[Congressional Record Volume 149, Number 170 (Friday, November 21, 2003)]
[Senate]
[Pages S15473-S15475]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. BROWNBACK (for himself, Mr. Ensign, Mr. Enzi, Mr. Hagel, 
        Mr. Inhofe, Mr. Nickles, Mr. Santorum, and Mr. Sessions):
  S. 1930. A bill to provide that the approved application under the 
Federal Food, Drug and Cosmetic Act for the drug commonly known as RU-
486 is deemed to have been withdrawn, to provide for the review by the 
Comptroller General of the United States of the process by which the 
Food and Drug Administration approved such drug, and for other 
purposes; to the Committee on Health, Education, Labor, and Pensions.
  Mr. BROWNBACK. Mr. President, I rise today to introduce a very 
important piece of legislation, the RU-486 Suspension and Review Act of 
2003. The abortion drug RU-486 increases in infamy as its lethal nature 
continues to reveal itself. As my colleagues may remember, in 
September, RU-486 claimed two more lives, one of whom was an 18-year-
old woman. Holly Patterson, a resident of the San Francisco suburb of 
Livermore, died from an infection caused by fragments of her baby left 
in

[[Page S15474]]

her uterus after she was administered RU-486 at a Planned Parenthood 
facility. This tragedy underscores the dangerous nature of this drug.
  The available data from the U.S. trials of RU-486 raises serious 
questions in my mind as to whether or not this drug truly is ``safe'' 
for the women who use it. Women who participated in the U.S. trials of 
this drug were carefully screened, and only those who were in the most 
physically ideal condition were accepted. Even so, among these 
physically ideal participants, troubling results emerged. Two-percent 
of the women participating hemorrhaged; one-percent had to be 
hospitalized; several others required surgery to stop the bleeding--
some of whom needed blood transfusions; and one woman in Iowa, after 
losing between one-half to two-thirds of her total blood volume, would 
have died if she had not undergone emergency surgery. If these side-
effects occurred in the most physically ideal candidates, what about 
those who are not in the physically ideal category? Is this drug 
``safe'' for women? I believe medical results suggest it is not.
  The bill I am introducing today will require the suspension of the 
Food and Drug Administration's approval of RU-486. Following this 
suspension, the General Accounting Office is directed to review the 
process the FDA used to approve RU-486 and to determine whether the FDA 
followed its own guidelines. If it is determined that the FDA violated 
its guidelines, RU-486 will be suspended indefinitely. Monty and Helen 
Patterson, the parents of Holly Patterson, have expressed their firm 
support for this legislation and have requested that it be known as 
``Holly's Law'' in honor of their daughter whose life was prematurely 
ended. I ask that their open letter on this subject be printed in the 
Record.
  The Food and Drug Administration should not have authorized this 
dangerous drug. RU-486 is perilous both to the baby and to the woman 
who uses it. I urgently call on my colleagues in this Chamber to 
support ``Holly's Law'' to prevent more unnecessary deaths.
  There being no objection, the letter was ordered to be printed in the 
Record, as follows:


                                                Livermore, CA,

                                                November 20, 2003.
       Dear Sir or Madam: The Alameda County Coroner's report has 
     validated what we already believed to be true. Holly has died 
     from an RU-486 chemical induced abortion. There are no quick 
     fixes for a pregnancy or magical pills that will make it go 
     away. Our family, friends and community are all deeply 
     saddened and forever marred by Holly's tragic and preventable 
     death.
       Holly lived as an adult by law for only 19 days, yet she 
     became pregnant when she was just 17 years old. We now know 
     that she learned about her pregnancy in the second week of 
     August and was so distraught over her unplanned pregnancy 
     that she sought help for depression from her family doctor on 
     September 10, 2003--the very day that she began the drug 
     induced abortion process.
       Holly was a strong, healthy, intelligent and ambitious 
     teenager who fell victim of a process that wholly failed her, 
     beginning with the 24-year-old man who had unprotected sex 
     with her, impregnated her, and then proceeded to facilitate 
     the secrecy that surrounded her pregnancy and abortion. Under 
     this conspiracy of silence, Holly suffered and depended on 
     the safety of the FDA approved pill administered by Planned 
     Parenthood and emergency room treatment by Valley Care 
     Medical Center where she received pain killers for severe 
     cramping and was sent home. On Saturday and Sunday, Holly 
     cried and complained of severe cramping and constipation, and 
     even allowed us to comfort her but could not tell us what she 
     was really going through. On September 17, 2003, she 
     succumbed to septic shock and died while many members of our 
     family waited anxiously, yet expectantly in the Critical Care 
     Unit for her to recover until we were forced behind the 
     curtain when it was clear that she was dying.
       And in those last moments of her life feeling utter 
     disbelief and desperation we formed a circle just beyond the 
     curtain and prayed aloud, cried and screamed, ``We love you, 
     Holly'' hoping beyond hope that those words would ring out 
     and save her life. And the other members of our family who 
     drove and flew from all over the country to be by her side 
     did not make it in time to say, ``I love you'' just one last 
     time. Holly was not alone, unloved, unprotected or 
     unsupported; she had a large family who willingly supported 
     her throughout her short life and tragic death.
       In the weeks since we buried Holly's body we are now able 
     to recall and share the memories of our daughter's brilliant 
     blue eyes, engaging smile, laughter, unwavering determination 
     and sheer gentle beauty that invoked our natural instinct to 
     protect and love her, but we will never be able to forget 
     those last moments of her life when she was too weak to talk 
     and could barely squeeze our hands in acknowledgement of our 
     words of encouragement. ``We love you, Holly'', ``Just hang 
     in there, the whole family is coming,'' ``You fight this 
     Holly, you can do it.''
       Because Holly has died this way, we have educated ourselves 
     about the grave dangers of this drug, become conscious of the 
     current lack of parental notification/consent laws in 
     California and now recognize the critical need for accurate, 
     impartial sources of information and resources for parents, 
     teenagers and young women who want to learn about the real 
     dangers and risks of unplanned pregnancy and abortion and the 
     dire need for a national movement to encourage prevention and 
     open dialogue in the home about unplanned pregnancy and 
     abortion.
       We will actively support ``Holly's Law'' in Congress by 
     Reps. DeMint, Bartlett and Senator Brownback to suspend and 
     review the abortion drug RU-486, the Tell-A-Parent (TAP) 
     bill, which requires parental notification laws in California 
     and a campaign to encourage prevention and open dialogue 
     about unplanned pregnancy and abortion in the home.
       As parents, we cannot allow our beautiful Holly's horrible 
     death to be in vain. RU-486 has caused serious injury and has 
     been implicated in the deaths of other young women. Now it 
     has killed our daughter. We have learned that the initial 
     trials were rushed and the drug was lumped in and approved 
     with drugs designed for life threatening illnesses such as 
     cancer and AIDS. Pregnancy is a natural process that a 
     woman's body is designed to support and has never been 
     classified as a life threatening illness. We need help to 
     develop a website and provide a place for teenagers and women 
     to report their stories and testimonials of their experience 
     on the serious and adverse affects using RU-486.
       The FDA has failed to carry out its mission of ensuring RU-
     486 is a safe and effective abortion drug regimen. According 
     to the FDA, it is ``responsible for protecting the public 
     health by assuring the safety, efficacy, and security of 
     human and veterinary drugs, biological products, medical 
     devices, our nation's food supply, cosmetics, and products 
     that emit radiation.'' Holly has already paid the ultimate 
     price. The RU-486 abortion drug should not be either a Pro 
     Life or Pro Choice issue. The most primary concern here must 
     be the health and welfare of our children and young women. 
     Hopefully, all parents can learn from Holly's horrible death 
     and our loss.
       According to Danco Laboratories, the abortion drug's 
     distributor, the RU-486 regimen fails to work 7-8 percent of 
     the time. Over a year ago the FDA received 400 reports of 
     adverse reactions to the drug including several deaths.
       Holly is yet another victim who was subject to an 
     unacceptable risk to a drug that has a significant failure 
     rate. And we demand that FDA Commissioner Mark McClellan and 
     Health and Human services Secretary, Tommy Thompson take RU-
     486 off the market immediately pending an extensive 
     investigation by the Comptroller General of the United States 
     before more parents suffer and women die.
       We respectfully request the name of the bill that is to be 
     presented to the House of Representatives, an Act as the 
     ``[RU-486 Approval and Review Act of 2003]'' to be known as 
     ``Holly's Law.'' With actively support a bill that halts the 
     use of the drug that took Holly's young life.
       We demand an investigation by the FDA and the California 
     State Health Department as to why abortion clinics like 
     Planned Parenthood are not following FDA approved regulations 
     to administer the drug. We question the purity of the drugs 
     they administer, especially when they are made in foreign 
     countries, such as China.
       In addition to the dangers of this drug and its 
     administration, we believe that health care providers such as 
     Valley Medical Center don't appear to be fully prepared to 
     evaluate and treat patients with RU-486 complications in 
     emergency situations. Holly was in the hospital twice and 
     died within 20 minutes before her follow up appointment with 
     Planned Parenthood.
       FDA Commissioner Mark McClellan and Health and Human 
     Services Secretary, Tommy Thompson should now have enough 
     evidence to pull this drug from the market. How many more 
     teenagers and young women will have to pay the price with 
     their health or with their life, before the FDA decides to 
     act?
       Currently in California, teenage girls under the age of 18 
     can't get their ears pierced or go on a school trip, but they 
     can have a medical or surgical abortion without parental 
     knowledge or consent. This prevents parents from being able 
     to talk to their children about a pregnancy that would allow 
     them to keep a baby or to be able to follow the abortion 
     process.
       The first line of defense for a child is a parent. Kids 
     wouldn't be walking into clinics under a veil of secrey if 
     parents were notified first hand where they could talk to 
     their children about abortion risks. We have now learned that 
     Holly first sought a pregnancy test in the months leading up 
     to her pregnancy while she was still 17 years old. We know 
     now that a parental notification law would have brought 
     Holly's activity to our attention and her needless death 
     could have been prevented if we had been aware and 
     intervened.
       We actively support the Tell-A-Parent (TAP) ballot 
     initative sponsored by Life on

[[Page S15475]]

     The Ballot www.LifeontheBallot.org. With enough petitions, 
     this initiative will be on the 2004 ballot and requires 
     parental notification 48 hours prior to an abortion in 
     California. As parents, we are concerned about the health and 
     welfare of all daughters; we are ``Pro Holly'' and look to 
     our California Senators Barbara Boxer and Dianne Feinstein to 
     support this initiative for the safety and protection of all 
     young women in California.
       Finally, we have suffered greatly with the realization that 
     it's not enough to avoid the issue or talk to our children 
     about why we don't want them to be involved in an unplanned 
     pregnancy or abortion, but as parents, we must also talk 
     about the tragic realities of unwanted pregnancy and abortion 
     and reassure both, our daughters and sons that while we don't 
     want this to happen, we will support them. We must focus on 
     prevention and they must be told that they are not alone in 
     this or any other unfortunate circumstances, regardless of 
     the outcome.
       We feel strongly that this country needs a national 
     campaign to promote open and frank discussions in the home 
     about unplanned pregnancy and the options that are available 
     to our daughters who find themselves in this unfortunate 
     predicament. We are eager to support such a campaign designed 
     to bring about awareness, encourage parental involvement, and 
     provide accurate information to minors, women, and parents 
     about abstinence, birth control, unplanned pregnancy, 
     abortion, parenting, and adoption options.
       While parents would prefer that their daughters abstain 
     from sex and many do, we must deal with the reality that many 
     don't. In addition to unplanned pregnancy, girls can contract 
     HIV and other STIs. As parents we need to prevent unplanned 
     pregnancy instead of relying upon abortion clinics and 
     agencies to educate our children and provide them with 
     inaccurate information. No parent wants to see his or her 
     teenage or college age daughter in the unfortunate situation 
     that Holly was faced with.
       We have lost our daughter, Holly, but we can still help to 
     prevent this terrible tragedy from happening in other 
     families. Holly's drive and determination to accomplish her 
     goals gives us strength to pursue these critical issues in 
     her name. Holly's memory and light will live on in our 
     hearts, family, friends and our work. We will actively 
     support the bill to suspend and review ``Holly's Law'' in 
     Congress by Reps. DeMint and Bartlett and Senator Brownback 
     to suspend and review the abortion drug RU-486, the Tell-A-
     Parent (TAP) bill, which requires parental notification laws 
     in California and a campaign to encourage prevention and open 
     dialogue about unplanned pregnancy and abortion in the home. 
     Please contact us with any questions or requests for support 
     of these very important issues.
           Sincerely,
     Monty and Helen Patterson.

                          ____________________