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Abortion pill access in jeopardy after judges issue conflicting rulings A
federal judge in Texas stayed the FDA's approval of the drug mifepristone, while
a federal judge in Washington state blocked any FDA change in access.


HEALTH


JUDGES' DUELING DECISIONS PUT ACCESS TO A KEY ABORTION DRUG IN JEOPARDY
NATIONWIDE

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Updated April 8, 20235:45 AM ET Originally published April 7, 20237:41 PM ET
Heard on All Things Considered

Sarah McCammon

JUDGES' DUELING DECISIONS PUT ACCESS TO A KEY ABORTION DRUG IN JEOPARDY
NATIONWIDE

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Mifepristone is part of a two-drug protocol that a recent study showed was used
in 98% of medication abortions in 2020. Allen G. Breed/AP hide caption

toggle caption
Allen G. Breed/AP


Mifepristone is part of a two-drug protocol that a recent study showed was used
in 98% of medication abortions in 2020.

Allen G. Breed/AP

Federal judges in two states issued contradictory decisions Friday evening that
could drastically impact access to a drug used in nearly all medication
abortions in the U.S.

In Texas, U.S. District Judge Matthew Kacsmaryk ruled that the Food and Drug
Administration improperly approved the abortion pill mifepristone more than 20
years ago. A coalition of anti-abortion rights groups called the Alliance for
Hippocratic Medicine sued the FDA last year. The judge issued a nationwide
injunction pausing the FDA's approval, which is set to take effect in seven
days.

Within hours of that decision, U.S. District Judge Thomas O. Rice issued a
ruling in a separate case in Washington state. That lawsuit filed by a coalition
of Democratic attorneys general in 17 states and the District of Columbia sought
to block the FDA from pulling the drug from the market.

Rice's decision blocks the FDA from "altering the status quo and rights as it
relates to the availability of Mifepristone."

Washington state Attorney General Bob Ferguson told NPR on Friday that he
believes the judge's ruling could make it possible for patients in those states
to continue using mifepristone for abortion in the short term — even after the
Texas decision takes effect.

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"If you live in Washington State or one of the 17 states that joined Washington
in our lawsuit...then the judge's ruling in our case preserves the status quo on
ensuring that access to mifepristone remains available," Ferguson said. For the
rest, he said, "The Texas judge's ruling seriously has the potential to
eliminate that access for mifepristone here in the coming days."

Most abortions already are illegal in about a dozen of those states, including
Texas, following last summer's Dobbs v. Jackson Women's Health Organization
decision.

Hours after the Texas ruling, the Justice Department appealed to the U.S. Court
of Appeals for the Fifth Circuit, which has a reputation for being a
conservative jurisdiction. The Justice Department says it is also reviewing the
decision in Washington state.


HEALTH CARE


FEDERAL JUDGE IN TEXAS HEARS CASE THAT COULD FORCE A MAJOR ABORTION PILL OFF
MARKET

President Biden said the ruling in Texas could have widespread consequences. "If
this ruling were to stand, then there will be virtually no prescription,
approved by the FDA, that would be safe from these kinds of political,
ideological attacks," the president said in a statement.

"It is the next big step toward the national ban on abortion that Republican
elected officials have vowed to make law in America," Biden added.

He said that the administration would fight the ruling, noting, "The Department
of Justice has already filed an appeal and will seek an immediate stay of the
decision."



Anti-abortion rights groups hailed the Texas decision. "By illegally approving
dangerous chemical abortion drugs, the FDA put women and girls in harm's way,
and it's high time the agency is held accountable for its reckless actions,"
Erik Baptist, senior counsel with Alliance Defending Freedom, said in a
statement.

Mifepristone was approved by the FDA in 2000 for use in combination with a
second drug, misoprostol. More than half of all abortions in the United States
are done using medication, as opposed to a surgical procedure, and the two-drug
combination was used for 98% of them in 2020, according to the Guttmacher
Institute.

Major medical groups say mifepristone, which is also used in miscarriage
management, has a well-established safety record and have been calling for
relaxing restrictions on its use for years.


POLITICS


WHY AN ULCER DRUG COULD BE THE LAST OPTION FOR MANY ABORTION PATIENTS

In its lawsuit, the coalition of abortion rights opponents said the protocol was
improperly approved by the FDA. The group had asked Kacsmaryk, who was appointed
by President Trump and has longstanding ties to conservative religious groups,
to overturn the approval.

The decision in that lawsuit comes three weeks after Kacsmaryk held a hearing in
Amarillo in a courtroom that had room for only a few dozen members of the public
and the press. No recording or public livestreaming was permitted.


NATIONWIDE IMPLICATIONS


NATIONAL


READ THE TRANSCRIPT: WHAT HAPPENED INSIDE THE FEDERAL HEARING ON ABORTION PILLS

Abortion providers nationwide say they've been preparing to rely on another
medication abortion regimen using misoprostol alone. Misoprostol is prescribed
primarily for ulcers, and is already widely used off-label for other
gynecological purposes in the United States.

Research suggests the single-drug regimen is somewhat less effective and often
causes additional side effects. But the World Health Organization says the
method, which has been used internationally for decades, can be safe and
effective at the appropriate dosage.

The decision likely will mean uncertainty and confusion for doctors and
patients, says Farah Diaz-Tello, senior counsel with the reproductive rights
legal advocacy group If/When/How.



"People who are seeking an abortion with pills ... are going to find it much
more difficult to do so, especially in the time period as providers figure out
what they're going to be able to do," she says. "So I think we're going to see
an immediate exacerbation of the crisis of access that already started in June
of 2022" with the U.S. Supreme Court decision last year in Dobbs v. Jackson
Women's Health Organization, which overturned decades of abortion-rights
precedent.

Diaz-Tello predicts more people will look to induce their own abortions without
medical supervision, using medications obtained online or in other countries.
She also worries about the risk of increased scrutiny of patients seeking
medical care for emergency complications from either self-managed abortions or
miscarriages.


NATIONAL


DEMOCRATIC STATE ATTORNEYS GENERAL SUE BIDEN ADMINISTRATION OVER ABORTION PILL
RULES

She says there are no state laws to her knowledge that require healthcare
providers to turn in patients suspected of inducing an abortion, but she worries
the ruling will fuel confusion and misinformation.

"I am worried that ... that is going to translate into a misunderstanding that
is going to lead to the criminalization of people who end their pregnancies,"
Diaz-Tello says.


DUELING DECISIONS

The implications of the Texas ruling is complicated by the outcome of the
Washington state lawsuit.

Prior to the rulings being issued, Amanda Allen, senior counsel and director for
the The Lawyering Project, which supports abortion rights, told NPR that the
prospect of "two very conflicting orders" from federal courts "could impose very
different obligations on the FDA that would be very untenable for the FDA to try
to reconcile."

Allen said the FDA could decide to issue guidance for prescribers about how to
interpret the rulings. But she says such a conflict between the federal courts
might well end up before the U.S. Supreme Court.

Lawyers and advocates on both sides of the case say it is likely to move quickly
through the federal appeals process.



"Everyone's eyes are now kind of pointed back towards D.C.," said Katie Glenn
Daniel, state policy director with Susan B. Anthony Pro-Life America. "We
anticipate that eventually, whether it's the merits of this case, or these
injunctions — now dueling injunctions — that the Supreme Court will have to
weigh in in some way."

 * mifepristone
 * misoprostol
 * Abortion rights
 * Supreme Court

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