Testimony Presented to the United States Food and Drug Administration’s Advisory Committee for Reproductive Health Drugs
January 24, 2007
My name is Dr. Beth Jordan. I am an internist and medical director of the Association of Reproductive Health Professionals. ARHP was founded in 1963 and is an international professional association whose members include physicians, advanced practice clinicians, researchers, educators, and advocates, all with expertise in reproductive health research or practice.
On behalf of ARHP and its 11,000 core and associate members, I’m pleased to provide comments before the Food and Drug Administration’s Advisory Committee for Reproductive Health Drugs.
For purposes of disclosure, ARHP is a 501c3 non-profit organization and is supported by unrestricted educational grants from many foundations and companies. We also receive individual donations from those interested in supporting evidence-based research and education. Relevant to this committee meeting, ARHP has current unrestricted educational grants from Ortho Women’s Health and Urology and Wyeth Pharmaceuticals.
ARHP is a leading source of trusted education and information on reproductive health issues, and is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education to health care providers through a variety of educational programs, meetings, and publications. ARHP advocates for evidence-based research and supports the availability of a wide range of safe, effective, and appropriately used contraception for women.
ARHP is pleased that the FDA is reviewing the manner in which hormonal contraceptive efficacy is measured. ARHP’s mission is to provide the highest quality evidence-based reproductive health information to health care providers and patients.
Choosing when and if to become a parent is one of the most important issues women face. Patients and health care providers alike depend on researchers and regulatory governmental agencies to use the best science available when making determinations of contraceptive effectiveness. For providers to accurately discuss the true risk of pregnancy with their patients who use contraceptive methods, those discussions should be predicated on the highest caliber research.
Given that many respected researchers and practitioners in the reproductive health field widely criticize the Pearl Index for being a flawed methodological tool, ARHP encourages the FDA to use Life Table methods as the standard for determining pregnancy rates at specific intervals of time. Not only is this method more accurate for determining the contraceptive effectiveness of a specific method, but unlike studies using the Pearl Index, one can reliably make useful comparisons of various methods from different studies.
ARHP advocates for the availability of as many safe, effective contraceptive methods as possible to women in the United States. This includes lower-dose options, as well as options for continuous and extended use, which some women find beneficial for lifestyle and/or medical reasons.
Many women experience fewer side effects on some of the newer, lower-dose pills. While these lower-dose pills might be found to be somewhat less effective than higher-dose pills, the real world significance of such a proposed difference is not clear and might well be insignificant in women’s lives if it offers them less side effects and consequently improved contraceptive adherence.
Every woman is unique and measures of acceptability will vary among users. Side effects which are problematic to some women may not be for other women—culture, history, lifestyle, and perception all play a role. For example, unscheduled bleeding while on hormonal contraception may be the number one problem to some women, while others may find mild breakthrough bleeding insignificant compared to other side effects from higher estrogenic compounds.
Information regarding product safety, efficacy, and effectiveness needs to be accurately and clearly conveyed to consumers both through product packaging and by the health care provider. Risks and benefits associated with different contraceptive products should be discussed between a patient and her health care provider, enabling the patient to make informed decisions about her reproductive health care. ARHP is very concerned about the way in which providers and package inserts convey risks and side effects to patients and we advocate for clear, simple product packaging. If there are post-approval concerns, ARHP advocates for follow-up, including post-marketing surveillance, in order to gather additional product safety data.
We would like to thank the committee for the opportunity to discuss this important issue.