Condom proposed rule at OMB

The Office of Management and Budget July 25 received FDA's proposed rule addressing congressional concerns about condom labeling regarding the effectiveness of the devices. The rule would amend labeling for condoms with and without nonoxynol-9 spermicidal lubricant to clarify the devices' capabilities. The rule also would amend labeling of condoms with N-9 to state that the substance could irritate the vagina, increasing the risk of HIV/AIDS transmission from an infected partner. OMB has 90 days to comment, an FDA spokesman says. FDA will then address OMB's comments before moving to the final rule stage of rulemaking...