ACT Brief: Makary's Turbulent FDA Tenure, Pediatric Trial Experience Design, and Weight Loss Maintenance Data

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• Marty Makary's 13-month tenure as FDA Commissioner ended amid leadership instability, internal conflict, and sponsor concerns about regulatory consistency. Six different leaders served as CDER director in a single year, and while Makary introduced accelerated-review initiatives and published 200 complete response letters for transparency, CRL patterns caught sponsors off guard, raising questions about the durability of prior FDA communications and development strategies.
• In a new contributed article, pediatric trial design often overlooks lived experience despite evidence that psychological safety, autonomy, and communication quality influence recruitment, retention, and data integrity. Early palliative care, consent revisited as prognosis evolves, and attention to caregiver burden are increasingly aligned with FDA patient-focused guidance and ICH E6(R3) quality-by-design principles, positioning experience as a structural variable affecting trial performance.
• Eli Lilly reported maintenance-phase data showing patients transitioning from higher-dose injectables to lower-dose Zepbound or oral Foundayo maintained near-complete weight loss through 112 weeks. The findings address weight regain following therapy interruption and reinforce industry recognition that obesity management increasingly resembles chronic disease treatment models requiring ongoing therapy for sustained benefit.

That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.