Food and Drug Administration
Agency Complied with Statutory Requirement to Reexamine Condom Labels Gao ID: GAO-08-565R April 25, 2008Sexually transmitted diseases (STDs) affect men and women of all backgrounds and economic levels and remain a major public health challenge in the United States. While substantial progress has been made in preventing, diagnosing, and treating certain STDs, an estimated 19 million new infections occur annually. According to the Centers for Disease Control and Prevention (CDC), correct and consistent use of a male latex condom can reduce, but not eliminate, the risk of STD transmission. Although male latex condoms have been proven to be highly effective in preventing HIV/AIDS, concerns have been raised over the past decade that condom labels do not include accurate information about condoms' effectiveness in preventing other STDs, including the human papillomavirus (HPV). A provision enacted as part of the Consolidated Appropriations Act, 2001, required the Secretary of Health and Human Services (HHS) to reexamine existing condom labels to determine whether they are medically accurate regarding the effectiveness of condoms in preventing STDs. Congress asked us to address issues related to condom labels. In this report, we discuss the scope of this statutory requirement and assess the extent to which the Food and Drug Administration (FDA)--the agency within HHS responsible for the regulation of medical devices, including condoms--complied with the requirement.
FDA reviewed studies on the relationship between use of male latex condoms and STDs and determined that existing condom labeling did not provide complete information about the effectiveness of condoms in preventing the transmission of certain STDs. Section 516(b) required that the agency reexamine existing condom labels for medical accuracy with respect to STDs; it did not require FDA to take specific regulatory action. Thus, FDA's actions complied with the statutory requirement. FDA reviewed available scientific information related to condom effectiveness, including its own evaluations and those conducted by other federal agencies. These studies addressed the effectiveness of condoms in preventing a range of STDs, including HPV. Among other things, FDA noted that condoms provide less protection against HPV, which can have multiple routes of transmission, than against certain other STDs. However, FDA found that condoms, when used correctly and consistently, can be effective in reducing the risk of transmission. Based on its review, FDA found limitations in existing condom labeling and identified several areas in which improved labeling would help provide reasonable assurance of condoms' safety and effectiveness. As a result, FDA initiated regulatory action under the Federal Food, Drug, and Cosmetic Act to improve condom labeling with regard to STDs.
GAO-08-565R, Food and Drug Administration: Agency Complied with Statutory Requirement to Reexamine Condom Labels
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April 25, 2008:
The Honorable Tom A. Coburn, M.D.:
Ranking Member:
Subcommittee on Federal Financial Management, Government Information,
Federal Services, and International Security:
Committee on Homeland Security and Governmental Affairs:
United States Senate:
Subject: Food and Drug Administration: Agency Complied with Statutory
Requirement to Reexamine Condom Labels:
Dear Senator Coburn:
Sexually transmitted diseases (STDs) affect men and women of all
backgrounds and economic levels and remain a major public health
challenge in the United States.[Footnote 1] While substantial progress
has been made in preventing, diagnosing, and treating certain STDs, an
estimated 19 million new infections occur annually.[Footnote 2]
According to the Centers for Disease Control and Prevention (CDC),
correct and consistent use of a male latex condom can reduce, but not
eliminate, the risk of STD transmission.
Although male latex condoms have been proven to be highly effective in
preventing HIV/AIDS, concerns have been raised over the past decade
that condom labels do not include accurate information about condoms'
effectiveness in preventing other STDs, including the human
papillomavirus (HPV). A provision enacted as part of the Consolidated
Appropriations Act, 2001, required the Secretary of Health and Human
Services (HHS) to reexamine existing condom labels[Footnote 3] to
determine whether they are medically accurate regarding the
effectiveness of condoms in preventing STDs.[Footnote 4] You asked us
to address issues related to condom labels. In this report, we discuss
the scope of this statutory requirement and assess the extent to which
the Food and Drug Administration (FDA)--the agency within HHS
responsible for the regulation of medical devices, including condoms--
complied with the requirement.
To perform our work, we reviewed laws, regulations, and guidance
related to condom labeling and the legislative history of section
516(b). We focused on male latex condoms (rather than female condoms or
condoms made of other materials) because, according to FDA, they
represent over 97 percent of condoms sold in this country and were the
focus of its review.[Footnote 5] We also interviewed FDA officials
about the agency's efforts to comply with this statutory requirement.
Through our interviews with FDA officials and our examination of
documents, we determined that the data we used were sufficiently
reliable for purposes of this report. We did not independently evaluate
the evidence relied upon by FDA and summarized in FDA documents. We
conducted our work from September 2007 through March 2008 in accordance
with generally accepted government auditing standards. Those standards
require that we plan and perform the audit to obtain sufficient,
appropriate evidence to provide a reasonable basis for our findings and
conclusions based on our audit objectives. We believe that the evidence
obtained provides a reasonable basis for our findings and conclusions
based on our audit objectives.
Results in Brief:
FDA reviewed studies on the relationship between use of male latex
condoms and STDs and determined that existing condom labeling did not
provide complete information about the effectiveness of condoms in
preventing the transmission of certain STDs. Section 516(b) required
that the agency reexamine existing condom labels for medical accuracy
with respect to STDs; it did not require FDA to take specific
regulatory action. Thus, FDA's actions complied with the statutory
requirement. FDA reviewed available scientific information related to
condom effectiveness, including its own evaluations and those conducted
by other federal agencies. These studies addressed the effectiveness of
condoms in preventing a range of STDs, including HPV. Among other
things, FDA noted that condoms provide less protection against HPV,
which can have multiple routes of transmission, than against certain
other STDs. However, FDA found that condoms, when used correctly and
consistently, can be effective in reducing the risk of transmission.
Based on its review, FDA found limitations in existing condom labeling
and identified several areas in which improved labeling would help
provide reasonable assurance of condoms' safety and effectiveness. As a
result, FDA initiated regulatory action under the Federal Food, Drug,
and Cosmetic Act to improve condom labeling with regard to STDs.
In commenting on a draft of this report, HHS did not comment on our
findings. HHS did provide technical comments, which we incorporated as
appropriate.
Background:
FDA assigns medical devices to one of three classes based on the level
of risk posed and the controls necessary to reasonably ensure their
safety and effectiveness:
* Class I devices are generally those with the lowest risk and include
such items as elastic bandages and tongue depressors. They are subject
to "general controls," such as good manufacturing practices and
requirements for manufacturers to register their devices and report
adverse events.[Footnote 6]
* Class II devices, including syringes and hearing aids, are of higher
risk and are often subject to "special controls" in addition to general
controls. Special controls may include guidance documents or
performance standards, which are designed to help provide reasonable
assurance of safety and effectiveness.[Footnote 7] Male latex condoms
are Class II devices.[Footnote 8]
* Class III devices, such as pacemakers, typically pose the highest
risk and support or sustain human life, are of substantial importance
in preventing impairment of human health, or present a potential
unreasonable risk of illness or injury.[Footnote 9] Because general and
special controls are insufficient to ensure safety and effectiveness,
Class III devices are also subject to a pre-market approval process.
In addition, marketed devices in all three classes are subject to
various statutory and regulatory requirements, including those related
to labeling. For example, labeling must not be false or misleading and
must include adequate directions for use.[Footnote 10] Some specific
devices, including condoms, are subject to additional labeling
requirements. For example, in 1997, the FDA required that condom
labeling include information on expiration dates and latex
sensitivity.[Footnote 11]
Condom labeling has been the subject of specific FDA actions besides
regulations. For example, in 1987, FDA sent a letter to condom
manufacturers with recommendations for labeling after the U.S. Surgeon
General recommended the use of condoms to protect against the spread of
HIV and AIDS. In addition, FDA issued voluntary guidance in 1998, which
included suggested language for condom labeling--that is, the primary
retail package, package insert, and the foil wrapper for individual
condoms--to address the protection provided against STDs.[Footnote 12]
Following this guidance, a retail package would include the statement:
"If used properly, latex condoms will help to reduce the risk of
transmission of HIV infection (AIDS) and many other sexually
transmitted diseases."
Since FDA issued the 1998 guidance, however, concerns have been raised
that condoms may not provide the same degree of protection against all
STDs. These concerns were supported by reviews of medical research. For
example, in 2000, a multi-agency workshop panel comprised of FDA and
other federal agencies, including the CDC, reviewed medical literature:
related to the effectiveness of condoms in preventing HIV/AIDS and
other STDs.[Footnote 13] The panel concluded that consistent condom use
decreased the rate of HIV/AIDS transmission by approximately 85 percent
and that there was insufficient information to determine the
association between condom use and HPV infection or disease.[Footnote
14] The panel also concluded that STD transmission was dependent on a
number of factors, such as a person's sexual behavior. It noted that
because much of the reviewed research described in the literature had
been inadequately designed, it could not provide a definitive
assessment of the effectiveness of condoms in preventing STD
transmission.
Subsequently, section 516(b) required HHS to reexamine existing condom
labels authorized under the Federal Food, Drug, and Cosmetic Act to
determine whether they are medically accurate regarding the overall
effectiveness or lack of effectiveness of condoms in preventing STDs,
including HPV.[Footnote 15]
Statute Required Only an Examination of Condom Labels:
The courts have long held that the language of a statute is the primary
vehicle for determining congressional intent[Footnote 16] and, based on
its language, section 516(b) required FDA to reexamine--that is, to
inspect or investigate[Footnote 17]--whether condom labels present
accurate information about the effectiveness of condoms in preventing
STDs. Therefore, by its own terms, section 516(b) did not require
condom manufacturers to change the labeling of their products, nor did
it require FDA to take action to achieve such a change. However, the
Federal Food, Drug, and Cosmetic Act authorizes FDA to take regulatory
action to improve the accuracy of condom labels based on the
reexamination required by section 516(b).[Footnote 18]
Section 516(b) differs significantly from earlier proposed requirements
on condom labeling and HPV. Legislation introduced in 1999 would have
amended the Federal Food, Drug, and Cosmetic Act to require that condom
labels and labeling "bear information providing that condoms do not
effectively prevent the transmission of the human papillomavirus and
that such virus can cause cervical cancer."[Footnote 19] This language
was included in the Breast and Cervical Cancer Prevention and Treatment
Act of 2000 when it was passed by the House of Representatives in May
2000.[Footnote 20] Subsequently, the Senate passed an amended version
of the bill, which did not contain a provision on condom labeling. When
the House of Representatives took up the Senate-passed version of the
legislation in October 2000, it again considered a condom labeling
provision. This provision would have required a reexamination of condom
labels, rather than a change in labeling.[Footnote 21] However, this
provision was not enacted as part of the Breast and Cervical Cancer
Prevention and Treatment Act of 2000. Nevertheless, a similar
provision--section 516(b)--was included in the Consolidated
Appropriations Act, 2001, enacted several months later. In short, the
language of section 516(b) evolved from a provision that would have
required changes to condom labeling to a provision that did not by
itself require such changes.
FDA Complied with the Statutory Requirement and Also Initiated
Regulatory Action:
By reviewing available studies on the relationship between condom use
and STDs and identifying limitations in condom labeling prepared under
existing guidance, FDA complied with the statutory requirement to
reexamine existing condom labels.[Footnote 22] In a 2005 notice of
proposed rulemaking concerning male latex condoms, FDA summarized its
extensive review of available scientific information, including its own
evaluations and those conducted by the National Institutes of Health
(NIH) and CDC, on the effectiveness of condoms in preventing a range of
STDs, including HPV.[Footnote 23] FDA considered whether a reduction in
STDs could be attributed to condom use and reviewed clinical data
specifically addressing condom effectiveness against various types of
STDs. FDA noted that condoms can limit the contact necessary for
transmission of STDs and, accordingly, may reduce the risk of
transmission. However, FDA also noted that because the risk of disease
varies by type of STD and route of transmission, the utility of condoms
in protecting against individual STDs may vary as well.[Footnote 24]
Because of its precise mode of transmission, FDA concluded that
condoms, when used correctly and consistently, provide less protection
against HPV than against certain other STDs.
Based on its review of scientific and medical research, FDA identified
limitations in existing labeling guidance. Most notably, FDA found that
labeling consistent with existing guidance would not provide specific
information about the reduced level of protection provided by condoms
against the transmission of certain STDs, such as HPV, "that can be
transmitted through contact with infected skin outside the area covered
by the condom."[Footnote 25] Further, the agency identified several
areas in which improved labeling would help provide reasonable
assurance of condoms' safety and effectiveness.
As a result of its reexamination of condom labeling, FDA initiated
regulatory action to improve condom labeling with regard to STDs.
Specifically, in the 2005 notice of proposed rulemaking, FDA proposed
to amend its regulations to designate labeling guidance, including
recommendations addressing the effectiveness of male latex condoms in
preventing STDs, as a "special control." Separately, FDA also issued
draft labeling guidance and invited comments on this guidance.[Footnote
26] Specifically, with respect to the transmission of STDs, FDA
recommended that labeling explain that condoms can greatly reduce, but
not eliminate, the risk of acquiring or transmitting HIV. It also
recommended that labeling explain that condoms can reduce the risk of
transmitting or acquiring certain STDs and that labeling identify
others, such as HPV, against which condoms provide less protection.
Table 1 compares the language regarding STDs recommended by existing
labeling guidance and recommended language contained in the draft
labeling guidance issued in 2005.
Table 1: Selected FDA Existing and Proposed Condom Labeling Language
Related to STDs:
Retail package;
Existing: If used properly, latex condoms will help to reduce the risk
of transmission of HIV infection (AIDS) and many other sexually
transmitted diseases;
Proposed: Front Panel: When used correctly every time you have sex,
latex condoms greatly reduce, but do not eliminate, the risk of
pregnancy and the risk of catching or spreading HIV, the virus that
causes AIDS;
Back Panel: Important information: There are many types of sexually
transmitted diseases (STDs) and different ways of catching or spreading
infection. A latex condom can reduce the risk of STD transmission to or
from the penis. However, some STDs can also be spread by other types of
sexual contact. For additional information on STD protection, please
read the enclosed insert.
Package insert;
Existing: If used properly, latex condoms will help to reduce the risk
of transmission of HIV infection (AIDS) and many other sexually
transmitted diseases, including chlamydia infections, genital herpes,
genital warts, gonorrhea, hepatitis B, and syphilis;
Proposed: Important Information: When used correctly every time you
have sex, latex condoms greatly reduce, but do not eliminate, the risk
of pregnancy and the risk of catching or spreading HIV, the virus that
causes AIDS. Latex condoms can also reduce the risk of other sexually
transmitted diseases (STDs), such as chlamydia and gonorrhea, that are
spread to or from the penis by direct contact with the vagina and
genital fluids;
Condoms provide less protection for certain STDs, including genital
herpes and human papallomavirus (HPV) infection, that can also be
spread by contact with infected skin outside the area covered by the
condom. Condoms cannot protect against these STDs when they are spread
in this way. Using latex condoms every time you have sex may still give
you some benefits against these STDs. For example, using a condom may
lower your risk of catching or spreading genital herpes. Using a condom
also may lower your risk of developing HPV- related diseases, such as
genital warts and cervical cancer;
For more information on STDs, consult your health care provider or
information provided by government public health agencies.
Individual condom package;
Existing: If used properly, latex condoms will help to reduce the risk
of transmission of HIV infection (AIDS) and many other sexually
transmitted diseases;
Proposed: When used correctly every time you have sex, latex condoms
greatly reduce, but do not eliminate, the risk of pregnancy and the
risk of catching or spreading HIV, the virus that causes AIDS.
Source: FDA; GAO presentation of FDA guidance.
Notes: In the November 14, 2005 draft guidance, FDA also proposed
labeling changes related to condom effectiveness in pregnancy
prevention.
The table does not include the existing or proposed labeling guidance
related to STDs that FDA developed for condoms with non-oxynol 9
spermicidal lubricant.
[End of table]
FDA received over 400 comments in response to the notice of proposed
rulemaking and draft guidance, about half of which suggested that the
recommended labeling language was confusing. Based on these concerns,
FDA initiated a two-stage condom label comprehension study to evaluate
public understanding of the proposed labeling recommendations and help
shape a final rule and accompanying labeling guidance.[Footnote 27] The
first stage was designed to test consumers' understanding of both
current condom labeling and the proposed labeling, and FDA officials
told us this stage was completed in December 2007. As of March 2008,
FDA officials said that the agency was analyzing the results of the
first stage. Agency officials were unsure when this analysis would be
completed and whether a second stage would be undertaken.
Agency Comments:
We provided a draft of this report to HHS for comment. The department
provided technical comments, which we incorporated as appropriate.
As agreed with your office, unless you publicly announce its contents
earlier, we plan no further distribution of this correspondence until
30 days after its date. At that time, we will send copies to the
Secretary of Health and Human Services and other interested parties. We
will also make copies available to others upon request. In addition,
this correspondence will be available at no charge on GAO's Web site at
[hyperlink, http://www.gao.gov].
If you or your staff have any questions about this correspondence,
please contact Kathleen King at (202) 512-7114 or kingk@gao.gov or
Dayna Shah at (202) 512-7648 or shahd@gao.gov. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
the last page of this report. Susan Anthony, Assistant Director; Helen
Desaulniers, Assistant General Counsel; Kelly Barar; Shirin Hormozi;
and Julian Klazkin made key contributions to this report.
Sincerely yours,
Signed by:
Kathleen King Director , Health Care:
Signed by:
Dayna K. Shah Managing Associate General Counsel:
[End of section]
Footnotes:
[1] Included among STDs are HIV/AIDs, the human papillomavirus,
gonorrhea, syphilis, and chlamydia.
[2] Centers for Disease Control and Prevention, Trends in Reportable
Sexually Transmitted Diseases in the United States 2004, National
Surveillance Data for Chlamydia, Gonorrhea, and Syphilis (November
2005).
[3] The term "label" generally refers to the written or printed matter
on the immediate container of a device, while "labeling" refers to all
labels and other printed materials on or accompanying a device. 21
U.S.C. §§ 321(k), (m).
[4] Pub. L. No. 106-554, app. A, § 516(b), 114 Stat. 2763, 2763A-73
(2000). Throughout this report, we refer to this provision as section
516(b).
[5] Female condoms comprise less than 1 percent of the condom market.
[6] Food manufacturing practice requirements address general aspects of
the device manufacturing process, including design, packaging,
labeling, and storage. They are intended to ensure that devices are
safe and effective and otherwise comply with the Federal Food, Drug,
and Cosmetic Act. 21 C.F.R. pt. 820 (2007).
[7] Manufacturers of medical devices are required to address the issues
identified in special control guidance documents, but are not bound to
comply with the precise terms of recommendations they contain.
According to FDA, most manufacturers follow the recommendations because
doing so is typically the least burdensome way to ensure that a product
will meet the standards of safety and effectiveness. 70 Fed. Reg.
69102, 69113 (Nov. 14, 2005).
[8] 21 C.F.R. §§ 884.5300(b), 884.5310(b) (2007).
[9] Female condoms are Class III devices. 21 C.F.R. 884.5330(b) (2007).
[10] 21 U.S.C. §§ 352(a), (f)(1).
[11] 21 C.F.R. §§ 801.435, 801.437 (2007). The regulation on expiration
dating, which is specific to condoms, addresses the risk of condom
deterioration due to product aging while the regulation on latex
sensitivity labeling, which applies to all devices that contain natural
rubber, responded to reports of severe allergic reactions and deaths
related to medical devices containing natural rubber.
[12] Food and Drug Administration, Guidance for Industry: Latex Condoms
for Men: Information for 510(k) Premarket Notifications: Use of
Consensus Standards for Abbreviated Submissions (July 23, 1998).
[13] FDA, the U.S. Agency for International Development, CDC, and
National Institutes of Health (NIH), cosponsored the workshop. During
the workshop, a panel comprised of agency representatives and outside
experts reviewed and discussed about 140 peer-reviewed publications to
evaluate evidence related to the effectiveness of male latex condoms in
preventing HIV/AIDS and other STDs.
[14] National Institute of Allergy and Infectious Diseases, National
Institutes of Health, and Department of Health and Human Services;
Workshop Summary: Scientific Evidence on Condom Effectiveness for
Sexually Transmitted Disease (STD) Prevention (July 20, 2001).
[15] Section 516(b) did not include a deadline for FDA to comply with
the statutory requirement.
[16] See, e.g., Hartford Underwriters Insurance Co. v. Union Planters
Bank, N.A. 530 U.S. 1 (2000); Aldridge v. Williams, 44 U.S. (3 How.) 9
(1845).
[17] See Philip B. Gove, editor, Webster's Third New International
Dictionary of the English Language (1966).
[18] 21 U.S.C. § 371 (authorizing FDA to promulgate regulations for the
efficient enforcement of the Federal Food, Drug, and Cosmetic Act). See
also 21 U.S.C. § 360c(a)(1)(B) (authorizing FDA to take appropriate
action, including the issuance of guidelines and recommendations as
special controls, to provide reasonable assurance that class II devices
are safe and effective); 21 U.S.C. § 352(a) (providing that a device
with labeling that is false or misleading is considered misbranded
under the Federal Food, Drug, and Cosmetic Act, and therefore, not
marketable).
[19] See H.R. 3248, 106th Cong. § 3 (1999).
[20] See 146 Cong. Rec. H2687-H2698 (daily ed. May 9, 2000) (regarding
consideration of H.R. 4386, Breast and Cervical Cancer Prevention and
Treatment Act of 2000).
[21] See 146 Cong. Rec. H9843-H9852 (daily ed. Oct. 12, 2000)
(regarding consideration of H.R. 4386, Breast and Cervical Cancer
Prevention and Treatment Act of 2000, as passed by the Senate); see
also See H. R. Rep. No. 106-975, at 3 (2000) (providing for House
consideration of H.R. 4386, as amended by the Senate, and adding at the
end of the Senate amendment additional provisions, including the
following: "The Secretary of Health and Human Services shall reexamine
existing condom labels that are authorized pursuant to the Federal
Food, Drug, and Cosmetic Act to ensure that the labels are medically
accurate and not misleading regarding the overall effectiveness and
lack of effectiveness of condoms in preventing sexually transmitted
diseases, including HIV infection and infection with the human
papillomavirus."
[22] In response to section 516(b), FDA assessed the medical accuracy
of condom labeling, considering the material accompanying condoms,
including packaging, as well as the foil wrapper in which individual
condoms are contained.
[23] 70 Fed. Reg. 69102 (Nov. 14, 2005). This notice of proposed
rulemaking also summarized FDA's conclusions regarding the
effectiveness of male latex condoms in other respects, such as in
pregnancy prevention, which were beyond the scope of our report.
[24] With respect to male latex condoms treated with nonoxynol-9 (N-9),
FDA concluded that the lubricant does not protect against HIV/AIDS or
other sexually transmitted diseases and that use can cause irritation,
which may increase the risk of HIV transmission with infected partners.
[25] FDA also found that existing labeling does not provide specific
information about the potential risks of N-9 lubricated condoms.
[26] Draft Guidance for Industry and FDA Staff, Class II Special
Controls Guidance Document: Labeling for Male Condoms Made of Natural
Rubber Latex; 70 Fed. Reg. 69156 (Nov. 14, 2005).
[27] See 72 Fed. Reg. 33232 (June 15, 2007).
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