Richard Klein, photographed during his tenure at the Food and Drug Administration in the 1990s.

As part of my first Lunch & Learn at VOZ Advisors, I had the opportunity to hear from Richard Klein, former Director of the Food and Drug Administration (FDA) Patient Liaison Program, who shared reflections on his pioneering work advancing patient advocacy within the agency. Beginning in the 1980s, during the height of the AIDS epidemic, Richard played a key role in bridging a critical gap between patient activists and regulatory science. Through the creation of what became the Office of Health and Constituent Affairs, his work shaped how the FDA engages with patient communities and established a lasting model for collaboration among patients, patient advocates, and scientific leaders to inform more responsive and inclusive decision-making in drug development.

As he reflected on his time at the FDA, several themes illustrated how the impact of his work carries through to patient advocacy today:

  • Incorporating lived experience into policy and regulation is essential to creating meaningful and effective outcomes.

Policy and regulatory efforts are often disconnected from the everyday realities of the individuals and communities they are intended to serve. Ensuring that lived experiences are represented makes the work more relevant, tangible, and actionable, and provides a clearer understanding of its real-world impact.

  • Organizational priorities must reflect a commitment to patient engagement.

To ensure that community voices are heard, an organization’s culture must actively support these priorities. Richard shared an example of the then-FDA commissioner David Kessler’s supportive response to this work, making patient engagement a priority even amidst differing opinions within the agency. The commissioner’s statement to “err on the side of compassion” still holds true for those of us working in healthcare and patient advocacy today, especially as we continue to engage with patients and ensure that their voices are heard and valued.

  • Building trust between communities ensures effective patient engagement.

Trust is a foundational step to supporting communities and bridging gaps between stakeholders. Strong relationships help communicate important nuances to the broader community to create a stronger understanding of how patient input can be incorporated to ensure meaningful and effective outcomes.

The lessons that Richard shared remain highly relevant as patient engagement continues to evolve. As someone early in their career, I found this extremely relevant to my work. Trust, meaningful collaboration, and ensuring that advocacy, policy, and science work in tandem are all critical to ensuring that the impact of patient engagement and advocacy efforts grows and is sustained over time.

– Srinidhi Murali, Associate, Client Services