FDA Plans Reduce External Expert Panels Drug Reviews

Under President Trump’s administration, the FDA is considering a significant shift away from its longstanding practice of involving external expert advisory committees in reviewing and voting on individual drug applications. George Tidmarsh, head of the FDA’s Center for Drug Evaluation and Research, argues that these panels are redundant, labor-intensive for both the FDA and drug companies, and that the agency prefers to focus on broader regulatory questions instead. Although advisory committees have historically provided transparency and diverse expert opinions, particularly in complex or controversial decisions like the 2021 approval of Aduhelm for Alzheimer’s disease despite committee opposition, the FDA plans to maintain committees only for general issues rather than specific drug approvals. Critics, including former FDA Commissioner Robert Califf and public health advocates, warn that reducing expert panel involvement could diminish public scrutiny and oversight, which are vital for understanding regulatory decisions and ensuring rigorous risk-benefit assessments. The FDA has also initiated publishing Complete Response Letters to companies denying drug approvals as a transparency measure, but opponents argue this does not replace the value of advisory committee deliberations. Overall, the move has sparked debate over balancing efficiency and transparency in drug approval processes.