[Congressional Record (Bound Edition), Volume 152 (2006), Part 18]
[House]
[Pages 23383-23385]
[From the U.S. Government Publishing Office, www.gpo.gov]




         GYNECOLOGIC CANCER EDUCATION AND AWARENESS ACT OF 2005

  Mr. BARTON of Texas. Mr. Speaker, I ask unanimous consent to take 
from the Speaker's table the bill (H.R. 1245) to provide for programs 
to increase the awareness and knowledge of women and health care 
providers with respect to gynecologic cancers, with a Senate amendment 
thereto, and concur in the Senate amendment.
  The Clerk read the title of the bill.
  The Clerk read the Senate amendment, as follows:

       Senate amendment:
       Strike out all after the enacting clause and insert:

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Gynecologic Cancer Education 
     and Awareness Act of 2005'' or ``Johanna's Law''.

     SEC. 2. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

       Section 317P of the Public Health Service Act (42 U.S.C. 
     247b-17) is amended--
       (1) in the section heading by adding ``(johanna's law)'' at 
     the end; and
       (2) by adding at the end the following:
       ``(d) Johanna's Law.--
       ``(1) National public awareness campaign.--
       ``(A) In general.--The Secretary shall carry out a national 
     campaign to increase the awareness and knowledge of health 
     care providers and women with respect to gynecologic cancers.
       ``(B) Written materials.--Activities under the national 
     campaign under subparagraph (A) shall include--
       ``(i) maintaining a supply of written materials that 
     provide information to the public on gynecologic cancers; and
       ``(ii) distributing the materials to members of the public 
     upon request.
       ``(C) Public service announcements.--Activities under the 
     national campaign under subparagraph (A) shall, in accordance 
     with applicable law and regulations, include developing and 
     placing, in telecommunications media, public service 
     announcements intended to encourage women to discuss with 
     their physicians their risks of gynecologic cancers. Such 
     announcements shall inform the public on the manner in which 
     the written materials referred to in subparagraph (B) can be 
     obtained upon request, and shall call attention to early 
     warning signs and risk factors based on the best available 
     medical information.
       ``(2) Report and strategy.--
       ``(A) Report.--Not later than 6 months after the date of 
     the enactment of this subsection, the Secretary shall submit 
     to the Congress a report including the following:
       ``(i) A description of the past and present activities of 
     the Department of Health and Human Services to increase 
     awareness and knowledge of the public with respect to 
     different types of cancer, including gynecologic cancers.
       ``(ii) A description of the past and present activities of 
     the Department of Health and Human Services to increase 
     awareness and knowledge of health care providers with respect 
     to different types of cancer, including gynecologic cancers.
       ``(iii) For each activity described pursuant to clauses (i) 
     or (ii), a description of the following:

       ``(I) The funding for such activity for fiscal year 2006 
     and the cumulative funding for such activity for previous 
     fiscal years.
       ``(II) The background and history of such activity, 
     including--

       ``(aa) the goals of such activity;
       ``(bb) the communications objectives of such activity;
       ``(cc) the identity of each agency within the Department of 
     Health and Human Services responsible for any aspect of the 
     activity; and
       ``(dd) how such activity is or was expected to result in 
     change.

       ``(III) How long the activity lasted or is expected to 
     last.
       ``(IV) The outcomes observed and the evaluation methods, if 
     any, that have been, are being, or will be used with respect 
     to such activity.
       ``(V) For each such outcome or evaluation method, a 
     description of the associated results, analyses, and 
     conclusions.

       ``(B) Strategy.--
       ``(i) Development; submission to congress.--Not later than 
     3 months after submitting the report required by subparagraph 
     (A), the Secretary shall develop and submit to the Congress a 
     strategy for improving efforts to increase awareness and 
     knowledge of the public and health care providers with 
     respect to different types of cancer, including gynecological 
     cancers.
       ``(ii) Consultation.--In developing the strategy under 
     clause (i), the Secretary should consult with qualified 
     private sector groups, including nonprofit organizations.
       ``(3) Full compliance.--
       ``(A) in general.--Not later than March 1, 2008, the 
     Secretary shall ensure that all provisions of this section, 
     including activities directed to be carried out by the 
     Centers for Disease Control and Prevention and the Food and 
     Drug Administration, are fully implemented and being complied 
     with. Not later than April 30, 2008, the Secretary shall 
     submit to Congress a report that certifies compliance with 
     the preceding sentence and that contains a description of all 
     activities undertaken to achieve such compliance.
       ``(B) If the Secretary fails to submit the certification as 
     provided for under subparagraph (A), the Secretary shall, not 
     later than 3 months after the date on which the report is to 
     be submitted under subparagraph (A), and every 3 months 
     thereafter, submit to Congress an explanation as to why the 
     Secretary has not yet complied with the first sentence of 
     subparagraph (A), a detailed description of all actions 
     undertaken within the month for which the report is being 
     submitted to bring the Secretary into compliance with such 
     sentence, and the anticipated date the Secretary expects to 
     be in full compliance with such sentence.
       ``(4) Authorization of appropriations.--For the purpose of 
     carrying out this subsection, there is authorized to be 
     appropriated $16,500,000 for the period of fiscal years 2007 
     through 2009.''.

  Mr. BARTON of Texas (during the reading). Mr. Speaker, I ask 
unanimous consent that the Senate amendment be considered as read and 
printed in the Record.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Texas?
  There was no objection.
  Ms. DeLAURO. Mr. Speaker, let me thank again everyone who has made 
this legislation

[[Page 23384]]

such a priority in the Congress--Congressmen Issa and Levin for their 
leadership, as well as everyone outside this institution, particularly 
Sheryl Silver--she is an inspiration. I have always said that when it 
comes to life and death issues like cancer, Congress speaks with one 
voice. And today, it does.
  For me, passage of Johanna's Law is one big battle in a fight I, 
myself, have waged for 20 years. Indeed, 20 years ago, I was diagnosed 
with ovarian cancer during an unrelated doctor's visit. I was fortunate 
to have excellent doctors who detected the cancer by accident in Stage 
1, and I underwent radiation treatment for the next two and a half 
months. Like many survivors, the experience still haunts me today--
hardly a day goes by that I do not think about those weeks, the most 
difficult of my life. But I am proud to say that I have now been 
cancer-free for a full two decades.
  And so you can understand when I say I take great pride in this 
victory against cancer today. Great pride--because making sure no woman 
has to depend on luck when it comes to cancer is personal. Moments like 
these are why I came to Congress.
  And this step is so critical. Almost 21,000 women are diagnosed every 
year with ovarian cancer; nearly 16,000 will die. With a 45-percent 5-
year survival rate, it claims the lives of nearly three-quarters of 
women diagnosed simply because the disease is not detected until it is 
too late.
  The tragedy is that ovarian cancer, like other gynecologic cancers, 
can be cured if it is detected soon enough. When ovarian cancer is 
detected in the early stages, 94 percent of women survive longer than 5 
years, and most are cured completely. Unfortunately, women have never 
had a reliable and accurate method of screening for ovarian cancer in 
the early stages. On top of that, many doctors misdiagnose this 
disease, with 85 percent of women reporting they do not know which 
symptoms to look for.
  For all our progress--through research at the NIH, at the Department 
of Defense, and with the recent approval of the HPV vaccine--Johanna's 
Law recognizes that one of the most effective weapons we have to beat 
gynecologic cancers like ovarian, cervical, and uterine cancer is 
public education. In creating a federal campaign to educate women and 
health care providers alike, as this legislation does, we can take a 
bold step toward ensuring women know which symptoms to look for and how 
to seek help before it is too late.
  This legislation represents only a first step. But this is a fight 
every woman has a stake in--a fight the Silver family has dedicated 
itself to making sure we win. And so I urge my colleagues to help us 
pass this bill and take such an important step forward. It is, indeed, 
an idea whose time has come.
  Mr. SOUDER. Mr. Speaker, today the House passed H.R. 1245, the 
Gynecologic Cancer Education and Awareness Act of which I am a co-
sponsor.
  This bill directs the Department of Health and Human Services (HHS) 
to carry out a national campaign to increase the awareness and 
knowledge of gynecologic cancers. It mirrors a similar law passed by 
Congress in 2000 that directed HHS to educate women and health care 
providers about cervical cancer. Unfortunately, the 2000 law has never 
been fully implemented which is, in part, why this new law is needed.
  I am pleased that the Senate revised the bill to set a deadline of 
March 2008 for HHS to enact this bill and the 2000 law.
  The Subcommittee on Criminal Justice, Drug Policy and Human 
Resources, which I chair, has been very active in cervical cancer 
issues over the past 5 years. I have been very disappointed with the 
lack of progress enacting the 2000 cervical cancer awareness law. I 
introduced a bipartisan resolution in 2003 urging federal agencies to 
comply with this law, held a hearing on the topic in 2004, and have 
sent numerous letters to the agencies responsible for carrying out this 
law. Yet 6 years after being signed, the law has still not been fully 
enacted and that is why setting a deadline has become necessary.
  This is important because thousands of women die of and many more are 
diagnosed with cervical cancer every year in the U.S. Yet many women 
and few Americans are even aware of the facts about cervical cancer, 
including what causes it and how it can be prevented.
  Medical experts agree that infection with certain strains of human 
papillomavirus (HPV) is the primary cause of nearly all cervical 
cancer. The Centers for Disease Control and Prevention (CDC) estimates 
20 million Americans are currently infected with HPV and 5.5 million 
Americans become infected with HPV every year. According to the 
American Cancer Society, nearly 13,000 women develop invasive cervical 
cancer annually in the United States and over 4,000 women die of the 
disease every year. HPV infection is also associated with other cancers 
and more than 1 million pre-cancerous lesions. By way of comparison, 
nearly the same number of women die annually as a result of cervical 
cancer as do of HIV/AIDS in the United States.
  HPV is a sexually transmitted disease and despite claims by condom 
manufacturers and advocates, studies have repeatedly found that condoms 
do not provide effective protection against HPV infection.
  In a February 1999 letter to the U.S. House Commerce Committee, Dr. 
Richard D. Klausner, then-Director of the National Cancer Institute, 
stated ``Condoms are ineffective against HPV because the virus is 
prevalent not only in the mucosal tissue (genitalia) but also on dry 
skin of the surrounding abdomen and groin, and it can migrate from 
those areas into the vagina and the cervix. Additional research efforts 
by NCI on the effectiveness of condoms in preventing HPV transmission 
are not warranted.''
  In 2001, the National Institute of Allergy and Infectious Diseases 
along with FDA, CDC, and the U.S. Agency for International Development 
issued a consensus report regarding condom effectiveness that concluded 
``there was no epidemiologic evidence that condom use reduced the risk 
of HPV infection.''
  In November 2002, a meta-analysis of ``the best available data 
describing the relationship between condoms and HPV-related 
conditions'' from the previous two decades was published in the journal 
Sexually Transmitted Diseases. The meta-analysis concluded: ``There was 
no consistent evidence of a protective effect of condom use on HPV DNA 
detection, and in some studies, condom use was associated with a 
slightly increased risk for these lesions.''
  CDC issued a report in 2004 that concluded:

       Because genital HPV infection is most common in men and 
     women who have had multiple sex partners, abstaining from 
     sexual activity (i.e., refraining from any genital contact 
     with another individual) is the surest way to prevent 
     infection. For those who choose to be sexually active, a 
     monogamous relationship with an uninfected partner is the 
     strategy most likely to prevent future genital HPV 
     infections. For those who choose to be sexually active but 
     who are not in a monogamous relationship, reducing the number 
     of sexual partners and choosing a partner less likely to be 
     infected may reduce the risk of genital HPV infection. . . .
       The available scientific evidence is not sufficient to 
     recommend condoms as a primary prevention strategy for the 
     prevention of genital HPV infection.

  Based on these findings, the law required CDC to ``prepare and 
distribute educational materials for health care providers and the 
public that include information on HPV. Such materials shall address 
modes of transmission, consequences of infection, including the link 
between HPV and cervical cancer, the available scientific evidence on 
the effectiveness or lack of effectiveness of condoms in preventing 
infection with HPV, and the importance of regular Pap smears, and other 
diagnostics for early intervention and prevention of cervical cancer.''
  The CDC has largely ignored this provision of the law and as a result 
few women are aware of HPV or its link to cervical cancer. According to 
a 2005 Health Information National Trends Survey, only 40 percent of 
women have ever heard about HPV. Of those that have heard of HPV, less 
than 20 percent knew that HPV could sometimes lead to cervical cancer, 
meaning that only about 8 percent of American women are aware that HPV 
can cause cervical cancer. The only factors associated with having 
accurate knowledge--knowing that it could lead to cervical cancer--was 
an abnormal Pap test or testing positive on an HPV test. This suggests 
that most women are finding out about HPV only after experiencing a 
negative consequence. This is the real life consequence of the CDC's 
failure to enact this law and to make women aware of the facts 
regarding HPV and cervical cancer.
  The law also directs the Food and Drug Administration (FDA) to ensure 
that such condom labels are medically accurate regarding the lack of 
effectiveness of condoms in preventing HPV infection.
  The Subcommittee first wrote to the FDA requesting a status update on 
the enactment of this law on August 23, 2001. ``FDA is currently 
developing an implementation plan for carrying out Public Law 106-
554,'' was the response from Melinda K. Plaisier, FDA Associate 
Commissioner for Legislation, dated November 20, 2001.
  On February 12, 2004, the Subcommittee wrote to Dr. Mark B. 
McClellan, FDA Commissioner, requesting ``the agency's timetable for 
relabeling condoms in compliance with Public Law 106-554.'' In a 
response to the Subcommittee dated March 10, 2004, Amit K.

[[Page 23385]]

Sachdev, FDA Associate Commissioner for Legislation, stated, ``the 
Agency is working on developing a proposed rule to be accompanied by 
draft labeling guidance for public comment later this year.''
  In a hearing before the Subcommittee on March 11, 2004, Dr. Daniel G. 
Schultz, FDA Director of Device Evaluation, stated ``FDA is working to 
present a balanced view of the risks and benefits in condom labeling . 
. . FDA is preparing new guidance on condom labeling to address these 
issues, with the target of publishing that guidance as a draft for 
public comment later this year.''
  On November 19, 2004, the Subcommittee sent a letter to Acting FDA 
Commissioner Lester Crawford requesting an update on whether or not the 
oft repeated deadline previously provided would be met.
  And earlier this year, I sent a letter to HHS Secretary Michael 
Leavitt again asking for a date certain when the FDA will finally be in 
compliance with Public Law 106-554 by requiring condom labeling to be 
medically accurate and an explanation for the continued delay by the 
FDA in complying with this 4-year-old law.
  Just this week, mere days before the 6-year anniversary of the 
signing of the law, FDA staff has admitted that the agency is still in 
the beginning stages of crafting a new medically accurate informational 
label for condom packages. By way of comparison, it took 410 days to 
build the Empire State Building and 2 years, 2 months and 5 days to 
construct the Eiffel Tower.
  Over the 6 years since this law was signed, CDC and FDA have 
repeatedly delayed and found excuses to avoid complying with the simple 
requirements of the law that would empower women with lifesaving 
information. This continued delay undermines the scientific integrity 
of both agencies and further jeopardizes the confidence of the public 
and many in Congress in these agencies' ability to fulfill their very 
important missions.
  It is my hope that a year from now Congress will not have to pass yet 
another new law to direct HHS, CDC and FDA to enact the existing law. 
The lives of our sisters, daughters, mothers, or friends are too 
important to allow yet another one to fall victim to this silent 
epidemic.
  Mr. LEVIN. Mr. Speaker, I rise in strong support of H.R. 1245, 
``Johanna's Law,'' which earlier today passed the Senate by unanimous 
consent.
  It was more than 4 years ago that Sheryl Silver first told me about 
her sister, Johanna, who died of ovarian cancer in 2000 after a fierce, 
hard-fought battle.
  This legislation, in honor of Johanna Silver and her valiant fight, 
is emblematic of the fight undertaken by so many women across the 
country battling gynecological cancer and their determination to help 
other women be treated sooner.
  Like so many women, Johanna had experienced symptoms, which were not 
identified initially. By the time she was properly diagnosed, her 
cancer had advanced significantly, to a point where treatment is 
considerably more complicated. Because gynecological cancers are highly 
treatable at early stages, public education for women and their primary 
care physicians is all the more important.
  Johanna's Law does just this, creating a national public information 
campaign to educate women and health care providers about the risk 
factors and early warning signs of gynecologic cancers, but goes a step 
further, requiring HHS to quickly develop a national strategy to get 
this information to women at the highest risk and their health care 
providers.
  After 3 years since this legislation was first introduced, it is 
finally coming to fruition. Its passage is a real victory for everyone 
who has been fighting to get the facts out about gynecologic cancers.
  I want to thank all the people whose determined efforts have gotten 
us to where we are today, including Sheryl Silver, who worked 
tirelessly from the conception of this legislation through to the 
organization of the advocacy done by many organizations and individuals 
to assure its passage, as well as cancer survivors and families across 
the country, physicians, my colleagues on both sides of the aisle, 
especially Darrell Issa, Rosa DeLauro, and Kay Granger, and our 
counterparts in the Senate for getting the bill back to us in such 
short order.
  I urge all of my colleagues to support Johanna's Law and strike a 
blow against gynecologic cancers.
  The SPEAKER pro tempore. Is there objection to the original request 
of the gentleman from Texas?
  There was no objection.
  A motion to reconsider was laid on the table.

                          ____________________