By Susan F. Wood, PhD
The Journal of Women’s Health published a special report and an editorial last month on the FDA’s Office of Women’s Health (FDA OWH) that provide information and insight into the multiple roles of such an office, and the importance of maintaining the scientific research funded there. The special report, “The Food and Drug Administration Office of Women’s Health: Impact of Science on Regulatory Policy” identifies some of the major projects initiated by the FDA OWH, more than 100 studies costing more than $14 million over 10 years. This is a very small amount compared to NIH or to what the regulated industry funds (billions each year), but is focused on elucidating data that can help the FDA make regulatory decisions that affect the health of both women and men.
Ruth Merkatz, PhD, RN, the founding Director of the FDA OWH writes in her editorial:
In this issue, the OWH reviews its science-based program and discusses its genesis and current activities.8 OWH focuses on the sex differences that influence product safety and impact the FDA’s regulatory mission. As described in their paper, one of the first studies that the OWH funded led to new revelations about a connection between the use of a number of marketed drugs and an increased incidence of torsades de pointe (TdP), a potentially fatal cardiac arrhythmia that affects women in particular as a result of the effect of female sex hormones on QT prolongation, but also affects men.9,10 Building on this important finding, OWH allocated some of its science-based funding to enhance postmarketing analysis of drug safety through data mining technology conducted before postmarketing surveillance became a prominent mechanism for ensuring the safety of marketed drugs. This technology identified a number of drugs undergoing review for marketing approval that were likely to have similar effects on the QT interval. The initiative also helped to clarify a variety of mechanisms leading to prolongation of the QT interval in both men and women. It is no small accomplishment that this work contributed subsequently to a new FDA guideline published in 2001 in conjunction with the International Conference on Harmonization (ICH) on assessment of the potential for the QT interval in both sexes.11 As pointed out by Obias-Manno et al. in this issue, 8 4 of 10 drugs withdrawn from the market between 1997 and 2001 were agents associated with an increased risk of TdP in both men and women. A number of other drugs received blackbox warning labeling, and some drugs were not approved for marketing.
The research described in the article by Obias-Manno, et al., ranges from studies on appropriate doses of medication for pregnant women to research on silicone breast implants to examining interactions between drugs and dietary supplements. These are all types of work, not as likely to be funded by NIH – the traditional federal research arm – or by industry, but relates directly to the development of guidances and decisions made by FDA.
Given that the funding FDA OWH was almost cut drastically this year, it is good to have this sort of report evaluating the outcome of the investment in FDA OWH over the last decade of its existence. Congress restored its funding and is likely to provide an increase for it for FY2008. We need to both ensure its continues existence and continue to expect that the outcomes maintain this high level of contributions to the mission of the FDA.
Susan F. Wood, PhD is Research Professor at George Washington University School of Public Health and Health Services, where she is part of the Project on Scientific Knowledge and Public Policy (SKAPP). She also served as Director of the FDA Office of Women’s Health from 2000-2005.