Makary ‘Missing the Point’ on Advisory Committees: Zuckerman
National Center for Health Research president Diana Zuckerman says FDA commissioner Marty Makary’s plan to rely on “spontaneous [and] robust” expert panels rather than advisory committees misses the point on the value of advisory committees and undermines the credibility of agency decisions. Writing in a Medpage Today opinion column, Zuckerman says there are many differences between advisory committees and the “expert panels” that FDA has convened this year.
She says advisory committee meetings typically are scheduled when there is conflicting evidence or a contentious difference of opinion within FDA or between FDA and other interested parties, such as a product’s sponsor.
“Typically,” she writes, “the meeting focuses on whether a new drug or device merits FDA approval, whether there is persuasive evidence that an approved product is less safe or effective than FDA previously concluded, or if a type of product may require more/less rigorous regulatory standards than currently required.”
Most advisory committee meetings last eight hours, she says, including time for the sponsor’s presentation and FDA’s presentation; an open public hearing for patients, family members, caregivers, and advocacy organizations to give their views; and time for committee member questions, discussion, and voting. Briefing materials are available to committee members and the public before a session, and a full meeting transcript is provided after the session.
Zuckerman says Makary has complained that the meetings are outdated because they are “bureaucratic, long, often conflicted, and very expensive.”
In contrast, she says, the expert panel meetings have lasted about two hours with some eight to 12 experts selected by the agency, “each speaking for a few minutes and answering softball questions asked by the FDA commissioner or other official. The list of speakers is not necessarily released in advance, no written documentation regarding the evidence has been provided to the public, and the panel members’ presentations appear mostly consistent with the commissioner’s opinion.”
Zuckerman discusses the shortcomings of advisory committees and the concerns about them raised by former FDA commissioner Robert Califf.
“Advisory committees are not perfect,” she concludes, “but I’ve never seen one that lacks a diversity of opinion. FDA scientists almost always raise important concerns that help committee members consider the risks and benefits of products and strengths and weaknesses of the research evidence…. Important FDA decisions deserve scientific scrutiny, challenging questions, differences of opinion, and nuanced summaries. These have, to date, been lacking in the FDA expert panels, making critical information less available to patients and their physicians.”