2000D-1350 - Draft Guidance for Industry on Labeling for Combined Oral Contraceptives; Availability
FDA Comment Number : EC1
Submitter : Dr. Markus Steiner Date & Time: 03/30/2004 05:03:47
Organization : Family Health International
International Organization
Category :
Issue Areas/Comments
Labeling for Combined Oral Contraceptives - Docket No. 2000D-1350

FHI?s Comment on Contraceptive Effectiveness Rates

The draft guidance document presents pregnancies per 100 women years for different contraceptives; for oral contraceptive pills the rate presented is 1% and for male condoms the rate is 15%. According to the document, these two estimates ?are derived from clinical trial data reviewed by the Food and Drug Administration.? However, the document does not state if these estimates apply to women using the method correctly and consistently or during typical use. We are familiar with results from three recent synthetic condom 510K FDA submissions (eZon, Avanti and Tactylon). In these studies, the six-month typical-use rates for the latex condom arms were 5.4%, 6.2% and 7.9%, respectively. Therefore we believe the reported 15% pregnancy rate for male condoms may be too high if the FDA chooses to rely on clinical trial data.

Although not based on a true systematic review, we believe Dr. Trussell has compiled the best available estimates of contraceptive effectiveness. These will soon be republished in the text Contraceptive Technology (18th edition currently in press). In particular, Dr. Trussell?s typical-use rates, based largely on the NSFG, are 8% and 15% for oral contraceptive pills and male condoms, respectively.. The annual perfect-use rates are 0.3% for oral contraceptive pills and 2% for condoms. Dr. Trussell provides an in-depth discussion of the data sources and rationale for choosing these data sources.

Dr. Trussell?s contraceptive effectiveness rates have been widely used to counsel women both domestically as well as internationally. If specific rates are to be mentioned, we hope the FDA will use these estimates as a starting point in future contraceptive labeling. However, our initial research of the comprehension of contraceptive labeling (Steiner et al, 2003) suggests that women may be confused when presented with numeric estimates of risk. We urge the FDA to conduct research on the presentation of risk to ensure the informed choice of women when they select a contraceptive method.