[Docket No. FDA-2019-D-2153-0002]
The Honorable Norman E. Sharpless, M.D.
Acting Commissioner of Food and Drugs
Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Dear Dr. Sharpless:
Thank you for the opportunity to comment on recently released guidance for safe and effective hormonal contraception. Being able to space, plan, and prevent pregnancy is vital to a woman’s health. We appreciate the agency’s interest in fostering the development of a wide range of innovative, safe and effective methods that prevent pregnancy regardless of a woman’s age, race, ethnicity, body mass, or where she lives.
The National Women’s Health Network is a nonprofit advocacy organization that works to improve the health of all women. We are supported by our members and do not accept financial support from drug companies or medical device manufacturers. We bring the voices, concerns and needs of women consumers to policy and regulatory tables. Since the NWHN’s founding more than 40 years ago, we have brought the voices of women to the FDA, advocating for medical products that meet women’s real life needs and a drug development process that reflects women's lived experiences.
The NWHN has a long history of working with the FDA to address the low rates of participation by diverse populations to allow for analysis and proper labeling of approved medical devices and pharmaceuticals. We commend the FDA for releasing guidance that explicitly states the need to ensure that hormonal contraceptives are both effective and safe for a diverse group of women, including women of color, adolescent women, women older than 35, and women with high body mass index scores. In particular, we welcome lines 57-60 calling for inclusion of enough women with BMI of at least 30 kg/m2 sufficient to perform a subgroup efficacy analysis. These women have been neglected by past drug sponsors even as they make up an increasing share of the U.S. population.
To that end, the guidance should make clear that efficacy comparisons with historical data will account for changes in participant population. A product tested in a truly representative group of potential users, for example, may have a higher Pearl Index than a previously approved product tested primarily or exclusively in thin, white women.
Finally, while we support calculating primary efficacy using a trial population of women younger than or equal to 35, it isn’t clear from the draft guidance that the proposed number of trial subjects and/or menstrual cycles is sufficient to both reach conclusions about efficacy in the younger group while also reaching conclusions about safety in women over 35. We have been willing to support modest decreases in both safety and efficacy in support of increasing the number of unique contraceptive options available to women—if women have enough information about the trade-offs to make an informed choice. A robust examination of a product’s safety is critical to that choice.
Thank you for recognizing the importance of continued development of contraceptive options for women and for the opportunity to comment.
Policy Advocacy Director
National Women’s Health Network