[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]



 
        RU-486: DEMONSTRATING A LOW STANDARD FOR WOMEN'S HEALTH?

=======================================================================

                                HEARING

                               before the

                   SUBCOMMITTEE ON CRIMINAL JUSTICE,
                    DRUG POLICY, AND HUMAN RESOURCES

                                 of the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED NINTH CONGRESS

                             SECOND SESSION

                               __________

                              MAY 17, 2006

                               __________

                           Serial No. 109-202

                               __________

       Printed for the use of the Committee on Government Reform


  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                               index.html
                      http://www.house.gov/reform
        RU-486: DEMONSTRATING A LOW STANDARD FOR WOMEN'S HEALTH?



        RU-486: DEMONSTRATING A LOW STANDARD FOR WOMEN'S HEALTH?

=======================================================================

                                HEARING

                               before the

                   SUBCOMMITTEE ON CRIMINAL JUSTICE,
                    DRUG POLICY, AND HUMAN RESOURCES

                                 of the

                              COMMITTEE ON
                           GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED NINTH CONGRESS

                             SECOND SESSION

                               __________

                              MAY 17, 2006

                               __________

                           Serial No. 109-202

                               __________

       Printed for the use of the Committee on Government Reform


  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
                               index.html
                      http://www.house.gov/reform


                    U.S. GOVERNMENT PRINTING OFFICE
31-397                      WASHINGTON : 2007
_____________________________________________________________________________
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                     COMMITTEE ON GOVERNMENT REFORM


                     TOM DAVIS, Virginia, Chairman
CHRISTOPHER SHAYS, Connecticut       HENRY A. WAXMAN, California
DAN BURTON, Indiana                  TOM LANTOS, California
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
JOHN L. MICA, Florida                PAUL E. KANJORSKI, Pennsylvania
GIL GUTKNECHT, Minnesota             CAROLYN B. MALONEY, New York
MARK E. SOUDER, Indiana              ELIJAH E. CUMMINGS, Maryland
STEVEN C. LaTOURETTE, Ohio           DENNIS J. KUCINICH, Ohio
TODD RUSSELL PLATTS, Pennsylvania    DANNY K. DAVIS, Illinois
CHRIS CANNON, Utah                   WM. LACY CLAY, Missouri
JOHN J. DUNCAN, Jr., Tennessee       DIANE E. WATSON, California
CANDICE S. MILLER, Michigan          STEPHEN F. LYNCH, Massachusetts
MICHAEL R. TURNER, Ohio              CHRIS VAN HOLLEN, Maryland
DARRELL E. ISSA, California          LINDA T. SANCHEZ, California
JON C. PORTER, Nevada                C.A. DUTCH RUPPERSBERGER, Maryland
KENNY MARCHANT, Texas                BRIAN HIGGINS, New York
LYNN A. WESTMORELAND, Georgia        ELEANOR HOLMES NORTON, District of 
PATRICK T. McHENRY, North Carolina       Columbia
CHARLES W. DENT, Pennsylvania                    ------
VIRGINIA FOXX, North Carolina        BERNARD SANDERS, Vermont 
JEAN SCHMIDT, Ohio                       (Independent)
------ ------

                      David Marin, Staff Director
                Lawrence Halloran, Deputy Staff Director
                       Teresa Austin, Chief Clerk
          Phil Barnett, Minority Chief of Staff/Chief Counsel

   Subcommittee on Criminal Justice, Drug Policy, and Human Resources

                   MARK E. SOUDER, Indiana, Chairman
PATRICK T. McHenry, North Carolina   ELIJAH E. CUMMINGS, Maryland
DAN BURTON, Indiana                  BERNARD SANDERS, Vermont
JOHN L. MICA, Florida                DANNY K. DAVIS, Illinois
GIL GUTKNECHT, Minnesota             DIANE E. WATSON, California
STEVEN C. LaTOURETTE, Ohio           LINDA T. SANCHEZ, California
CHRIS CANNON, Utah                   C.A. DUTCH RUPPERSBERGER, Maryland
CANDICE S. MILLER, Michigan          MAJOR R. OWENS, New York
VIRGINIA FOXX, North Carolina        ELEANOR HOLMES NORTON, District of 
JEAN SCHMIDT, Ohio                       Columbia

                               Ex Officio

TOM DAVIS, Virginia                  HENRY A. WAXMAN, California
                       Marc Wheat, Staff Director
               Michelle Gress, Professional Staff Member
                           Malia Holst, Clerk
          Richard Butcher, Minority Professional Staff Member


                            C O N T E N T S

                              ----------                              
                                                                   Page
Hearing held on May 17, 2006.....................................     1
Statement of:
    Harrison, Donna J., M.D., member, Mifeprex Subcommittee of 
      American Association of Prolife Obstetricians and 
      Gynecologists..............................................   135
    Patterson, Monty L., Livermore, CA...........................   117
    Rarick, Lisa D., M.D., RAR Consulting, LLC...................   128
    Snead, O. Carter, associate professor, University of Notre 
      Dame Law School, and former general counsel for the 
      President's Council on Bioethics...........................   338
    Wood, Susan F., former Assistant Commissioner for Women's 
      Health and Director of the Office of Women's Health, Food 
      and Drug Administration....................................   122
    Woodcock, Janet, M.D., Deputy Commissioner for Operations, 
      Food and Drug Administration, U.S. Department of Health and 
      Human Services.............................................    87
Letters, statements, etc., submitted for the record by:
    Cummings, Hon. Elijah E., a Representative in Congress from 
      the State of Maryland, prepared statement of...............    75
    Harrison, Donna J., M.D., member, Mifeprex Subcommittee of 
      American Association of Prolife Obstetricians and 
      Gynecologists, prepared statement of.......................   137
    Patterson, Monty L., Livermore, CA, prepared statement of....   120
    Rarick, Lisa D., M.D., RAR Consulting, LLC, prepared 
      statement of...............................................   131
    Ruppersberger, Hon. C.A. Dutch, a Representative in Congress 
      from the State of Maryland, prepared statement of..........    85
    Snead, O. Carter, associate professor, University of Notre 
      Dame Law School, and former general counsel for the 
      President's Council on Bioethics, prepared statement of....   340
    Souder, Hon. Mark E., a Representative in Congress from the 
      State of Indiana:
        Information concerning lower standards for RU-486........   112
        Judicial Watch Report....................................     3
        Prepared statement of....................................    69
    Waxman, Hon. Henry A., a Representative in Congress from the 
      State of California, prepared statement of.................    81
    Wood, Susan F., former Assistant Commissioner for Women's 
      Health and Director of the Office of Women's Health, Food 
      and Drug Administration, prepared statement of.............   125
    Woodcock, Janet, M.D., Deputy Commissioner for Operations, 
      Food and Drug Administration, U.S. Department of Health and 
      Human Services, prepared statement of......................    90


        RU-486: DEMONSTRATING A LOW STANDARD FOR WOMEN'S HEALTH?

                              ----------                              


                        WEDNESDAY, MAY 17, 2006

                  House of Representatives,
Subcommittee on Criminal Justice, Drug Policy, and 
                                   Human Resources,
                            Committee on Government Reform,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 2:04 p.m., in 
room 2203, Rayburn House Office Building, Hon. Mark E. Souder 
(chairman of the subcommittee) presiding.
    Present: Representatives Souder, Schmidt, Shays, Cummings, 
Davis, Watson, Ruppersberger, Norton, and Waxman.
    Staff present: Marc Wheat, staff director and chief 
counsel; Michelle Gress, professional staff member and counsel; 
Malia Holst, clerk; Karen Lightfoot, minority senior policy 
advisor and communications director; Sarah Despres, Tony 
Haywood, Kimberly Trinca, Naomi Seiler, minority counsels; 
Richard Butcher, minority professional staff member; and Teresa 
Coufal, minority assistant clerk.
    Mr. Souder. The subcommittee will come to order. We are 
here today because there is a drug on the market associated 
with the deaths of at least 8 women, 9 life-threatening 
incidents, 232 hospitalizations, 116 blood transfusions, and 88 
cases of infection. There are more than 950 adverse event cases 
associated with RU-486 out of only 575,000 prescriptions, at 
most. Adverse events are typically under-reported, since they 
are offered voluntarily by consumers and health care 
professionals, so it is most likely that there are many more 
cases that we don't even know about.
    It is very clear that there is a serious problem with RU-
486. In failing to address this problem by disguising it, 
ignoring it, minimizing it, or causing confusion, it is a 
shameful failure for anyone with the ability and desire to 
protect women from needless harm.
    RU-486 is a common name for Mifeprex. It is produced by 
Danco Laboratories, a corporate entity located in the Cayman 
Islands which produces only that single drug and nothing else. 
Mifeprex is approved by the FDA for the termination of 
pregnancy through 49 days of development. It is used in 
combination with another drug called Misoprostol, which causes 
uterine contractions that expel the dead fetus. This is an off-
label use for the Misoprostol, which contains a black box 
warning against using the drug during pregnancy.
    At least five of the deaths following the use of RU-486 
have been the result of toxic shock-like syndrome initiated by 
the bacteria Clostridium Sordellii. This bacteria is thought to 
exist in low numbers in the reproductive tracts of many women 
and is normally combatted by the immune system. Experts in 
immunology, pharmacology, and maternal-fetal medicine have 
suggested that because RU-486 interferes with the innate immune 
response, the bacteria, if present, is allowed to flourish, 
causing a widespread multi-organ infection in the woman. These 
infections are not accompanied by a fever and the symptoms 
match those that are expected after taking the RU-486 regime, 
including cramping, pain, bleeding, nausea, vomiting. Each of 
the women infected with C. Sordellii after taking RU-486 were 
dead within 5 to 7 days.
    To investigate the nature of this bacteria, the CDC and FDA 
held a scientific workshop last week called ``Emerging 
Clostridial Disease.'' The workshop panelists noted that the 
rapid growth of the C. Sordellii bacteria in the RU-486 context 
likely forecloses effective treatment and that there is no 
currently identifiable window of opportunity for treatment once 
a woman is infected, even with major interventions such as a 
hysterectomy. The fatality rate has been 100 percent for the 
women who have contracted C. Sordellii infection after using 
RU-486.
    Any other drug associated with a 100 percent fatal septic 
infection that kills otherwise healthy adults within days, with 
no apparent window for treatment, and associated with an 
exponential amount of severe reactions would normally prompt an 
immediate withdrawal. But we are talking about a drug regimen 
that is administered to cause an abortion, manufactured by a 
drug company based in the Cayman Islands with no other drugs on 
the market, and therefore no incentive to voluntarily withdraw 
its product, no matter how dangerous.
    Many abortion advocates feel they have to defend RU-486 
because it is an alternative to surgical abortion. However, 
with eight deaths that we know about, RU-486 is 10 to 14 times 
more likely to be fatal than surgical abortion during the first 
7 weeks of pregnancy, the period during which the drug is 
administered. To continue defending this dangerous drug in 
light of the mounting scientific evidence, injury, and death is 
to allow one's zeal for abortion to truly distort their view 
about what is right for women's health. The 10-times-more-
deadly danger posed by RU-486 should not be considered an 
acceptable risk that justifies keeping this drug on the market.
    The approval of RU-486 was made under extreme political 
pressure from the Clinton administration, which is well 
documented in a recent report by Judicial Watch entitled ``The 
Clinton RU-486 Files.'' I ask that this report be included in 
the hearing record.
    [The information referred to follows:]

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    Mr. Souder. RU-486 was forced through the FDA using an 
extraordinary provision called Subpart H, reserved only for 
drugs that treat life-threatening illnesses and for which 
existing treatments are insufficient. It was obvious even to 
the drug's sponsor that RU-486 did not fall within the narrow 
scope of Subpart H, saying the FDA's imposition of Subpart H 
was unlawful, unnecessary, and undesirable. But that did not 
deter the FDA in its extraordinary political complicity with 
President Clinton's administration from forcing an abortion 
pill onto the market, no matter how distorted the approval 
process was or what the price.
    We are paying that price now. Almost 1,000 women have 
suffered adverse effects after taking RU-486. We know that 
eight have died. We have a responsibility to consider the 
dangers that this drug poses and question whether the FDA has 
the authority to remove it from the market in the light of the 
severe problems associated with this drug and the 
manufacturer's failure to comply with post-marketing 
restrictions.
    I anticipate that the defenders of RU-486 will try to 
detract from the cold, hard facts or cause confusion by talking 
about other septic infections in other pregnancy situations. 
This tactic ignores what the panelists reported at last week's 
CDC conference, that Mifeprex compromises the innate immune 
system, providing an environment for rapid growth of the deadly 
infection.
    C. Sordellii infection in the RU-486 context is 100 percent 
fatal, with no opportunity for intervention. To ignore the 
immune system connection with Mifeprex, or to say that there 
have been only five such deaths and advocate only for better 
surveillance and informed consent will be no comfort to the 
family of the next women who dies suddenly after taking RU-486.
    To the shallow objection that those of us who are pro-life 
have no business looking into the problems associated with RU-
486, let me respond that this is a smokescreen and is 
incredibly shameful. Anyone who honestly cares about women's 
health has to take a critical look at the potential dangers of 
this drug. To argue otherwise, on the basis that it is simply 
an abortion issue, is to demonstrate a blind allegiance to 
abortion at any cost, including women's lives.
    Representing the FDA on the first panel is Dr. Janet 
Woodcock, Deputy Commissioner for Operations.
    On our second panel, we will hear from Monty Patterson, the 
father of Holly Patterson, who was 18 years old when she died 
after taking RU-486; Dr. Susan Wood, former FDA Assistant 
Commissioner for Women's Health; Dr. Lisa Rarick of RAR 
Consulting; Dr. Donna Harrison, a member of the Mifeprex 
Subcommittee of the American Association of Prolife 
Obstetricians and Gynecologists, and Carter Snead, Associate 
Professor of Law at Notre Dame and former General Counsel for 
the President's Council on Bioethics.
    I wish to note that the medical director for Danco, the 
Cayman Islands-based manufacturer for RU-486, initially agreed 
to testify at this hearing, but pulled out 2 days ago. I intend 
to followup with Danco to request answers in a sworn affidavit 
to critical questions regarding Danco's failure to comply with 
the post-marketing restrictions for RU-486.
    Last of all, I want to note that I notified the FDA last 
December that this subcommittee would conduct a hearing into 
RU-486. FDA's compliance with this oversight committee's 
document requests has been quite frustrating. We were getting 
critical documents related to our December request as late as 
last night. This hearing is not the end of our document 
requests and I invite better cooperation from the agency moving 
forward. Now that we are here and we have most of the documents 
we requested 5 months ago, it is time to seek some answers 
about what can be done to protect women from this deadly drug.
    [The prepared statement of Hon. Mark E. Souder follows:]

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    Mr. Souder. Now I yield to the ranking member, Mr. 
Cummings, for his opening statement.
    Mr. Cummings. Thank you very much, Mr. Chairman. I want to 
join you in welcoming all of our witnesses testifying this 
afternoon on a very important subject, protecting women's 
health.
    And particularly, I want to acknowledge Mr. Monty 
Patterson, who lost his 18-year-old daughter, Holly, when she 
died as a result of a rare bacterial infection. I offer my 
sincere condolences to the Patterson family and want to commend 
Mr. Patterson and his family for their efforts to become well-
versed in this subject area in the wake of a terrible family 
tragedy.
    As you know, Mr. Chairman, C. Sordellii is a bacterium that 
normally resides in soil. Although cases of human illness are 
rare, the effect is usually fatal when the bacteria produces 
toxins that cause rapid onset of shock that physicians are 
powerless to curtail.
    To date, medical literature reflects a total of 
approximately 30 reported fatalities from C. Sordellii 
infection. Cases of infection have involved both males and 
females of all ages. At least eight of the reported fatalities 
occurred in women who had just given birth, and two occurred 
after miscarriages.
    The selective focus of today's hearing centers on five 
fatal cases that have occurred over the past 5 years and also 
involved pregnancy. Four of these cases occurred in California, 
the other in Canada. The key factor linking this small subset 
of cases is that they occurred in women who underwent medical 
abortion.
    Last week, the Centers for Disease Control, as you said, 
convened a scientific meeting on C. Sordellii and another 
related bacterium. The meeting served to underscore just how 
little is known about the cause of human C. Sordellii 
infections. Although a number of theories were advanced and 
debated, the meeting produced no solid answers as to how the 
infection is acquired. The only consensus was that much more 
needs to be learned if additional deaths are to be prevented.
    Despite the overwhelming scientific uncertainty among 
experts, a number of policymakers and policy shapers apparently 
have already arrived at the conclusion that the drug 
Mifepristone, also known as RU-486 and marketed in the United 
States under the name Mifeprex, is the likely cause of the 
infection in the five cases involving patients who underwent 
medical abortion. Consequently, they are advocating the FDA's 
immediate withdrawal of Mifeprex from the market. What is the 
basis for this belief? Is it science, or is it something else?
    It is difficult to overlook the fact that adherents to this 
point of view generally opposed the introduction of 
Mifepristone into the United States in the first place, or to 
ignore the fact that they did so on an ideological grounds, 
knowing that there had been no reported fatalities among as 
many as 2 million users of the drug in Europe.
    To bolster their argument, proponents of withdrawing FDA 
approval suggest that the FDA, in effect, rushed the drug to 
market. But the record shows that the approval process was 
thorough and unusually lengthy. However, it resulted in more 
stringent restrictions on distribution than apply to most other 
drugs.
    Mr. Chairman, I hope it is fair and correct to presume that 
not one participant in today's hearing takes the health of 
women lightly. As a matter of fact, every single one of us take 
women's health very seriously. My own concern for both women's 
health and women's rights leads me to wonder, however, why the 
narrow focus on these cases and on this drug as the suspected 
culprit? Why not concern ourselves with all the possible causes 
of infection in not only these 5 cases, but also the other 9 or 
10 reported cases in which pregnancy was the common 
denominator?
    If ensuring a high standard of health care for American 
women is our pure objective, it just seems to me, Mr. Chairman, 
that our focus should be seeking the truth concerning the cause 
of C. Sordellii infection rather than attempting to bully the 
FDA into taking action, unsupported by science, that would have 
just one certain impact, limiting access to abortion for many, 
many women.
    Therefore, I hope today's hearing can serve the purpose of 
promoting thorough scientific inquiry and supporting a research 
agenda that will lead us to answers that can prevent infection 
and death from infection.
    Concentrating on five cases involving medical abortion to 
the exclusion of a larger number of equally tragic cases 
appears to serve the narrow purpose of whittling away at a 
women's constitutional right to choose by limiting practical 
access to abortion. I only hope that, in this case, appearances 
are deceiving.
    I look forward to the testimony and I thank the witnesses 
for being with us, and with that, Mr. Chairman, I yield back.
    [The prepared statement of Hon. Elijah E. Cummings 
follows:]

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    Mr. Souder. I now yield to other Members wishing to make 
opening statements. Mr. Waxman, do you have an opening 
statement? I am going to ask for this process. It has been a 
practice if Members are members of the full committee but not 
the subcommittee, that we let them participate, and I ask 
unanimous consent that Mr. Shays be allowed to participate, and 
he will go to the back of the rest of everybody else's opening 
statements.
    I yield to Mr. Waxman.
    Mr. Waxman. Thank you very much, Mr. Chairman. I appreciate 
this chance to make an opening statement and to attend this 
hearing because this is an important hearing. It gives us a 
chance to talk about the deaths of several women who had taken 
Mifepristone, RU-486--we all have been stumbling over that 
word--which is the medical abortion pill. These deaths were 
tragic and I also want to join in extending my deepest 
sympathies to the Patterson family, who lost their daughter, 
and thank you for coming today.
    We are going to discuss these cases as part of a broader 
pattern of C. Sordellii infection. This is an infection that 
has killed men, women, and children. It has killed women who 
have just given birth, women who had miscarriages, and women 
who had not even been pregnant. As with any infection we do not 
yet understand well, we need better research and surveillance 
to fight it.
    But before we begin this discussion, I would like to say 
something about another reason I believe we are here. There are 
people who have wanted RU-486 to be pulled off the market since 
the day it was approved. In fact, they didn't want it to be 
approved. I respect their judgment because they are very 
strongly against an abortion, whether it be by RU-486 or by a 
medical procedure.
    But that is not the issue of safety and it is not an issue 
of science and it is not an issue of data. That makes it an 
ideological opposition to a woman's right to choose abortion. 
And, in fact, many of those who want to take this drug off the 
market want women to have virtually zero access to any kind of 
abortion, whether it be medical or surgical.
    I need not remind people what happened before abortion 
became legal and safe in the United States. Hundreds of 
thousands of women per year sought out illegal abortions or 
tried to induce abortions themselves. Tens of thousands 
suffered major infections and other injuries. And even after 
the introduction of antibiotics, hundreds of women died every 
year before abortion was made legal and safe.
    There are many who want us to have States' rights to pass 
the kind of law that was just adopted in South Dakota, to ban 
all abortions, even in the case of rape or incest, or even to 
preserve the health and well-being of the mother. That is the 
ultimate expression of their point of view, but it is not the 
point of view I share and it is not the point of view that I 
think most people would share.
    This drug, which is the subject of today's hearing, has 
some promising characteristics. It offers women an alternative 
to surgery for early termination of pregnancy. It is available 
to many women who do not have access to surgical abortions. And 
it has been widely and safely used in Europe.
    On the other hand, questions have been raised about whether 
there may be a link between the drug and the tragic deaths of 
several young women. That is the question. Is there a link 
between this drug and those deaths? And that is a scientific 
issue, not an ideological one, and it is an issue that we ought 
to leave to the Food and Drug Administration scientists to look 
at the evidence.
    Now, it has been asserted by the chairman that the side 
effects may be understated because there is voluntary 
disclosure. Well, that is true of all drugs--there is voluntary 
disclosure of adverse effects--but not this drug, because the 
drug had a lengthy period of time during which it was under 
surveillance at the Food and Drug Administration. It was 
approved ultimately under Subpart H, which put a lot of 
restrictions in place on the use of this drug which are not in 
place for the use of other drugs that are available on the 
market today in the United States. And one of the limits to its 
use was that a physician had to agree in advance to report any 
adverse consequences from use of this drug to the manufacturer 
and the manufacturer is obligated under law to report it to the 
FDA. So we have a pretty clear picture of what has been going 
on.
    This is not like the Plan B drug, which has not been 
approved by the FDA for over-the-counter use because of 
political pressure on the FDA. This drug was not approved by 
political pressure, it was approved under the usual standards 
of safety and efficacy.
    Now, other drugs have been approved under that status and 
have been taken off when we saw that there were consequences to 
it which changed the balance of whether it was a safe and 
efficacious drug, and that is the issue of whether this drug 
should remain available to women. It should be resolved based 
on scientific assessment of its benefits and dangers. If the 
best scientific evidence turns out to demonstrate that the 
risks do, in fact, outweigh the benefits, then the FDA should 
make a decision accordingly. But it should be kept on the 
market or removed using the same legal and scientific standards 
that are used for all other drugs.
    For today, let us take a close and serious look at C. 
Sordellii infection. We must encourage our scientists to figure 
out why these women and the other victims of this bacteria, 
which had no relationship that we know of to RU-486, why they 
died, and we should do everything we can to improve detection 
and treatment. But in the end, we need to make sure any 
regulatory decision about RU-486 is based on the science and 
the law and not the politics of the abortion debate.
    Thank you, Mr. Chairman.
    [The prepared statement of Hon. Henry A. Waxman follows:]

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    Mr. Souder. Ms. Holmes Norton, do you have an opening 
statement?
    Ms. Holmes Norton. Thank you very much, Mr. Chairman. Mr. 
Chairman, first, I want to say that if there is a drug, if it 
is a contraceptive drug, if it is a drug related in any way to 
the health of women, that scientists tell us causes death or 
injury of any kind, that drug should have no approval.
    I don't think this committee is qualified to make that 
judgment. I think that judgment has to be committed to the kind 
of scientific study you would do if you were serious about 
these eight deaths. The most important thing we can do is to 
find out causation here, because then we know how to prevent 
the deaths or injury. Anything that stands in the way of that 
link is not a serious attempt to deal with it. Anything that 
jumps over the appropriate scientific inquiry is not serious 
about these eight deaths.
    I think RU-486 has been very important in preventing 
abortions and in getting to where American women are going to 
get anyway. We simply will never be able to keep this kind of 
drug, which has not been shown to be harmful by scientists, out 
of the hands of people. So if it is going to get into the hands 
of people, one thing we want to know is what causes it.
    What we don't want is to investigate scientists, for 
example, who give us answers contrary to our personal or moral 
or religious beliefs. We want to leave them free and unfettered 
to tell us what the scientific method reveals to them.
    Finally, Mr. Chairman, I particularly regret not being able 
to stay throughout this hearing because of other hearings, but 
I do want to go on the record indicating the unthinkable series 
we have witnessed during this term that show the unmitigated 
politicization of the one area that Americans always held off 
from politics, and that is science itself. Whether Schiavo or 
creationism renamed intelligent design or stem cell research 
or, God help us, global warming itself, there are views 
floating around this Congress that essentially reach 
conclusions on these matters of huge scientific moment based on 
their own personal belief.
    I never thought that the country that has stood at the 
forefront of science in the world would ever reduce science to 
personal, political, and religious views and opinions and I 
don't believe that, in effect, that is what the country is 
going to let us do when they see the long list before them of 
bills, of things we now can't do, of things we do do, only 
because of the personal, political, and religious views of some 
Members. When they see that the attempts that have been made 
during this session of Congress and during this administration 
to burden scientists with the personal views of Members of 
Congress, it is a shameful day for American science and I think 
we have to wipe it away if we do nothing else.
    Thank you, Mr. Chairman.
    Mr. Souder. Mr. Davis.
    Mr. Davis of Illinois. Thank you very much, Mr. Chairman, 
and I shall be brief. Let me just thank you for calling this 
hearing. I think that every single one of us are indeed 
concerned about the health, safety, and well-being of every 
single individual as they make use of a drug, medical 
procedure, or pattern of treatment. I would hope especially 
given the fact that we are talking about safety of a drug, that 
we discuss and debate the science and not the ideological 
expressions of individuals who may be bent one way or another 
around the question and the issue of abortion.
    And so I look forward to the witnesses and look forward to 
the information that is going to be presented and I yield back 
the balance of my time.
    Mr. Souder. Mr. Ruppersberger.
    Mr. Ruppersberger. Thank you, Mr. Chairman, for having this 
hearing. We know the issue of abortion is a very difficult 
issue for many citizens in this country and there are different 
people that have different points of view. One of the issues it 
looks like--you can't hear? That is probably a good thing. 
[Laughter.]
    Starting again, we know the abortion issue is a very 
difficult issue and we also know that individuals, no matter 
which side of the issue you are on with respect to abortion, is 
something that you are probably not going to change. It would 
be more positive for our whole country if we could come to some 
resolution, but I don't think that is going to happen.
    But I think in today's hearing it is important that we 
really don't use the political issue of abortion but focus on 
this RU-486. With that in mind, RU-486 underwent a vigorous, a 
rigorous 4-year review process at the FDA, more rigorous than 
most drugs. As you know, it was considered under a select set 
of regulations called Subpart H, which allowed the FDA to add 
more conditions on the drug's distribution and use.
    But since its approval in the year 2000, nearly 600,000 
women in the United States have used RU-486. It has proven to 
be a safe and effective means of terminating early pregnancy. 
Because of this medical option, millions of women worldwide, 
including survivors of sexual assault, have had the right to 
end an early pregnancy with privacy and dignity.
    Tragically, there have been four confirmed deaths in the 
United States from bacterial infection in women who used RU-
486. At this point, we do not know what caused these infections 
or if these deaths are at all related to the use of RU-486.
    Fortunately, the CDC and FDA have moved quickly to 
investigate these incidents. Early this month, RU-486 
scientists from the Nation's leading public health agencies 
gathered in Atlanta to discuss the bacteria that caused these 
deaths and the risk it poses to pregnant women. Career 
scientists and doctors are the best equipped to investigate 
this issue and I know they will get to the bottom of it. We 
must rely on accepted medical standards for determining the 
safety and efficacy of a medication. The future of RU-486 
should lie with the FDA and the medical community, not with 
Congress, who do not have yet the full picture and have 
scientific data before us to make a decision on women's health.
    I yield back.
    [The prepared statement of Hon. C.A. Dutch Ruppersberger 
follows:]

[GRAPHIC] [TIFF OMITTED] T1397.075

    Mr. Souder. Ms. Watson.
    Ms. Watson. I want to thank you, Mr. Chairman. I applaud 
the subcommittee for bringing this topic up to educate the 
American public.
    It is very important that the FDA, our drug watchdog 
agency, is engaged with the scientific community and the 
population at large in order to provide informed choices for 
the women of the United States. Mifepristone, or RU-486, has 
been utilized for nearly two decades by women all over the 
globe. This drug provides an early abortion option that does 
not require surgery. It has been reported that since the FDA 
approved RU-486 in 2000, significantly more than half a million 
American women have used this medication.
    Mr. Chairman, let us be very clear during this hearing 
today. Ideological debate pro or anti-abortion is a discussion 
that we have been afforded the free speech right to talk about. 
Medical process and drug effectiveness should not be subject to 
any debate of that style. It is imperative to the health of our 
Nation that Congress, the FDA, health care delivery 
professionals, and the scientific community and patients 
approach the utilization of any drug from an educated, 
scientifically tested, and unbiased perspective.
    So I am interested to hear the testimony of our witnesses 
because oversight is a serious responsibility that we undertake 
on behalf of the American people, and the use of RU-486 is a 
subject that must be treated with unbiased integrity and regard 
for the overall health of women.
    Four women have died of sepsis. All four were infected by 
the same type of bacteria. What does the medical and scientific 
community say to this situation? Is Mifeprex responsible? So 
our decision should be based on education and scientific 
investigation and I look forward to hearing about that 
information.
    I yield back my time, Mr. Chairman. Thank you very much.
    Mr. Souder. Thank you. Mr. Shays.
    Mr. Shays. Thank you, Mr. Chairman. I want to thank you, 
one, for having a hearing on this issue, to encourage you to 
use that same logic to have a hearing on Plan B, which is a 
related drug that doesn't require an abortion but can 
accomplish the same task. I want to say that I have 
extraordinary respect for you, and in spite of your bias one 
way and my bias the other, I am convinced that this will be a 
fair hearing and I appreciate that.
    I guess I would just end by saying that I appreciate 
particularly the thoughtful statement of your ranking member, 
Mr. Cummings, and the ranking member of the full committee. I 
think others have said the same thing, but I think they covered 
it well. If I could have written a statement in time, I would 
have been pleased to have written either of those two 
statements, so I would like to stand on their statements.
    Again, thank you for allowing me to participate.
    Mr. Souder. Thank you, and the record needs to show that 
there have been 8 women, at least, who have died, 950 adverse 
events, and not all are necessarily associated with the other 
infection.
    Also, I would like to ban abortion, but this isn't about 
abortion. We can't ban abortion. This is a health question. 
Just because scientists disagree doesn't mean that one person 
is trying to put an ideological view on it and other people 
have a scientific view.
    In a number of issues lately, I have been accused of being 
anti-science because the scientists I support disagree with the 
scientists who another group support. In fact, this drug was 
cleared in an expedited process, not using mostly U.S. 
research, and we have a right to look into this drug and we 
should be looking into this drug. Scientists disagree and we 
should hear the debate. Just because one group of scientists is 
political doesn't mean that the other group of scientists 
aren't political, too. We all know that science requires 
judgments, as well. If it was just an ideological view, we 
couldn't hold this hearing. We are not hearing from ideological 
people, we are hearing from medical people, we are hearing from 
researchers, and we will hear the debate and I am looking 
forward to that debate.
    I ask unanimous consent that all Members have 5 legislative 
days to submit written statements and questions for the hearing 
record and that any answers to written questions provided by 
the witnesses also be included for the record. Without 
objection, it is so ordered.
    I also ask unanimous consent that all exhibits, documents, 
and other materials referred to by Members and the witnesses 
may be included in the hearing record, that all Members be 
permitted to revise and extend their remarks, and without 
objection, it is so ordered.
    Our first panel is composed of Janet Woodcock. Dr. Woodcock 
is Deputy Commissioner for Operations at the FDA. If you could 
come forward, remain standing. As an oversight committee, it is 
our standard procedure to swear in our witnesses. If you will 
raise your right hand.
    [Witness sworn.]
    Mr. Souder. Let the record show that the witness responded 
in the affirmative.
    We thank you for coming today and we are looking forward to 
your testimony.

  STATEMENT OF JANET WOODCOCK, M.D., DEPUTY COMMISSIONER FOR 
 OPERATIONS, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF 
                   HEALTH AND HUMAN SERVICES

    Dr. Woodcock. Good afternoon, Mr. Chairman, Congressman 
Cummings, and Members of the subcommittee. I am Janet Woodcock, 
Deputy Commissioner for Operations at the Food and Drug 
Administration. Today, I will discuss the approval history and 
the current regulatory status of the product Mifepristone, 
currently marketed in the United States under the trade name 
Mifeprex and indicated for termination of early pregnancy.
    First, I would like to correct any misconceptions that may 
exist about the initial approval of the drug. Mifeprex was 
approved in September 2000 after extensive FDA review of the 
application, which included three adequate and well-controlled 
trials documenting the efficacy and safety profile of the drug 
when used for this indication. In addition, post-market 
experience in Europe included over 620,000 exposures for 
pregnancy termination, of which 415,000 were in combination 
with Misoprostol. These data fully conform with FDA's standards 
for approval.
    In order to assure that Mifeprex was used by qualified 
specialists, FDA and the sponsor agreed that the drug would be 
approved under 21 CFR 314.520. This section of Subpart H 
concerns safety, not effectiveness. This infrequently used 
regulatory provision allows approval of a drug with 
restrictions to assure safe use. In this case, distribution of 
Mifeprex is restricted to physicians qualified to supervise 
medical abortion and its complications and who have agreed to 
fully inform patients and obtain their written agreement to 
provide an FDA-approved patient information sheet and agreed to 
report serious adverse events to the sponsor.
    This product met the requirements of all applicable laws 
and regulations, including Subpart H. As FDA made clear in the 
preamble to the final rule, the Subpart H regulations were 
intended to apply to serious or life-threatening conditions, 
such as depression, not only to diseases. Approval of Mifeprex 
under restricted distribution had nothing to do with 
accelerated approval based on a surrogate end point, which is a 
separate provision of the regulations.
    FDA has monitored reports of Mifeprex-related adverse 
events very carefully after marketing. As of March 31, 2006, 
950 cases related to the approved use were submitted to FDA. 
Consistent with the clinical trials' experience and the drug 
label, heavy vaginal bleeding was the most frequently reported 
adverse event, with 422 cases, followed by incomplete abortion, 
with approximately 400 cases. Other serious events included 88 
instances of infection, with 18 of them considered severe, and 
27 ectopic pregnancies. This adverse event profile was 
consistent with prior experience with medical termination of 
pregnancy.
    Since approval, FDA has evaluated nine reports of death in 
the United States potentially associated with the approved 
indication. Three of these have either been found or appear to 
be unrelated to medical abortion. An additional death was due 
to a ruptured ectopic pregnancy. The use of Mifeprex is 
contraindicated in ectopic pregnancy. Five deaths were due to a 
rapidly fatal toxin mediated shock syndrome. One of these was 
caused by infection with Clostridium Perfringens. The four 
additional deaths, all in California, were caused by infection 
with a rare anaerobic bacterium, Clostridium Sordellii. An 
additional Clostridium Sordellii fatality previously occurred 
in a clinical trial in Canada.
    This rapidly fatal toxin mediated shock syndrome was not 
anticipated to be a complication of medical abortion. It has 
not been reported in the extensive European experience to date, 
estimated over 1.5 million uses of the drug. Eight previous 
U.S. cases of fatal shock due to C. Sordellii, primarily after 
vaginal delivery or Caesarian delivery, have been reported in 
the obstetrical literature.
    FDA responded aggressively to the reports, with extensive 
followup and expert consultation. Last week, NIH, CDC, and FDA 
cosponsored a scientific workshop on potential emerging 
Clostridium infections. CDC researchers identified three 
additional C. Sordellii cases, two fatal, that occurred after 
spontaneous abortion. CDC has also instituted an investigation 
in California looking into 321 unexplained pregnancy-associated 
deaths between 2000 and 2003. They have excluded 303 cases from 
being related to toxic shock-related syndrome and are further 
investigating 18 more.
    Given that the information on this infection and its 
epidemiology is still emerging, it is not possible at this time 
to determine whether the current Mifepristone/Misoprostol 
regimen for medical abortion results in an increased risk of C. 
Sordellii infection or whether the reporting requirements under 
the Mifeprex approval and subsequent intensive investigations 
have uncovered what is an emerging risk in pregnancy overall. 
FDA is collaborating with the CDC and NIH on further research 
into this infection and will continue to provide timely public 
information.
    I will be happy to answer your questions.
    [The prepared statement of Dr. Woodcock follows:]

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    Mr. Souder. Let me ask this first question as a multi-part. 
This drug went through a different type of an approval process 
than others, Subpart H in the approval process, and it allows 
the FDA to impose certain restrictions on the distribution of 
Mifeprex, which you covered in your written testimony. How do 
you monitor Danco's compliance with each of these restrictions 
and what do you do when they are not in compliance? 
Furthermore, are they absolutely required to report all the 
incidents?
    Dr. Woodcock. Yes. FDA has, once the drug was approved 
under these provisions, put into place an inspectional system 
for FDA to inspect the manufacturer to assure they were 
complying with the provisions of the approval, and we have done 
frequent inspections to oversee their compliance with this 
program.
    Mr. Souder. And are they required under the law to report 
all adverse effects?
    Dr. Woodcock. All manufacturers are required under the law 
to report adverse events that they find out about with drugs 
that they manufacture or distribute to the FDA.
    Mr. Souder. Are you tracking that?
    Dr. Woodcock. Yes.
    Mr. Souder. And then if you are, how did the manufacturer 
not know about some of the things that you referred to, or did 
you discover those through the manufacturer? Have they reported 
any of these? Do you view them as cooperative?
    Dr. Woodcock. The vast majority of reports that we have 
received, which are over 1,000, counting duplicates, have come 
directly from the manufacturer. The physicians who have signed 
the physician agreement are instructed to report adverse events 
to the manufacturer.
    Mr. Souder. We heard a number of the opening statements 
refer to that there is a regimen, but yet RU-486 is frequently 
used past the 49 days as it is recommended and it is 
administered at a dosage of 200 rather than the FDA-approved 
600 dosage. It is often prescribed without the required patient 
agreement form and its counterpart, Misoprostol, is used 
vaginally despite its approval for oral use only. Furthermore, 
although the manufacturer is required to have the ability to 
track its use to the patient level, the manufacturer estimates 
to arrive at usage rates for the purposes of safety and 
promotional material, WHO, Planned Parenthood, and a number of 
these are not following your regimen. Would it be fair for one 
to conclude from this evidence that RU-486 is not being used 
according to the restriction that you imposed on it in Subpart 
H?
    Dr. Woodcock. There is no restriction in the approval 
letter or in the physician agreement that says the physician 
must use a specified dose or regimen. The manufacturer, who FDA 
regulates, is complying with the restrictions that were placed 
on the drug distribution at the time of approval.
    Mr. Souder. So you are saying that individuals are--let me 
ask this. Would it be fair for one to conclude that the 
restrictions placed on RU-486 have failed to ensure that the 
drug will be used in a manner consistent with the FDA's opinion 
on safe use? In other words, when you cleared the drug, it was 
cleared on the basis of the usage. Now what you are telling me 
is there is no checking to see that it is being used in the way 
you approved it, and could not that explain some of the 
problem?
    Dr. Woodcock. The restriction program was pub in place to 
ensure that physicians who prescribe the drug could date a 
pregnancy--that is a very important aspect of using this 
regimen--could rule out with professional experience an ectopic 
pregnancy, and were manage the complications of medical 
abortion, which include requirements for surgical intervention. 
So that was the purpose of the restriction program.
    FDA reviews data that is submitted to it when FDA approves 
a dose and a regimen in an approved indication for use of the 
drug. Subsequently, based on medical literature, physicians may 
deviate from the recommended dose and this occurs very 
frequently. The restricted distribution program had to do with 
distribution to physicians who were qualified. So the drug is 
not available in pharmacies. It cannot be prescribed by 
physicians who are not qualified and have not gone through the 
program.
    Mr. Souder. So let me see if I can understand, see if this 
is an oversimplification of what you just said. You said you 
tested it with one regimen. Then you didn't put that in force 
because you concluded after the tests, based on information 
that regimen wasn't essential to the safety of the individuals?
    Dr. Woodcock. FDA----
    Mr. Souder. Because the regimen dealt with other subjects 
other than the safety.
    Dr. Woodcock. FDA reviewed the data based on the safety and 
effectiveness information that was included in the application. 
That was the recommended regimen, the approved regimen that is 
in the drug label. The patient agreement and so forth discuss 
that regimen. All the approved patient labeling discusses that 
regimen. It is quite common in the United States, however--a 
recent article showed that about 21 percent of drug usage in 
the United States deviates somewhat from the label directions--
--
    Mr. Souder. Let me, because my time is up, when I came as a 
freshman, I was vice chair of Mr. Shays' subcommittee and I 
remember on the secondary use of drugs one of the huge 
questions is the FDA, however, does not give its blessing to 
non-approved regimens and non-prescribed ways of doing it. And 
I would also like to insert in the record at this point a 
history of other drugs where with one or two deaths, they have 
been pulled off the market. Usually, scientific research does 
not go forth while there is a question on a drug, and I think 
an exception has been made in this for political reasons. It is 
exactly the reverse of what has been charged.
    [The information referred to follows:]

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    Mr. Souder. I yield to Mr. Cummings.
    Mr. Cummings. Thank you very much, Mr. Chairman.
    First of all, thank you for being with us, Dr. Woodcock. 
Dr. Woodcock, there have been allegations that there was 
something unusual about the approval of Mifeprex. You were the 
Director of the Center for Drug Evaluation and Research back 
then, is that not correct?
    Dr. Woodcock. That is true.
    Mr. Cummings. And did the FDA treat Mifeprex using the 
appropriate scientific and legal standards for safety and 
efficacy?
    Dr. Woodcock. We used the scientific and legal standards 
that we use for every drug that we evaluate.
    Mr. Cummings. Now, anti-choice advocates have criticized 
the approval on a number of grounds, including the fact that 
there was no double-blind placebo controlled study of this 
drug. But it is hard for me to imagine how someone could 
conduct a placebo-controlled study of an abortion drug. That 
would mean giving the women seeking an abortion a placebo that 
would not terminate the pregnancy, is that right?
    Dr. Woodcock. I suppose. The need for a placebo occurs when 
there is a tremendous variability in the outcome, and so you 
can't tell whether the outcome was due to the intervention or 
other events. For many types of interventions, such as 
anesthesia, all right, we don't have a randomized control group 
because you can easily tell whether people are unconscious and 
they don't become unconscious spontaneously very often. The 
same is true for contraceptives, where we have a very good 
background rate of pregnancy with unprotected intercourse. So 
in various situations, a totally accurate control is what is 
called a historical control, where we know what happens in that 
situation without an intervention.
    Mr. Cummings. There seems to be confusion about the way 
that Mifeprex was approved. It was approved under provisions 
known as Subpart H, is that correct?
    Dr. Woodcock. Yes.
    Mr. Cummings. Some of these provisions provide for an 
accelerated approval of drugs for life-threatening conditions. 
But a different part of Subpart H guides not expedited approval 
but the restricted distribution of certain products. Why was 
Subpart H used in the case of Mifeprex?
    Dr. Woodcock. For Mifeprex, it was felt important that the 
distribution be limited to qualified practitioners, because 
although the intervention was found to be safe and effective, 
it was in the hands of individuals in the clinical trials who 
were able to diagnose pregnancy and date it properly, who were 
able to rule out ectopic pregnancy with a high degree of 
accuracy, and who were able to deal with the complications of 
medical abortion, including incomplete abortion. The drug would 
not be safe in the hands of practitioners who did not routinely 
take care of pregnant women, for example. So that is why these 
restrictions were put into place.
    Mr. Cummings. So this had nothing to do with accelerating 
approval?
    Dr. Woodcock. Nothing to do with it. The evidence on 
effectiveness for Mifeprex was submitted in three trials that 
FDA found to be adequate and well-controlled trials for the 
purpose of demonstrating termination of pregnancy.
    Mr. Cummings. Well, the marketing application was submitted 
in March 1996, is that correct?
    Dr. Woodcock. Yes.
    Mr. Cummings. But the drug wasn't approved until September 
2000. That is like 4\1/2\ years later. The average time for 
approval is about 18 months, is that correct?
    Dr. Woodcock. Yes.
    Mr. Cummings. So why did the approval process take so long?
    Dr. Woodcock. FDA asked many questions and subjected this 
application, everything from the manufacturing of the drug, the 
pharmacology, the distribution of the drug, and the safety and 
efficacy to a very thorough review, such as we would for any 
drug, and in this case, it took that long.
    Mr. Cummings. I mean, what is the record, do you know, 
length of time?
    Dr. Woodcock. Longer.
    Mr. Cummings. All right. I see my time is about up so I 
will submit questions.
    Mr. Souder. Let me ask Congresswoman Schmidt and 
Congressman Shays, did you want to ask questions of this 
witness?
    Mrs. Schmidt. I do.
    Mr. Souder. Do you have questions, as well, Mr. Shays?
    Mr. Shays. I don't want to ask her to have to stay after an 
hour of hearings after our votes.
    Mr. Souder. We are going to have about an hour's worth of 
votes, so Mrs. Schmidt, why don't you ask some of your 
questions here.
    Will you answer any written questions that we give you from 
the different Members, because it is going to be a long voting 
stretch, probably at least an hour here.
    Dr. Woodcock. Certainly.
    Mr. Souder. Mrs. Schmidt.
    Mrs. Schmidt. Thank you, Mr. Chairman. What I am 
understanding is that there are seven deaths recorded from this 
drug. As a woman, why aren't we pulling this drug from the 
market?
    Dr. Woodcock. You have to distinguish, first of all, and I 
know it is very confusing, you have to distinguish reports to 
the FDA, deaths that are actually occurred or related to 
administration of the drug in some way, and then where there is 
a causal relationship between administration of the drug and 
the death.
    FDA actually has nine reports of death related to medical 
abortion in the United States. Three of those we find unrelated 
to administration of the drug. In one case, we cannot--either 
the patient is not documented to have taken the drug or other 
reasons unrelated. One death was due to ruptured ectopic 
pregnancy. Ruptured ectopic pregnancy, if the patient doesn't 
seek medical care rapidly, can be fatal. The ectopic pregnancy 
itself was a preexisting condition, was not caused by 
administration of Mifepristone and Misoprostol.
    There were five deaths were due to sepsis, to infection, 
and what we don't know is whether or not medical abortion 
increases the probability of getting this infection. This 
infection has occurred after vaginal delivery, after Caesarian 
section, and after spontaneous abortion or so-called 
miscarriage, and there are documented cases in each of those 
instances. So we do not know if in medical abortion there is an 
increased rate of this infection or whether or not we are 
simply seeing these because of our intense scrutiny of outcomes 
after medical abortion due to the restricted distribution.
    Mrs. Schmidt. May I have a followup, sir? I am having a 
problem with your explanation and I will tell you why. The 
ectopic pregnancy, the drug should never have been administered 
if she had an ectopic pregnancy, period, case closed. I don't 
care what the reason why the drug was administered. It was 
administered wrongly. That woman died because of it. So there 
is a problem.
    But more importantly, the five of the infections, just 
because you don't know how the infection occurred, we do know 
they took the drug and they died. To me--I am from a farm 
community--it sounds like you need to pull the drug until you 
can be absolutely sure that there are no deaths related.
    I have a whole list here of drugs that have been pulled 
from the market either voluntarily or involuntarily. There has 
just been a contact solution that has been pulled from the 
market because of serious eye infection, including the loss of 
sight. So we are real careful about other things about our 
body, but when it comes to a woman's body, I am just finding a 
problem that we are just not that careful.
    I think this drug needs to be pulled from the market. It 
needs to be pulled from the market now and it is time that the 
FDA does something about it.
    Mr. Souder. Thank you. We will send you some additional 
questions. May I ask you quickly, the FDA reported 116 cases of 
blood transfusion. Do you believe Mifeprex caused these 
hemorrhage cases?
    Dr. Woodcock. Hemorrhage is a common complication of 
childbirth, spontaneous abortion, surgical abortion, and 
medical abortion. So when a woman is pregnant, she faces a 
possibility of experiencing hemorrhaging after childbirth and 
so forth. Yes, we expected----
    Mr. Souder. So you believe these were common hemorrhaging 
cases, not extraordinary hemorrhaging cases?
    Dr. Woodcock. It was expected and was observed in the 
clinical trial. There was a case of needing transfusion, so it 
was expected that some women after the medical abortion regimen 
would have bleeding requiring transfusion. That is correct.
    Mr. Souder. So you believe that 116 cases in 575,000 is 
roughly similar to the population that would normally have it?
    Dr. Woodcock. Yes. We feel that all the side effects except 
the Sordellii are within what we would expect in this 
population.
    Mr. Souder. Thank you. We will submit----
    Mr. Shays. Mr. Chairman.
    Mr. Souder. Yes, Mr. Shays.
    Mr. Shays. If I could submit questions in writing, because 
I do have questions. I just don't want to hold her for an hour.
    Mr. Souder. OK.
    Mr. Shays. So I will have questions. I will submit them 
through you.
    Mr. Souder. Thank you.
    Mr. Shays. Thank you.
    Mr. Souder. The subcommittee stands recessed until we get 
back from votes.
    [Recess.]
    Mr. Souder. The subcommittee is back in session.
    If the second panel could come forward. The second panel is 
Monty Patterson, father of Holly Patterson, who was 18 years 
old when she died taking RU-486; Dr. Susan Wood, former FDA 
Assistant Commissioner for Women's Health; Dr. Lisa Rarick, RAR 
Consulting; Dr. Donna Harrison, a member of the Mifeprex 
Subcommittee of the American Association of Prolife 
Obstetricians and Gynecologists; and law professor O. Carter 
Snead from the University of Notre Dame, former general counsel 
for the President's Council on Bioethics.
    As an oversight committee, it is our customary practice to 
swear in each of the witnesses. Will you raise your right 
hands.
    [Witnesses sworn.]
    Mr. Souder. Let the record show that each of the witnesses 
responded in the affirmative.
    We thank you each for coming. Thank you for your patience 
of putting up with the congressional procedure of having 
multiple amendments and bills. It makes for a long afternoon 
but one that we can never predict when we schedule a hearing.
    We will start with Mr. Patterson. Thank you for coming, and 
once again, we express from all of us in the committee our 
sympathies for the loss of your daughter.

         STATEMENT OF MONTY L. PATTERSON, LIVERMORE, CA

    Mr. Patterson. Thank you very much. First of all, I just 
want to show you a picture of Holly so you know that we are 
talking about my daughter and who she is.
    Mr. Souder. Why don't you pull the mic closer to you.
    Mr. Patterson. I said I wanted to show you a picture of my 
daughter so at least you see what I have lost and actually what 
she lost.
    I owe and dedicate my presence here to those who have no 
voice and particularly to my daughter, Holly, who died at 18, 
and the other women who have died or have been seriously hurt 
by taking the RU-486 medical abortion drug regimen as a 
solution to their unplanned pregnancy.
    I am here to testify about my personal experience as the 
father of a victim of this drug and my consequent knowledge, 
experiences, and views pertaining to RU-486, the drug. I want 
to be clear that my views and testimony should be divorced from 
any debate about abortion. I feel we must examine the dangers 
associated with RU-486 for early medical pregnancy termination 
that are separate and apart from any particular view about a 
women's right to access and choice.
    Twelve days after Holly's 18th birthday, on September 10, 
2003, she walked into a Planned Parenthood clinic to be 
administered an RU-486 medical abortion regimen. By the 4th 
day, she was admitted to the emergency room of a local 
hospital. She was examined. She was given pain killers. She 
complained of bleeding, cramping, constipation, and pain, but 
subsequently, she was sent home.
    Seven days after taking RU-486, Holly returned to the same 
emergency room hospital complaining of weakness, vomiting, 
abdominal pain. Hours later, I was called to the hospital, 
where I found her surrounded by doctors and nurses, barely 
conscious and struggling to breathe. Holly was so weak she 
could barely hold onto my hand. Feeling utter belief and 
desperation, I watched Holly succumb to a massive bacterial 
infection as a result of a drug-induced abortion with RU-486.
    With the support of my family and friends, I have spent 
thousands of hours researching medical and scientific journals, 
talking to doctors, legislators, State and Federal agencies, 
and to learn about the drug RU-486, otherwise known as 
Mifepristone.
    I believe that RU-486 is the substantial contributing 
factor responsible for Holly's death. Currently, there have 
been eight deaths reported by the FDA linked with the drug. 
Furthermore, there are 900 or more serious health consequences 
associated with RU-486.
    One year after Holly's death, I met with FDA and White 
House officials, in September 2004, to discuss concerns over 
the drug's safety and health issues. Two months later, the FDA 
announced additional black box warnings highlighting serious 
infections and death.
    On May 11, 2006, I attended the CDC-FDA-NIH scientific 
conference in Atlanta whose main purpose was to discuss the 
safety of the drug regimen RU-486 to terminate early 
pregnancies. I presented a compilation of nearly 400 medical 
and scientific publications as a result of my 2\1/2\ years of 
extensive research. It is my hope this work will help to 
facilitate the understanding and causal relationship of RU-486 
and medical abortion infections. Medical experts, Dr. Esther 
Sternberg, Dr. James McGregor, and Dr. Ralph Miech presented 
their concurring studies that RU-486 has serious and lethal 
medical implications as evidenced through animal models. I have 
brought that disk here today for the subcommittee for their 
review.
    The FDA is responsible for protecting public health and, 
therefore, must reconsider the use of RU-486 in early medical 
pregnancy terminations. It should explore active epidemiology 
and study animal models that show the alteration of the immune 
response by its reaction with RU-486 as it relates to serious 
and lethal infections. The FDA needs to provide the medical 
community reliable means and methods to recognize cases of 
serious adverse events associated with RU-486. Finally, the FDA 
needs to implement a confident reporting apparatus of these 
events so they can accurately evaluate the safety and health 
consequences with the use of the drug.
    Patients, families, and their physicians are entitled to 
have all the information necessary to make informed choices. 
The safety, health, and welfare of women considering medical 
abortion with RU-486 is paramount and should not be jeopardized 
with a drug that can seriously cause them harm or death. Women 
have paid the ultimate price with their health and their lives. 
How many must die needlessly before this drug is removed from 
the market?
    Women have been and are still relying upon what they think 
is truthful information concerning the limited risk involved 
with a medical abortion. Yet, does the average patient, a 
teenager like Holly, understand she may be risking her life 
taking RU-486 when she is repeatedly exposed to statements 
like, ``It is what women have wanted for years. It is the first 
FDA-approved pill providing women with a safe and effective 
non-surgical option for ending early pregnancy.''
    There are no quick fixes or magical pills to make an 
unplanned pregnancy go away. My family, friends, and community 
were deeply saddened and are forever marred by Holly's 
preventable and tragic death. It is my vibrant memory of Holly 
and her premature death that have inspired me to make the 
public aware of the serious and lethal effects of the RU-486 
regimen. Not a day goes by that I do not recall her brilliant 
blue eyes, engaging smile, laughter, and sheer gentle beauty.
    Holly's personal drive and unwavering determination 
continue to inspire me and give me strength to pursue these 
critical issues in her name. It is a natural instinct to 
protect our loved ones and speak for those who cannot speak for 
themselves. Thank you.
    Mr. Souder. Thank you, and thank you for your willingness 
to speak out.
    [The prepared statement of Mr. Patterson follows:]

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    Mr. Souder. Dr. Wood.

 STATEMENT OF SUSAN F. WOOD, FORMER ASSISTANT COMMISSIONER FOR 
 WOMEN'S HEALTH AND DIRECTOR OF THE OFFICE OF WOMEN'S HEALTH, 
                  FOOD AND DRUG ADMINISTRATION

    Ms. Wood. Thank you, Mr. Chairman, and thank you, members 
of the subcommittee. My name is Susan Wood and for the last 15 
years, I have worked in women's health policy within the 
Federal Government. In each of my positions, I have advocated 
for the promotion of women's health through increased research, 
services, and prevention.
    From November 2000 through August 2005, I was the Assistant 
Commissioner for Women's Health and Director of the Office of 
Women's Health at the U.S. Food and Drug Administration. Prior 
to that, I was Director of Policy and Program Development at 
the Department of Health and Human Services Office on Women's 
Health.
    But I began my work in women's health in 1990 as 
congressional staffer for the bipartisan Congressional Caucus 
for Women's Issues. My scientific training is as a Ph.D. in 
biology and my research focused on basic cell biology and 
biochemistry, carried out at Boston University and at Johns 
Hopkins University School of Medicine.
    Over the last 15 years, I have been proud to be part of the 
following advances we have made in women's health: expanded 
research at the NIH in areas such as breast and ovarian cancer, 
osteoporosis, heart disease, HIV/AIDS, and menopause; more 
inclusion of women in clinical research studies funded by NIH 
and regulated by the FDA; increased screening of women for 
cancer and for sexually transmitted diseases that lead to 
infertility; better quality mammography; coverage for 
preventive screenings by Medicare; and improved prevention and 
services for victims of domestic violence.
    While I was at FDA, the Office of Women's Health supported 
groundbreaking research, including research on medications 
taken during pregnancy, to help find out about the proper doses 
of different medications that should be taken during the 
different stages of pregnancy. We also funded important health 
outreach programs in areas such as safe medication use, 
diabetes, menopause, and hormone therapy. The office also 
worked to implement and track the inclusion of women in 
clinical studies reviewed by FDA and to ensure the analysis of 
the data for important sex differences in safety and efficacy.
    These advances and more were made through the concerted 
efforts of Members of Congress, the various agencies of the 
Department of Health and Human Services, the research and 
clinical communities, and women's health advocates across the 
country. One of the core principles that led to this progress 
was and remains ensure that we move forward based on the best 
available scientific and medical evidence, and when that 
evidence is lacking, go out and do the studies necessary to get 
it.
    My commitment to women's health is founded on these 
scientific principles, knowing that this is the best way to 
expand our knowledge and improve the health of women and men 
both here in the United States and abroad. My commitment to 
women's health, particularly to drug safety, is also founded in 
personal experience. I lost my much-loved sister to cancer at 
age 34, caused directly by a drug given to our mother while she 
was pregnant, the drug DES, also known as diethylstilbestrol. I 
can assure you that my commitment to drug safety for women is 
deeply felt and always at the forefront of my mind.
    I appreciate your invitation to testify before this 
subcommittee on the issue of Mifepristone and whether or not 
FDA has held this drug to the best standard of review on safety 
and efficacy.
    Let me point out that Mifepristone is not Plan B emergency 
contraception, which prevents unintended pregnancy and the need 
for abortion, but Mifepristone, RU-486, is a medication that 
causes abortion in the first few weeks of pregnancy.
    Now, I was working at the Department of Health and Human 
Services Office on Women's Health at the time of the 
Mifepristone review. I, therefore, have no direct knowledge of 
the evaluation and the review that was happening at FDA, and 
that is exactly how it should be. The FDA was working 
independently, reaching its conclusions and decisions based on 
its usual processes and evaluation of the data. In fact, there 
was curiosity among many of us at the Department level about 
the subject, but we were given clear instruction by senior 
management of the Department that we were not to inquire, even 
informally, of our women's health colleagues at FDA about the 
status of the Mifepristone application. This was to ensure that 
there was not even a perception of Departmental influence on 
this highly visible application.
    Upon my arrival at FDA in the fall of 2000 as head of 
women's health there, this independence of decisionmaking was 
confirmed to me by the professional staff that was directly 
involved in the review. The evidence presented to the FDA and 
the subsequent experience with the marketed product in the 
United States tells us that this is a safe and effective method 
for early termination of pregnancy.
    Now, the recent deaths due to Clostridium Sordellii in 
women who have had a medical abortion are truly tragic and I do 
offer my sincere condolences to Mr. Patterson, his family, and 
the families of all the women. These deaths due to this 
bacterial infection have put us on notice that health 
professionals and women need to be aware of this potential 
risk.
    More importantly, the close surveillance of adverse events 
associated with the use of Mifepristone have alerted us that 
this bacterial infection is present and caused the death of 
other women who have given birth or had a miscarriage--more, in 
fact, than the number of women who underwent a medical 
abortion. This pattern of infections and deaths after pregnancy 
is indeed disturbing and tells us once again that we need to do 
more to ensure safe pregnancy and safe motherhood. This is not 
limited to women who have been exposed to Mifepristone, and to 
focus solely on the women who have had a medical abortion is to 
miss the real threat to the health of women.
    Our surveillance systems for maternal mortality and 
morbidity have been limited over the years due to limited 
funding and lower priority. These systems need to be improved 
and expanded to capture not only the impacts of Clostridium, 
but also so that we can understand and prevent the other risks 
that women face with pregnancy.
    With Mifepristone, we can be confident that we have 
identified all or most of the adverse events and deaths. We 
cannot say the same for infections and deaths caused by C. 
Sordellii in women who have given birth or had a miscarriage, 
and those numbers may indeed be higher.
    I applaud the CDC, FDA, and NIH for holding the scientific 
meeting on May 11th to begin the process of examining the data 
that we currently have on the nature of these infections, 
potential strategies for prevention, early detection, and 
effective treatment, and the research agenda that needs to be 
undertaken to answer the critical questions that exist. 
Although I did not attend, I understand that meeting 
participants presented current information and discussed the 
future needs to address this emerging infection.
    Questions have been raised about whether Mifepristone is 
involved through changes of the immune system. These are 
serious questions that need to be studied, but at this point do 
not seem to be the compelling mechanism. Experts at CDC, FDA, 
and NIH reviewed the current information and appear to 
recognize that the infections and death due to C. Sordellii are 
not due to a simple drug effect. Rather, this is a complex 
situation that involves multiple factors that are linked to 
pregnancy. Getting to the bottom of what puts women at risk for 
this infection and what can be done to prevent and treat it is 
of the highest importance.
    The experts at the meeting last week identified several 
clear areas of research that are needed, including improved 
surveillance of infection in women who have given birth or had 
a miscarriage, improved diagnosis, the role of antibiotics, the 
possible development of an antitoxin or other therapies, and 
further research on the nature of the Clostridium bacterium 
itself.
    I strongly urge the subcommittee to support this research 
and surveillance agenda to address this threat to women's 
health. By doing so, we can improve the health outcome of all 
pregnant women and also help ensure improved maternal outcomes. 
Please do not allow politics to trump science once again when 
the health of women is at stake. Thank you.
    Mr. Souder. Thank you.
    [The prepared statement of Ms. Wood follows:]

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    Mr. Souder. Dr. Rarick.

     STATEMENT OF LISA D. RARICK, M.D., RAR CONSULTING, LLC

    Dr. Rarick. Good afternoon, and thank you, Mr. Chairman and 
members of the subcommittee, for the opportunity to provide 
testimony in this important discussion of the use of 
Mifepristone for medical abortion.
    My name is Lisa Rarick. I am a medical doctor with training 
and board certification in obstetrics and gynecology. I 
received my medical degree from Loma Linda University School of 
Medicine and my OB/GYN training at Georgetown University. After 
my residency, I remained on the faculty of the Department of 
OB/GYN at Georgetown and soon also began to work at the U.S. 
Food and Drug Administration.
    Although my work at the FDA began as a part-time position 
in the Center for Drug Evaluation and Research looking into 
fetal effects of drug exposure, I quickly grew interested in 
CDER's broader mission of protecting and promoting public 
health through pharmaceutical regulation.
    I transitioned to full-time employment at the FDA by 
September 1989. My work at CDER progressed from the review and 
analysis of fetal exposure information to work as a primary 
medical reviewer, also called medical officer, for new drugs in 
the Division of Metabolic and Endocrine Drug Products. As a 
medical officer, I had responsibility for the review of 
investigational and approved drugs used in various conditions 
for women's health.
    In 1996, a new division, the Division of Reproductive and 
Urologic Drug Products, was created. I was named as its first 
Director. During that time, I was well acquainted with the 
application for Mifepristone and participated in the review as 
well as the Advisory Committee meeting discussions regarding 
this product. I was actively involved in the regulatory actions 
taken for this product during my tenure as Division Director.
    By the year 2000, I continued to move up CDER's 
organizational ladder in various positions and I spent my final 
year at the FDA, July 2002 to July 2003, in FDA's Office of 
Women's Health.
    My conclusions after review of the available scientific 
information regarding Mifepristone while at the agency, as well 
as my subsequent review, are consistent with the FDA's 
conclusions. The approval of Mifepristone in September 2000, 
more than 4 years after its application was submitted, was 
based on more than the necessary number of studies submitted 
and reviewed by the division of which I was Director. As many 
are aware, an application submitted to the FDA to support a new 
drug approval must contain adequate and well-controlled studies 
to confirm efficacy and safety. Generally, the word ``studies'' 
is interpreted as requiring two adequate studies. Although 
there are some instances where one study is acceptable, most 
applications contain the usual two confirmatory clinical 
trials. In the case of Mifepristone, three studies were 
submitted in order to establish efficacy and safety for early 
intrauterine pregnancy termination.
    The clinical review of this product included an analysis of 
all human studies utilizing Mifepristone, including these three 
large Phase 3 studies involving close to 2,500 women. The 
Reproductive Health Drugs Advisory Committee was convened in 
1996 and asked to discuss and provide recommendations during 
the review of this application. The committee reviewed these 
Phase 3 studies. They also heard from over 30 speakers during 
the open public hearing portion of that meeting. They 
recommended by a vote of six-to-nothing, with two abstentions, 
that benefits exceeded risk.
    The approval action taken by the agency in September 2000 
utilized the regulatory option of Subpart H restrictions for 
this product. Contrary to the assertion that Subpart H 
designation was based on a desire for accelerated approval of 
Mifepristone, this is clearly not the case. In this case, the 
application of Subpart H regulations actually provided FDA with 
more rigorous oversight and allowed for the formal imposition 
of restricted distribution. In essence, a Subpart H approval is 
meant to restrict the use of Mifepristone, not accelerate its 
availability.
    Clearly, since approval, the FDA has remained extremely 
vigilant in its regulatory oversight of Mifepristone. The 
labeling has been revised three times since its year 2000 
approval. Each of these labeling change actions followed a 
complete FDA review of the clinical studies and post-marketing 
information available for Mifepristone and resulted in updated 
presentations of scientific information for consideration by 
prescribers and patients. Labeling revisions such as these are 
an important and expected part of drug regulation and indicate 
active and appropriate review of post-approval information.
    As with any medication, when reports of serious adverse 
events associated with Mifepristone use are received by FDA, 
they are carefully analyzed and rigorous investigation is 
employed to ascertain the relationship, if any, between the 
drug and the event as well as to ascertain mechanisms to 
prevent similar events in the future.
    I applaud the FDA's efforts to better understand the recent 
findings of serious bacterial infection reported in a small 
number of women after Mifepristone use and in other pregnancy-
related conditions. In particular, as you have heard, the FDA, 
CDC, and NIH held a joint meeting on May 11th of this year. 
This meeting was an effort in which experts came together to 
better understand reports of morbidity and mortality associated 
with Clostridial infections. My understanding from those who 
attended the meeting is that the rare cases of Clostridial 
infection and death reported in Mifepristone users are, at this 
time, not explained by a simple drug-based association. In 
fact, the presentations and the discussion made it clear that 
these infections are occurring in various pregnancy-related 
conditions, not only post-abortion settings.
    I say this not to dismiss the fact that some infections are 
occurring in women who have chosen medical abortion but to 
emphasize that the agencies must and are looking at the 
infection trends more broadly. Further investigation and 
understanding of these infections and various pregnancy-related 
outcomes is essential.
    In conclusion, I urge this subcommittee to allow the FDA to 
continue to do its job. There is no evidence that FDA is shying 
away from the difficult questions of risk and benefit for this 
indication. Risks are being investigated. Adverse event 
reporting for medical abortion is uncovering and forcing 
investigation of previously unexplored risks related to 
pregnancy and post-pregnancy events. Let us all continue to 
support the FDA and others as they fulfill their mission to 
protect and promote the public health.
    The public can only have confidence in the FDA's conclusion 
if it knows that it is impervious to political pressure. I urge 
us to resist the temptation to interfere in this instance and 
instead for Congress to allow the dedicated public health 
professionals at the FDA to do their jobs, continue their 
investigations, and take any actions that might be needed to 
protect and promote women's health. Thank you.
    Mr. Souder. Thank you.
    [The prepared statement of Dr. Rarick follows:]

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    Mr. Souder. Dr. Harrison.

    STATEMENT OF DONNA J. HARRISON, M.D., MEMBER, MIFEPREX 
 SUBCOMMITTEE OF AMERICAN ASSOCIATION OF PROLIFE OBSTETRICIANS 
                       AND GYNECOLOGISTS

    Dr. Harrison. Chairman Souder, Mr. Waxman, Ranking Member 
Cummings, and distinguished members of the committee, I present 
my testimony based on my observations and research as a board-
certified obstetrician-gynecologist who has personally examined 
850 of the 950 adverse event cases reported to the FDA after 
RU-486 abortions and also based on data from the CDC presented 
at the CDC workshop in Atlanta last week, which I attended.
    The FDA outlined areas of consideration prior to 
withdrawing approval of RU-486 and these are as follows: 
Examining the evidence that RU-486 caused the adverse events; 
how soon these events occurred after RU-486; how severe these 
events are; can these adverse events be predicted or avoided; 
and how safe is the alternative treatment, surgical abortion?
    I will speak first about the five Clostridium Sordellii 
deaths. At the CDC-FDA workshop in Atlanta last week, Drs. 
Sternberg, Miech, and McGregor detailed the evidence that RU-
486 interferes with the body's ability to fight infection by 
blocking glucocorticoid receptors in the immune system. One of 
the many studies demonstrated that mice injected with a certain 
bacterial product die at a rate of 13 percent, but when these 
mice are given even tiny doses of RU-486, 100 percent of the 
mice die. The five women who died from infection with C. 
Sordellii during their RU-486 abortions tragically illustrate 
the same concept, as illustrated by data from the CDC presented 
by Drs. Fischer and McGregor.
    The statement has been made by some spokespeople from the 
FDA that the C. Sordellii deaths may be due to a change in the 
bacteria itself. This question was specifically addressed and 
specifically refuted by CDC data presented by Dr. McDonald. 
Some FDA spokespeople have implied that there are comparable 
numbers of deaths from C. Sordellii in term pregnancy. This is 
epidemiological nonsense. Dr. Fischer reported CDC data which 
revealed 5 deaths from C. Sordellii in 550,000 RU-486 
abortions. Dr. Fischer reported 8 deaths from C. Sordellii in 
30 years out of well over 70 million deliveries. The risk of 
death from C. Sordellii with RU-486 is well over 50 times 
greater.
    Dr. Fischer reported no deaths from C. Sordellii in 30 
years of surgical abortion data. Dr. Greene reported 25 deaths 
from other causes of infections in 13,161,608 surgical 
abortions. The risk of death from Clostridium Sordellii with 
RU-486 is 10 times greater than the risk of death from all 
other kinds of infections in surgical abortion. Dr. Greene from 
Harvard recently published this data. Remember also that the 
women who died during their RU-486 abortions were all healthy. 
They had no risk factors predisposing them to death, especially 
from a bacteria that rarely causes death in humans with a 
normal immune system. The CDC-FDA panelists were unable to 
identify any risk factors to predict who is more likely to die 
from C. Sordellii infection, nor could they identify any 
treatment that would save a woman once she was diagnosed with 
C. Sordellii infection. C. Sordellii infection during an RU-486 
abortion is 100 percent fatal, despite any and all treatment. 
These deaths are completely preventable.
    But septic deaths are not the only health hazard posed by 
RU-486 abortions. At least 116 women have been transfused from 
massive bleeding, and at least 54 of them lost over one-half of 
their blood volume. The medical literature states that 1 to 2 
out of every 1,000 women will need to be transfused for massive 
hemorrhage. Studies that compared surgical and RU-486 abortions 
show much higher rates of blood loss in RU-486 abortions. These 
are detailed in my written testimony. And there is no way to 
predict who will hemorrhage.
    The hazards to women's health from just the infections and 
hemorrhages alone due to RU-486 clearly constitute ample cause 
for the FDA to withdraw approval from RU-486. Thank you.
    Mr. Souder. Thank you.
    [The prepared statement of Dr. Harrison follows:]

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    Mr. Souder. Professor Snead.

 STATEMENT OF O. CARTER SNEAD, ASSOCIATE PROFESSOR, UNIVERSITY 
 OF NOTRE DAME LAW SCHOOL, AND FORMER GENERAL COUNSEL FOR THE 
                PRESIDENT'S COUNCIL ON BIOETHICS

    Mr. Snead. Thank you very much. Thank you, Chairman Souder, 
Ranking Member Cummings, Ranking Member Waxman, Congresswoman 
Schmidt. Thank you very much for inviting me today to discuss 
the legal dimensions of this question, which I think are not 
controversial and not contentious despite the contentious 
nature of the underlying issue that we are discussing.
    In my written comments, I lay out for the committee the 
various regulatory options that the FDA would have and also 
that the Secretary of Health and Human Services would have if 
they were to decide that the circumstances warranted 
intervention in this matter beyond the changing in labeling and 
the public health advisories that have already been undertaken.
    The central conclusion that I reach in my written testimony 
is that the FDA is well equipped to respond forcefully to the 
concerns raised by the co-panelists today regarding the safety 
of Mifepristone should it decide that such a response is 
warranted, and I focus on three principal mechanisms in my 
written testimony that are available both to the FDA and to the 
Secretary of Health and Human Services. In my oral testimony, I 
am going to focus on the one mechanism that is unique to 
Mifepristone given the circumstances of its approval, that is 
to say under Subpart H, which has received some discussion 
today already.
    Subpart H was devised by the FDA to permit the approval of 
drugs intended to treat serious or life-threatening illnesses 
where such drugs imposed a greater-than-normal acceptable risk 
to the patient. That is, Subpart H was designed in part as an 
alternative means of approval for useful drugs that would 
otherwise fail the traditional risk-benefit calculus required 
for FDA approval. Subpart H facilitated approval of such drugs 
by imposing additional post-marketing restrictions above and 
beyond what was required in the normal mechanisms of approval, 
as has been mentioned by numerous panelists.
    These post-market restrictions are absolutely crucial both 
in terms of their effectiveness and in terms of compliance with 
those restrictions if the mechanism of Subpart H is to serve 
its purpose. As the FDA has said in its own final rule, and I 
am quoting from the final rule, ``For drugs approved under the 
accelerated procedure regulations, the risk-benefit assessment 
is dependent upon the likelihood that post-marketing 
restrictions will enable safe use.''
    Most important for present purposes, it is clear that 
Subpart H provides a mechanism for expedited withdrawal of 
approval upon a finding that the post-marketing restrictions 
are either ineffective or are not being observed by the 
manufacturer. As the FDA noted in its final rule also, if the 
restrictions do not lead to safe use, the risk-benefit 
assessment for these drugs changes significantly. FDA believes 
that if that occurs, rapid withdrawal of approval as set forth 
in this rule is important to the public health.
    So this is a unique mechanism, and as the representatives 
and former representatives of the FDA have noted already, 
Subpart H is intended to facilitate the move to market of drugs 
through the imposition of these additional post-market 
restrictions. It is not difficult to see the implications of 
Subpart H for the case of Mifepristone.
    Danco Laboratories benefited from these unique approval 
regulations, the cost of which was a promise to comply with the 
post-market restrictions that the FDA thought appropriate under 
the circumstances. Thus, if the FDA--and I formulate this as a 
conditional because I am not privy to any facts that would go 
to this conclusion, this is a judgment that would have to be 
made based upon an evaluation of Danco's behavior--if, in fact, 
the FDA were to conclude that Danco was not in compliance with 
these post-market restrictions, or alternatively that the post-
market restrictions themselves were not effective to render the 
drug safe for its approved use, then the FDA would be within 
its authority to withdraw approval following notice and an 
opportunity for hearing for the drug itself.
    And, in fact, it would be difficult to imagine that if FDA 
did come to that conclusion, that they would not regard it as 
its duty to withdraw approval, because in the absence of 
effective post-market restrictions, Mifepristone would 
presumably not be able to satisfy the statutory criteria for 
safety. If this were not the case, Mifepristone would have been 
approved under the traditional provisions rather than under 
Subpart H.
    So essentially, among the mechanisms that I discuss in my 
written testimony, Subpart H provides a unique opportunity for 
the FDA to maintain control over the use of Mifepristone, and 
if under its own inquiries the FDA finds that the post-
marketing restrictions are not effective or are not being 
observed, then the truncated and expedited withdrawal 
provisions would be activated and FDA would be fully authorized 
to withdraw approval.
    As has been suggested, I agree, I think FDA would have the 
obligation to answer any open questions regarding the efficacy 
of the post-market restrictions and also to answer--to inquire 
about and answer any questions and respond appropriately to any 
concerns regarding Danco's compliance with the post-marketing 
restrictions.
    Thank you very much.
    Mr. Souder. Thank you.
    [The prepared statement of Mr. Snead follows:]

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    Mr. Souder. I would like to start with a question for Dr. 
Wood and Dr. Rarick. In your testimony, you pretty aggressively 
said, both of you, that there was no evidence to support the 
hypothesis that Mifeprex interferes with the immune response. 
NIH researcher Esther Sternberg's studies directly conflict 
with your assertion. Dr. Sternberg has conducted animal studies 
that demonstrate that RU-486 can suppress natural immune 
response. Dr. James McGregor of Los Angeles Women's and 
Children's Hospital has published work hypothesizing the 
pathway by which C. Sordellii causes multi-organ infection 
after suppressing the immune response. Ralph Miech of Brown 
University describes a mechanism whereby RU-486 suppresses the 
immune system and causes shock.
    Have either of you read in entirety any of these papers, 
not just a summary, but have read those papers, and are you 
aware of any research that calls into question Sternberg, 
McGregor, and Miech's conclusion that Mifepristone may 
interfere with the immune response? You made a flat assertion. 
What about those studies?
    Ms. Wood. I will say, no, I have not read those studies in 
full. However, I spoke to Dr. Sternberg and discussed her 
findings and I would agree with you that there are certain--
this is certainly a pathway that needs to be investigated. I 
think the issues and the use of the questions that arise about 
studies is that they are not questioning the studies themselves 
or even the outcomes of their studies, but they are, in fact, 
limited to particular species of rat and mouse and do not apply 
across even the different species of rats and mice. There is 
great variability in the level of the responses to different 
things.
    This is an extraordinarily complex issue of how the immune 
system is regulated, either regulated up or regulated down by 
various----
    Mr. Souder. So let me ask you----
    Ms. Wood. This is complex, and I agree with you, there 
are----
    Mr. Souder. Let me ask you this question. So I don't 
misrepresent what you said, you said you have talked to Dr. 
Sternberg and you think that it is inconclusive, but in fact, 
in certain types of animals, the study shows that it 
suppresses?
    Ms. Wood. In her animal studies, it shows what it shows----
    Mr. Souder. And----
    Ms. Wood [continuing]. But it is very preliminary----
    Mr. Souder [continuing]. You are not familiar with McGregor 
or Miech's studies?
    Ms. Wood. I have----
    Mr. Souder. Then how in the world under oath could you make 
an assertion like you did, under oath?
    Ms. Wood. I asserted that this is a very worthwhile and 
serious pathway to explore----
    Mr. Souder. You said there was no evidence.
    Ms. Wood [continuing]. But it does not look like----
    Mr. Souder. Under oath, you said there was no evidence.
    Ms. Wood. I did not say that.
    Mr. Souder. OK.
    Ms. Wood. I said there is not compelling evidence.
    Mr. Souder. Dr. Rarick----
    Ms. Wood. I said there needs to be further research.
    Mr. Souder. Dr. Rarick, are you familiar with these 
studies? Have you read them through and----
    Dr. Rarick. No, and I did not attend the meeting at the 
CDC. I similarly looked at some of the slides from the CDC 
presentation. I think the last part of your question was the 
most key word, which you said, don't you agree that they may 
be--that there may be a mechanism. I don't think we are 
disputing that there may be some mechanism of Mifepristone on 
glucocorticoid receptor issues and that the science in animals 
may have both sides of this story. Pregnancy, as you well know, 
is a complicated hormonal milieu with all kinds of receptor 
activations and inactivations of the various hormones that are 
happening during a pregnancy and pregnancy.
    I think the last part of your question, which was ``may,'' 
do we know that Mifepristone is causing an immune reaction in 
women? No. Might they? Possibly.
    Mr. Souder. Well, it is very important because I was 
subjected to opening statement after opening statement with the 
implication that we are inserting politics. You in your 
statement said--it is really interesting, because if you want 
to restore the faith of the American people, they have to feel 
that there is actually an honest debate going on, and there is 
an increasing feeling that certain people who get control of 
the establishment research want to jam their views down 
everybody else and not listen to alternative research. And the 
assertion was made that there is no contradiction. There is a 
debate going on. We need to make sure that debate goes through.
    Now, I was blown off in a question, quite frankly, to the 
Assistant Commissioner on the blood question. Dr. Harrison, my 
understanding of what you--did you go through the different 
cases on those who were reported? You seem to imply that these 
were transfusion cases and fairly serious bleeding, whereas I 
got the impression, oh, bleeding is common. This wasn't 
extraordinary bleeding.
    Dr. Harrison. I have had a chance, an opportunity to review 
850 of the 950 cases, which we obtained by Freedom of 
Information Act. Of those 950 cases, I reviewed 68 women who 
were transfused. Of those 68 women who were transfused, we have 
9 transfusion cases where the women received over four units of 
blood. We have 10 cases where they received over three units of 
blood and 38 cases where two units of blood were transfused. 
And there were also 10 cases where the adverse event report to 
the FDA did not document the number of cases transfused, and 
this is in settings where the clinical picture in the adverse 
event report was consistent with massive hemorrhage, which to 
me is unconscionable if you are actively trying to give the 
description of how much bleeding is there, to not even have a 
hemoglobin concentration or not even have an amount of blood 
transfused.
    In addition to those that I reported in my paper, which is 
what I just quoted, there were an additional 12 in the adverse 
event cases from September 2004 to July 2005, and I would refer 
you to my spreadsheets that I gave you. And of those cases, the 
12 that I mentioned were life-threatening hemorrhages. So of 
the life-threatening hemorrhages, it is basically 54 life-
threatening hemorrhages altogether as of July 2005.
    When I use the CTCIE criteria for coding these, that is a 
criteria that is used by the--developed by the National Cancer 
Institute to grade adverse events and to determine how serious 
they are so that you can compare them. What I used was a 
criteria of a women with a documented hemoglobin of less than 
7--remember, the normal hemoglobin is 13--and transfused at 
least two units. So these are women who have lost over half of 
their blood volume.
    I have in that time, from September 2000 to July 2005, 54 
cases. Now, if you look at that compared to the number that the 
FDA reports, which is 119, that is almost half of the women who 
were transfused were in life-threatening situations. That is 
not the kind of bleeding that you normally expect from surgical 
abortion. It is also not the kind of bleeding that you normally 
expect from a spontaneous abortion. In fact, it is more 
comparable to the kind of bleeding you see in major motor 
vehicle accidents. So this bleeding that is being said as 
normal and expected is a large amount of blood.
    Mr. Souder. Thank you, and one question for Mr. Snead. Is 
there a way that during additional research, and maybe Dr. 
Rarick or Dr. Wood would be able to answer, under normal 
research, that a drug cannot be taken--to me, taken off the 
market implies it is not coming back on, but could be suspended 
while additional research is done?
    Mr. Snead. Sure. I take up three mechanisms in my 
testimony, two of which are mechanisms that require notice and 
an opportunity for a hearing before the actual approval is 
withdrawn. But the third option that I take up is actually an 
option that is exercisable only by the Secretary of Health and 
Human Services. It is a non-delegatable authority vested in the 
Secretary of Health and Human Services to declare a particular 
an imminent hazard. If he does so, the effect of that is to 
immediately suspend the approval of the drug and then the 
manufacturer then provided an expedited sort of post facto 
hearing to make their case for why it was improvidently 
declared an imminent hazard.
    Mr. Souder. What about if--that still puts the burden on--
because this is obviously a very explosive political question 
because it is abortion. Whether I like it or not or whether 
anybody likes it or not, it is a legal process and we don't 
have a right to stop it. I personally have my views on RU-486. 
Other members have their views on RU-486. The question is to 
say that it is being stopped and then the manufacturer has to 
make a case is different than saying additional research needs 
to be done, because that would imply that the government has 
determined that it is unsafe as opposed to additional research 
needs to be done.
    Mr. Snead. That is right. In order to effect the imminent 
hazard privilege the Secretary enjoys, he would have to make a 
determination that it does, in fact, present an imminent 
threat, which is a judgment about the safety of the drug 
itself. There is a provision in the regulations for an 
administrative stay. The Secretary or the Commissioner has the 
authority to stay the effective date of any decision at any 
point in the process, which I think is more of what you are 
talking about, which is sort of--it is the equivalent in civil 
litigation to a temporary restraining order or a permanent 
injunction which sort of holds in place--which freezes the 
status quo and then tries to resolve whatever dispute or 
questions that there might be.
    Mr. Souder. Mr. Cummings.
    Mr. Cummings. Thank you very much, Mr. Chairman.
    Dr. Wood, I want to go back for a moment. I have always 
been one to--I don't like to leave things hanging. It seems 
like you were trying to say something and I want to give you an 
opportunity. The chairman asked you some questions and implied 
that you said something that you said you didn't say. I just 
wanted to give you the opportunity to clear that up if you 
would like. If you don't want to, that is fine.
    Ms. Wood. I would just make the point that I actually agree 
with the chairman and also with Mr. Patterson about the need 
for answering all of these questions. Is the immune system 
involved or compromised? What is it that causes this bacteria 
to become so virulent in women? What is it about pregnancy, 
either the ending of pregnancy either through termination or 
through childbirth, that has led to these deaths and these 
infections?
    So I actually would agree that more research is necessary 
and my statement in my written statement and I believe orally 
was that I just don't--my reading of it at the point is that 
the evidence is not compelling to be conclusive that is the 
answer, but I certainly would urge any and all research to 
address these questions.
    Mr. Cummings. Thank you very much. Let me just go on from 
there. Tell me, Dr. Wood, could you explain why some women 
would prefer Mifeprex over a surgical abortion?
    Ms. Wood. Mifeprex is available to women much earlier in 
the course of pregnancies and so the termination of the 
pregnancy can be done in a matter of days after the pregnancy 
is established, of implantation in the womb, and up to several 
weeks. This is much earlier than a regular surgical abortion, 
which is required to wait a few more weeks. So this provides an 
earlier option if the women is determined to end pregnancy. It 
is also one that can be more private and also avoid surgery, 
which certainly many people prefer in making a decision.
    I would also agree that access to all information about any 
known risks as they become known for any type of medical 
procedure needs to be available to women, and in the case of 
Mifeprex, because of the patient information that is required 
under the distribution restrictions on Mifeprex, that, in fact, 
we can work to assure that all women do get up-to-date 
information on any risk of any medical abortion.
    Mr. Cummings. It seems that as I listen to Mr. Snead and I 
am listening to your testimony and others, it seems as if the 
key question is where is the line drawn with regard to taking a 
drug off the market and I am just trying to figure out, what is 
taken into account when determining whether a drug should stay 
on the market, like this, for example? It seems that Mr. Snead 
has very eloquently stated all the options that could happen if 
the line is crossed. The question, it seems to me, is where is 
the line and when is it crossed.
    Ms. Wood. That question is the type of question that FDA 
has to deal with every day looking at every product when they 
get in a report of adverse events or deaths. And it is not 
simply the report of the deaths, but it is whether or not there 
are causal links, the magnitude of the response, how many 
people are affected in terms of the baseline use. There are 
many factors in trying to determine when a product should come 
off the market. It is not a simple question, but it is that 
balance of risks and benefits, and that is something the 
scientists and clinicians at FDA do every day and I would just 
urge that they be allowed to continue what they are doing, 
which is investigating this, evaluating it, and making their 
determinations without intervention.
    Mr. Cummings. Now, have you ever been in a position, you or 
Dr. Rarick, where you are, say for example, any position and 
certain evidence was presented to you and you were the person 
who suggested that we, or had the power to suggest that FDA 
take another look at a drug to determine whether or not it 
stays on the market at all, either one of you?
    Dr. Rarick. I think I can speak to that, thank you. FDA 
does that kind of determination all the time. Every time you 
see a new labeling come out on a product, that means the FDA 
has relooked at the studies as well as the post-marketing 
events to assess it. Maybe there is a new safety issue that 
needs to be put on the label or not. When those discussions 
happen, there is always the option of considering withdrawal of 
the product if those risks outweigh benefits and that 
calculation is done often for all the products that are 
available.
    Mr. Cummings. I see my time is up, but just one last 
question. You heard Dr. Harrison.
    Dr. Rarick. Yes.
    Mr. Cummings. Is there anything that she said that would 
make you all say, well, you know, maybe--I am just trying to be 
fair here--make you all say, well, maybe this is something we 
need to take another look at? I am just curious. Have you heard 
something, anything here today that causes you any kind of 
radar to go up?
    Dr. Rarick. My perspective is what I have heard here today 
is extremely important, but it is all information that the FDA 
is well aware of.
    Mr. Cummings. OK.
    Dr. Rarick. The adverse event reporting that Dr. Harrison 
is quoting is from the FDA.
    Mr. Cummings. OK.
    Dr. Rarick. They are looking at this every day. They were 
involved in the CDC meeting last week. My impression from this 
discussion is that, yes, FDA is on the case. It is looking into 
this. These are really important questions and they should take 
an action that is appropriate with the data.
    Mr. Cummings. Thank you very much.
    Mr. Souder. I want to make sure in the record that we are 
clear. Dr. Wood stated, this is a question to be studied, and 
to the degree I said there was--you said there was no evidence, 
that was incorrect. But you did say, if the immune system were 
suppressed, we would expect to see, and we didn't. We would 
expect to have seen this, and we didn't. Somewhere, we would 
expect to see this, and we didn't. Thus far, this pattern has 
not emerged. Basically, what you said was there was no 
evidence, and what I asked you was about three studies. Then 
you said those studies need to be studied further.
    And then on top of that, you had denied, in effect, what 
was the consensus of the CDC panel, that there was, in fact, 
evidence. Dr. Rarick said in her statement, to date, there is 
no evidence that has emerged to support the hypothesis, which 
did not refute either of the three studies or the fact that the 
scientific community at a recent panel of which neither of you 
were present concluded the opposite conclusion.
    Now, more research needs to be done on it, I will grant 
that, and I think that has been clear today. But it was not a 
false assertion that I made about Dr. Rarick said specifically 
in her testimony, no evidence, and Dr. Wood basically didn't 
cite any evidence. But I think we all agree more study needs to 
be done to see how common and how you disaggregate the two 
types of things.
    Mr. Cummings. Would the gentleman yield just for 1 second 
for a clarification?
    Mr. Souder. Yes.
    Mr. Cummings. Mr. Chairman, all I was trying to do when I 
asked the question is I don't like for witnesses--I think when 
people are--these are professional people and I don't want them 
to ever be in the position where they come before the committee 
and for whatever reason they don't get a chance to explain 
something that puts into question what they have said, their 
credibility. I just think it is, as one human being to another, 
bad to do that. That is all.
    Mr. Souder. And I understand the gentleman's concern, but 
you also know in a 5-minute rule that she had answered the 
question and she was then off to another. I didn't mean to 
cutoff her ability to respond, and that is why I want to grant 
that you, in fact, said more study was needed and the direct 
``there was no evidence'' quote was actually Dr. Rarick's, not 
Dr. Wood's, but Dr. Wood had a series of things that suggested 
it wasn't. I want to make sure the record reflects accurately, 
as you did.
    Mrs. Schmidt.
    Mrs. Schmidt. Thank you, Mr. Chairman. I actually have 
questions for Dr. Rarick, Dr. Harrison, and Mr. Patterson, if 
that is all right.
    Dr. Rarick, Dr. Wood stated that politics--she didn't want 
to see politics triumphing science once again, and none of us 
want to see that. My concern is how this product came to market 
in 2000. Dr. Wood stated that controlled trials were performed 
in support of the RU-486 FDA application. Could you tell us 
what the control group was in those trials that made those 
trials controlled? More specifically, was there a double-blind 
study, and if so, how did it result?
    Dr. Rarick. Certainly. In this area of pregnancy-related 
conditions, including contraception or birth control, 
oftentimes the FDA accepts clinical trial designs that are 
appropriate and use historical controls. So, for example, you 
can't have women who come in and want to contracept and suggest 
that they should be blinded and randomized to placebo versus a 
contraceptive that you expect to work and expect that to be an 
ethical trial design.
    Similarly, in medical abortion, when a woman comes in with 
a request to terminate a pregnancy, you can't suggest to her, 
well, we think this pill will terminate your pregnancy based on 
all the science, but we want you to sign a consent form that 
states you will be randomized to a pill that we know has no 
effect--a sugar pill, a placebo pill--on your pregnancy and 
then let us know if you abort or not. That is just simply not a 
reasonable trial design.
    In this setting, you know if you don't do anything, there 
is almost a 100 percent chance that they will continue to be 
pregnant, although there is a miscarriage rate, as you well 
know. But in an early intrauterine pregnancy termination, you 
can't expect placebo to have any potential effect. So you go 
back to the sort of historical control concept, that if you 
didn't give the woman anything, what would be the chances of 
her aborting versus giving her something.
    Mrs. Schmidt. Mr. Chairman, I have to comment on this 
because I am troubled by this statement. In 1995, my father was 
involved in a very critical car wreck and he almost died and 
they put him on a clinical trial regarding getting him off of 
oxygen, because the longer you stay on oxygen the harder it is 
to get off the oxygen. It was a double-blind study. We didn't 
know whether they were giving him the opportunity to wean off 
quicker or not. The alternative obviously is more of an 
opportunity to die.
    So the argument that a double-blind study can't be used in 
this case but it can be used in a life or death case of a man 
in an ICU unit at University Hospital, that just doesn't fly in 
my face and that is what makes me concerned with all of this, 
is that I believe politics was there in 2000. I think that 
while I was back home in another role in my life, I think that 
there was a rush to judgment to get this drug to market and 
what we are seeing now are some problems that are arising from 
it.
    My concern is we don't have adequate knowledge one way or 
another whether RU-486 has a direct or an indirect cause for 
death. We do know that there is a relationship between the 
death and the taking of the drug. We don't know whether it is 
direct or indirect. But we do know that there is a 
relationship. And my concern is that politics, once again, is 
playing out.
    But my next question is actually for Dr. Harrison. Your 
colleagues say that if the theory were true that Mifeprex 
comprised the immune system, then we would see a higher rate of 
other kinds of infections. Your colleagues say this. What is 
your response to that?
    Dr. Harrison. Well, I think the focus of the CDC meeting 
and most of our discussion today has been on the infectious 
deaths, but there were actually at least 7 other life-
threatening infections to date in the 850 severe adverse event 
reports that I reviewed, 1 of them being a 15-year-old who 
spent several weeks in the intensive care unit but lived.
    So there is an issue of critically looking at those 
infection-related complications and there is a secondary issue 
in even identifying those infection-related complications, 
because if Mifepristone suppresses the immune system, the 
infection may not be pelvic, and if it is not pelvic, it may 
not be recognized as being related to the Mifepristone abortion 
and, therefore, never reported. So we have a number of women 
walking around potentially with a decreased immune system or 
decreased ability to fight off infection whose connection with 
their Mifepristone abortion will not be known, and that is a 
big concern.
    Mrs. Schmidt. Thank you, and my final question is for you, 
Mr. Patterson. I am so glad that you are brave enough to bring 
this to our attention and I know that your daughter is smiling 
down on you. You are a very brave person.
    What do you have to say about the assertion that the 
benefits for RU-486 weigh the risks associated with it and what 
do you think should be done to protect other families from the 
same tragic fate that your family continues to experience?
    Mr. Patterson. I think if you were to ask Holly here today, 
had she lived, if the benefit outweighed the risk, I think she 
would disagree. I have spent many, many hours researching this 
drug and I can tell you that I feel very strongly about the 
link that this drug does impair the innate immune system and 
predisposes women to these--and can predispose these women to 
serious and lethal infections. There has been a lot of 
discussion of that at the CDC, FDA, and NIH conference.
    I think the research is absolutely necessary. I think we 
have information that has come out from very well renown and 
respected doctors. It is very compelling that we need to pursue 
this research to answer these questions.
    Had Holly been given all the information in the very 
beginning, you know, talking about the risk-benefit profile and 
weighing those options, I think that had she been given all the 
information she needed, she certainly would not have chosen an 
RU-486 abortion because Holly was not the kind of young lady 
that would risk her life for any reason whatsoever. Being the 
pinnacle of fitness and the type of healthy individual that she 
was, she would have chosen an alternate method and I can't say 
enough that it is all about having all the information to make 
an informed choice that is in the best interest of that 
particular individual and the family that are making those 
decisions.
    Mr. Souder. Mr. Waxman.
    Mr. Waxman. Thank you, Mr. Chairman.
    I am trying to sort out these different positions and I 
guess the first thing we are talking about is an infection that 
has proved to be fatal in some cases and this infection is 
called C. Sordellii. The first question is, is this infection 
caused by this drug? People who didn't use this drug have had 
this infection, is that accurate, Dr. Rarick?
    Dr. Rarick. Yes.
    Mr. Waxman. So it is not related exclusively to this drug. 
Now, we know that some people who used this drug had the 
infection. We don't know whether it caused the infection, is 
that accurate?
    Dr. Rarick. Correct.
    Mr. Waxman. So we need to get an answer to that. If the 
theory is that the immune system is suppressed because of the 
RU-486, wouldn't we have a lot of evidence more of other 
infections besides this one, because this is a fairly rare kind 
of infection, isn't it?
    Dr. Rarick. It is a very rare infection and I think this 
situation is that it seems to be cropping up in pregnancy-
related events, not just medical abortion, but deliveries, 
vaginal and Caesarian, and other conditions of post-pregnancy 
conditions. I think the FDA is actively looking at whether they 
agree or not that Mifepristone has any component of making it a 
higher risk in women who are using it for medical abortion 
versus other kinds of miscarriages or pregnancy termination.
    Mr. Waxman. Well, this is not an issue that Congressmen 
should decide. This is a very clear scientific issue. Evidence 
ought to be reviewed very carefully. The Food and Drug 
Administration, the Centers for Disease Control, the National 
Institutes of Health all met on this issue this last week, is 
that correct, Dr. Wood?
    Ms. Wood. Yes.
    Mr. Waxman. So they are looking at it. Dr. Harrison, do you 
have any information that the FDA does not have?
    Dr. Harrison. No. I have less information than the FDA 
does. My information on the adverse event reports were obtained 
by FOIA----
    Mr. Waxman. From the FDA?
    Dr. Harrison [continuing]. From the FDA, and my information 
that I presented on the risk of C. Sordellii was directly from 
the notes that I took from the meeting in Atlanta on----
    Mr. Waxman. Were you able to share----
    Dr. Harrison [continuing]. Dr. Fischer and Dr. McGregor's 
testimony, who both are from the CDC.
    Mr. Waxman. Were you able to share your views with people 
at the FDA and perhaps at that meeting last week?
    Dr. Harrison. I was not a participant and the panelists, 
the speakers and those who were in research, were segregated 
from the rest of the observers. I was in an observer spot and 
not allowed to talk with the speakers until after.
    Mr. Waxman. Are you able to submit your views to them in 
writing?
    Dr. Harrison. Someone from the FDA has requested a reprint 
of my adverse event analysis that was printed in January and I 
think that was the last request that I had or contact with the 
FDA.
    Mr. Waxman. You are listed on our list of witnesses today 
as a member of the Mifeprex Subcommittee of the American 
Association of Prolife Obstetricians and Gynecologists. In 
January 2001, your organization issued a statement--this was 
several months after the FDA's approval of Mifepristone. The 
statement said, ``The American Association of Prolife 
Obstetricians and Gynecologists opposes the destruction of an 
unborn human being at any stage of development. Therefore, we 
oppose pharmaceutical abortion with the same vigor that we 
oppose surgical abortion.'' Would your organization hold the 
same position on Mifepristone no matter what the safety data 
said?
    Dr. Harrison. I did not write that statement, although I am 
a member of the American Association of Prolife Obstetricians 
and Gynecologists. We characterize ourselves as pro-woman and 
prolife and this is a women's health issue. When it becomes 
clear that a method of abortion is 10 to 50 times more risky 
than its alternative, then this takes it out of the realm of 
the abortion debate and puts it into the realm of the women's 
health debate----
    Mr. Waxman. No doubt about it, but your organization--
excuse me, your organization----
    Dr. Harrison. I would like to finish, please.
    Mr. Waxman. No, no, let me, because I only have a very 
limited time. Your organization's position is that you oppose 
destruction of an unborn human being at any stage of 
development, whether it is a pharmaceutical abortion or a 
surgical abortion. So if that is your organization's position, 
it is really unrelated to how safe or unsafe this may be. I 
gather what you are saying is in addition to that, you feel it 
is unsafe, but your organization started off with the position 
that you don't want any abortions under any circumstances. Do 
you subscribe to that view?
    Dr. Harrison. I wouldn't agree with the way you said it, 
no. What I would say is that in this particular----
    Mr. Souder. Dr. Harrison.
    Dr. Harrison. Yes, sir?
    Mr. Souder. You do not have to state your position on 
abortion or I am going to ask all the witnesses their position 
on abortion.
    Mr. Waxman. Well, Mr. Chairman----
    Mr. Souder. The question is what the----
    Mr. Waxman. Mr. Chairman----
    Mr. Souder [continuing]. Issue at hand is, not what her 
personal position on abortion is.
    Mr. Waxman. Mr. Chairman, she is here representing an 
organization and that organization has taken a position against 
abortion under any circumstances. And they took that position 
when RU-486 was approved without any of these other 
complications or possible causations or connections ever came 
about. And so my question of her is since they took that 
position, no matter what the safety data said, how I should 
view that as a representative from that organization. Did you 
agree with the organization's position even if the safety data 
didn't convince you further that this is a possible problem 
with this drug?
    Dr. Harrison. If the issue were whether or not there is a 
human being being destroyed during the RU-486 abortion process, 
that is a separate and completely different issue than the 
issue this committee is authorized and mandated to look at, 
which is oversight of the FDA process by which this drug was 
approved, and are they doing their job to take an unsafe drug 
off the market.
    Mr. Waxman. Well, I appreciate that. I appreciate that, and 
our job is to make sure that the FDA is doing its job. But FDA 
is a scientifically based organization. They have to follow the 
science. It may lead to a conclusion one way or it may lead to 
a conclusion another way, but I want them to follow the 
science, not some preconceived notion, and I think that is the 
important point that I would make.
    I see my time is up and I will conclude on that note.
    Dr. Harrison. May I respond to that?
    Mr. Waxman. Well, no, because we are not going to argue 
that issue. The position, it seems to me, is there may be a 
problem that is related to this drug. There may be a problem 
that has no relationship to this drug. Let us get the truth. 
Let us get to the scientific evidence and let the scientists 
decide it, not politicians, no matter what our views may be on 
the abortion question, because this is strictly, to me, a 
scientific question.
    Thank you, Mr. Chairman.
    Mr. Souder. Mr. Waxman and I fence a lot in the media, even 
though we have tremendous personal respect for each other and 
get along real well, and it is awkward when we have deeply held 
views of he believes that I and others are trying to impose our 
political views and I and others believe the political views 
have been imposed on the system already.
    But what I really find disconcerting, and I understand 
where you were headed here, because there are two issues. We 
can't undo whatever abortion rights are in America. This is a 
question about this drug. But you cannot possibly hold the 
position that prolife people who oppose abortion can't 
participate in a debate----
    Mr. Waxman. And I wouldn't take that position.
    Mr. Souder. Then what----
    Mr. Waxman. I certainly wouldn't take that position.
    Mr. Souder. What is the relevance of her position on RU-
486, because if you are asking her, can she be neutral on the 
research, that is the question, not what her position is.
    Mr. Waxman. My question related to the fact that if she is 
representing an organization that took the position, we don't 
care about safety data, we are just against the drug 
accomplishing the purpose for which it is intended, which was 
to terminate a pregnancy, if that is your position--let us put 
it the other way. If you had somebody who said, I want to 
terminate all pregnancies whether anybody wants to do it, which 
is not my position, by the way. I don't want to see abortions, 
but I don't want the decision made by you or Mr. Cummings or 
myself. It ought to be made by the individual with the 
consultation with a physician and an ethicist and others. It is 
a personal decision, not one to be decided in Washington.
    But if somebody takes the position that they are from an 
organization that is against RU-486 under any circumstances, 
even if it were safe, then you sort of wonder, well, if they 
come in and say, well, we don't want this drug because it is 
unsafe, I think their views ought to be submitted to the FDA 
and they ought to evaluate them.
    Mr. Souder. I don't think that is a--I think that, in 
effect, that is why so many conservatives have a deep distrust 
of our current research structure when we hear that it is 
nonpolitical, because, in fact, what you just outlined was 
something--a position that somebody who deeply believes that 
all babies are human cannot detach that view or should be 
somehow demeaned if they belong to any organization that is 
pro-life as if we are under extra scrutiny as a doctor, as a 
researcher, as a politician, that somehow, then, we are not 
allowed to have a scientific discussion without wondering 
whether our motives are impure.
    Mr. Waxman. Well, she is not here as a well-known doctor, 
as I understand it. She is listed as here representing that 
organization. Now, if she happened to be somebody from NIH or a 
researcher very well known in the field and she is here for her 
expertise alone, that is one thing. But she is here 
representing an organization.
    Mr. Souder. It is really interesting, because she gave very 
compelling testimony, very detailed testimony on the individual 
cases, more than we got by far on blood transfusion actually 
from FDA, and that rather than debate about her testimony, you 
choose to attack the witness.
    Mr. Waxman. No, I am not attacking her, but Mr. Patterson's 
daughter didn't die from hemorrhaging. She died from this 
particular infection and this infection is a very dangerous 
infection and we need to know if it is connected to this drug. 
If it is, even though I am pro-choice, I would be the first, 
along with you, to say it ought to be taken off the market, or 
it ought to be labeled as such. But if it is not a safety 
threat, then I don't think it ought to be accused of being a 
problem just because it shouldn't have been approved in the 
first place by the people who want to take it off the market.
    Mr. Souder. Furthermore, she is a published author in 
research documents. I----
    Mrs. Schmidt. Mr. Chairman, I think in fairness, I want to 
know where everybody stands on the issue of abortion----
    Mr. Souder. I don't think----
    Mr. Waxman. Do you want to start off with yourself?
    Mrs. Schmidt. Sure. I would be more than happy to.
    Mr. Souder. Reclaiming, I think the line of questioning was 
inappropriate. I made my statement. Mr. Waxman is the senior 
ranking member of the full committee. He is free to do that. I 
think the public can judge whether that was a fair approach, 
but it certainly will reinforce people across the country who 
are watching, a feeling that there is a discrimination against 
people who are pro-life from being able to participate in 
research, and that is some of why there is so much questioning 
about this whole science debate.
    Mr. Waxman. Would you yield to me just for me to make one 
comment? I appreciate your views. I don't agree with you. But 
the only comment I would make is that the Government 
Accountability Office did an evaluation of FDA's action on the 
Plan B contraceptive drug, and even though the scientific 
committee appointed to review it said it should be approved, 
even though the researchers at NIH said it should be approved, 
it appeared that a political judgment was made because of the 
Bush administration that it shouldn't be approved and its 
approval is now in limbo. Many of us look at that as clear 
politics when the science points in a different direction.
    I want to know what the science says about this issue. You 
say it is compelling. It is not compelling if scientists are 
still evaluating the matter. I want them to see whether it is 
compelling, whether there is a clear case made, and I don't 
want politics interfering with science.
    Mr. Souder. You can keep repeating that, but the funny 
thing is, I have been a staffer here, I have been a member 
here. We all know who requested the GAO study, who has picked 
on the GAO study, which is heavily steered. GAO will do a study 
on either side depending on who basically pushes it and what 
mixes are. We have gone into this.
    Mr. Waxman. Well, now you are attacking the GAO's 
credibility just because it came up with a study that you 
disagreed with.
    Mr. Souder. No, I am questioning----
    Mr. Waxman. That is more of an attack than I ever did with 
Dr. Harrison.
    Mr. Souder. As the GAO----
    Mr. Waxman. And I didn't mean--I attacked the research----
    Mr. Souder. As I have said, when you get into controversial 
political subjects, the GAO, how you phrase the question, who 
does it, in any honest--forget here for a second that the TV is 
on--you know full well that we have problems in the GAO as far 
as what kind of study you get back, and to act like it is a 
pure scientific study out of the GAO--they do good research, 
they research it, but they are going to have a bias based on 
who is put on a given study and who is requesting the different 
study. And if I request it with Republicans, you are going to 
get a slightly different study back than you do.
    There are subjects where they aren't that kind of laden 
with the political overlay on this and the GAO will be very 
forthright. You can go through the researchers they contracted. 
You can look at the footnotes. You can look at the previously 
published records of it. I am saying the GAO is transparent on 
it, but when you go through the evaluation, you will see who 
they hired as a contractor will determine what research they 
get back.
    Mr. Waxman. We have another Member who wants to ask 
questions----
    Mr. Souder. Yes, I----
    Mr. Waxman [continuing]. But I just want to defend GAO. 
Requesting a study by GAO doesn't mean that they have to come 
out with your preferred conclusion. I think they have a lot 
more integrity and honesty than you are suggesting. They can 
decide who they are going to do the investigation. I think they 
are a reputable source of information. Sometimes they come up 
with conclusions I like, sometimes not, but they come up with 
the facts and then we can draw the conclusions. I want the 
science reviewed and then we can let the appropriate 
policymakers reach the conclusion, but----
    Mr. Souder. Ms. Watson----
    Mr. Waxman [continuing]. Ms. Watson has been very nice 
here.
    Ms. Watson. I came in late and I am sorry about that. I 
would like to know what we are investigating and looking at in 
this particular meeting. Now, reading from the information that 
was given to us, it says ``RU-486: Demonstrating a Low Standard 
for Women's Health?'' May I ask, I would maybe ask Dr. Rarick 
or Dr. Harrison, the question. Let me start with Dr. Rarick.
    Are we talking about a low standard for women's health, and 
if so, what is that? And are you agreeing that we have seen 
more women die after using this drug than women who die after 
having abortions? I just want to focus this discussion. I think 
we have gotten off the track. So can you respond to that, 
because we are looking at a low standard for women's health. At 
least, that is what I thought this meeting was about and not 
our beliefs and what sides we are taking. So can you answer 
that question, the low standard question?
    Dr. Rarick. Certainly. I will start with that. Mifepristone 
in its review at the FDA was held to the highest standards, 
similar to any drug product that is reviewed in the Center for 
Drugs. It was reviewed in a rigorous way. It took over 4 years 
from its submission to its approval. It was appropriately 
labeled. It was held to the highest standards for women's or 
men's health at the FDA and I believe they are still treating 
it that way. They are looking at the issues that you are asking 
about.
    Are there more deaths reported with Mifepristone than with 
surgical abortion? Some would say that there is tenfold more 
deaths. I think we just heard that reported. But again, we have 
to think about how they are looking at this data. Is there a 
way to get more accurate data on surgical abortions, etc.? Is 
there a way to understand the Mifepristone-associated deaths so 
that they can be prevented? The issue is risk and benefit. They 
are looking at that very seriously and I think it is being held 
to the appropriate and high standards.
    Ms. Watson. As the department of government that looks at 
drugs and their usage and results, what would be the next step 
if you then conclude that there appears to be a higher number 
of deaths associated with the approval and the use of this 
particular drug? What is the next step?
    Dr. Rarick. Well, the next steps would be to look into 
those types of deaths in all pregnancy-related events to try to 
understand those better, make providers aware of those 
infections and that potential, understand how to prevent it, 
understand how to treat it, do women the service of 
understanding pregnancy-related deaths in the broader sense, 
not just related to Mifepristone. Many more women die from 
childbirth than die from using Mifepristone for medical 
abortion. Putting money into those questions, surveillance into 
maternal mortality, appropriate money to explore maternal 
mortality in its broadest sense, those would be the next steps.
    Should the FDA look at all this information? Absolutely. As 
was said before, they have all the information and more than 
Dr. Harrison has referred to. They are looking at it very 
seriously. If they believe that--they come to the conclusion 
that the risks do not outweigh the benefits, they will take 
appropriate action.
    Ms. Watson. OK. And do you feel that we are demonstrating a 
lower standard for women's health?
    Dr. Rarick. Not at all.
    Ms. Watson. All right. I would hope that this committee 
would provide the oversight as FDA moves along and we would 
then look at the empirical evidence that would emanate from 
your studies to address this question. If we are demonstrating 
a lower standard, then provide the scientific evidence. I would 
beg that we don't discuss the ``A'' word in terms of looking at 
this particular drug. It gets us off track, as it did just 
about a minute ago. What I want to be presented with as a 
decisionmaker is what evidence we might have that we have 
approved a drug that lowers the standards for women. Thank you.
    Mr. Waxman. Will the gentlelady yield to me?
    Ms. Watson. Yes, I will, certainly.
    Mr. Waxman. I wasn't even aware of it until you just 
pointed it out. The chairman said it depends on how you ask the 
question, but the hearing is titled for today, ``RU-486: 
Demonstrating a Low Standard for Women's Health?'' so that is 
the way we are asking the question. I think we need to see 
whether there is a--and you answered that question and I was 
pleased with your answer, but I think the question should be, 
is there a connection between Mr. Patterson's daughter and the 
five people that have died from this particular infection and 
the use of RU-486? That seems to me the key to it, because if 
there is a connection with the use of this drug and getting 
something as deadly as this infection, that is a serious 
matter. So we need to explore it, but evidently it is not so 
clear when we find people have had the infection who didn't 
have the drug. So I agree with you. Let us get the science. Let 
us get the facts.
    Mr. Souder. Dr. Rarick, I was a little confused by your 
response. You said that if, in fact, there were deaths, you 
would work for or believe there should be further notification 
to doctors. I inserted this earlier, but Palladone, Purdue 
Pharma agreed to voluntarily suspend, and they said, to date, 
FDA is not aware of any patients who had life-threatening side 
effects from drinking alcohol while taking Palladone, but they 
took it off the market.
    Tysabri Biogen voluntarily suspended marketing of the drug 
as well as its use in clinical trials until more detailed 
information could be gathered on one death and one other 
adverse effect.
    In NeutroSpec, Palatin Technologies voluntarily suspended 
sales and marketing of NeutroSpec. No determination was made 
regarding the relationship between that and reported adverse 
effects.
    In Cylert, Abbott chose to stop sales and marketing based 
on 13 reports of liver failure, but they did not grant--and RU-
486 had 10 to 14 times more than surgical abortion, even though 
in this case liver failure was 10 to 25 greater in the general 
population.
    Bextra, Pfizer voluntarily withdrew Bextra from the market 
even though it concluded that the overall risk versus benefit 
was unfavorable.
    In Baycol, they withdrew after reports of 31 deaths. In 
Roplin, it was 5 deaths.
    In Lontronex, it was a total of 70 cases of adverse effects 
of which 34 required hospitalization without surgery and it was 
pulled off.
    In Orlaam, it was discontinued after a report of severe 
cardiac-related events among opiate-addicted patients. They 
pulled it off the market, not just warnings.
    So is your position that FDA should treat this drug unlike 
other drugs, because when there are adverse effects with deaths 
and so on, at the very least, you think it would be suspended. 
That has been the whole pattern. The problem here is you have a 
drug company that only has one drug. It is in the Cayman 
Islands. There is no incentive to do what all these other 
companies did which went off the market. And so what is the 
responsibility of the Federal Government when the private 
sector won't act responsibly like the others.
    Now, I happen to believe, even though I don't want RU-486 
on the market, that there may be some debate here as to whether 
it is the primary, and that is why I was asking questions of 
can it be suspended while we find that out. But I see no 
pattern of FDA that we leave something on the market while we 
are doing that study, because it is clear that it was toxic in 
a disproportionate amount if you are using RU-486, that the 
blood transfusions were certainly disproportionate, and under 
any standard of the past, you would at least suspend, hence the 
question of the hearing.
    Dr. Rarick. I would simply disagree with you. You can list 
all the ones that have been suspended, but you have to think of 
the thousands of drugs that are on the market that have post-
marketing reports of deaths. The easiest example is Viagra, 
where we had at least several hundred deaths during its first 
year of prescription, the same company, Pfizer, that you 
mentioned there for Bextra. There are all kinds of examples of 
post-marketing death adverse event reports and other serious 
adverse event reports where the majority are certainly not 
suspended from marketing.
    Mr. Souder. Even if it was directly related to that 
product, the FDA does--then what standard would you have FDA 
intervene?
    Dr. Rarick. The standard that they use, which is a risk-
benefit analysis for each particular case.
    Mr. Souder. Mr. Snead, what is your response to that?
    Mr. Snead. I think, essentially, that is exactly right, 
namely that you need a risk-benefit analysis that is undertaken 
to determine whether or not a drug is initially approved. But I 
would like to add something that I think would be informative 
to the Members. What we are talking about here as a legal 
matter is a drug that has been approved under Subpart H, and 
what that means is that creates an inference that the FDA in 
approving Mifepristone had a concern, safety concern, that 
required additional safeguards beyond the normal safeguards 
that attend a normal risk-benefit analysis.
    In the passage that I read before from the FDA's final 
rule, they said the risk-benefit analysis that yields the 
conclusion that this should be approved assumes that these 
post-marketing requirements will, A) be effective, and B) be 
observed. So there has been much discussion about the safety 
piece of that particular question. But what seems to be getting 
lost among the discussion is there is a second question, a 
second grounds under Subpart H, which is a factual question 
about the compliance with the post-marketing restrictions by 
Danco Corp.
    So I would just draw the committee's attention back to the 
fact that, of course, safety is a principal concern as laid out 
in the withdrawal approvals of Subpart H as well as with the 
other withdrawal approvals that I take up in my written 
testimony, but the question of compliance is equally important 
of a question, because without meaningful compliance by Danco, 
the risk-benefit analysis is not what the FDA intended it to 
be. The risk-benefit analysis depends on the assumption that 
there is compliance, and if there is no compliance, then the 
risk-benefit analysis is substantially different.
    Mr. Waxman. Mr. Chairman, could you yield to me?
    Mr. Souder. Yes.
    Mr. Waxman. Do you have evidence of noncompliance?
    Mr. Souder. I have no evidence of any kind. I am just 
simply describing to you what the considerations are.
    Mr. Waxman. So you are saying if there hadn't been 
compliance with the limitations----
    Mr. Souder [continuing]. I am making a conditional 
statement. If the FDA were to determine that there was no 
compliance, then they would have additional grounds to withdraw 
approval under Subpart H.
    Mr. Waxman. But I hadn't heard anybody assert that there 
hadn't been compliance of the approval itself under the Subpart 
H. Of course, this is unusual, because most drugs are just 
approved and once they are approved, they can be used for any 
purpose. This one was approved for limited purposes under 
limited circumstances so that there would be extra care taken. 
I guess I should ask that question of Dr. Rarick. Am I correct 
in that? It wasn't----
    Dr. Rarick. Correct----
    Mr. Waxman [continuing]. Approved like most other drugs, go 
ahead and use it----
    Dr. Rarick. There was a determination that it shouldn't be 
released through pharmacies, that it had to be provided by 
specific types of prescribers.
    Mr. Souder. And I should say for the record that we did 
invite Danco so we could address that question and they 
withdraw 2 days before the hearing and we didn't have a chance 
to get somebody else to directly address the question, but it 
is a fair question.
    Mr. Waxman. It is not a fair question unless you know there 
has been some non-compliance.
    Mr. Souder. No, your question is a fair question, because 
we don't know for sure about compliance. I tried to address 
that with FDA. I don't think, personally, that what was tested 
has been followed through the way it was tested, but the 
Assistant Commissioner explained why she thought that was still 
allowable, but we don't have Danco here and we don't have a 
substitute for Danco to follow through that question, but it is 
a question we need to followup in our written questions and we 
said at the beginning that I was going to do that with Danco.
    Dr. Harrison, could you talk about the proportionate use 
effect, too? Viagra is used over and over. RU-486 would not be. 
And any comments you had on Dr. Rarick saying, look, there are 
other drugs we allow on the market, because that is a fair 
point. If there are lots of drugs on the market that have 
adverse effects, why should this be treated differently than 
those?
    Dr. Harrison. The issue is not the absolute number of 
adverse events. The issue is, as is stated in the FDA letter to 
this committee, the evidence whether or not RU-486 was causally 
related to the adverse events, the timing of the event--
remember that these RU-486 septic deaths happened within 7 
days. There is no issue of confounding factors here. These 
women were healthy. They didn't have other medical conditions 
that could explain why they would suddenly get an extremely 
rare bacterial infection that doesn't usually kill normally 
immuno-competent people. How severe these events are--the death 
is the ultimate severe adverse event.
    And I would have to add that transfusions are also a 
significant severe adverse event, and to minimize the 
significance of having a blood transfusion is to underestimate 
the care that goes into clinically judging whether or not this 
person needs a transfusion. Transfusions aren't done lightly. 
They are done when there is a significant risk to the person's 
life.
    Can the adverse events be predicted or avoided? The CDC 
meeting was absolutely clear that at this point in time, there 
is no way to predict who is going to get--who is going to die 
from C. Sordellii. Because we can't predict who and we can't 
identify risk factors, we also can't avoid C. Sordellii in 
Mifepristone abortions. There has been a consistent 
spontaneous--a consistent rate, excuse me, of about 1 death for 
every 100,000 Mifepristone uses. So if that continues unabated 
while we debate these questions of how much research and who 
gets the grant money and all that stuff, that means that for 
every 1,000 uses of Mifepristone, one more American woman is 
going to die, and I think that is something that has to be put 
into perspective. These are human beings that are being 
subjected to a completely unnecessary risk.
    Surgical abortion is available and legal and safer, and how 
safe is the alternative treatment, and that is the other issue. 
Surgical abortion is available. It is legal. And to say that 
Mifepristone is being used in cases where surgical abortion 
isn't available, think about what would have happened to these 
transfusion deaths if there hadn't been surgical abortion 
available. Any place that has the capability to--excuse me. Any 
place that doesn't have the capability to have an abortion 
clinic also doesn't have the capability to do transfusion. We 
are talking pretty sophisticated medical facilities. So the 
person you absolutely do not want to use Mifepristone is the 
one who has no access to surgical facilities to complete this 
under an emergency circumstance, so I think that is kind of a 
spurious argument.
    So that would be my response. Thanks.
    Mr. Cummings. Mr. Chairman, may I please----
    Mr. Souder. Yes.
    Mr. Cummings. Thank you.
    Mr. Souder. Mr. Cummings.
    Mr. Cummings. I have sat here and I have listened to all of 
this and I was sitting here saying to myself, I am so glad that 
there are women making these arguments. I would hate to see a 
group of men. They would probably say that we were not as 
sensitive as we need to be, and I say that to say this, that I 
think we are all concerned about women's health. As a matter of 
fact, I know that we are.
    I don't think that in this country we are talking about low 
standards. Let us not kid ourselves. This is the United States 
of America. There is no way that I think any member of this 
panel would in any way accept a low standard or even a mediocre 
standard. The witnesses, I know you feel the same way. We may 
differ on your opinions and what have you.
    The key is, Mr. Patterson, is we want to make sure that we 
do everything in our power, as I know you want us to do, to 
make sure this does not happen to anyone else. That is what 
this is all about.
    And I would hope and I would think that you, Dr. Rarick, 
when I asked you the question a little earlier, because I 
really wanted to get a sense of exactly--obviously, there is a 
procedure that you have there at FDA, and obviously, and you 
can tell me if I am wrong, you try to keep the politics out of 
it because you are talking about people living and dying, I 
guess. I trust that you do.
    But you have heard the testimony of Dr. Harrison and I 
would assume that you would be, as we all are, as sensitive to 
women's health. Is there anything that you have heard that you 
would question whether you all have a low standard? I know that 
may be a sort of self-serving question and I am not trying to 
do that, but I am trying to get to the bottom of this, because 
sometimes we can get so caught up in our politics that we 
forget where we are trying to get to and we get sort of off-
track. The key is that we want to make sure, all of us, that 
FDA has a standard which will protect every woman with regard 
to her health choices.
    So that leads me to this. Somebody said a few minutes ago, 
I think it was you, Mr. Patterson--it was you--when you were 
talking about your daughter, you said if there was information, 
if she had access to all the information, she probably would 
not have made that choice.
    Now, I am asking you, based upon all that you know, Dr. 
Rarick, is there anything that you could have or the FDA could 
have put on the label or put on the little description of the 
drug's side effects, whatever, that should have been there, 
just based on what you know to this date? I am not talking 
about--I know there is still research to be done and all that 
kind of stuff--that should have been on there?
    Dr. Rarick. Well, I would stand behind the FDA's labeling 
at each point when they revised their labeling, and if you look 
at the current labeling, it does describe that there has been 
some unusual and severe bacterial infections and deaths. It 
describes some of the way the regimen was given in those cases. 
It provides that information.
    I agree with you that the FDA has to look at this very 
seriously and always decide, do the benefits remain to outweigh 
the risks?
    If you ask me about high standards, I would say the FDA 
holds this to a very high standard. I believe if you are 
looking for low standards in women's health, it would be that 
we don't have very much information about maternal mortality in 
general, not just post-abortal or post-medical abortion 
mortality, but just infections and pregnancy outcomes, any 
events in general.
    But in terms of Mifepristone being held to a particularly 
low standard, absolutely not. It is held to the highest 
standards. I think the FDA is considered the most rigorous 
regulatory body in the world and it, of course, meets those 
needs.
    I agree with you that these things are incredibly serious. 
Nobody is trying to minimalize any of these events. I believe 
the FDA is looking at this from their scientific viewpoint. 
They at the meeting last week I think were quoted as saying 
they initially saw this as probably a simple drug-based 
association and they realized when they looked into it that 
simply wasn't true, that it was much more complicated than just 
Mifepristone and infection and they are looking at it.
    Mr. Cummings. Now, you said the labeling has changed. I am 
going to get back to you, Mr. Patterson, in 1 second. I see you 
shaking your head. But you said the labeling has changed, is 
that right?
    Dr. Rarick. Yes. The labeling has been updated, I think at 
least three times since its original approval.
    Mr. Cummings. And I take it that when Mr. Patterson's 
daughter took the--there have been changes since Mr. 
Patterson's daughter used this medication?
    Dr. Rarick. Yes.
    Mr. Cummings. Maybe one of you all could tell us, were 
those the changes that you just authorized? You said something. 
I am just trying to figure out, have we made much progress with 
regard to going back to what you said, Mr. Patterson, putting 
it out there, as much information as possible that we feel 
comfortable is accurate?
    Mr. Patterson. Well, first of all, I would like to say 
again that if Holly had all the information to make an informed 
choice, she wouldn't have chosen Mifepristone or an RU-486 
medical abortion.
    There is evidence that a death did occur in Canada with an 
infection and she, in fact, did die from C. Sordellii, and that 
was what I uncovered in my medical research that was not very 
well known or very well published. As a matter of fact, the 
author of the paper of the woman who died in Canada was Dr. 
Christian Sinave. It just so happens that at the time, my wife 
and I, when we called Dr. Sinave, we were the very first person 
or concerned people to call about that particular infection as 
it is associated with RU-486. He said in his own words that he 
had been discouraged to write the paper and that we were like 
the only ones that had ever showed any interest, and since 
then, there has been a considerable interest over this 
infection and its relationship with the drug.
    To say that this drug, there is no causal relationship, I 
think is ridiculous. My daughter took the drug and she died. I 
mean, it is that simple. So the medical community was aware of 
it. Danco was aware of it. The Population Council was aware of 
it and there were studies showing that there were infections as 
a result of medical abortion. However, Holly was not indicated 
in the label and Holly was not given that information.
    Since my daughter died, I have been to Washington. I have 
discussed my concerns with the FDA over these safety and health 
concerns. There have been--consequently, there have been four 
more women died after Holly and some very shortly, within 
months, after Holly. As a matter of fact, with the reporting, 
it took one of the deaths right after Holly, it took almost a 
year and a half to get reported. That is why today I have 
discussed there needs to be some very accurate mechanisms to be 
able to evaluate from the FDA's level what is really going on 
out there. I am very concerned that women are dying and these 
events are not getting reported so that the FDA can actually do 
their job.
    Mr. Cummings. All right. So there have been--and thank you 
very much. Just a last question. There have been some updates 
with regard to the warnings, is that right?
    Dr. Rarick. Correct.
    Mr. Cummings. I think in November 2004, the black box 
warning was revised and strengthened to add new information on 
the risk of serious bacterial infections, sepsis, bleeding, and 
death that may occur following any termination of pregnancy, 
including Mifeprex. In July 2005, apparently the FDA approved a 
labeling supplement to again strengthen the black box warning 
on the product, but noting that atypical presentations of 
serious infection can occur without fever, bacteria, or 
significant findings on pelvic exam, etc. Is that accurate?
    Dr. Rarick. My review of the label, I believe would agree 
with that. I have the label here if you want to see the whole 
label.
    Mr. Cummings. No problem. I just wanted to make sure that 
it is being updated.
    Mr. Souder. Anything else, Mr. Waxman?
    Mr. Waxman. This issue of death associated with a drug, 
when FDA approves drugs, they look at the safety and they look 
at the efficacy, whether the drug accomplishes what it is 
intended to accomplish. Aren't there risks associated with a 
lot of drugs, Dr. Rarick?
    Dr. Rarick. Oh, every drug has risks associated with it, 
yes.
    Mr. Waxman. Viagra could cause death. Penicillin could 
cause death. They are on the market. But I assume they are on 
the market because there is a risk-benefit analysis that even 
though there may be a rare case of death, it is not so out of 
control that it diminishes the fact that there is a benefit 
from those drugs. Is that what we mean by a risk-benefit 
analysis?
    Dr. Rarick. Correct, that you look at those risks, those 
death reports and rates in contrast to the benefits.
    Mr. Waxman. There is a question in my mind about deaths or 
harm associated with a drug as opposed to death or harm caused 
by the drug. Can you clarify what that means in terms of FDA 
regulation?
    Dr. Rarick. It sounds like a legal term, but I will try. 
When you think of cause and causation, you think, you know, if 
I tell my kid, don't touch the hot stove, you are going to get 
burned, and he touches the hot stove and gets burned, to me, 
that is cause and effect. When you look at drugs and the risks 
associated with them, it is very rare that you can actually say 
X drug causes Y, because, as you know, many, many people take 
the drugs that don't get that effect. The majority of people 
who take a particular drug won't have the side effects that are 
described in the label, but there are going to be side effects 
in many people, and there, you would call that a side effect 
that is associated with the use of that product.
    Mr. Waxman. Well, Mr. Patterson has pointed out, I think 
appropriately, that he wished his daughter would have known 
that there was this potential side effect. Now, FDA has issued 
public health advisories in connection with safety concerns 
related to Mifepristone in 2004, 2005, and most recently, in 
March 2006. The FDA has consistently highlighted the fact that 
the cases of severe infection occurred with regimens of 
Mifepristone and Misoprostol that were not in approved 
labeling, although the relationship of the infections to such 
use remains unknown. What does that mean? Could you tell us 
more about this, if you know?
    Dr. Rarick. That means even though the products are being 
used outside of their labeled instructions, the FDA wants to 
make sure that providers and patients are aware that it has 
been associated with these infections. Whether it would be 
associated with those infections if it had been used as per 
label, they are not stating. They are simply saying--they could 
just say, well, that wasn't used by the label. We don't even 
need to put it on the label. But instead, they are saying, no, 
we need to make sure providers and patients are aware that in 
certain circumstances, we have had these reports. They are not 
suggesting that it is absolutely that circumstance that caused 
the increased risk, but they want to make sure that information 
is available.
    Mr. Waxman. Well, I thank you for that clarification and I 
will conclude by saying I just hope the FDA will continue to 
reevaluate all the evidence, advise people of information that 
is pertinent, and if they see there is a real threat to this 
drug, or any other drug, they need to take actions, including 
taking the drug off the market. But I don't think they ought to 
act until they look at the science and reach some conclusions 
on this drug or any other drug.
    Thank you, Mr. Chairman.
    Mr. Souder. Thank you. Rather than ask Dr. Harrison the 
question again, I think we will insert in the record your 
earlier response on the causal link, that there were multiple 
things, including alternatives such as surgical abortions and 
so on, because you gave a complex answer to that question early 
on. Did you have anything you want to add?
    Dr. Harrison. No, that is fine.
    Mr. Souder. Ms. Watson.
    Ms. Watson. I just hope that we can have, Mr. Chairman, a 
followup hearing as FDA proceeds along its track to assess the 
risks of this drug, that we will do the oversight that we are 
responsible for here in Congress, and I would hope that we 
would base our debate on the results of your studies so that we 
can come from a scientific base as we discuss this.
    So I want to thank the chair for this hearing. I think it 
has opened up a debate on the efficacy of this drug that has 
been approved and we need to see what the effects actually are. 
So thank you so much for the hearing and thanks to the panel.
    Mr. Souder. Thank you, and I want to thank each of the 
witnesses and I want to say this directly to Dr. Wood and Dr. 
Rarick. Whether we agree on the nuances here, or maybe we do 
long-term or not, that your work long-term, Dr. Wood 
particularly but also Dr. Rarick, on women's health issues, 
because certainly it was an area that was underrepresented in 
the research, and without aggressive advocacy, we wouldn't be 
where we are on breast cancer, on the whole range of women's 
health issues. So regardless of where we stand on this issue, I 
appreciate your lengthy career working with that, Dr. Rarick, 
as well.
    I thank Mr. Patterson for speaking out, Dr. Harrison for 
giving us that detailed analysis of each of the type of cases 
and your rigorous analysis of that, and Mr. Snead for bringing 
the legal aspects in and we will find out, particularly if 
Danco responds, how to address some of their questions legally 
on whether they have been following through on the guidelines 
of FDA.
    With that, the subcommittee stands adjourned.
    [Whereupon, at 6 p.m., the subcommittee was adjourned.]
    [Additional information submitted for the hearing record 
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