Last month, the head of the US Food and Drug Administration’s (FDA) Centre for Drug Evaluation and Research (CDER) George Tidmarsh said the agency would move away from convening independent advisory committees to adjudicate on specific drug approvals.
The statements, which Tidmarsh later walked back on, came amidst a number of changes in policy within the agency. Earlier this year, FDA Commissioner Marty Makary limited pharma company employees from serving on advisory committee meetings except where required by statute. The Advisory Committee for Immunization Practices (ACIP) at the Centers for Disease Control and Prevention (CDC), which advises on immunisation practices has also seen tumult in the last few months.
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If the FDA considers overturning this practice, which stretches back to 1972, critics warn the agency will lose much of its expert advice and procedural transparency. Such moves have fuelled accusations that the FDA is becoming increasingly politicised.
In this episode, Frankie Fattorini, reporter for Pharmaceutical Technology and GlobalData Insights, speaks with Dan Troy, managing director at Berkeley Research Group, to discuss the rationale behind the move and what it may mean for the agency’s future. Troy was a chief counsel at the FDA during the 2000-2004 period, also talks about how the public may perceive the actions of the FDA.
