Explainer-What does the FDA's new rule mean for the fight over abortion
pills?
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[January 05, 2023]
By Brendan Pierson
(Reuters) - The U.S. Food and Drug Administration on Tuesday finalized a
rule allowing mifepristone, one of two drugs used in medication
abortions, to be dispensed by retail pharmacies. The rule will make
medication abortion, which accounts for more than half of U.S.
abortions, more accessible in states where abortion remains legal, but
its impact in states that have banned abortion will be limited.
WHAT CHANGES FOR PATIENTS UNDER THE NEW RULE?
Patients will be able to get the drug more quickly.
Previously, mifepristone had to be dispensed by an authorized clinic or
through certain specialty mail-order pharmacies — a process that could
take days or even weeks if a clinic is busy.
Once pharmacies begin dispensing the drug in states that allow abortion,
it "will make it much easier to access the pill," according to Naomi
Cahn, a professor at University of Virginia School of Law.
WHAT DOES NOT CHANGE?
All patients still need a prescription to get mifepristone. It will not
be available over the counter.
Most significantly, the FDA's new regulation will not help patients get
abortion pills in states that have banned abortion, said Amanda Allen of
the Lawyering Project, a legal group that defends abortion rights.
![](http://archives.lincolndailynews.com/2023/Jan/05/images/ads/current/moriearty_sda_LUAL_2022.png)
Nonetheless, Allen said, the rule could make it easier to travel out of
state for a medication abortion. Currently, a patient seeking a
medication abortion in another state must both obtain the prescription
and the pill in that state. That will become much easier if the pill can
be picked up at a retail pharmacy, she said.
As of November, 16 states that permit some abortions had laws
restricting mifepristone, including requirements that it be provided by
a physician, according to the Kaiser Family Foundation. It is not clear
whether pharmacies must comply with these laws; some legal scholars have
argued that federal rules should override them, but the issue has not
been tested in court.
HOW LONG BEFORE MIFEPRISTONE IS AVAILABLE IN PHARMACIES?
It is not yet clear, because pharmacies must first be certified by one
of the drug's manufacturers to dispense it in accordance with federal
safety rules.
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![](../images/010523PIX/health29.jpg)
A pack of Mifeprex pills, used to
terminate early pregnancies, is displayed in this picture
illustration taken May 11, 2022. REUTERS/Caitlin Ochs/Illustration
![](http://archives.lincolndailynews.com/2023/Jan/05/images/ads/current/werth_quarter_LUAL_2022.png) Walgreens Boots Alliance, the
largest U.S. retail pharmacy chain, said Wednesday that it intended
to get certified. CVS Health and Rite Aid Corp have said they are
reviewing the new rule and intended to comply with federal and state
law but have not yet confirmed that they plan to dispense the drug.
COULD THE NEW REGULATION FACE LEGAL CHALLENGES?
Yes. Anti-abortion groups represented by the conservative legal
group Alliance Defending Freedom already filed a lawsuit in November
seeking to undo the FDA's approval of mifepristone for abortion
entirely on alleged safety grounds.
If the Trump-appointed judge rules in favor of suspending the FDA's
20-year-old approval of the drug, it would effectively pull the drug
from the market nationwide and render the latest FDA rule moot.
The judge, Reed O'Connor, has been friendly to conservative causes
before, previously ruling the entire Affordable Care Act
unconstitutional and ruling against the Biden administration in a
case over healthcare coverage for transgender people
Alliance Defending Freedom senior counsel Julie Blake said in a
statement that the new rule "just bolsters the strength and
importance of our case."
COULD ANTI-ABORTION STATES TAKE FURTHER STEPS TO RESTRICT MEDICATION
ABORTION?
Some conservative policy groups and lawmakers have proposed laws
that would make it a crime to help someone travel to another state
for abortion or mail them abortion pills.
Experts have said there would be little if any direct precedent for
whether such laws would be enforceable, potentially triggering a new
round of legal battles.
(Reporting by Brendan Pierson in New York, Editing by Alexia
Garamfalvi and Lisa Shumaker)
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