For Patients

Patient Engagement Collaborative

The FDA and the Clinical Trials Transformation Initiative (CTTI) will be working together to create a new work group with patient advocacy organizations to talk about patient engagement at the FDA.

FDA Patient Engagement Collaborative

As the FDA continues to advance its patient engagement efforts, it is important that an ongoing forum exists to discuss how to achieve more meaningful patient engagement in medical product development and other regulatory discussions.

Acknowledging the needs and concerns of patients, caregivers, and advocates, the FDA continues to identify ways to better serve the patient community.  One way the commitment is being addressed is through a new initiative. The FDA, together with the Clinical Trials Transformation Initiative,  are establishing a group of patient organization and individual representatives to discuss topics focusing on enhancing patient engagement in medical product development and regulatory discussions at FDA.  The Patient Engagement Collaborative (PEC) is another advancement in FDA’s efforts to strengthen its relationship with patient communities and is one of the activities that is being coordinated by the FDA’s Patient Affairs Staff (PAS) in the Office of Medical Products and Tobacco (OMPT).

Patient communities and other stakeholders commented in public feedback on Food and Drug Administration Safety and Innovation Act (FDASIA), section 1137, Patient Participation in Medical Product Discussions, to create an outside group to provide input on patient engagement across the agency.  In response to that feedback, FDA and CTTI established this Collaborative with help from patient organization representatives.

This new Collaborative is also facilitated by provisions in both the 21st Century Cures Act of 2016 and the Food and Drug Administration Reauthorization Act of 2017.  Both provisions aim to foster patient participation and incorporate patient experiences in the regulatory process.

The PEC will provide an ongoing forum to discuss how to achieve more meaningful patient engagement in medical product development and other regulatory discussions.  Topics to be discussed may include:

  • making patient engagement more systematic

  • how to improve transparency

  • education and communication on the medical product regulatory process

  • new strategies for enhancing patient engagement

  • new models for patients to collaborate as partners in the medical product development and FDA review process.

Representatives from the patient community to participate in the PEC including:

  • Patients who have personal disease experience.

  • Caregivers who have personal experience with the disease by supporting the patient. A caregiver can be a parent, child, partner, family member, or friend.

  • Representatives from patient groups who, through their role in the patient group, have direct or indirect disease experience. 

Following an official call for nominations, a selection committee consisting of patient advocates, staff from the Clinical Trials Transformation Initiative, and FDA staff from multiple medical product centers, has chosen the following 16 individuals to serve as the first slate of PEC members.  A great deal of emphasis was placed on ensuring involvement of representatives with a variety of perspectives and inclusion of patients, caregivers, and representatives from a diversity of patient organizations.  Members are expected to serve for a total of 2 to 3 years, with this first slate beginning their terms as of August 2018.

  PEC Member List
 Adrienne Shapiro  Lawrence "Rick" Phillips
Anne Hall Lynne Quittell
Dave White Melissa Hogan
Dawn Aldrich Nancy Lenfestey
Elizabeth Joniak-Grant Philip Posner
Isabelle Lousada Ronald Bartek
Jeffrey Goldstein Stephanie Monroe
Karen Erickson Theresa Strong

For more information about the Patient Engagement Collaborative email the Patient Affairs Staff-  PatientAffairs@fda.hhs.gov

Page Last Updated: 07/10/2018
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