Patient and Consumer Stakeholder Consultation Meeting, MDUFA V Reauthorization

Presentation on diversity and equity by Dr. Thomas Eagen representing the Patient, Consumer, and Public Health Coalition.

Good afternoon and thank you for providing this opportunity to speak during this important meeting. My name is Dr. Thomas Eagen and I am speaking on behalf of members of the Patient, Consumer, and Public Health Coalition, including the Breast Implant Safety Alliance, The Jacob’s Institute of Women’s Health, Our Bodies Ourselves, MRSA Survivors Network, National Center for Health Research, and Woodymatters. The Coalition includes both large and small nonprofit organizations across the country that are united to ensure that medical treatments are safe and effective, and to enhance the scientific and public health focus of the FDA.

It is vitally important that the treatments approved by the FDA are proven to be both safe and effective for all patients. The only way this can be accomplished is through increased diversity and improved equity. Diversity is needed throughout the entire development process, from the beginning to the end, to ensure safety for end users. In addition to race, ethnicity, and sex, this includes representing different age groups and people with disabilities.

There is also a need to improve diversity and subgroup analyses to improve the informed consent process and reduce health disparities. We understand that it is impossible to include all groups of patients in pre-market studies of device effectiveness, but major groups should be included. Post-market studies must ensure diversity and subgroup analyses must be conducted to review the effects of the device on different populations. Adverse event reporting should also be used to help include and analyze those who may not have been included in the original studies.

Finally, there is a need to improve overall accessibility to information related to medical device development and approval. Information must be provided in accessible formats to improve informed consent and usability for all patients. If information is not presented in an accessible format from the start, groups of patients and consumers cannot participate and are excluded. Accessible formats for public information include using plain language, captioning all videos, formatting websites to be used by screen readers, and providing alternate text descriptions for any images.

Thank you for the opportunity to speak today.

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