FDA Actions Follow Advisors 88% of Time: Analysis
Harvard Medical School researchers say that for the 409 human drug advisory committee meetings held from 2010-2021, FDA regulatory actions followed the committees’ recommendations 88% of the time. Writing in JAMA Health Forum, the researchers also say the agency called fewer committee meetings as the years progressed (50 meetings in 2012 to 18 in 2020 and 2021).
“This study demonstrated that these committees have played a key role in FDA’s decision-making process but that FDA sought independent expert advice less frequently over time even as it continued to follow it,” the analysis concludes. “The role of advisory committees in the current regulatory landscape should be more clearly and publicly defined.”
The researchers say advisory committees provide agency leaders with valuable insights and also allow FDA to build public trust. “When its decisions align with advisory committee recommendations,” they write, “FDA uses supportive committee votes in public statements to bolster its credibility, such as when it authorized the COVID-19 vaccine for children7 and took steps to withdraw the drug hydroxyprogesterone caproate (Covis’ Makena).”
The article suggests that committees’ ability to support FDA credibility may be growing in importance given polls showing a decreasing trust in the agency since the Covid-19 pandemic. The authors also cite recent controversies that they say have drawn public scrutiny of the agency’s use of advisory committees, such as questions about the accelerated approval of the Biogen/Eisai Alzheimer’s drug Aduhelm following a near-unanimous committee recommendation that it not be approved.
The study says the “dramatic decrease” in committee meetings suggests FDA is “leaning away” from independent expert advice, even as it continues to follow it. “It may be that FDA is becoming more selective about how it convenes committees,” the authors say. “It is also possible that FDA is relying more on other sources of information, such as its own internal reviews or input from industry experts, to inform its decisions.”
The researchers say they found that discordance between FDA actions and advisory committee votes was most likely to involve agency approval after a negative vote. They say many of the negative-vote approvals came years after the vote, suggesting the emergence of new evidence to support approval.
“Reforms are necessary to clarify FDA’s commitment to independent expert advice as an integral part of its regulation of prescription drugs,” the study concludes.