Pregnancy and the Pharmaceutical Industry

Pregnancy and the Pharmaceutical Industry

The Movement towards Evidence-Based Pharmacotherapy for Pregnant Women

1st Edition - May 24, 2019

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  • Author: Kristine Shields
  • eBook ISBN: 9780128190746
  • Paperback ISBN: 9780128185506

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Pregnancy and the Pharmaceutical Industry: The Movement towards Evidence-Based Care for Pregnant Women explores the issues surrounding the decision to undertake clinical trials with pregnant women. There is currently a lack of data on the safety and effectiveness of medications used during pregnancy as it is impossible to extrapolate that information from drug studies on men and non-pregnant women. As a majority of pregnant women confront a medical condition during their pregnancy, from simple pain, to ongoing or new medical issues, this book quantifies the current absence of pregnant women in drug studies and identifies ethical issues, barriers, litigation fears and opportunities. Those in the pharmaceutical industry, IRB members who approve or deny drug study plans, doctors, nurses and midwives working in obstetrics or involved in conducting studies at their institutions will find this book an essential resource.

Key Features

  • Explores the medical, ethical, scientific and legal rationales behind the inclusion of pregnant women in drug studies
  • Describes how pharma and biotech companies can safely implement the new FDA guidance and begin to include pregnant women in drug testing
  • Shares views from pharmaceutical industry insiders about company risks, reluctance to implement guidance, and the ultimate need to include pregnant women in studies


Anyone involved in clinical trials including pharmaceutical company researchers and executives, research physicians and nurses, personal injury lawyers, medical ethicists

Table of Contents

  • Part I. The Background, the Debate, and the Ethics Involved
    1. Drug Testing and Pregnant Women: Background and Significance
    2. The Rationales for and Against Inclusion
    3. The Ethics Involved

    Part II. Quantitative and Qualitative Discoveries
    4. A Measure of Exclusion
    5. Perspectives from the Industry: On Exclusion
    6. Perspectives from the Industry: On Inclusion
    7. Perspectives from the Industry: On Litigation, Regulation, Incentives, and Indemnity
    8. Perspectives from the Industry: On Ethics

    Part III. Uniting the Regulators, the Industry, and the Advocates
    9. The FDA Guidance, Public Comment, and Affinity with Stakeholders
    10. Proposed Actions for FDA and the Pharmaceutical Industry
    11. A Chance at Change
    12. After the Guidance

    FDA Guidance Document - Pregnant Women: Scientific and Ethical Consideration for Inclusion in Clinical Trials
    Taskforce on Research Specific to Pregnant Women and Lactating Women: Report to the Secretary, Health and Human Services. Executive Summary

Product details

  • No. of pages: 244
  • Language: English
  • Copyright: © Academic Press 2019
  • Published: May 24, 2019
  • Imprint: Academic Press
  • eBook ISBN: 9780128190746
  • Paperback ISBN: 9780128185506

About the Author

Kristine Shields

Dr. Shields is an OB/GYN nurse practitioner with a doctoral degree in Public Health. As a clinician she provided inpatient and ambulatory care in obstetrics and gynecology. As an epidemiologist she was responsible for the development and operation of the Pregnancy Registry Program at Merck, one of the earliest and most comprehensive pregnancy registry programs within the pharmaceutical industry. As a researcher/writer, she has published scientific papers in Obstetrics & Gynecology, Pediatrics, Birth Defects Research and other medical journals. Dr. Shields is most widely known for her research into medication safety during pregnancy.

Affiliations and Expertise

Women’s Health Clinician, Researcher, and Advisor, Shields’ Medical Writing and Consulting

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  • Freda S. Tue Aug 27 2019

    Pregnancy and the Pharmaceutical Industry: The Movement Towards Evidence-Based Care for Pregnant Women

    By offering this book, Dr. Shields broadens and deepens the much-needed conversation surrounding evidence-based care for pregnant women. For a wide variety of reasons, all of which are examined in Shield's book, illnesses (minor and major) suffered by pregnant women go untreated due to an unwillingness to include them in clinical trials. She makes a detailed and highly readable argument for why it's critical to better understand why this is the current state and provides potential paths to improvement.

  • Tony S. Mon Jul 29 2019

    Pregnancy and the Pharmaceutical Industry: The Movement towards Evidence-Based Care for Pregnant Women

    The lack of information on the use of medication in pregnant and lactating women has bothered practitioners for decades. The US government is exploring ways to increase research in this area, but there are impediments based on superstition, practical difficulties, and fear of litigation. Kris Shields takes on the issue with a review of the way things are and with practical suggestions for improvement. Dr. Shields has been a health care provider and a researcher for industry in human pregnancy exposures. Her book is a thorough and even-handed exploration of the issues. She does not point fingers or lay blame, and the result is a careful examination that is easy to read. Highly recommended.