New Labeling for Contraceptive Drugs

by Erik Swain, Senior Editor

FDA is proposing extensive new warning labeling for all over-the-counter (OTC) vaginal contraceptive drug products containing nonoxynol 9.

Citing a number of studies, the agency wants manufacturers to alert consumers that not only do such products fail to prevent users from contracting the HIV virus or other sexually transmitted diseases, but they can increase vaginal irritation and thus may put users more at risk for contracting HIV and STDs from infected partners. The industry published a proposed rule in the January 16, 2003, Federal Register [68 FR:2254-2262]. 

FDA proposes that three warnings be added to the outer packaging of the products and a statement encouraging the use of latex condoms be added to their package inserts. 

The agency is encouraging manufacturers to add these as soon as possible, pending any changes that may arise from public comments to the proposal. When the rule is finalized, the agency wants any such products whose labeling has not yet converted to the "Drug Facts" format to convert to the new format under the "first major labeling revisions" provision of that rule. Products already in the new format will have to add the new labeling by the effective date of the final rule. 

Written or electronic comments may be submitted by April 16, 2003. Written comments should be sent to the Dockets Management Branch (HFA-305), FDA, 5630 Fishers Ln., Rm. 1061, Rockville, MD 20852. The site for electronic comment submissions is www.fda.gov/dockets/ecomments.