trump appointee who openly opposed Roe v. Wade, asked attorneys in the case a series of questions about legal precedent and the drug approval process during the hearing Wednesday.

Kacsmaryk at one point asked Erik Baptist, one of the anti-abortion groups' attorneys, if he could name any other cases in which a court had intervened when a drug had already been on the market for several years.

Baptist responded that he could not, and proceeded to explain that his clients had been trying for years to challenge the approval through citizen petitions that they say the FDA did not respond to in time.

The judge also asked the defendants, represented by the Department of Justice, about the FDA's use of a specific process known as Subpart H to originally approve mifepristone, noting that it had typically been used for drugs that treat diseases such as cancer and HIV.

The big picture: While Wednesday’s court hearing was open to the public, attendance was limited. Fewer than 19 reporters and 19 members of the public were allowed in the courtroom, according to the Center for Reproductive Rights.

"We represent and advise clinics who provide abortion care to patients across the country, and who could be directly impacted by this lawsuit, yet we were not allowed entry to the hearing despite traveling to Amarillo at a moment’s notice and waiting in line for hours," said Elisabeth Smith, the Center's director of state advocacy.

Worth noting: Kacsmaryk had initially planned to delay telling the public about the hearing due to security concerns, per a previous court transcript.

After The Washington Post reported his plans and several news outlets demanded that the hearing schedule be made public, the judge announced the details on Monday evening.

What we’re watching: A decision to suspend the FDA’s authorization of mifepristone would make it unavailable nationwide, and would impact how health providers across the country offer abortion care.

Some abortion providers have already said they plan to switch to a misoprostol-only regimen for medication abortions, and others say they plan to solely focus clinical abortions.

State of play: Kacsmaryk said after the hearing that he would issue a ruling "as soon as possible."

2023mar15-hippocratic-medicine-pi-hrg

Editor's note: This story has been updated with additional details from the transcript. 

READ: Transcript from high-stakes hearing on abortion pills

The case could potentially reverse the agency's authority on drug regulation for the first time.

Photo of Mifeprex pills laid out next to the brand's box

Mifepristone tablets. Photo: Stormi Greener/Star Tribune via Getty Images

The fight over abortion pills has been escalating since before Roe v. Wade was overturned, but the pills' availability is in danger now more than ever.

Why it matters: With pills now accounting for the majority of abortions, opponents of the procedure are focusing on legislatures and courts to erect barriers. But that's triggering thorny legal questions, foremost of which is playing out in a federal court in Texas over whether the FDA has the final say on whether the pills are safe.

Abortion pills have been available in the U.S. for decades, and while the FDA says that medical evidence shows they are safe and effective, the drugs have been subject of fights over manufacturing, distribution, insurance coverage and who can provide them.

Confusion around the drugs continues in the U.S., where nearly half of adults say they are not sure whether medication abortion is legal in the state they live in, according to a recent KFF survey.

Over half of abortions in the U.S. occur via abortion pills, according to the Guttmacher Institute, a research organization that supports abortion rights. 

Abortion pills are often accessed online and mailed to patients, effectively working to circumvent state bans and restrictions that took effect after the Supreme Court overturned Roe v. Wade.

Medication abortion normally consists of two pills: mifepristone and misoprostol.    

Mifepristone is approved by the FDA to be used alongside misoprostol to end a pregnancy during the first 10 weeks — this includes elective abortions and miscarriages. 

A patient first takes 200 milligrams of mifepristone orally to stop the pregnancy from growing. This is followed 1-2 days later by 800 milligrams of misoprostol taken buccally — placed between the gums and cheek — which causes cramping and bleeding to empty the uterus.

The mifepristone-misoprostol combination regimen has been found to be at least 95% effective at terminating a pregnancy.

Zoom in: Misoprostol — which is approved for the prevention and treatment of gastric ulcers — can also be taken on its own for medication abortion, a method that is supported by the World Health Organization.

While misoprostol is not specifically FDA-approved for abortions, it can still be used to terminate a pregnancy. A health provider has the authority to prescribe the drug for off-label use if they consider it to be medically appropriate.

The misoprostol-only method is slightly less effective than the combination regimen. A February study with over 1,000 U.S. participants found that using misoprostol alone was 88% effective at ending a pregnancy. 

How are the pills used in miscarriage care?

The mifepristone-misoprostol method is considered the most effective medication regimen for managing early miscarriages, per Planned Parenthood. 

The drugs are used to make sure that pregnancy tissue passes after there has been a miscarriage, which makes the patient experience bleeding.

While pregnancy tissue can pass naturally and take a few weeks to do so, the experience can be incredibly distressing for the pregnant person, so they can take mifepristone and misoprostol to ease and speed up that process.

Details: A 2018 study from the New England Journal of Medicine found that the combination regimen was more effective than the use of misoprostol alone, and reduced the likelihood for additional treatments — which might include additional doses of misoprostol or potentially surgical intervention.

Abortion pills are considered safe and effective by major medical groups, such as the American Medical Association and the American College of Obstetricians and Gynecologists.

"Medication abortion using mifepristone and misoprostol has always been part of my practice. It's incredibly safe and effective for people to end their pregnancies or to treat their pregnancy losses or miscarriages," said Jamila Perritt, president and CEO of Physicians for Reproductive Health and an OB-GYN in Washington, D.C., during a roundtable with abortion providers.

Zoom out: Mifepristone is approved for abortion use in over 80 countries.

Why is mifepristone at risk of becoming unavailable?

A coalition of anti-abortion groups in November filed a lawsuit challenging the FDA's overall approval of mifepristone. The plaintiffs argue that that the FDA did not properly authorize mifepristone for terminating pregnancies.

The lawsuit was filed in the Northern District of Texas, where a Trump-appointed federal judge who has openly opposed Roe v. Wade is considering whether to temporarily block the FDA's approval of mifepristone, which would make the medication unavailable even in states that protect access to abortion.

Meanwhile: Two lawsuits in North Carolina and West Virginia are challenging restrictions in those states to settle the question on whether states can regulate or limit drugs that have been approved by the FDA.

Another lawsuit brought by Democratic attorneys general challenges the FDA's dispensing restrictions on mifepristone, arguing that they are "unnecessary" because they drug is considered to be safe and effective.

The FDA first approved mifepristone for pregnancy termination in 2000 under the agency's Risk Evaluation and Mitigation Strategy, a program that adds dispensing restrictions to certain drugs, including requiring specific certifications for those who prescribe them. 

Since its initial approval, the FDA has loosened mifepristone's REMS restrictions over the years, including getting rid of the original in-person requirement and allowing the drug to be accessible via telehealth, as well as letting pharmacists become dispensing-certified.

State of play: Patients can go on websites like Aid Access, Hey Jane and Choix to get the drugs online and have them mailed.

Yes, but: At least 17 states have laws in place that prohibit the use of telemedicine to access abortion medication, and instead require patients to take the treatments in a health care facility.

So-called trigger laws took effect that can make it impossible for people to access abortion pills. Since then, pill providers have experienced soaring demand online.

Most of these bans and restrictions are specific to the pill provider, not the patient. As a result, a user could travel across state lines to pick up the pills. 

Some telemedicine providers — such as Aid Access — are located overseas and mail the pills to all 50 states. However, people who live in red states face a higher risk of prosecution.

What's happening: The FDA recently made a regulatory change to allow retail pharmacies to offer abortion pills, an update that looks to expand access as more red states move to ban or restrict access to abortion.

Walgreens and CVS, two of the largest U.S. pharmacy chains, have said that they plan to have some of their pharmacies certified to dispense mifepristone, as long as it does not conflict with state and federal law. 

Editor's note: This story has been updated with information about the lawsuit from Democratic attorneys general. 

How abortion pills work and why they're in the spotlight

Demand for abortion pills has soared since the Supreme Court decided to overturn Roe v. Wade.

A combination pack of mifepristone (left) and misoprostol tablets, two medicines used together as the abortion pill. Photo: Elisa Wells/ Plan C/AFP via Getty Images

Axios Explains: Abortion

President Biden has made the COVID-19 crisis and a post-Trump return to national unity and traditional democratic ideals his top priorities. From vaccinations to stimulus to schools, Biden is seeking bipartisan compromise while showing a willingness to use executive authority and bare Democratic majorities in the U.S. House and Senate to implement his policies. Republican leaders are navigating deep party divisions over if and how to move beyond former President Trump.

Politics & Policy

The biggest U.S. insulin manufacturers have each committed to lower the cost of their products — a move that will save them money by lowering the amount they'd otherwise have to rebate Medicaid.

Driving the news: Sanofi yesterday said it plans to cap out-of-pocket costs for its most prescribed insulin, Lantus, at $35 per month for people with private insurance, following similar steps from Eli Lilly and Novo Nordisk.

Eli Lilly earlier this month also committed to $35 per month. Novo Nordisk, on the other hand, said it would lower prices by 75%, with its lowest price at $48.20.

The big picture: The companies were facing pressure from President Biden and some in Congress to cap out-of-pocket insulin costs, after the Inflation Reduction Act limited monthly costs of the medicine for Medicare beneficiaries.

Over 1 million adults in the U.S. say they ration insulin due to the high costs of the drug.

Be smart: The companies said they decided to lower costs to ensure that patients could afford their medications. But Novo Nordisk and Sanofi's changes kick in on Jan. 1 and coincide with the elimination of a cap that limits how much manufacturers have to rebate Medicaid.

What this means: Federal law tries to ensure that Medicaid pays the lowest possible price for prescription drugs, and manufacturers who want their product covered have to agree to pay a rebate.

If a drug manufacturer raises its prices faster than inflation, then the rebate they pay also increases.

Insulin prices had risen so much that the rebate owed was higher than the price of the drug. But the law limited what drugmakers to the insulin's price. 

That will end on Jan. 1, when a requirement from the American Rescue Plan takes hold. Then, Eli Lilly, Sanofi and Novo Nordisk's new low costs will save them from owing the government millions.

Additionally, with the price drop, Medicaid will likely end up paying the companies more in order to purchase and cover their drugs, per Ars Technica.

By the numbers: Eli Lily is avoiding paying around $430 million per year in new Medicaid rebates and Novo Nordisk would save $350 million, Spencer Perlman, the director of health care research at Veda Partners, told Bloomberg.

Pharma lowers insulin costs to save money

Illustration of a syringe pulling from a vial with a hundred dollar bill as a label.  

Medicaid

Questions still swirl over Paxlovid as FDA full approval nears

Illustration of a gavel hovering over a block with an image of a red cross.

COVID-19 treatments

Three hospital workers have been charged with second-degree murder in the death of Irvo Otieno, bringing the total to 10 people charged in the case, the Dinwiddie County Commonwealth's Attorney said Thursday.

Driving the news: The three, who worked at Central State Hospital at the time of Otieno's death, were arrested Thursday after seven Sheriff's deputies arrested and charged earlier this week.

Details: The cases of Darian M. Blackwell, 23, Wavie L. Jones, 34, and Sadarius D. Williams, 27, will be presented to a Dinwiddie County grand jury next week for a final determination of charges, per the prosecutor's office. They are being held without bail.

"A key element" of the evidence is the surveillance video from Central State Hospital that captured the intake process, said Dinwiddie County Commonwealth’s Attorney Ann Cabell Baskervill in an emailed statement. 

The prosecutor added that she would not publicly release the video at this time "to maintain the integrity of the criminal justice process."

The video shows the seven deputies pushing a handcuffed Otieno down, Mark Krudys, an attorney for Otieno's family, said at a news conference Thursday.

"You can see that they’re putting their back into it. Every part of his body is being pushed down with absolute brutality," he added.

Of note: Civil rights attorney Ben Crump, who represented George Floyd's family, announced Thursday that he's joined Otieno's family's legal team.

"It is truly shocking that nearly three years after the brutal killing of George Floyd by police, another family is grieving a loved one who allegedly died in nearly the exact same manner — being pinned down by police for 12 agonizing minutes," Crump said in a statement.

 Background: Otieno, 28, died on March 6 during the intake process at the mental health facility where he was being transferred to from county jail. 

He was physically restrained at the time of his death, according to the prosecutor.

The Richmond medical examiner's office identified asphyxiation as a cause of death.

3 Virginia hospital workers charged in death of Irvo Otieno

Civil rights attorney Ben Crump, who's joined the Otieno family's legal team, called the case "shocking."

Attorney Ben Crump during a news conference in Houston, Texas, last May. Photo: Brandon Bell/Getty Images

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