By Janet R. Hardy, PhD, MPH, MSc, and Melissa S. Tassinari, PhD, DABT
The social media feed read ‘...Women are under-researched, under-diagnosed, and dying unnecessarily…help close the research gap’. There’s a lot of truth in that statement. Attention to women’s health research has lagged behind men since…well, since the beginning.
But just as every important story has an element of transformation, the period for transforming women’s health is now. And just as the PRGLAC is a critical piece of that transformation, the Society for Birth Defects Research and Prevention (BDRP) and Organization of Teratology Information Specialists (OTIS) have the expertise to play a role in that transformation.
The PRGLAC refers to the Task Force on Research Specific to Pregnant Women and Lactating Women. This Task Force was established in 2017 by the 21st Century Cures Act, a law designed to help speed up medical product development. Managed by the National Institutes of Health (NIH), the PRGLAC is made up of representatives of all Federal agencies with responsibilities for women’s health and research, clinicians, industry and other experts.
In Phase I, PRGLAC was charged with identifying gaps in knowledge and research regarding safe and effective therapies for pregnant women and lactating women. The Task Force conducted four public meetings in 2017 and 2018 and submitted their conclusions to Congress and the Secretary of Health and Human Services in a publicly available report. The report provides 15 specific recommendations to address the areas under the PRGLAC charge (Figure 1). Overall, the report provides thoughtful detail on the magnitude of challenges currently facing research for pregnant women and lactating women. It identifies where data are needed to help inform therapy choices and recognizes that data needs are different for these two populations. Additionally, a central theme emerged from the public discussions: that progress will be made only after a change occurs in long-held cultural assumptions about the participation of pregnant and lactating women in clinical research. Operationally, this would translate into the inclusion of pregnant and lactating women in clinical research or a firm justification for their exclusion.
For BDRP and OTIS clinicians and researchers, the recommendations and discussion theme will not be new, but an important platform for conversation has been set.
In May 2019, the PRGLAC re-convened with a two-year mandate and a new charge for Phase II: to develop plans for implementing the recommendations laid out in the Phase I report. The PRGLAC membership was expanded and divided into four working groups, to address the recommendations of the report: WG1 Research and Training; WG2 Regulatory; WG3 Communication and Registries; and WG4 Discovery. Deliberations within each of the four working groups are currently underway and a new report is being drafted.
Members of BDRP and OTIS participated in the Phase I PRGLAC meetings and the Society submitted written comments to the public docket. The report highlighted opportunities for BDRP, OTIS and their respective members to take a more active role as PRGLAC progressed into Phase II activities. Following the annual BDRP meeting in San Diego, June 2019, a joint BDRP-OTIS PRGLAC Working Group was formed, including members from both societies, which we are co-chairing along with Beth Conover. The charge of this working group is to:
- Influence the PRGLAC discussions and in so doing, highlight both societies and make a positive impact on research specific to pregnant and lactating women;
- assist in Implementation of the PRGLAC recommendations; and
- support Communication of PRGLAC recommendations to a larger community.
The main BDRP-OTIS PRGLAC Working Group activities thus far include:
- The group has produced a document of thoughtfully constructed comments in response to the PRGLAC Phase I report. These were submitted to the PRGLAC and made publicly available. Additionally, a summary of the comments was presented by Janet Hardy, representing both societies, during the meeting’s public discussion period, of which a recorded webcast is available.
- The group also developed a member survey based on the four topics of PRGLAC working groups. The purpose was to identify BDRP and OTIS members whose research and program work could be directly relevant and/or helpful to the PRGLAC. The preliminary results are currently being analyzed. The results may also better inform the membership of both societies regarding work conducted by members, expertise of members, and future priorities.
The efforts of PRGLAC provide a fresh conversation to address long-standing issues to provide evidence-based information for the treatment of pregnant and lactating women. The PRGLAC stands to impact many aspects of BDRP and OTIS members’ work, and to impact the lives of pregnant women and lactating women. Similarly, BDRP and OTIS have the history, and members have the depth of experience to meaningfully impact PRGLAC’s discussions and work. It’s a partnership that is imperative to nourish.
So, fellow BDRP and OTIS members: The populations and work we have been passionate about throughout our careers are in the spotlight…for a short period. Where PRGLAC is a call to action…for us, it’s a call to pay attention and to engage in the transformation.
Janet Hardy, PhD, MSc, MPH is Assistant Professor (affiliate) at U. South Florida College of Public Health, and Consultant, providing expertise-driven research & programmatic consulting to nonprofit, for-profit & legal organizations in 1) pharmacoepidemiology; and 2) maternal-child health research/programming in global low-resource settings. Dr. Hardy has been a BDRP member since 2005 and has served on the Education, Program and Science Committees.
Melissa S Tassinari, PhD, DABT has been a member of BDRP since 1978 and has served on Council and as Society President [2005-06]. She is a developmental toxicologist with experience in regulatory policy and is now retired after a career focused on maternal and child health at Pfizer and as a Senior Clinical Advisor in the Division of Pediatric and Maternal Health at the FDA.
Executive Summary, Box 2: Task Force on Research Specific to Pregnant Women and Lactating Women Recommendations
- Include and integrate pregnant women and lactating women in the clinical research agenda
- Increase the quantity, quality, and timeliness of research on safety and efficacy of therapeutic products used by pregnant women and lactating women
- Expand the workforce of clinicians and research investigators with expertise in obstetric and lactation pharmacology and therapeutics
- Remove regulatory barriers to research in pregnant women
- Create a public awareness campaign to engage the public and health care providers in research on pregnant women and lactating women
- Develop and implement evidence-based communication strategies with health care providers on information relevant to research on pregnant women and lactating women
- Develop separate programs to study therapeutic products used off-patent in pregnant women and lactating women using the National Institute of Health (NIH) Best Pharmaceuticals for Children Act (BPCA) as a model
- Reduce liability to facilitate an evidence base for new therapeutic products that may be used by women who are or may become pregnant and by lactating women
- Implement a proactive approach to protocol development and study design to include pregnant women and lactating women in clinical research
- Develop programs to drive discovery and development of therapeutics and new therapeutic products for conditions specific to pregnant women and lactating women
- Utilize and improve existing resources for data to inform the evidence and provide a foundation for research on pregnant women and lactating women
- Leverage established and support new infrastructures/collaborations to perform research in pregnant women and lactating women
- Optimize registries for pregnancy and lactation
- The Department of Health and Human Services Secretary should consider exercising the authority provided in law to extend the PRGLAC Task Force when its charter expires in March 2019
- Establish an Advisory Committee to monitor and report on implementation of recommendations, updating regulations, and guidance, as applicable, regarding the inclusion of pregnant women and lactating women in clinical research
Task Force on Research Specific to Pregnant Women and Lactating Women; Report to Secretary, Health and Human Services, Congress, September 2018