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 The ACLU filed the lawsuit in U.S. District Court in Hawaii to
challenge FDA restrictions that limit the dispensing of the pill,
Mifeprex, to clinics, medical offices or hospitals rather than
retail pharmacies.
The ACLU said that as a result, the FDA's restrictions delay and in
some cases block a woman's access to abortion by requiring her to be
handed Mifeprex by healthcare providers who have arranged to stock
it in their facilities.
That is despite the fact that Mifeprex, which can be used for
abortions up to 10 weeks into a pregnancy, is considered safe and
has been recognized by the FDA itself as providing "meaningful
therapeutic benefit," the lawsuit said.
"The unique and harmful restrictions the FDA imposes on where and
how a patient may receive Mifeprex deny women meaningful access to
this safe and effective treatment with no medical justification,"
the complaint said.
The FDA declined to comment.
Mifeprex, manufactured by Danco Laboratories, was approved in 2000
to terminate early pregnancy when given in combination with
misoprostol, an anti-inflammatory drug that was originally approved
to prevent gastric ulcers.
The lawsuit came after the FDA in March 2016 announced a decision to
relax restrictions on the use of Mifeprex that were in place for
over a decade.
The FDA eased access to it by updating the prescribing information
on the drug's label, thus expanding use to 70 days of gestation from
49 days, cutting the recommended dose of the drug and reducing the
number of required visits to a doctor.
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The ACLU filed its lawsuit on behalf of three healthcare
associations and a family medicine doctor, Graham Chelius, who is
based on the Hawaiian island of Kauai, which has no abortion
providers.
According to the ACLU, while Chelius is qualified and willing to
provide the pill, he cannot stock it at the hospital where he works
due to objections from some colleagues and as a result his patients
must fly to another island for abortions.
To support its case, the ACLU cited a June 2016 U.S. Supreme Court
ruling that struck down a Texas abortion law imposing strict
regulations on doctors and facilities.
(Reporting by Nate Raymond in Boston; Editing by Jonathan Oatis)
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