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In 2023, NICHD formed the PRGLAC Implementation Working Group of Council to put recommendations from the congressionally mandated, NICHD-led PRGLAC, established as part of the 21st Century Cures Act, into practice.
The PRGLAC Implementation Working Group of Council is a subgroup of NICHD’s National Advisory Child Health and Human Development (NACHHD) Council. It monitors and reports on how the Task Force's recommendations are being implemented to improve knowledge and research on safe and effective therapeutics for pregnant and lactating women.
The working group hosted a series of meetings on implementation activities beginning in November 2023. Afterward, the group presented on updates and findings (PDF 672 KB) to the NACHHD Council in June 2024 and released its report on implementation progress (PDF 1 MB) in July 2024.
Meetings
Sponsor/Co-Sponsor(s)
NICHD
Location
Building 31, 6C, Room A, NIH Main Campus, Bethesda, Maryland
Purpose
In 2023, NICHD formed the PRGLAC Implementation Working Group of Council to monitor and report on the implementation of recommendations for improving knowledge and research on safe and effective therapeutics for pregnant and lactating women. The recommendations came from the congressionally mandated, NICHD-led PRGLAC, established as part of the 21st Century Cures Act.
The current PRGLAC Implementation Working Group of Council will host this series of meetings on implementation activities, with the anticipated goal of presenting updates and findings to NACHHD Council in June 2024.
Individuals who need any other reasonable accommodations to participate in this activity should contact Emma Carpenter at emma.carpenter@nih.gov at least 5 days in advance.
Agenda and Presentations
- Meeting agenda (PDF 121 KB)
- Opening remarks presentation (PDF 644 KB)
- Session I presentations
- Clinical Pharmacology Training Network (CPTN) (PDF 1.2 MB)
Lesley Samedy Bates, Pharm.D., PhD., Program Officer, Obstetric and Pediatric Pharmacology and Therapeutics Branch, NICHD - American College of Obstetricians and Gynecologists (ACOG) Presentation (PDF 229 KB)
Rachel Gandell Tetlow, Senior Director, Government and Political Affairs, ACOG - Society for Maternal-Fetal Medicine Presentation to the NICHD PRGLAC Implementation Working Group of Council (PDF 614 KB)
Rebecca Abbott, Senior Director of Advocacy, Society for Maternal-Fetal Medicine
- Clinical Pharmacology Training Network (CPTN) (PDF 1.2 MB)
- Session II presentations
- MotherToBaby: PRGLAC Implementation Meeting (PDF 2 MB)
Christina Chambers, Ph.D., M.P.H., Distinguished Professor, Department of Pediatrics, University of California San Diego - Centers for Disease Control and Prevention (CDC) Communications Efforts Related to Medications and Pregnancy (PDF 2.2 MB)
Kara Polen, M.P.H., National Center on Birth Defects and Developmental Disabilities, CDC
- MotherToBaby: PRGLAC Implementation Meeting (PDF 2 MB)
Contact
Emma Carpenter, Office of Legislation, Public Policy, and Ethics, Office of the Director, NICHD
Email: emma.carpenter@nih.gov
January 19, 2024 (Noon-4 p.m.)
Sponsor/Co-Sponsor(s)
NICHD
Location
Virtual; NIH VideoCast
Purpose
In 2023, NICHD formed the PRGLAC Implementation Working Group of Council to monitor and report on the implementation of recommendations for improving knowledge and research on safe and effective therapeutics for pregnant and lactating women. The recommendations came from the congressionally mandated, NICHD-led PRGLAC, established as part of the 21st Century Cures Act.
The current PRGLAC Implementation Working Group of Council will host this series of meetings on implementation activities, with the anticipated goal of presenting updates and findings to NACHHD Council in June 2024.
Individuals who need any other reasonable accommodations to participate in this activity should contact Emma Carpenter at emma.carpenter@nih.gov at least 5 days in advance.
Presentations
- Opening remarks presentation (PDF 966 KB)
- Session I presentations
- Leveraging Clinical Trial Networks for Advancing Therapeutics in Pregnancy (PDF 2 MB)
Nahida Chakhtoura, M.D., Ms.G.H., Chief, Pregnancy and Perinatology Branch, NICHD - Catalyzing Innovation in Maternal Therapeutics: Novel Networks and Drugs (PDF 4 MB)
Aaron C. Pawlyk, Ph.D., Chief, Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB), NICHD - Progress on Prioritization of Drug, Vaccine, and Dietary Supplement Research Needs for Pregnant, Postpartum, and Lactating Persons (PDF 329 KB)
Camille Fabiyi, Ph.D., M.P.H., Program Officer, OPPTB, NICHD
- Leveraging Clinical Trial Networks for Advancing Therapeutics in Pregnancy (PDF 2 MB)
- Session II presentation
- U.S. Food and Drug Administration (FDA) Update: Recommendation 10 (PDF 586 KB)
Lynne Yao, M.D., Director, Division of Pediatrics and Maternal Health; Office of Rare Diseases, Pediatrics, Urology, and Reproductive Medicine; Office of New Drugs; Center for Drug Evaluation and Research; FDA
- U.S. Food and Drug Administration (FDA) Update: Recommendation 10 (PDF 586 KB)
Contact
Emma Carpenter, Office of Legislation, Public Policy, and Ethics, Office of the Director, NICHD
Email: emma.carpenter@nih.gov
November 17, 2023 (Noon-4 p.m.)
Sponsor/Co-Sponsor(s)
NICHD
Location
Virtual
Purpose
In 2023, NICHD formed the PRGLAC Implementation Working Group of Council to monitor and report on the implementation of recommendations for improving knowledge and research on safe and effective therapeutics for pregnant and lactating women. The recommendations came from the congressionally mandated, NICHD-led PRGLAC, established as part of the 21st Century Cures Act.
The current PRGLAC Implementation Working Group of Council will host this series of meetings on implementation activities, with the anticipated goal of presenting updates and findings to NACHHD Council in June 2024.
Individuals who need any other reasonable accommodations to participate in this activity should contact Emma Carpenter at emma.carpenter@nih.gov or 202-205-2279 at least 5 days in advance.
Agenda and Presentations
- Meeting agenda (PDF 176 KB)
- Session I presentation: Overview of Original PRGLAC Task Force and Current Group Goals (PDF 388 KB)
- Session II presentations
- Update on NICHD’s Support for Leveraging Data Resources (PDF 2 MB)
Katie M. Vance, Ph.D., Associate Chief, Obstetric and Pediatric Pharmacology and Therapeutics Branch, NICHD - MaternalHealthLink (PDF 526 KB)
Juanita Chinn, Ph.D., Program Director, Population Dynamics Branch, NICHD
- Update on NICHD’s Support for Leveraging Data Resources (PDF 2 MB)
- Session III presentations
- U.S. Core Data for Interoperability (USCDI)+ for Maternal Health (PDF 803 KB)
Stephanie Garcia, M.P.H., Branch Chief, Office of Technology, Office of the National Coordinator for Health Information Technology, U.S. Department of Health and Human Services - PRGLAC Task Force Experience from FDA CDER’s Sentinel System: Using Electronic Health Record Data to Link Mother and Infant Records (PDF 3 MB)
Patricia Bright, Ph.D., Regulatory Science Staff, Office of Surveillance & Epidemiology, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA) - FDA Updates Relevant to PRGLAC Recommendation 13: Optimize Registries for Pregnancy and Lactation (PDF 807 KB)
Leyla Sahin, M.D., Deputy Director for Safety; Division of Pediatrics and Maternal Health; Office of Rare Diseases, Pediatrics, Urology, and Reproductive Medicine; Office of New Drugs, CDER, FDA
- U.S. Core Data for Interoperability (USCDI)+ for Maternal Health (PDF 803 KB)
More Information
Contact
Emma Carpenter, Office of Legislation, Public Policy, and Ethics, Office of the Director, NICHD
Email: emma.carpenter@nih.gov
Phone: 202-205-2279
Council Roster
| Co-Chairs |
|---|
| Christina Bucci-Rechtweg, M.D. Global Head, Pediatric and Maternal Health Policy Novartis Pharmaceuticals |
| Susan Abdel-Rahman, Pharm.D. Chief Scientific Officer Health Data Synthesis Institute |
| Members |
|---|
| Rebecca Abbot Senior Director of Advocacy Society for Maternal-Fetal Medicine |
| Rebecca Abbot Senior Director of Advocacy Society for Maternal-Fetal Medicine |
| Alison August, M.D. Chief Medical Officer Comanche Biopharma |
| Pamela D. Berens, M.D. Chief of Service Department of Obstetrics, Gynecology, and Reproductive Sciences Lyndon B. Johnson General Hospital – Harris Health System |
| Christina Chambers, Ph.D. Distinguished Professor of Pediatrics and Vice Chair of Clinical Research University of California San Diego |
| R. Alta Charo, J.D. Warren P. Knowles Professor Emerita of Law and Bioethics University of Wisconsin - Madison |
| Rebecca Clifton, Ph.D. Associate Research Professor of Epidemiology Milken Institute School of Public Health The George Washington University |
| Alison Cowan, M.D. Head of Medical Affairs Mirvie |
| Anthony DeLise, Ph.D. Global Head, Developmental and Reproductive Toxicology Novartis Institutes for BioMedical Research Novartis Pharmaceuticals Corporation |
| Camille Fabiyi, Ph.D., M.P.H. Program Officer Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health |
| Elena Gorodetsky, M.D., Ph.D. Research Program Officer Office of Research on Women’s Health National Institutes of Health |
| Julie Grimes, IBCLC, RLC Lactation Education Resources |
| Janet Hardy, Ph.D., M.Sc. Independent Consultant |
| Alison Harrill, Ph.D. Associate Director for Toxicology U.S. Environmental Protection Agency |
| Kenneth (K.J.) Hertz Senior Director Federal Affairs March Of Dimes |
| Elisa A. Hurley, Ph.D. Consultant, Bioethics and Human Subject Research |
| Yasaswi Kislovskiy, M.D., M.Sc., FACOG Director of Reproductive Infectious Disease Center for Innovative Research on Gender Health Equity University of Pittsburgh |
| Sharon Nachman, M.D. Professor of Pediatrics Stony Brook University |
| Sara Quinney, Pharm.D., Ph.D. Professor Department of Obstetrics and Gynecology Indiana University School of Medicine |
| Jennita Reefhuis, Ph.D. Branch Chief, Birth Defects Monitoring and Research Branch Centers for Disease Control and Prevention |
| Kathryn Schubert, M.P.P., C.A.E. President and Chief Executive Officer Society for Women's Health Research |
| Rachel Gandell Tetlow Senior Director, Government and Political Affairs American College of Obstetricians and Gynecologists |
| Eleni Tsigas Chief Executive Officer Preeclampsia Foundation |
| Jasmina Varagic, M.D., Ph.D., FAHA Program Director National Heart Lung and Blood Institute National Institutes of Health |
| Kevin Watt, M.D., Ph.D. Robert M. Ward Presidential Endowed Chair in Clinical Pharmacology Department of Pediatrics Spencer Fox Eccles School of Medicine University of Utah |
| Kaveeta Vasisht, M.D., Pharm.D. Associate Commissioner for Women’s Health U.S. Food and Drug Administration |
| Lynn Yee, M.D., M.P.H. Thomas J. Watkins Memorial Professor of Obstetrics and Gynecology Northwestern University Feinberg School of Medicine |
Contact
Nahida Chakhtoura, Chief, Pregnancy and Perinatology Branch
nahida.chakhtoura@nih.gov