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Condoms labeling

This article was originally published in The Tan Sheet

Executive Summary

"It is critically important that FDA inform consumers that condoms do not provide effective protection against infection that can cause cervical cancer as required by law," Rep. Mark Souder (R-Ind.) maintains in a letter inviting FDA, NCI, CDC and Centers for Medicare & Medicaid Services to a Jan. 28 House Government Reform/Human Resources Subcommittee hearing. Indiana Republican points to a 2001 report by the National Institute of Allergy & Infectious Diseases showing "evidence is currently insufficient" to assess condom use for prevention of HPV, among other STDs (1"The Tan Sheet" July 23, 2001, p. 13). Souder's letter notes that Public Law 106-554, enacted in 2000, mandates that FDA "reexamine existing condom labels...to determine whether the labels are medically accurate regarding the overall effectiveness or lack of effectiveness in preventing sexually transmitted diseases, including HPV." Hearing is slated for 10 a.m. in Room 2154, Rayburn House Office Building...

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Reps. Tom Davis (R-Va.) and Mark Souder (R-Ind.) are pressing FDA to fulfill a legislative mandate directing the agency to review condom labeling to ensure information on the products' ability to prevent human papillomavirus (HPV) is "medically accurate." HPV recently was added to federal lists of known cancer-causing agents because certain strains are linked to cervical cancer. Last year, FDA pledged to address HPV and condom labeling by year-end as part of a guidance, but the document has yet to be published, Souder and Davis note in a Feb. 11 letter. The reps request FDA provide within 30 days "a date certain as to when the [agency] will finally be in compliance with Public Law 106-554" and "an explanation for the continued delay by FDA in complying with this four-year-old law." Souder spearheaded a similar effort early last year (1"The Tan Sheet" Jan. 5, 2004, In Brief)...

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