Rules of engagement

How an NHC framework could allay concerns about regulatory pitfalls of patient engagement

An upcoming publication from the National Health Council on good practices for sponsor-patient interactions could help companies overcome fears that their outreach could be construed as promotional. Several executives told BioCentury that having guardrails established by a trusted third party could get more companies to engage with patients during drug development.

In the future, companies also want principles on how to engage patients most effectively.

NHC released a summary of its work, titled “Sponsor-Patient Interactions During Drug Development: Good Practice Insights on Patient Engagement,” on Nov. 2. The summary is based on discussions at a June 15 meeting co-hosted with Genetic Alliance Inc. and the Food and Drug Law Institute, with participation from patient advocacy groups, life science companies, government agencies including NIH, academic institutions, non-profit organizations and professional and industry trade associations.

It describes general principles that sponsors can adopt to avoid engaging with patients in a way that is or could be misinterpreted as promotional. The full framework will be submitted for publication this month.

The principles start with establishing and articulating up front a clear objective for the engagement. NHC SVP of Strategic Initiatives Eleanor Perfetto said this is one of the most important elements in a good sponsor-patient interaction.

“If your reason is sound, it’s easier for the rest

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