During my tenure as Director of the FDA Center for Drug Evaluation and
Research (CDER), advisory committees provided essential input in the
product review process. These committee meetings remain as critical to
the Agency today.
With the explosion of new medical product categories including gene
therapies, bi-functional molecules, and live virus oncolytics, the FDA must
frequently rely on outside experts, in the form of FDA advisory committees,
to help assess product efficacy and safety.
It is hard to overstate the importance of these meetings, or the challenges
that advisory committee members face in trying to provide a fair
recommendation to the FDA. In addition to their “day jobs,” these clinicians,
academicians, and patient representatives have only days to pour through
a sponsor’s briefing book and assess years of data a few hours to hear
both the FDA’s and sponsor’s analyses of the data and even less time to
ask the sponsor and the Agency questions.
While I was at FDA, I saw case after case of sponsors who either weren’t
effective in putting forth the true benefit of their product, were not confident
when answering committee member’s questions, or went too far in making
statements and conjecturing in ways that couldn’t be supported by their
data. However well-intentioned, they lost credibility and often an advisory
committee member’s positive recommendation.
Because the FDA almost always follows the advice of its advisory committee
members, their recommendations are critical to public health. As a result,
it’s essential that sponsor companies take charge of their portion of the
meeting and skillfully moderate their session. They must present their data
in a clear, credible, and convincing way, and confidently answer advisory
committee members’ questions—to satisfy both the company’s interests
and serve the greater good.
Forward FORWARD
Research (CDER), advisory committees provided essential input in the
product review process. These committee meetings remain as critical to
the Agency today.
With the explosion of new medical product categories including gene
therapies, bi-functional molecules, and live virus oncolytics, the FDA must
frequently rely on outside experts, in the form of FDA advisory committees,
to help assess product efficacy and safety.
It is hard to overstate the importance of these meetings, or the challenges
that advisory committee members face in trying to provide a fair
recommendation to the FDA. In addition to their “day jobs,” these clinicians,
academicians, and patient representatives have only days to pour through
a sponsor’s briefing book and assess years of data a few hours to hear
both the FDA’s and sponsor’s analyses of the data and even less time to
ask the sponsor and the Agency questions.
While I was at FDA, I saw case after case of sponsors who either weren’t
effective in putting forth the true benefit of their product, were not confident
when answering committee member’s questions, or went too far in making
statements and conjecturing in ways that couldn’t be supported by their
data. However well-intentioned, they lost credibility and often an advisory
committee member’s positive recommendation.
Because the FDA almost always follows the advice of its advisory committee
members, their recommendations are critical to public health. As a result,
it’s essential that sponsor companies take charge of their portion of the
meeting and skillfully moderate their session. They must present their data
in a clear, credible, and convincing way, and confidently answer advisory
committee members’ questions—to satisfy both the company’s interests
and serve the greater good.
Forward FORWARD