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The Health 202

A newsletter briefing on the health-care policy debate in Washington.

Can states outright ban abortion pills? It's unclear.

The Health 202

A newsletter briefing on the health-care policy debate in Washington.

Good morning, and happy Friday ☀️ Today’s newsletter top was written with our colleague Laurie McGinley. Send news, tips or otherwise to rachel.roubein@washpost.com

Today’s edition: Oklahoma lawmakers passed the nation’s strictest ban on abortion. A dive into what the growing number of positive cases from administration officials says about who Biden is in contact with. But first …

Abortion pills have been FDA-approved for years – so banning them could be tricky for states

Republican-led states are moving swiftly to restrict access to medication abortion.

The efforts so far have focused on regulations around the pills, such as banning them from being shipped or prescribed. But can states ban the actual abortion pill itself, even though the Food and Drug Administration has approved it? That question could be the next frontier in the abortion wars. 

The short answer comes down to this: The issue isn’t settled law and will likely be litigated in the courts. Some argue states may be hard-pressed to ban the federally approved medication, though antiabortion advocates disagree. 

Here’s what our FDA reporter Laurie McGinley and I learned after posing this question to multiple experts and advocates over the past week. 

Back up, what are abortion pills?

In 2000, the FDA approved mifepristone for medication abortion, and the drug is used with a second pill, misoprostol, to induce what is essentially a miscarriage. The FDA said the drugs were safe and effective for use in the first 10 weeks of pregnancy, and put in place a series of safety protocols around its use. Roughly 20 years later, medication abortion accounts for more than half of all abortions in the United States. 

Have states banned medication abortions?

Some states have introduced bills focused on banning abortion pills, but they haven’t gotten a lot of traction, per Elizabeth Nash, an interim associate director at Guttmacher Institute, a research group that supports abortion rights. (A recent exception is Oklahoma, whose Republican governor is poised to sign legislation banning abortions – including medication abortions – from the moment of “fertilization.")

Rather, states are banning the practice of medicine around the pills. For instance: At least 19 states ban the use of telehealth for medication abortion, and some states have additional restrictions, like prohibiting pills from being mailed. 

Yet, if Roe v. Wade is overturned, some states may try to ban the actual medication. And states already have gestational limits and other abortion bans on the books that could kick in quickly if Roe is overturned — and those likely encompass limitations on the pills, experts said.

Can states ban a medication the FDA has signed off on? 

There’s no clear precedent here. 

Some states may argue they can ban medication abortion because states have the authority to regulate the practice of medicine. The FDA, on the other hand, is the acknowledged authority on medical products, such as the abortion pill. But the line between medical practice and medical products is not always clear.

And if a state squared off against the federal government over an FDA-approved drug … “We don’t know how the court would rule. It’s an open question,” Patti Zettler, an associate professor of law at Ohio State University and former associate chief counsel in the FDA’s Office of the Chief Counsel.

What are the arguments?

Some experts contend that there is a strong argument that the FDA approval of a drug preempts state action — and argue that state bans wouldn’t pass muster in federal courts. 

  • The fact that the FDA has a list of safety requirements governing the use of the drug — rules that many advocates say are not needed — actually strengthens the preemption argument, says Greer Donley, an assistant professor of law at the University of Pittsburgh Law School.
  • That’s because it suggests the FDA has done considerable work to gauge how and when the drug can be safely used, she argues.

But antiabortion advocates contend that state law would still be permitted. 

  • There are medical risks with the drugs, there should be more federal oversight and so states have a “compelling interest” in regulating them — and could impose bans, said Clarke Forsythe, the senior counsel at Americans United for Life, a group that focuses on writing and promoting antiabortion legislation.

What do the courts have to say?

There’s not much litigation here, but one case came up time and time again in conversations with experts. 

That’s the 2014 Zohydro case in Massachusetts. The state tried to prohibit the use of a new FDA-approved opioid, called Zohydro. But when the ban was challenged by the manufacturer, a federal district judge swatted down the state’s arguments, saying the FDA — whose job it is to determine whether drugs are safe and effective — preempted state restrictions.

Massachusetts decided not to appeal the decision, so the ruling didn’t affect other courts or establish a precedent.

There’s also a case pending in Mississippi, though it’s not over an all-out ban of the pills. GenBioPro, which makes the generic version of the abortion pill, sued over additional requirements the state imposed on the pill, such as a counseling appointments and a 24-hour waiting period. The lawsuit was filed in October 2020 and is still pending.

Expect more legal action if the Supreme Court overturns Roe v. Wade’s decades-old protections. “I think we’re very much in a gray zone,” said Laurie Sobel, an associate director at the Kaiser Family Foundation.

Reproductive wars

Oklahoma lawmakers pass strictest abortion ban in the nation

Oklahoma lawmakers passed legislation banning abortions from the moment of “fertilization,” which would outlaw nearly all abortions in the state. If signed by Gov. Kevin Stitt (R), it would take effect immediately and be the strictest prohibition on the procedure in the country, our colleagues Amy B Wang, Felicia Sonmez and Caroline Kitchener report.

The Oklahoma ban employs an enforcement mechanism similar to the one that was signed into law in Texas last year. The law relies on private citizens to file lawsuits against those who perform or seek an abortion — an effort to evade legal challenges. 

  • The bill makes exceptions for medical emergencies, and for pregnancies resulting from rape, sexual assault or incest that are reported to law enforcement. It explicitly allows for the use of the Plan B pill, a widely used form of emergency contraception, but would prohibit medical abortions using pills.

Within hours, Planned Parenthood and the Center for Reproductive Rights said they plan to challenge the most recent ban in court.

Just two weeks ago, Stitt approved a ban on abortions once a fetal heartbeat is detected without exceptions for rape or incest. Earlier this year, he signed off on another measure that would make performing the procedure a crime punishable by up to 10 years in prison, which is slated to go into effect this summer. 

Oklahoma Rep. Wendi Stearman (R), sponsor of the newly passed bill:

Alexis McGill Johnson, president of Planned Parenthood:

Coronavirus

CDC recommends Pfizer booster for children as young as 5

Following a meeting of outside advisers, the Centers for Disease Control and Prevention recommended that children ages 5 to 11 get a third dose of the Pfizer-BioNTech coronavirus vaccine to boost their immunity as infections tick upward across the United States, The Post’s Katie Shepherd reports. 

CDC Director Rochelle Walensky greenlit the recommendation yesterday evening and encouraged parents of children in the age group who have yet to be vaccinated to get their first shot soon. As of now, fewer than 30 percent of children ages 5 to 11 have completed their initial two-shot series, per The Post’s coronavirus tracker.

The agency also strengthened its recommendation that people over 50 should receive a second booster dose — a fourth shot in most cases — to be considered up to date on their coronavirus vaccinations.

Nathan T. Chomilo, pediatrician: 

Passing more coronavirus funding just got even more complicated

In a move of solidarity with the Congressional Hispanic Caucus, members of the leadership of the Congressional Progressive Caucus said they would oppose any attempts to prevent the White House from relaxing Trump-era pandemic restrictions at the U.S. border. That presents a challenge for passing billions of dollars in pandemic relief.

Key context: Democrats have been pressing to approve new pandemic aid to replenish the nations reserves of vaccines, therapeutics and testing, but the funding deal has been held up in the Senate by Republican leadership seeking a vote on the border provision, Title 42, as a prerequisite.  

  • Politico reported that some Senate Democrats have signaled they might be willing to give Republicans a vote on the border policy if it moves coronavirus funding forward. But if enough of the Congressional Progressive Caucus’ members oppose doing so, House Democratic leadership would have to rely on GOP lawmakers to pass more dollars to fight covid-19.

Meanwhile … In a 52-to-43 vote, the Senate failed yesterday to advance $48 billion in pandemic aid for restaurants and other businesses yesterday.

Rep. Jesús “Chuy” García (D-Ill.), vice chair of the CPC:

Not a close contact

The rising number of coronavirus cases within the White House and President Biden’s inner circle have indirectly revealed that few people, including top advisers and family members, appear to spend more than 15 minutes with him, our colleague Annie Linskey writes.

Biden hasn't been in “close contact” with the high-ranking officials testing positive by the CDC’s definition, meaning he hasn’t been less than six feet from an infected person for more than 15 minutes in a 24-hour period.

  • Keeping the 79-year-old president healthy amid the ongoing public health crisis is a top priority of the White House. Beyond his health and well-being, Biden could pay a political price for contracting a disease he’d promised to defeat.
  • Before meeting with Biden, visitors must all produce a negative coronavirus test. As for White House staff, aides are required to be masked and socially distanced from the president.

But for Biden, a politician who famously enjoys handshakes and hugs with those around him, the regular headlines about people in his orbit but have not been physically close serves as a reminder of how isolating it can be being the president of the United States — even without a global pandemic. 

Quote of the week

Health reads

Baby formula plant may be open within a week, FDA commissioner says (By Laura Reiley | The Washington Post)

Why Louisiana’s maternal mortality rates are so high  (Sarah Owermohle | Politico)

This Rural, Red Southern County Was a Vaccine Success Story. Not Anymore. (Brett Kelman l Kaiser Health News)

Sugar rush

Thanks for reading! See y'all Monday.

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