2000D-1350 - Draft Guidance for Industry on Labeling for Combined Oral Contraceptives; Availability
FDA Comment Number : EC6
Submitter : Dr. Kavita Nanda Date & Time: 05/06/2004 07:05:32
Organization : Family Health International
Health Care Association
Category :
Issue Areas/Comments
Thank you for the opportunity to comment on the draft labeling for combined oral contraceptives (COCs). Family Health International (FHI) is a nonprofit public health organization that works to improve access to safe, effective, and affordable family planning. We also work to translate health information into programs that influence individual behavior and improve community health. We appreciate all the work the FDA has put into this labeling, and the language is more readable than earlier versions. However, we have some areas of concern.
Foremost, the standards the FDA has used for acceptance of scientific literature appear unbalanced. For example, older studies relating to high-dose pills have been cited to support hazards of today?s low-dose pills. In contrast, older studies relating to high-dose pills have been excluded to support the non-contraceptive benefits of low-dose pills. This is internally inconsistent, and potentially misleading. The same inclusion criteria for evidence must be used for both risks and benefits. The draft label needs updated references and better scientific balance. Although randomized trial data is not available for all aspects of COC effectiveness and safety, the best data are still obtained from well-conducted thorough systematic reviews. We have reviewed this literature systematically and extensively as part of Cochrane Collaboration reviews and collaboration with the World Health Organization?s (WHO?s) program on Medical Eligibility Criteria (MEC) for contraceptive use. We would be happy to share these reviews (some of which are not yet published) with the FDA, and would appreciate the opportunity to further assist the FDA in ensuring that this new labeling is accurate, comprehensive, and understandable.