Industry groups urge FDA to add clarity and flexibility to manufacturer-payor communication guidance

Industry associations and other stakeholders have asked the U.S. Food and Drug Administration to give more detail and flexibility in its updated guidance on how drug and device makers talk with payors and related parties about their products.

The groups say clearer rules would help manufacturers share information on clinical value, pricing and reimbursement without running afoul of regulatory limits.

They also warn that overly rigid guidance could hinder effective communication and delay patient access, and they are urging the agency to consider a more adaptable approach.

FDA officials have not yet responded, but the request highlights ongoing tension between regulators and the industry over how best to balance transparency with compliance.