A seismic shift is underway at the FDA that could fundamentally alter how drugs reach American patients. Recent reporting reveals the agency is dramatically scaling back its use of independent advisory committees—consulting external experts on just 3% of medications this year, down from the historical 20-50%. This quiet revolution prioritizes efficiency but raises profound questions about transparency and public trust.At stake is a decades-old system designed to provide objective external scrutiny of new medications before they enter the marketplace. These independent panels, comprising clinicians, researchers, and patient advocates, have traditionally offered crucial scientific perspectives beyond what FDA staff might present, created transparency through public meetings, and helped mitigate risks through peer review. Now, as the FDA increasingly bypasses these committees to streamline approvals, pharmaceutical companies face a complex new landscape.For pharma executives, the implications are far-reaching. While faster approvals mean quicker time to market and potentially earlier revenue, they also create heavier post-marketing surveillance burdens when external scrutiny happens only after launch—if at all. Marketing teams may struggle with physician skepticism about drugs approved without traditional peer review, while patient access teams could face more challenging payer dialogues about comparative efficacy and value. Most concerning is the potential erosion of patient trust, as public hearings have historically provided rare windows into how approval decisions are made. With research showing that 74% of Americans support advisory committee use for novel drugs, pharmaceutical companies must now consider how to fill this transparency gap proactively—through open science initiatives, robust real-world evidence programs, and enhanced digital tools for monitoring outcomes and patient experiences post-prescription. The fundamental question facing our industry now becomes: how do we maintain credibility when regulatory review becomes less visible? Whether you're developing launch strategies, designing patient support programs, or building digital health solutions, addressing this challenge will be essential for success in this new regulatory era. Join us as we explore the profound implications of this regulatory shift and the opportunities it creates for innovation in patient-centered approaches to drug development and commercialization.PostScripts Rx is not intended to constitute medical advice, nor is it intended to influence prescribing decisions or any other medical or clinical decision-making. All medical and clinical judgment and decision-making, prescribing decisions, and all related considerations remain exclusively the responsibility of providers and patients.

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