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Preparing for an FDA Advisory
Committee: High Risk, High Reward
By Michael J. Vivion
16
For regulatory professionals, the statement
“You’re going to have an Advisory Committee
Meeting” can generate waves of anxiety. For
them, and their companies, a Food and Drug
Administration (FDA) Advisory Commit-
tee Meeting1 can be a defining event. For the
regulatory participant, such a meeting can be
career-defining, offering the opportunity to
demonstrate cross-functional leadership, com-
munication excellence and organizational talent.
For companies, the meeting’s outcome can range
from facilitating a first-cycle approval to, for a
small company, virtual death.
For those involved in the drug and biologic
approval process, the response also generates
a series of challenges: months of preparation,
huge resource demands, reliance on external
Key Opinion Leaders (KOLs), large outlays for
expenses and high stakes. Consequently, this
chapter focuses on the Advisory Committees
directly involved in the drug approval process.
Everyone who prepares for any of these meet-
ings faces one common truth—FDA Advisory
Committees come with a level of unavoidable risk.
Because these meetings are public, compa-
nies’ practices and research outcomes are scru-
tinized. The vote and the recorded discussion
provide material for use in future discussions
with FDA, for sales and marketing, for com-
petitive intelligence and for investor decision
making. FDA faces the same public scrutiny the
vote and discussion establish a public rationale
for action—and occasionally a public outcry over
an unpopular decision.
The FDA Advisory Committee Meeting has
been called everything from the Super Bowl of
FDA meetings to regulatory theater. The meeting
is unique—part regulatory, part science, part med-
ical care, part public policy and part performance.
The first was convened by George Washington
in 1794 to discuss the Whiskey Rebellion. They
were formalized for FDA by the Federal Advisory
Committee Act of 1972—and further impacted
by the Sunshine Act of 1976 and the more recent
Physician Payment Sunshine Act. FDA relies on
its Advisory Committees to provide advice and
recommendations on a wide range of matters
related to public health: from responses to biologic
terrorism to regulating tobacco products to scien-
tific issues to new drug approvals.
But the Advisory Committee that has the
most impact on American health is the meeting
that focuses on a medicinal product’s approval.
For that reason, the rest of this chapter will
focus on the elaborate and intense preparation
for an approval meeting sponsored by the Cen-
ter for Drug Evaluation and Research (CDER)
or the Center for Biologics Evaluation and
Research (CBER).
Advisory Committee Overview
A product Advisory Committee is convened
when FDA needs external expertise to make an
approval decision. This need for advice is gener-
ally scientific or medical, e.g., a review of a first-
in-class therapy, one that adds to or challenges
current general knowledge. A product’s approval
might establish a precedent or impact public pol-
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Preparing for an FDA Advisory
Committee: High Risk, High Reward
By Michael J. Vivion
16
For regulatory professionals, the statement
“You’re going to have an Advisory Committee
Meeting” can generate waves of anxiety. For
them, and their companies, a Food and Drug
Administration (FDA) Advisory Commit-
tee Meeting1 can be a defining event. For the
regulatory participant, such a meeting can be
career-defining, offering the opportunity to
demonstrate cross-functional leadership, com-
munication excellence and organizational talent.
For companies, the meeting’s outcome can range
from facilitating a first-cycle approval to, for a
small company, virtual death.
For those involved in the drug and biologic
approval process, the response also generates
a series of challenges: months of preparation,
huge resource demands, reliance on external
Key Opinion Leaders (KOLs), large outlays for
expenses and high stakes. Consequently, this
chapter focuses on the Advisory Committees
directly involved in the drug approval process.
Everyone who prepares for any of these meet-
ings faces one common truth—FDA Advisory
Committees come with a level of unavoidable risk.
Because these meetings are public, compa-
nies’ practices and research outcomes are scru-
tinized. The vote and the recorded discussion
provide material for use in future discussions
with FDA, for sales and marketing, for com-
petitive intelligence and for investor decision
making. FDA faces the same public scrutiny the
vote and discussion establish a public rationale
for action—and occasionally a public outcry over
an unpopular decision.
The FDA Advisory Committee Meeting has
been called everything from the Super Bowl of
FDA meetings to regulatory theater. The meeting
is unique—part regulatory, part science, part med-
ical care, part public policy and part performance.
The first was convened by George Washington
in 1794 to discuss the Whiskey Rebellion. They
were formalized for FDA by the Federal Advisory
Committee Act of 1972—and further impacted
by the Sunshine Act of 1976 and the more recent
Physician Payment Sunshine Act. FDA relies on
its Advisory Committees to provide advice and
recommendations on a wide range of matters
related to public health: from responses to biologic
terrorism to regulating tobacco products to scien-
tific issues to new drug approvals.
But the Advisory Committee that has the
most impact on American health is the meeting
that focuses on a medicinal product’s approval.
For that reason, the rest of this chapter will
focus on the elaborate and intense preparation
for an approval meeting sponsored by the Cen-
ter for Drug Evaluation and Research (CDER)
or the Center for Biologics Evaluation and
Research (CBER).
Advisory Committee Overview
A product Advisory Committee is convened
when FDA needs external expertise to make an
approval decision. This need for advice is gener-
ally scientific or medical, e.g., a review of a first-
in-class therapy, one that adds to or challenges
current general knowledge. A product’s approval
might establish a precedent or impact public pol-