86% is the magic number...
According to a McKinnsey Study based on approval of drugs between 2001 and 2010, whopping 86% of the time the FDA would approve on AdCom positive suggestion, Study states that it also depends a bit on other factors too such as sensitity/specificity, meetings, and 'number of days' it took to get there.
FDA Advisory Commitee Outcomes
McKinsey Center for Government
FDA Advisory
Committee Outcomes
Philip Ma, Navjot Singh, Jeff Smith, Seth Townsend
FDA Advisory
Committee Outcomes
FDA advisory committee meetings are high-stakes interactions, with many years of effort,
millions of dollars of investment, potential regulatory approval, and billions of dollars in
potential sales for a new drug riding on the outcome. We have analyzed publicly available
data and established a fact base that provides all stakeholders with a better characterization
and greater transparency into the outcomes of advisory committee meetings. We also
consider the implications for how sponsors can use this information to improve R&D
decision-making.
During the pre-market review process for drugs
and medical devices, many regulatory agencies
seek unbiased advice from external experts to
address areas of scientific or technical uncertainty.
The US Food and Drug Administration (FDA) in
particular has a well-defined process for obtaining
expert input from its advisory committees and
incorporating the input into its review processes.
FDA reviewers complete an initial review of a
product application and identify questions where
external input is needed. The FDA then convenes
an advisory committee meeting and obtains
the requested input through a combination
of presentations, discussion, and voting by
committee members. After the meeting, FDA
reviewers take into account the input received
when making product approval decisions,
although the recommendations of the committee
are not binding.
FDA advisory committee meetings are high-stakes
interactions, with many years of effort, millions
of dollars of investment, potential regulatory
approval, and billions of dollars in potential sales
for a new drug riding on the outcome. However,
despite the fact that sponsors recognize the
crucial nature of these meetings and are familiar
with the processes, we have found limitations in
the quantitative understanding of their outcomes.
In this article, we have analyzed publicly available
data on FDA advisory committee meetings with
the aim of helping to address these limitations. We
investigated several important issues, including
the total number of meetings by type and
therapeutic area, the frequency with which new
product applications are subjected to advisory
committee meetings, consistency between the
advisory committee votes and FDA approval
decisions, and the duration between an advisory
committee meeting and the final FDA approval
date for a product.
1
Exhibit 1 | Characteristics of FDA advisory committee meetings between 2001 and 2010.
All other
meetings (262)
AC meetings
for drugs
2001–2010 (543)
Original NDAs
or BLAs (190)
NDA- or BLA-
focused
meetings (281)
Voting on approval
question (63)
c 50
Voting, all others (70)
No voting (57)
Supplemental
NDAs or BLAs (91)
Voting, all others (26)
43.8
35.9
32.8
Voting on approval
question (22)
43.8
41.4
40
a
42.9
35.2
31.6
0 37.0
30
20
No voting (43)
b
10
8.2%
8.2%
M
lN
7.5%
13.5%
6.4%
Al
281
meetings
0
??Oncological drugs AC
??Cardiovascular and renal drugs AC
??Anti-infective drugs AC
??Endocrinological and metabolic drugs AC
??Antiviral drugs AC
??Psychopharmacological drugs AC
??Arthritis AC
??All others
5.3%
21.4%
29.5%
All NMEs (2001–2010)
??Date
??Molecule type
??Priority status
??Orphan status
a | Overall characteristics of 543 US Food and Drug Administration (FDA) advisory committee (AC) meetings held for drugs between 2001 and 2010.
b | Distribution by committee of the 281 meetings focused on new drug applications (NDAs) or biologics license applications (BLAs).
c | Percentage of approved new molecular entities (NMEs) that were the subject of an AC meeting. NBE, new biological entity; NCE, new chemical entity.
Analysis
We conducted an outside-in analysis of the
outcomes of FDA advisory committee meetings
held for drugs during the decade from 2001
to 2010 by reviewing publicly accessible
materials, including meeting minutes, posted
on the FDA’s website.
32.8% in the 2001–2005 period to 41.4% in the
2006–2010 period, suggesting a slight increase
in the FDA’s use of advisory committee input to
help inform product approval decisions. Additional
data analysis shows that new biologics, priority
status applications, and orphan drugs were the
subject of more meetings, on a percentage basis,
than new chemical entities, standard applications,
and non-orphan drugs.
Of the 543 total advisory committee meetings
held for drugs in the 2001-2010 period (Exhibit
1a), 281 were focused on a single product, of
which 190 were for original new drug applications
(NDAs) and biologics license applications (BLAs),
and 91 were for supplemental NDAs or BLAs.
The distribution of meetings by therapeutic area
is shown in Exhibit 1b. With regard to novel drugs,
37% of FDA-approved new chemical entities or
new biological entities in the 2001–2010 period
were the subject of an advisory committee meeting
(Exhibit 1c). This percentage increased from
We considered in detail a subset of 63 of the 190
meetings related to original NDAs or BLAs, at
which committee members were asked to vote
for or against approval of the drug of interest. In
the analysis, we looked at the voting record to
determine whether the committee provided an
endorsement for the approval of the drug (identi-
fied as a simple majority of votes recommending
approval). We then identified whether the FDA
2
Exhibit 2 | Analysis of a subset of 63 FDA advisory committee meetings that included votes for or against the
approval of a new drug between 2001 and 2010.
2
12
Yes
b 80
68.2
70
c 800
700
60
50
40
30
20
19.1
12.7
10
0
699
600
6
43
Sensitivity: 95.6% Specificity: 66.7%
Percentage of meetings
a
500
400
300
191
200
140
100
=33
33–67
=67
0
=33
33–67
=67
No
Did the FDA approve the product?
Percentage of advisory committee
vote in favour of approval
Percentage of advisory committee
vote in favour of approval
a | Summary of US Food and Drug Administration (FDA) advisory committee recommendations and approval decisions.
b | Clarity of outcome of voting decisions. We considered the effect of the strength of the advisory committee endorsement by creating three equal
categories: =33% endorsement for approval; between 33% and 67% endorsement for approval; and =67% endorsement for approval. In 87% of
committee meetings, the result was either a clear “yes” or “no” vote.
c | Association between the strength of the endorsement by the advisory committee, as measured by the percentage of panel members voting for
approval, and the median duration between the meeting and the FDA approval date. The duration varies inversely with the strength of the endorsement.
approved the drug, and for those drugs that were
approved we also identified the duration of time
between the meeting and the approval date.
Exhibit 2b shows that in 87% of committee
meetings the result was either a clear “yes”
or “no” vote. One possible explanation for this
observation is that the committee members
have a deep expertise in their field and can
readily address the areas of uncertainty in the
application. An alternative explanation could be a
“herding effect” in advisory committee meetings,
where one or more influential members convince
other panel members of their point of view. The
open, role-call voting system of most meetings
could further contribute to this effect. In practice,
it seems likely that both explanations contribute
to this observation.
As shown in Exhibit 2a, the FDA’s approval
decisions have been broadly consistent with the
recommendations of its advisory committees.
The FDA approved 88% of the original NDAs
or BLAs that were endorsed by its advisory
committees, and did not approve 86% of
those that the committees did not endorse. In
addition, in those instances when the approval
decision made by the FDA differed from the
recommendation of the advisory committee,
the FDA did so at the same rate regardless
of whether the panel endorsed approval. The
sensitivity and specificity of advisory committee
recommendations as a test for FDA approval is
96% and 67%, respectively. In addition, at 78%
of advisory committee meetings the members
recommended drug approval.
The association between the strength of the
endorsement by the committee (as measured
by the percentage of panel members voting for
approval) and the duration between the advisory
committee meeting and FDA approval date is
shown in Exhibit 2c. As might be anticipated,
3
the duration varies inversely with the strength
of the endorsement, suggesting that strongly
endorsed products tend to be approved on the
first review cycle, whereas products that are not
as strongly endorsed could be associated with
multiple review cycles. Our results also show
that advisory committees endorse approximately
the same percentage of products for approval
as the FDA approves applications (~75%). This
suggests that the FDA is not disproportionately
pre-screening either clear approvals or rejections
prior to selecting applications to review at an
advisory committee meeting. Instead, the
results are suggestive of a two-cohort model of
applications based on whether FDA reviewers
feel they have sufficient input and knowledge to
make approval decisions without an advisory
committee meeting. This supports the notion
that advisory committees have a crucial role
in providing necessary input to FDA reviewers
during the pre-market review process.
Implications
We believe that these results have important
implications for companies that are preparing for
potential advisory committee meetings. Given
the characteristics of advisory committees
that we have described here, we believe that
the use of bodies akin to advisory committees
could be considerably expanded by industry,
and could be a major driver for improved
decision-making. Companies currently use
mock advisory panels to help rehearse and
prepare for advisory committee meetings.
However, given the sensitivity and specificity of
the approach, companies may be better served
by incorporating the approach into decision-
making, not merely preparation. This could be
applied at different points in the life cycle of a
product where important investment decisions
are made—for example, following Phase II
development—in addition to pre-submission.
Editor’s note: This article was previously published
in Nature Reviews Drug Discovery.
4
McKinsey Center for Government
October 2013
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Copyright © McKinsey & Company
www.mckinsey.com/mcg
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