SWHR Principles Addressing Disparities in Drug Development

Policy Engagement

Published 2/21/19

SWHR developed a set of principles to address diversity within the Patient-Focused Drug Development (PFDD) Program. The PFDD Program, housed under the Food and Drug Administration (FDA), is designed to obtain patient perspectives on diseases and disease treatments. The program also provides opportunities for key stakeholders in the drug development process to better understand patient needs.

SWHR’s principles focus on the need to reduce sex and gender disparities in drug development. Women comprise over half of the population and make approximately 80% of health care spending decisions. However, sex and gender disparities in drug development persist.

SWHR calls for the inclusion of participants within PFDD Program research that accurately represent the target population. The principles also suggest updates to patient experience data to accurately reflect both physical and psychosocial impacts of the disease or treatment. In addition, SWHR supports the use of a variety of research methods, hypothetical case examples, a standard glossary of PFDD terms, and a clear and predictable process for all stakeholders to engage with the FDA on these issues.

Review The Full List of SWHR Principles Here