2004N-0556 Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom with Spermicidal Lubricant
FDA Comment Number : EC13
Submitter : Miss. Eugerie Douge Date & Time: 12/09/2005 04:12:54
Organization : Miss. Eugerie Douge
Category : Health Professional
Issue Areas/Comments
As a concerned citizen as well as a health professoinal, I am angered by
Senator Colburn's attempts to change the FDA label on condoms to suggest
that they are less effective against preventing pregnancy and preventing STI
transmission than is currently stated.
>From the CDC's website the following data can be easily obtained
demonstrating the efficacy of condoms:
"Laboratory studies have demonstrated that latex condoms provide an
essentially impermeable barrier to particles the size of STD pathogens.
Sexually transmitted diseases, including HIV Latex condoms, when used c
consistently and correctly, are highly effective in preventing transmission
of HIV, the virus that causes AIDS. In addition, correct and consistent use
of latex condoms can reduce the risk of other sexually transmitted diseases
(STDs), including discharge and genital ulcer diseases. While the effect of
condoms in preventing human papillomavirus (HPV) infection is unknown,
condom use has been associated with a lower rate of cervical cancer, an
HPV-associated disease."

It is disturbing that the FDA would allow social conservative politics, or
any politics at all, to influence FDA policy and guidelines. This
demonstrates a serious lack of commitment to the health and safety of all
Americans. Scientific fact and evidence-based medicine should be the only
influence the FDA heeds when making decisions. The FDA would be misleading
and misinforming millions of Americans if the label is changed to reflect
Sen. Colburn's socially conservative agenda. The FDA cannot put the health
and lives of millions of Americans at risk. The fact that the FDA is even
considering a label change demonstrates a serious failure to prioritize the
health and safety of Americans over politics.