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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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