FDA to review low-dose OC standards

The US Food and Drug Administration has said that it is reconsidering its standards for reviewing the failure rate of new low-dose estrogen and progestin oral contraceptives, according to papers released by the agency and reported by the Wall Street Journal.

The reason for its move is that studies have indicated a higher failure rate with the low-dose OCs, and the FDA aims to establish what represent an "acceptable failure rate" for new drugs.

The FDA documents note that, in the 1970s, the agency set a policy of only approving OCs with a failure rate of less than 1.5 per 100 "woman-years," or the number of those who had used such a drug. More recently, the WSJ says, the agency approved some pills with failure rates of more than two per 100 woman-years. The FDA is to seek input from advisers for new guidelines.