Task Force on Research Specific to Pregnant Women ...

1 TASK Force ON Research Specific TO Pregnant Women . AND LACTATING Women . Report to Secretary, Health and Human Services Congress September 2018. 1. Contents Executive Introduction ..9. Section 1. A Plan to Identify and Address Gaps in Knowledge and Research Regarding Safe and Effective Therapies for Pregnant Women and Lactating Women , including the Development of Section 2. Ethical Issues Surrounding the Inclusion of Pregnant Women and Lactating Women in Clinical Section 3. Effective Communication Strategies with Health Care Providers and the Public on Information Relevant to Pregnant Women and Lactating Women ..29. Section 4. Identification of Federal Activities ..37. Section 5. Recommendations to Improve the Development of Safe and Effective Therapies for Pregnant Women and Lactating Women .

2 44. Section 6. Appendices ..49. Appendix I Legislation ..50. Appendix II - Task Force Appendix III - Meeting Agendas ..56. Appendix IV Meeting Minutes ..73. Appendix V - Public APPENDIX VI - Research on Therapies in Pregnant Women and Lactating APPENDIX VII - Federal Activities Related to Pregnancy and Lactation, by Agency ..271. Appendix VIII - Pregnancy Registries, Cohorts, and Databases ..313. Appendix IX - Request for Information (RFI) and RFI Appendix X Historical Recommendations Regarding Testing of Therapies Used by Pregnant Women and Lactating Women ..350. 2. Appendix XI - Lessons Learned from Implementing the Best Pharmaceuticals for Children Act: Implications for PRGLAC ..362. Appendix XII Pregnancy and Lactation Labeling Rule Appendix XIII List of 3. Executive Summary The Task Force on Research Specific to Pregnant Women and Lactating Women ( Task Force or PRGLAC ).

3 Was established by section 2041 of the 21st Century Cures Act, 114-255 (report, Section 6: Appendix I). and convened in accordance with the Federal Advisory Committee Act (5 App.) with membership as outlined in the Act (report, Section 6: Appendix II). The Task Force was charged with providing advice and guidance to the Secretary of Health and Human Services (HHS) on activities related to identifying and addressing gaps in knowledge and Research on safe and effective therapies for Pregnant Women and lactating Women , including the development of such therapies and the collaboration on and coordination of such activities. In addition to advising the Secretary, the Task Force was charged with preparing and submitting to the Secretary and Congress a report that includes five elements (Executive Summary, Box 1).

4 The Task Force developed 15 Executive Summary, Box 1. Statutory charge to the Task Force recommendations (report, on Research Specific to Pregnant Women and Lactating Section 5) based on Women , as established by the 21st Century Cures Act. information gleaned during Provide advice and guidance to the Secretary of the Department of Health and four open meetings and a Human Services and prepare a report, for the Secretary to transmit to Congress, that public comment period includes the following: (1) A plan to identify and address gaps in knowledge and Research regarding safe and (report, Section 6: Appendices effective therapies for Pregnant Women and lactating Women , including the III, IV, V, IX). This Executive development of such therapies. Summary provides context for (2) Ethical issues surrounding the inclusion of Pregnant Women and lactating Women the recommendations in clinical Research .

5 (Executive Summary, Box 2). A (3) Effective communication strategies with health care providers and the public on information relevant to Pregnant Women and lactating Women . central theme resonated (4) Identification of Federal activities, including throughout the recommendations the need (a) the state of Research on pregnancy and lactation;. to alter cultural assumptions that have significantly limited (b) recommendations for the coordination of, and collaboration on Research related to Pregnant Women and lactating Women ;. scientific knowledge of therapeutic product safety, (c) dissemination of Research findings and information relevant to Pregnant effectiveness, and dosing for Women and lactating Women to providers and the public; and Pregnant and lactating Women . The cultural shift is necessary (d) existing Federal efforts and programs to improve the scientific understanding of the health impacts on Pregnant Women , lactating Women , to emphasize the importance and related birth and pediatric outcomes, including with respect to and public health significance pharmacokinetics, pharmacodynamics, and toxicities.

6 Of building a knowledge base (5) Recommendations to improve the development of safe and effective therapies for to inform medical decision- Pregnant Women and lactating Women . making for these populations. Consequently, Research on therapies for these populations must be facilitated and greatly augmented. 4. Over six million Women are Pregnant in the United States each year. Of these Women , more than 90. percent take at least one medication during pregnancy and lactation (report, Section 6: Appendix VI). However, Pregnant Women and lactating Women are often excluded from clinical Research that could ultimately help these populations. The Task Force recommends that this trajectory of exclusion be altered to include and integrate Pregnant Women and lactating Women in the clinical Research agenda (Recommendation 1).

7 To date, their exclusion may be motivated by concern about possible harms of medication use during pregnancy or lactation. Although the potential harms of unmedicated disease for both the woman and the developing fetus or breast-fed newborn usually elicit less study, they are nonetheless important. A comprehensive review of Research in recent years conducted for the Task Force deliberations clearly showed the extremely limited information available on medication use in pregnancy and lactation (report, Section 6: Appendix VI). Executive Summary, Box 2: Task Force on Research Specific to Pregnant Women and Lactating Women Recommendations 1. Include and integrate Pregnant Women and lactating Women in the clinical Anecdotal reports state that many Research agenda Pregnant Women and lactating 2.

8 Increase the quantity, quality, and timeliness of Research on safety and efficacy of Women also use herbal and dietary therapeutic products used by Pregnant Women and lactating Women supplements, but there are limited to 3. Expand the workforce of clinicians and Research investigators with expertise in no data to inform their use, dosing, or obstetric and lactation pharmacology and therapeutics 4. Remove regulatory barriers to Research in Pregnant Women therapeutic levels. Since these dietary 5. Create a public awareness campaign to engage the public and health care supplements are regulated differently providers in Research on Pregnant Women and lactating Women than drugs by the United States Food 6. Develop and implement evidence-based communication strategies with health and Drug Administration (FDA) and do care providers on information relevant to Research on Pregnant Women and lactating not require pre-market approval, our Women ability to understand the safety and 7.

9 Develop separate programs to study therapeutic products used off-patent in Pregnant Women and lactating Women using the National Institute of Health (NIH). efficacy of what Women consume Best Pharmaceuticals for Children Act (BPCA) as a model during pregnancy and lactation is 8. Reduce liability to facilitate an evidence base for new therapeutic products that limited. may be used by Women who are or may become Pregnant and by lactating Women 9. Implement a proactive approach to protocol development and study design to Evidence-based answers are required include Pregnant Women and lactating Women in clinical Research 10. Develop programs to drive discovery and development of therapeutics and new for Women and their clinicians to therapeutic products for conditions Specific to Pregnant Women and lactating make fully informed choices based on Women the risks and benefits of medicating or 11.

10 Utilize and improve existing resources for data to inform the evidence and not medicating conditions during provide a foundation for Research on Pregnant Women and lactating Women pregnancy and lactation. The 12. Leverage established and support new infrastructures/collaborations to perform Research in Pregnant Women and lactating Women provision of clinical data is essential to 13. Optimize registries for pregnancy and lactation increasing the quantity, quality, and 14. The Department of Health and Human Services Secretary should consider timeliness of Research on safety and exercising the authority provided in law to extend the PRGLAC Task Force when its efficacy of therapeutic products used charter expires in March 2019. by Pregnant Women and lactating 15. Establish an Advisory Committee to monitor and report on implementation of recommendations, updating regulations, and guidance, as applicable, regarding the Women (Recommendation 2).