Proposed Bill Would Reinstate
Safeguards for Women Taking RU486
by Randall K. O'Bannon, Ph.D.
NRLC Director of Education and Research

(February 8, 2001) -- Under pressure from pro-abortion groups and many of their sympathizers
in the medical establishment, the Food and Drug Administration (FDA)
modified or set aside many of the patient protections the FDA had
considered just months before when it approved the abortifacient RU486
last September. Now, two pro-life legislators want to put those
safeguards back in place and have introduced a bill in Congress that
will offer these women a higher degree of protection.

On February 6, 2001, Senator Tim Hutchinson (R-Ar.) and Congressman
David Vitter (R-La.) introduced the “RU-486 Patient Health and Safety
Protection Act.” (S. 251, HR 482) 

Senator Hutchinson and former Congressman Tom Coburn
(R-Ok.) offered similar legislation last fall when approval of RU486 was
first announced. However, the measure never came up for a vote. Coburn, a physician, retired from Congress at the end of last term, allowing Rep. Vitter to take up the banner in the House.

Hutchinson and Vitter’s bill would require that physicians prescribing
RU486 meet the following five conditions:

1. Be qualified to handle complications of an incomplete abortion.

2. Be legally authorized to perform an abortion and trained to do so.

3. Be certified to read an ultrasound in order to date the pregnancy and
identify an ectopic pregnancy.

4. Be properly trained in the administration of this drug through an
FDA-approved curriculum.

5. Have admitting privileges at a nearby hospital, in case of
complications requiring emergency care, such as heavy bleeding, which is
relatively common with this procedure.

Press accounts which surfaced in June 2000 indicate that each of these
measures was under consideration as a condition of approval as late as
last summer. Those regulations addressed concerns of the FDA panel which met and originally recommended approval in July 1996.

Despite that recommendation, panel members expressed serious
reservations about the ability of prescribing physicians without
surgical or obstetrical training to handle complications, date
pregnancies, or handle the surgical backup for those chemical abortions
which “failed” (see NRL News, October 9, 1996, and June 2000)—precisely some of those concerns the earlier regulations considered by the FDA and the measures proposed by Hutchinson and Vitter sought to address.

The rationale behind these patient protections bears examination.
Owing to the abortion lobby hype extolling the so-called safety and
simplicity of “the abortion pill,” a great deal of misunderstanding and
misinformation exists about RU486, not only in the general public, but
even among doctors. Few realize that the chemical method is actually a
painful, drawn out, complex, two-drug, multiple-visit regimen that
carries a great many risks and potential dangers (see NRL News, August
10, 1999).

In place of the training in the use of the drug that the FDA once
considered calling for, the FDA now asks only that a physician sign a
letter attesting that he or she has “read and understood” the
prescribing information for the drug and will follow the guidelines set
out in the letter. Though better than nothing, there are serious doubts
about whether a physician merely reading about the process can fully
appreciate or be fully prepared for the medically complex, messy reality
of chemical abortions.

Indeed, in U.S. clinical trials, abortionists’ discomfort with the
quantity of blood loss was one of the reasons cited for the higher
percentage of surgical interventions and lower “success” rates in this
country.

Current FDA policy calls for ultrasound only “as needed,” leaving the
decision to the “medical judgment of the physician.” Yet ultrasound is
critical for two reasons: first, because the “effectiveness” of RU486 as
an abortifacient drops off precipitously after the 49th day of
pregnancy; second, because RU486 will not work against ectopic
pregnancy.

Giving a woman RU486 without giving her an ultrasound thus invites
futility, if not outright disaster, if a doctor miscalculates the length
of a woman’s pregnancy or fails to eliminate the possibility of a tubal
pregnancy.

Despite claims of RU486’s safety and efficacy, complications and failure
are actually quite common.

Even at the time frame mandated by the FDA (up to the 49th day of
pregnancy), U.S. trials showed there was a “failure” rate of 8%. This
means nearly 1 out of every 12 women taking RU486 did not abort at all
or did not completely abort. At least 2% of women in the U.S. trials
hemorrhaged (current FDA labeling actually appears to put this figure at
5%) and as many required some form of what the researchers termed
“surgical intervention.”

Who will provide those “surgical interventions” or handle those
“failures”? The FDA’s original proposal limiting prescription to
physicians with surgical abortion experience or training at least gave
the woman the benefit of knowing that the doctor who gave her the pills
could handle the situation if she showed up at his office doorstep
gushing blood. Now, under current guidelines, she may have to rely on
some other doctor, a stranger whom she has never met, whose number is
scrawled on the back of some crumpled-up piece of paper at the bottom of
her purse.

Doctors who originally could have been called upon to practice within an
hour of appropriate emergency facilities and have admitting privileges
at local hospitals now only have to “assure patient access to medical
facilities equipped to provide blood transfusions and resuscitation, if
necessary.”

Whether this means more than pointing out appropriately equipped
facilities in the phone book is unclear. It could mean that when a woman
gets there, the doctor who gave her the drug will be nowhere to be found
— if she can get to the designated place in time.

Even with the patient protections called for in Hutchinson and Vitter’s
bill, the U.S. would still have milder regulations on RU486 than those
in place overseas. In France, where the drug originated, women can only
get RU486 at specially authorized health centers equipped with an
electrocardiograph and emergency resuscitative equipment nearby.

In Britain, another one of the handful of countries with nearly a decade
of experience with the drug, pills are numbered to ensure that they are
released only to trained personnel. Women are not actually allowed to
leave the hospital or clinic until they abort, even if that entails an
overnight stay.

The abortion lobby has complained nonetheless, dismissing
Hutchinson and Vitter’s bill as a political ploy and calling the
proposed regulations “medically unnecessary.”

It is worth asking, therefore, whose interests and agenda the FDA had in
mind when it decided to go with the more minimal standards. The truth is
that the guidelines put out by the FDA in September 2000 made things
more convenient for abortionists, but did not make things safer for the
women involved.

The net effect of dropping the more stringent requirements was to vastly
expand the pool of potential prescribers, to open the method up to
family practitioners, pediatricians, and any other doctor with a
prescription pad, something the abortion lobby desperately wanted.
Because of the FDA’s capitulation, those prescribing RU486 no longer
need have any special training or skills beyond their medical school
diploma.

The FDA also reduced potential overhead for would-be prescribers. With
ultrasounds no longer mandatory, there is no additional expensive
equipment to buy, no ultrasound specialists to hire or train. By
dropping the requirement that doctors prescribing the drug have surgical
experience, the FDA allows doctors to make complications and late-night
emergency phone calls somebody else’s problem.

In announcing the introduction of his bill, Sen. Hutchinson said in a
statement, “The FDA must ensure the safety of all drugs it approves, and
RU-486 is no exception. I have no doubt that if women were asked whether their doctor should be required to be able to read an ultrasound, handle complications, and get them admitted to the hospital in case of
emergency, they would not hesitate to demand those levels of
competence.”

Senator Hutchinson said that this bill “seeks to ensure that the health of women who take this drug will not be jeopardized due to improper
administration of the drug by an inadequately trained health
professional.”

In his own press release, Congressman Vitter added, “The politicized
approval of RU-486 last year will not only increase the number of
abortions performed each year, it will create serious and potentially
dangerous side effects for women using the drug...The least we can do is
ensure that this drug does not endanger the health of the mother.”


Actual Text of Hutchinson Bill -- Requires Acrobat Reader