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Tuesday, March 26, 2024
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Abortion Pill Case

 * Supreme Court to Hear Arguments
 * What to Know
 * A Central Question
 * Mifepristone, Explained
 * Who Is Erin Hawley?


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LiveUpdated 
March 26, 2024, 9:50 a.m. ET1 minute ago
1 minute ago


LIVE UPDATES: SUPREME COURT TO HEAR ARGUMENTS ON ABORTION PILL ACCESS

A decision by the justices could cut off prescriptions by telemedicine and pills
sent by mail, and also have implications for the regulatory authority of the
F.D.A.


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Demonstrators for and against abortion rights outside of the Supreme Court on
Tuesday.Credit...Maansi Srivastava/The New York Times
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Updated 
March 26, 2024, 8:54 a.m. ET57 minutes ago
57 minutes ago

Abbie VanSickle

Reporting from Washington


HERE’S THE LATEST ON THE CASE.

The Supreme Court is expected on Tuesday to weigh the availability of a commonly
used abortion pill, raising the possibility that it could sharply curtail access
to the drug — even in states where abortion access remains legal.

The case means that abortion is once again before the court, less than two years
after a conservative majority eliminated the constitutional right to abortion
and said it would cede the question of access “to the people and their elected
representatives.”

A decision by the justices, expected by late June, could cut off prescriptions
by telemedicine and pills sent by mail, two changes in recent years that
broadened distribution. It could also have implications for the regulatory
authority of the Food and Drug Administration, potentially calling into question
the agency’s ability to approve and distribute other drugs.

The current challenge involves mifepristone, a drug approved by the F.D.A. more
than two decades ago that is used in nearly two-thirds of abortions in the
country. At issue is whether the agency acted appropriately in expanding access
to the drug in 2016 and again in 2021.

Here’s what else to know:

 * The court is also expected to consider whether the plaintiffs, a group of
   anti-abortion doctors and organizations, can show that they will suffer
   concrete harm if the pill remains widely available. Lawyers call this
   requirement standing. If the court agrees that the plaintiffs have standing,
   Danco, a manufacturer of mifepristone, has contended that would invite a wave
   of litigation, paving the way for doctors who disliked a drug or regulation
   to challenge it by suing.

 * The Biden administration had asked the Supreme Court to intervene after a
   three-judge panel of a federal appeals court favored curbing distribution of
   the drug. Until the justices decide, access to mifepristone remains
   unchanged, delaying the potential for abrupt limits on its availability.

 * Since the decision overturning Roe v. Wade ended a nationwide right in place
   for nearly a half-century, abortion pills have increasingly become the focus
   of political and legal fights.

 * The case began in November 2022, when a group of anti-abortion doctors and
   medical organizations sued the F.D.A., asserting that the agency erred when
   it approved the drug in 2000. The coalition brought the challenge in
   Amarillo, a city in the Texas Panhandle where a single federal judge heard
   all new civil cases. The move all but guaranteed that Judge Matthew J.
   Kacsmaryk, a Trump appointee openly opposed to abortion, would be assigned
   the case.

 * Last March, Judge Kacsmaryk issued a preliminary ruling invalidating approval
   of the drug and taking the pill off the market.

 * In August, a three-judge panel of the U.S. Court of Appeals for the Fifth
   Circuit, one of the country’s most conservative appeals courts, determined
   that mifepristone should remain legal but imposed significant restrictions on
   access that are now on hold. They focused on the F.D.A. decisions in 2016 and
   2021.

Show more
March 26, 2024, 9:50 a.m. ET1 minute ago
1 minute ago

David W. Chen


2023 WAS A LANDMARK YEAR FOR ABORTION BILLS IN STATES. 2024, NOT SO MUCH.

Image

Anti-abortion demonstrators in Clearwater, Fla., in 2023. Floridians are
awaiting a ruling from the State Supreme Court on the constitutionality of the
state law banning most abortions after 15 weeks.Credit...Octavio Jones/Reuters

Last year, when state legislatures convened for the first time since the Supreme
Court overturned the constitutional right to abortion in Dobbs v. Jackson
Women’s Health Organization, lawmakers filed more than 1,000 bills related to
abortion and enacted more than 120, typically along partisan lines.

With Republicans in charge, Florida, North Carolina and Nebraska were among the
states to pass laws banning most abortions after six or 12 weeks of pregnancy.
But in Michigan, where Democrats took full control of state government for the
first time in four decades, legislators repealed a 1931 abortion ban that made
it a felony to administer an abortion.

2024 has been a different story.

Only a couple of dozen bills have been enacted to date out of 600 that have been
introduced, and none of them are considered as ambitious or as polarizing as the
bans or protections states adopted in 2023.

“They’ve been very small potatoes,” said Ingrid Duran, director of state
legislation for the National Right to Life Committee, who has been monitoring
abortion legislation for nearly two decades.

The slowdown, such as it is, reflects the fact that the abortion debate seems
more focused these days on what is happening in the courts and at the ballot
box.

Floridians are awaiting a ruling from the State Supreme Court on the
constitutionality of the state law banning most abortions after 15 weeks. If the
court affirms the ban, then a six-week ban that the legislature passed in 2023
would be allowed to take effect.

Two other notable laws from 2023 also remain blocked by the courts. Idaho’s
“abortion trafficking” law would make it a felony to help a minor obtain an
abortion in another state without parental consent. Wyoming would explicitly ban
the use of pills for abortion.

Meanwhile, abortion rights activists, buoyed by ballot victories to protect
abortion in conservative states like Ohio, Kansas and Kentucky, are devoting
much of their organizational muscle to qualifying for as many as 15 ballot
initiatives in November, said Mary Ziegler, a law professor and historian at the
University of California, Davis.

“Both movements don’t really want to deal with state legislatures right now,”
she said.

One area where anti-abortion forces have been active in the states is pushing
for more tax breaks and educational materials. Gov. Kristi Noem of South Dakota,
a Republican who is considered a possible vice-presidential pick for former
President Donald J. Trump, recently signed into law a requirement that the state
Health Department produce a video and other materials explaining the state’s
abortion ban.

“That was the first of its kind, and something we want other states to do,” said
Kelsey Pritchard, who is director of state public affairs for Susan B. Anthony
Pro-Life America, and a South Dakota resident.

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March 26, 2024, 9:40 a.m. ET11 minutes ago
11 minutes ago

Pam Belluck and Abbie VanSickle


WHAT’S AT STAKE IN THE ABORTION PILL CASE?

Image

Mifepristone is currently used in nearly two-thirds of all abortions in the
United States.Credit...Evelyn Hockstein/Reuters

The main dispute before the Supreme Court centers on whether changes the F.D.A.
made in 2016 and 2021, which significantly broadened access to mifepristone,
should remain in effect.

Mifepristone, the first pill taken in a two-drug regimen for medication
abortion, is currently used in nearly two-thirds of all abortions in the United
States. More than five million women in the United States have used mifepristone
to terminate their pregnancies, and dozens of other countries have approved the
drug for use.

Before those regulation changes, mifepristone had to be prescribed and dispensed
only by a specially certified doctor and picked up in person by the patient, who
would have to visit the doctor three times during the medication abortion
process.

Reinstating the pre-2016 rules would effectively prevent patients from using
telemedicine to get a prescription and from receiving mifepristone by mail — the
way many patients now get access to medication abortion, including patients who
live in states with abortion bans. The pre-2016 rules would also prevent other
types of certified providers — nurse practitioners, nurse midwives and physician
assistants — from prescribing mifepristone, so patients would be able to obtain
the pill only from doctors and might have to travel significant distances to do
so.

In 2016, the F.D.A. also extended the time frame for mifepristone use during
pregnancy, authorizing it until 10 weeks instead of seven weeks.

The decision by the appeals court would technically reinstate that seven-week
limit. But it would have less practical impact because physicians in most states
can legally use medical discretion to prescribe mifepristone until 12 weeks into
pregnancy, the time frame recommended by the World Health Organization, as there
is scientific evidence that abortion pills are safe and effective for the
patient within that time frame.


Show more
March 26, 2024, 9:37 a.m. ET14 minutes ago
14 minutes ago

Linda Qiu

About a dozen activists gathered on the grass on the Capitol grounds, where the
police encircled them and are handcuffing and arresting them. Organizers told me
many protesters who traveled with the Women’s March are prepared to be arrested
today to underscore the severity of the abortion case.

March 26, 2024, 9:25 a.m. ET26 minutes ago
26 minutes ago

Adam Liptak and Abbie VanSickle


THE CASE SEEKS TO PUSH ANOTHER GOAL OF THE CONSERVATIVE LEGAL MOVEMENT:
DISMANTLING THE ADMINISTRATIVE STATE.

Image

The abortion pill case before the court is also an attack on an administrative
agency’s determinations.Credit...Haiyun Jiang/The New York Times

The Supreme Court has in recent years become increasingly skeptical of the power
of administrative agencies. In 2022, it restricted the Environmental Protection
Agency’s ability to tackle climate change and the Occupational Safety and Health
Administration’s power to limit the spread of the coronavirus in the workplace.

The term that will end by July features three more sets of cases seeking to
advance a major goal of the conservative legal movement: dismantling the
administrative state. In the most important of them, the justices are
considering whether to do away with Chevron deference, a doctrine that empowers
agencies by requiring courts to defer to their reasonable interpretations of
ambiguous statutes.

The abortion pill case is also an attack on an administrative agency’s
determinations. In an interview, Erin Hawley, a lawyer for Alliance Defending
Freedom, the conservative Christian legal advocacy organization challenging
approval of the pill, said she viewed the case as a critical check on the power
of agencies.

Ms. Hawley, who grew up in a cattle ranching family, drew an analogy between the
Food and Drug Administration’s regulations of the pill and environmental
regulations she had watched play out in the lives of farmers.

She said she had seen “how those regulations impact people that are really
living on the ground and sometimes for good, and sometimes maybe not for good.”

“And so being pro-life and believing that every child, no matter how small, no
matter if they’re not yet born, is invested with inherent dignity and worth,
government action can have a lot to say about that as well,” she said.

In a brief to the Supreme Court, Alliance Defending Freedom argued that the
F.D.A.’s defense of its rules for the pill, mifepristone, “boils down to one
word: deference.”

The F.D.A. had overstepped its bounds, the group wrote, adding that its “removal
of long-existing and common-sense safety standards like the ongoing care of a
doctor was arbitrary and capricious.”

Earlier challenges differed in two ways from the current attempt to curtail the
availability of the drug: They contested whether the agency in question had been
authorized by Congress or the Constitution to act at all, and they were brought
by businesses subject to agency regulation.

By contrast, the pharmaceutical industry supports the regulatory authority of
the Food and Drug Administration in connection with mifepristone, and more
generally.

Legal experts said there were more promising ways for the Supreme Court’s
conservative majority to undercut the authority of agencies.

“If you’re a justice looking for a case in which to undermine the administrative
state, this is not a particularly elegant one,” said Mary Ziegler, a law
professor and historian at the University of California, Davis. “Everything
about this case makes it an imperfect vehicle, except for the fact that it’s
about abortion and the administrative state. This is boundary testing.”

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March 26, 2024, 9:10 a.m. ET41 minutes ago
41 minutes ago

Margot Sanger-Katz and Claire Cain Miller


HOW COMMON IS MEDICATION ABORTION?

Image

Boxes of Mifepristone, a medical abortion drug, prepared to be shipped to
patients in an office building in Peabody, Mass. last October.Credit...Sophie
Park for The New York Times

Medication abortions involving the drug mifepristone now represent the majority
of abortions in America.

Its use has grown since the federal government eased access to it starting in
the pandemic — allowing pills to be prescribed online and sent by mail or picked
up at pharmacies. Also, some states have passed shield laws that protect
clinicians who prescribe and mail pills into states with abortion bans or
restrictions.

The Supreme Court is considering changes that would tighten access to the drug
by requiring a doctor to give pills to a patient in person.

A growing share of medication abortions are prescribed by telemedicine, where
patients communicate with a clinician online, via chat or video, and the pills
are shipped in the mail. At least one in six abortions, around 14,000 a month,
was conducted via telehealth from July through September 2023, according to
research from the Society of Family Planning, which conducts a census of
abortion providers.

Medication abortion has long been the most typical form in Europe, but it was
less common in the United States until the Covid-19 pandemic, when visits to
clinics became more difficult and the Food and Drug Administration changed its
telemedicine regulations.

In 2020, medication abortions tipped over 50 percent, according to research from
the Guttmacher Institute, which surveys abortion providers. The share has
continued to grow since then: According to a recent Guttmacher report,
medication abortions represented 63 percent of all legal abortions in 2023. But
that data is an underestimate, since it did not include the pills mailed across
state lines under shield laws. (It also doesn’t count pills obtained outside the
formal health system, usually from overseas.)

If the Supreme Court decides to uphold the Fifth Circuit’s ruling restricting
mifepristone access, that number is expected to fall substantially. The ruling
would prevent providers from mailing pills to patients directly, and would
prevent patients from filling a prescription in a pharmacy, instead requiring
every patient visit an abortion provider to receive the pills in person. It
would also restrict prescribing to doctors alone, eliminating abortions now
prescribed by nurse practitioners, midwives and other health professionals. That
change would limit access to abortions in every state, not just those that have
legally restricted access since Roe was overturned.

Abortion pills shipped from outside the country may fill some of that gap. In
the early months after states began banning abortions, shipments of such pills
increased substantially. But they have been largely replaced by pills prescribed
and mailed by U.S. health care providers under shield laws. If the mailing of
mifepristone is banned, more women could again turn outside the U.S. medical
system.

Show more
March 26, 2024, 9:05 a.m. ET46 minutes ago
46 minutes ago

Linda Qiu

Protesters with the Women’s March have also blocked four cross streets near the
Supreme Court. Some have traveled from Amarillo, Texas, where this case
originated and which activists described as “ground zero” in the fight over
abortion.

March 26, 2024, 9:03 a.m. ET48 minutes ago
48 minutes ago

Linda Qiu

Hundreds of protesters supporting and opposing abortion have gathered in front
of the Supreme Court, hours before arguments are set to begin.

Image

Credit...Maansi Srivastava/The New York Times

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March 26, 2024, 8:58 a.m. ET53 minutes ago
53 minutes ago

Pam Belluck


THE IMPACT OF THE COURT’S DECISION COULD BE FAR BROADER THAN ONE MEDICATION.

Image

If the Supreme Court sides with the plaintiffs and decides to roll back or
invalidate Food and Drug Administration regulations on mifepristone, it would be
the first time the court undercut the federal agency’s authority.Credit...Jackie
Molloy for The New York Times

The abortion pill case before the Supreme Court could have implications far
beyond abortion, potentially undermining the regulatory system for all medicines
in the United States.

The lawsuit, filed against the Food and Drug Administration by a consortium of
anti-abortion doctors and groups, seeks to curtail the availability of
mifepristone, the first pill in the two-drug medication abortion regimen. It was
approved by the F.D.A. in 2000 and has been used by more than five million women
in the United States.

If the Supreme Court sides with the plaintiffs and decides to roll back or
invalidate F.D.A. regulations on mifepristone, it would be the first time the
court undercut the federal agency’s authority to independently decide the
conditions governing when and how a drug can be used.

Experts on drug policy and hundreds of pharmaceutical companies have raised
alarm at that prospect. Such a ruling could spur lawsuits over other drugs, they
say, including those that have been politically divisive, such as vaccines or
morning-after pills. Companies say that if they cannot rely on the F.D.A.’s
regulatory authority, it could affect their decisions about which drugs to
develop and how to make them available.

“The resulting litigation and regulatory uncertainty could destabilize the
drug-approval process, undercut drug development and investment, chill
innovation, and compromise patient health,” an amicus brief filed by more than
300 leaders of companies and industry associations said.

The lawsuit, filed in November 2022, sought to overturn the approval of
mifepristone. Last April, Judge Matthew J. Kacsmaryk of the Northern District of
Texas, a Trump appointee who is a longtime opponent of abortion, issued a
preliminary ruling to pull the medication off the market. Later, a panel of the
U.S. Court of Appeals for the Fifth Circuit kept the initial drug approval in
place but rolled back changes the F.D.A. made in 2016 and 2021 that increased
the accessibility of mifepristone to for patients.

If the Supreme Court sides with the Fifth Circuit and orders that mifepristone
be subject to pre-2016 regulations, patients would no longer be able to obtain a
prescription by telemedicine and receive abortion pills in the mail. They would
have to pick up mifepristone in person from a doctor and would have to visit the
doctor three times during the medication abortion process. Nurse practitioners,
nurse midwives and physician assistants would no longer be able to prescribe
mifepristone, further limiting patients’ access.

“If allowed to stand, the Fifth Circuit’s approach could render drug development
unworkable and freeze approved conditions of us in time, depriving patients of
the benefits of evolving science and imposing outdated, unnecessary burdens on
health care providers,” the pharmaceutical industry’s amicus brief said.

“Far from being limited to a single drug,” the brief said, such a decision “will
create chaos in the processes for drug development, approval, and modification.”

The impact of the Supreme Court’s decision depends on how broadly it rules. For
example, some legal experts say the F.D.A. might be able to keep the 2016 and
2021 regulations in place while it gathers additional data for those regulations
in way that would pass muster with the court. In addition, since a ruling would
apply to the F.D.A. and not to abortion providers, some medication abortion
services have been stockpiling mifepristone and may continue prescribing and
mailing their supply.

If providers could not obtain mifepristone, many would prescribe only the second
drug in the medication abortion regimen, misoprostol, which is used for other
medical conditions and is widely available by prescription. It is used on its
own in many countries, although it is considered somewhat less effective and
more prone to causing uncomfortable side effects like nausea, chills and
diarrhea.

Show more
March 26, 2024, 8:53 a.m. ET58 minutes ago
58 minutes ago

Adam Liptak and Abbie VanSickle


THE ARGUMENT WILL MOST LIKELY FOCUS ON LIMITING ACCESS TO THE ABORTION PILL, NOT
INVALIDATING IT.

Image

The Food and Drug Administration first approved mifepristone in
2000.Credit...Andrew Kelly/Reuters

When the Supreme Court hears arguments on Tuesday about the availability of a
widely used abortion pill, the discussion is likely to focus on rules around
prescribing the drug by telemedicine and sending it by mail.

Those changes, which broadened access to the pill starting in 2016, are at the
center of the debate because an appeals court narrowed the scope of the case.

The appeals court imposed some limits on a sweeping ruling from a judge in Texas
that had suspended approval of the pill because it had found that the statute of
limitations — the deadline for filing lawsuits — for certain aspects of the drug
had lapsed.

The Food and Drug Administration first approved the pill, mifepristone, in 2000,
long before the current lawsuit was filed in November 2022.

The F.D.A.’s regulations require groups objecting to its actions to file a
petition with the agency. If that petition is denied, the challengers then have
six years to sue.

Two of the groups in the current suit filed the required petition in 2000, and
the F.D.A. failed to act on it for 16 years before finally denying it in March
2016. That gave the plaintiffs until March 2022 to sue over the initial
approval. They missed that deadline by more than six months.

Judge Matthew J. Kacsmaryk of the Federal District Court in Amarillo, Texas,
nevertheless allowed the challenge to proceed, saying that later actions by the
agency had “reopened” the deadline and restarted the six-year clock. He added
that, in any event, the deadline should be waived under the doctrine of
“equitable tolling.” Under the doctrine, tardy suits are sometimes allowed in
the name of fairness when, as the Supreme Court has put it, the plaintiff
encountered “extraordinary circumstances that stood in the way of timely
filing.”

Judge Kacsmaryk said the F.D.A.’s “unreasonable delay” in responding to the
petition and “the public interest in this case” were sufficiently extraordinary
to warrant equitable tolling.

A divided three-judge panel of the United States Court of Appeals for the Fifth
Circuit endorsed much of Judge Kacsmaryk’s reasoning. But it drew the line,
tentatively, at allowing the untimely challenge to the 2000 approval.

“Although a close call, we are unsure at this preliminary juncture and after
truncated review that F.D.A. reopened the 2000 approval,” the majority wrote,
adding that “no ‘extraordinary circumstance’ prevented plaintiffs from filing
within six years of F.D.A.’s 2016 petition denial.”

But the panel concluded that “the lion’s share of the challenged actions are
squarely within the six-year window,” referring to actions by the agency that
increased access to the pill starting in 2016. The appeals court’s ruling
effectively reinstated requirements for in-person visits with doctors, rolled
back the availability of mifepristone from the first 10 weeks of pregnancy to
seven weeks and barred dispensing it by mail.

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March 26, 2024, 8:53 a.m. ET58 minutes ago
58 minutes ago

Claire Cain Miller and Margot Sanger-Katz


WHAT IS MIFEPRISTONE AND HOW IS IT USED?

Image

Medication abortions are considered as safe as surgical abortions administered
by a doctor in a clinic.Credit...Meridith Kohut for The New York Times

Mifepristone is one of two drugs used in a medication abortion. It is combined
with a second drug, misoprostol, to end a pregnancy.

Mifepristone blocks a hormone called progesterone that is necessary for a
pregnancy to continue. Misoprostol brings on uterine contractions, causing the
body to expel the pregnancy as in a miscarriage.

In U.S. studies, the combination of these pills causes a complete abortion in
more than 99 percent of patients, and is as safe as an abortion procedure
administered by a doctor in a clinic. A variety of research has found that
medication abortion has low rates of adverse events, and a study published in
The Lancet last year found that patients are generally satisfied with it.

Growing evidence from overseas suggests that abortion pills are safe even among
women who do not have a doctor to advise them.

While the only F.D.A.-approved method in the United States is to use both pills,
misoprostol can also end a pregnancy when used alone, and its availability will
not be affected by any ruling on mifepristone. Misoprostol — which is around 80
percent effective on its own, although it sometimes has to be taken more than
once — is also prescribed to treat ulcers, and is available over the counter in
many countries, including Mexico.

The Food and Drug Administration has approved medication abortion for up to 10
weeks of pregnancy, while World Health Organization guidelines say it can be
used up to 12 weeks at home and after 12 weeks in a medical office. The vast
majority of abortions occur before 12 weeks.

More than half of people who get legal abortions in the United States — and
three-quarters in Europe — use medication abortion. During the Covid-19
pandemic, it became more common because patients wanted to avoid going to
clinics in person, and a change in federal regulation made it easier for them to
get prescriptions via telemedicine and to fill them in a pharmacy.

Since nearly two dozen states banned or restricted abortion following the
Supreme Court’s Dobbs ruling, some women in those states have turned to
mail-order abortion pills instead. Clinicians in several states have begun
mailing pills into states with bans, protected by so-called shield laws. And
foreign nonprofit groups and entrepreneurs have shipped some women pills from
overseas. A court decision restricting mifepristone would affect providers in
all states, including those where abortion remains legal. But it would not
influence the availability of the overseas pills, which operate outside the
bounds of the legal U.S. health care system.


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