Download 1 Statement of Vicki Saporta, President and CEO National Abortion

Statement of Vicki Saporta, President and CEO
National Abortion Federation
Submitted to the House Subcommittee on
Criminal Justice, Drug Policy, and Human Resources
May 17, 2006
The National Abortion Federation (NAF) is the professional association of abortion
providers in the United States and Canada. NAF’s mission is to ensure safe, legal, and
accessible abortion care to promote health and justice for women. NAF’s members
include physicians, advanced practice clinicians, nurses, counselors, administrators, and
other medical professionals at more than 400 facilities. NAF members are recognized
experts in abortion care and include non-profit and private clinics, women's health
centers, Planned Parenthood facilities, hospitals, and private physicians’ offices, as well as
nationally and internationally recognized researchers, clinicians, and educators at major
universities and teaching hospitals. Together, they care for more than half the women
who choose abortion each year in the United States.
NAF welcomes the opportunity to submit comments to the House Subcommittee on
Criminal Justice, Drug Policy, and Human Resources. NAF has extensive experience
with mifepristone (also known as RU-486 and marketed in the United States under the
name Mifeprex). We developed education and training resources for health care
providers, patient education materials, and information for the general public to coincide
with the approval of mifepristone in 2000. Since its approval, NAF has continued to
educate and train providers in its use, educate women about the option, and has carefully
monitored developments concerning mifepristone’s safety and efficacy.
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Mifepristone has a long and well-established record of safety. First licensed in France
and China in 1988, it has since been approved in 36 countries. Millions of women
world-wide have safely used mifepristone, including approximately 600,000 women in
the United States. Mifepristone in conjunction with misoprostol is a safe and effective
regimen for early medical abortion. Major complications associated with its use are rare.
The FDA approved mifepristone based on extensive medical and scientific evidence.
Since its approval, however, opponents of abortion have attempted to restrict women’s
ability to access this safe and effective method for early abortion.
Numerous allegations have been made that the FDA “fast-tracked” their review of
mifepristone. The FDA approved mifepristone following more than four years of review,
contrasting with a median 15.6 month approval time for all other new molecular entities
approved in that year. The approval of mifepristone was not accelerated, nor did
mifepristone bypass the standard review process for new medications. For the approval of
mifepristone, the FDA invoked a provision known as “Subpart H,” which allows the
FDA to establish a distribution system to assure safe use of certain drugs the agency has
found to be effective. Subpart H was only invoked after the clinical trials had been
concluded and an approvable letter had been issued. There has been a great deal of
confusion over this provision as it has also been invoked for accelerated approvals in other
contexts, such as with certain HIV and cancer treatments. The safety and efficacy of
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mifepristone, however, was thoroughly reviewed during regular clinical trials, which were
not accelerated or abbreviated.
Since its approval by the FDA in 2000, there have been two revisions to the labeling for
mifepristone, most recently in July 2005, in order to incorporate expanded safety
information including precautions and warning signs for infection, ectopic pregnancy,
and excessive bleeding. Corresponding patient education materials from the manufacturer
have been amended to reflect these changes, and have been incorporated into NAF's
educational materials.
Six deaths in the United States have been reported in women following the use of
mifepristone/misoprostol. One death reported following the use of mifepristone and
misoprostol was due to a ruptured ectopic pregnancy. Ectopic pregnancy is a pre-existing
condition not caused by the use of mifepristone and misoprostol, and these medications
are not an effective treatment for ectopic pregnancy. Ectopic pregnancies develop outside
of the uterus, usually in the fallopian tube, occur in 2% of all pregnancies, and are the
most common cause of death in the first trimester of pregnancy. As an ectopic pregnancy
grows, it damages the tube causing it to rupture (burst) and bleed.
Reports of fatal infection in women using mifepristone/misoprostol are very rare. Four
deaths have been attributed to sepsis following Clostridium sordellii infection and one
death reportedly linked to another clostridial organism, Clostridium perfringens, is
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currently under investigation. Clostridium sordellii is a species of bacteria that in very rare
cases causes toxic shock that is rapidly fatal. Four of the confirmed cases of Clostridium
sordellii have occurred in California. Very little is known about how or why Clostridium
sordellii becomes lethal. Clostridium sordellii has also been identified as a cause of death
following childbirth, surgery, and trauma.
The public health community is seriously studying the rise in clostridial disease. A
second strain of bacteria, Clostridium difficile, has been responsible for hundreds of deaths
in the United States. On May 11, the Centers for Disease Control, the Food and Drug
Administration, and the National Institute of Allergy and Infectious Diseases held a
scientific meeting on emerging clostridial disease in the United States. As advocates for
women’s health, we are deeply concerned about the deaths of four women from
Clostridium sordellii following medical abortion and the larger pattern of fatal infection
among obstetric and gynecologic patients.
NAF will work with public health officials as they develop resources and guidelines for
preventing and treating clostridium infections. In reviewing the four cases following use
of mifepristone, the FDA has not found a causal relationship between the Clostridium
sordellii infections and either of the two drugs used in medical abortion, mifepristone and
misoprostol, or their method of administration. The FDA tested batches of mifepristone
and misoprostol and confirmed that they were not contaminated. Notably, clostridium
bacteria are found in about 4-18% of healthy women and one estimate is that 1% of those
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women carry the sordellii species. Scientists do not yet know what causes deadly toxins to
be produced.
Based on the medical and scientific evidence, mifepristone is a safe and effective way to
terminate an early pregnancy. Mifepristone has been well accepted by patients and
providers; approximately 600,000 American women have chosen mifepristone to end
their pregnancies. Women choose mifepristone over surgical abortion for a variety of
reasons. Many women choose medical abortion because it is noninvasive and may seem
more natural and more private. Also, some women have conditions that may make
medical abortion preferable such as vaginal scarring, large uterine fibroids, certain
abnormalities of the uterus or cervix, or obesity.
As an organization representing health care providers and the women for whom they
care, NAF is committed to ensuring the highest standards of medical care. We fully
support scientific inquiry into the recent cases of Clostridium sordellii and Clostridium
difficile. Such investigations, however, should be based on medical and scientific
evidence, not political agendas. Women deserve the best available health care options,
including access to mifepristone, a method proven to be safe and effective for ending an
early pregnancy. The withdrawal of mifepristone from the market or the imposition of
medically unjustified restrictions on its use without sound scientific evidence would set a
dangerous precedent for the regulation of health care in the United States. NAF urges
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members of the Subcommittee to consider science rather than politics when debating this
very important public health issue.
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