Analysis-In US abortion pill case, FDA could soften blow of
court-ordered restrictions
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[March 23, 2023]
By Julia Harte, Gabriella Borter and Brendan Pierson
(Reuters) - A conservative federal judge in Texas could soon order the
U.S. Food and Drug Administration to reconsider its 22-year-old approval
for a pill used in the most common form of abortion in the United
States, or order the approval revoked outright.
Of the various potential rulings possible in the case involving the
abortion pill mifepristone, either of those outcomes would be
unprecedented judicial intervention in the agency's regulatory process.
The FDA declined to comment on the litigation or its next steps. But
interviews with nine U.S. food and drug law scholars and attorneys,
including six who signed onto a brief filed in the Texas case, revealed
the agency has the power to delay or soften the blow of a court-ordered
ban on the drug or reconsideration of its approval.
Any ruling in the case is expected to be appealed. Even if higher courts
upheld a decision against the FDA, the agency could help prevent
mifepristone from being immediately withdrawn from the market, these
experts said.
Some of the FDA's options could be politically and legally risky both
for the agency and mifepristone suppliers, they said.
Mifepristone is part of a two-drug regimen with misoprostol that
accounts for more than half of U.S. abortions.
The agency's role in determining mifepristone's future has gotten little
notice in a court battle that has drawn widespread attention as the most
consequential abortion case since the U.S. Supreme Court last year
overturned the 1973 Roe v. Wade ruling that established federal abortion
rights.
At a hearing last week in Amarillo, Texas, anti-abortion groups asked
U.S. District Judge Matthew Kacsmaryk to halt sales of mifepristone
nationwide – even in states where abortion is legal – while their
lawsuit against the FDA proceeds.
The groups contend the agency used an improper process when it approved
mifepristone in 2000 and did not adequately consider the drug's safety
when used by girls under age 18. The FDA said the pill was deemed safe
after extensive studies and use, and that the challenge comes much too
late.
What happens next will depend on whether Kacsmaryk finds he has the
authority to overrule the FDA's decision.
POSSIBLE OUTCOMES
If Kacsmaryk orders the FDA to reconsider the drug's approval, that
could trigger a years-long process during which the pill would remain
legally available.
Under FDA statutes and regulations, drug approval withdrawal generally
begins with an informal hearing, which can entail extensive document
preparation and the convening of an advisory committee.
The process is often triggered by post-approval studies showing
inefficacy, according to Harvard Law professor I. Glenn Cohen.
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Used boxes of Mifepristone pills, the
first drug used in a medical abortion, fill a trash at Alamo Women's
Clinic in Albuquerque, New Mexico, U.S., January 11, 2023. REUTERS/Evleyn
Hockstein/File Photo
That was the case in 2019 with
Makena, a pre-term birth prevention drug. The manufacturer protested
the FDA's action and subsequent administrative hearings dragged out,
allowing Makena to be sold for more than three years before the
drugmaker took it off the market this month.
Mifepristone makers also would likely challenge a withdrawal under
this process, and the FDA could decide at the end not to remove the
drug's approval, said Greer Donley, an associate professor at the
University of Pittsburgh Law School.
If the judge takes the more extreme option of ordering
mifepristone's approval withdrawn, experts said the FDA would have
another countermove: it could choose not to enforce the ban.
That could mean refraining from any action to prevent continued
mifepristone sales. Or, the FDA could go further and publicly state
it would not take such action.
Some lawyers said the FDA might assert its enforcement discretion
under Democratic President Joe Biden's administration, but
acknowledged that would elicit political and even legal blowback.
Alta Charo, a University of Wisconsin law professor emerita who was
a senior FDA policy adviser during the Obama administration, said
she doubted the agency would actively ignore a court decision, in
part because U.S. lawmakers could retaliate with measures including
budget cuts.
The FDA could also be sued by anti-abortion groups or officials for
not enforcing the order, as could mifepristone makers and sellers
for continuing to make it available.
Continued access to the pill would depend on how much legal risk
manufacturers and sellers were willing to assume, the scholars said.
"If you have the Supreme Court saying that this is an unsafe drug,
at that point the legal risks go up enormously, no matter what the
FDA does," said Donley.
U.S. mifepristone makers told Reuters their decisions about whether
to keep manufacturing the pill would follow the FDA’s lead.
Overseas provider Aid Access, an Austria-based service that ships
abortion medication to U.S. patients, said it would continue
providing the pill no matter how the FDA responds.
Kacsmaryk also is presiding over a lawsuit filed by the anti-vaccine
group Children's Health Defense and others accusing media companies,
including Reuters, of violating federal antitrust laws by allegedly
working with tech companies to censor information about COVID-19. A
Reuters spokesperson has denied the allegations.
(Reporting by Julia Harte and Brendan Pierson in New York, and
Gabriella Borter and Ahmed Aboulenein in Washington; Editing by
Colleen Jenkins and Bill Berkrot)
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