Bush
FDA Nominee Cites Safety Concerns Over RU-486
By Christine Hall
CNSNews.com Staff Writer
November 20, 2002
(CNSNews.com)
- Obstetrician W. David Hager Tuesday said his opposition
to the abortion drug RU-486 is based on safety considerations
and inadequate testing, not his position on abortion.
The
Christian physician is under consideration by the Bush administration
to head the Food and Drug Administration's Reproductive Health
Drugs Advisory Committee and has been the subject of controversy
among liberals who oppose his nomination.
Even
though the committee's most immediate task will be to consider
issues related to hormone replacement therapy, Hager's pending
appointment has drawn criticism from groups who claim he will
try to hinder FDA approval of certain drugs and medical devices
and make abortion more difficult to obtain. Hager is pro-life.
Speaking
at a Capitol Hill forum hosted by Concerned Women for America,
he made no secret of the fact that he thinks the FDA flouted
its normal drug approval process in approving abortion regimen
RU-486, also known as Mifeprex, in September 2000.
"This
certainly violated the general trend," of drug approval,
said Hager, who thinks the drug should be withdrawn from the
market until further tests can be conducted to determine whether
the drug is safe.
Short
of pulling the drug from the market, he said the FDA should
amend RU-486 regulations to restrict its use to adult women
and require that doctors administer an ultrasound to determine
whether there is a uterine pregnancy.
If
an ultrasound doesn't show a uterine pregnancy, that's a signal
to the doctor to check for an ectopic (fallopian tube) pregnancy,
which cannot be terminated by use of RU-486 and can be fatal
if left untreated.
Because
RU-486 causes some of the same symptoms as do ectopic pregnancies,
like bleeding and cramping, Hager and other doctors fear that
the ectopic pregnancies will go untreated, causing injury
or death.
He
and other critics of RU-486 say that the final FDA regulations
do not track with precautions taken during the French and
American drug trials. For example, the trials did use ultrasounds
on patients, a practice that is optional under current FDA
RU-486 regulations.
And
adolescents did not participate in the two trials, yet the
FDA waived the so-called "pediatric rule" that requires
testing on children and adolescents before a drug is approved
for their use.
Concerned
Women for America joined the American Association of Pro-Life
Obstetricians and Gynecologists (AAPLOG), and the Christian
Medical Association, of which Hager is a spokesman, in petitioning
the FDA to halt all distribution and marketing of the RU-486.
"FDA,
in approving Mifeprex, acted in a manner inconsistent with
its statutory authorization, regulations and well-established
policies," commented Dr. Donna Harrison, speaking for
AAPLOG.
"The
approval of Mifeprex was...arbitrary, capricious [and] an
abuse of discretion," said Harrison. "It must be
reversed."
Two
groups most responsible for introducing Mifeprex to American
consumers, Danco Laboraties and the Population Council, have
both defended the abortion drug, calling it safe and effective.
"Every
aspect of the drug's manufacturing, marketing and distribution
was reviewed by the FDA prior to approval," a Danco spokesperson
told CNSNews.com in April. "We fully stand behind the
safety and efficacy of the Mifeprex regimen."
The
status of Hager's appointment was uncertain Tuesday. Hager
himself declined to comment on it, referring such inquiries
to FDA Deputy Assistant Secretary for Public Affairs Bill
Pierce, who did not return calls seeking comment.
Spokespeople
for Planned Parenthood and the Coalition for Reproductive
Choice said they did not know of any decision reached by the
administration.
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