Pro-life advocates oppose new FDA guidelines for RU-486 use

By Dennis Sadowski

(CNS) — Pro-life advocates expressed dismay with new Food and Drug
Administration guidelines that effectively expand how pregnant women can use RU-486,
a drug that induces abortion.

The new
rules, announced March 30, allow a woman to use RU-486 — known generically as mifepristone
and by its brand name Mifeprex
— later into pregnancy and with fewer visits to a doctor.

“People need to know this
is a very, very serious expansion of the use of RU-486,” Deirdre
McQuade, spokeswoman for the U.S. Conference of Catholic Bishops’ Secretariat for Pro Life Activities, told
Catholic News Service March 31.

“Clearly the loosening of
the FDA guidelines puts more women, girls and unborn children at risk,”
McQuade said, while expressing concern that women and girls will be faced with
the possibility of delivering a “recognizably human child” at home
with no one in attendance.

“Women panic. They don’t
know what to do. Who’s there for them to care for them?” she said.

McQuade also expressed concern
that the new guidelines allow non-physicians to dispense or prescribe the drug.
“This raises a huge question. Do we want nurses, physician’s assistants,
non-MDs overseeing the prescription of a drug that has very serious
consequences for women?”

Dr. Grazie Pozo Christie, an
advisory board member with the Catholic Association, in a March 31 statement called
the extension of time that RU-486 can be used “substantial.” She said
women “will feel the deplorable effects of this change” when they
will return home “to endure a painful and shocking process by themselves
and of course their babies.”

a radiologist who said she performs fetal ultrasound daily, explained that a 10-week-old fetus is “a well-developed and recognizably human creature. Head,
hands, feet and vigorous movement are evident even to the untrained eye.”

at issue is the psychological and physical impact on a woman, sent home to
experience the very painful cramps of a chemical abortion of a fetus that size,”
she added. “Besides the considerable blood loss and pain, there is every
chance of a woman recognizing a fully formed fetus amongst the expelled
‘products of conception.'”

Randall K. O’Bannon, director of
education and research at National Right to Life, said in a statement
March 30 that the new guidelines do not make chemical abortion safer.

the end, it is obvious that the FDA’s new protocol serves only the interest of
the abortion industry by expanding their base of potential customers,
increasing their profit margin and reducing the level of staff and amount of
resources they have to devote to the patient,” O’Bannon said.

He added
that while the announcement was welcomed by some, documents detailing the
impact on women’s safety has been released.

“Certainly, none of the modifications is of any benefit to the unborn child,” O’Bannon

The new
FDA guidelines for RU-486 brings the regimen for taking the drug in line with what has become standard
medical practice:

— Extending the period when a
woman can take the drug to 70 days of pregnancy from 49 days.

— Lowering the dosage to 200
milligrams from 600 milligrams.

— Reducing the number of visits
to a doctor by a woman to two from three.

is used with another drug called misoprostol, a prostaglandin, to induce a chemical abortion by blocking the hormone progesterone needed to sustain a pregnancy. The
FDA said it changed the guidelines governing RU-486 “based on data and information submitted by
the drug manufacturer.”

abortion opponents said the announcement was politically motivated in the midst
of presidential and congressional elections as Republican and Democrat
candidates seek support from women.

said in the announcement that its decision was based on medical science.

“After reviewing the
supplemental application, the agency determined that Mifeprex is safe and
effective when used to terminate a pregnancy in accordance with the revised
labeling,” the agency said.

Dr. Mark S. DeFranceso, president of the American Congress
of Obstetricians and Gynecologists, welcomed the new regimen in a
statement, saying it “reflects the current available scientific evidence
and best practices and includes many of the recommendations that ACOG had
presented to the agency. Extending approved use of mifepristone through 70 days
of gestation is proven to be safe and effective, and will give women more time
to make the decision that is right for them.”

The new
guidelines run contrary to laws in some states that require doctors to follow
more stringent FDA regulations regarding RU-486 use that were adopted in 2000.
Supporters of legal abortion in North Dakota, Ohio, Texas and elsewhere have challenged
the laws in court.

response to a court order putting a law similar to those in Texas and Ohio on
hold, Arizona legislators recently sent a bill to Gov. Doug Ducey requiring abortion-inducing
medications to be administered according to FDA protocol that was in effect as
of Dec. 31.

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Follow Sadowski on Twitter: @DennisSadowski.

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