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Bristol-Myers Squibb
Pharmaceutical Research Institute
Richard L. Gelb Center for Pharmaceutical Research and Development
5 Research Parkway P.O. Box 5!00 Wplli g rd, CT ()$492- $0
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February 8, 1999
Food and Drug Administration
Dockets Management Branch
Room 1061, HFA-305
5630 Fishers Lane
Rockville, MD 20852
Dockets Management Branch Administrator:
Re: Docket Number 98 N-0339
Background
At the January, 1999 NCCLS Subcommittee on Antimicrobial Susceptibility Testing
(SAT) meeting, the November 6, 1998 letter written by John V. Bergen, Ph.D.
(Executive Director of the NCCLS) to the FDA was shared with members of the
Subcommittee. This letter stated that as a stakeholder, the NCCLS could help the
FDA by setting breakpoints and quality control ranges of antimicrobial drugs,
thereby saving FDA resources. F. Alan Andersen (President Elect of the NCCLS)
presented the NCCLS stakeholder position. Representatives from the FDA and
the pharmaceutical industry expressed viewpoints that differed from those
expressed in the letter. This discussion concluded with acknowledgment that there
was no industry input in the formation of the NCCLS letter. Given that the NCCLS
organization has a tripartite relationship with industry groups, government (FDA
and CDC) and health professionals, the pharmaceutical industry was encouraged
to make member-company views known to the FDA on the NCCLS proposal.
Bristol-Myers Squibb views on the FDA vs. NCCLS role in setting
breakpoints for antimicrobial agents
We believe that the FDA is the more appropriate organization for setting
breakpoints for antimicrobial agents, Our reasons are expressed as follow,
contrasting the approach of the FDA with that of the NCCLS (italicized):
●
The FDA is a non-partisan organization, thus ensuring a more level playing
field for establishing breakpoints. Though the /VCCLS tries to be n o n partisan, funded studies conducted in the laboratories of NCCLS voting
members could lead to bias.
●
The interactions between the FDA and the drug sponsor are valued by the
industry. These interactions are documented with a paper trail and occur in
sufficient frequency to allow for a rapid drug approval process. Questions
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from one side to the other are prepared in advance prior to an agreed upon
meeting time; this allows for an adequate duration for the preparation of a
response. The AfCCLS SAT group meets only twice a year. Whi/e the recent
trend in drug development is to compress ihe development time, the
infrequency of SAT group meetings can slow down the approva/ process. It
is not uncommon to postpone breakpoint decisions by the SAT group to a
subsequent meeting when the drug sponsor lacks ready answers to one of
the group’s questions. In general, minutes of the SAT meetings are not
sufficiently detailed, making it difficult at times to recreate how a particular
decision was made. Thus, there are inconsistencies in decision making
among drugs and on different days.
●
Moreover, the confidentiality of the NDA and the proprietary nature of the
drug compound are important to the sponsor who has invested much time
and monies in its discovery and development. Review of the NDA by the
FDA maintains this confidentiality. The NCCLS SAT group includes voting
members from other pharmaceutical companies and investigators funded by
Thorough NDA review by this group will breach the
the industry.
confidentiality of this process.
●
The NDA document comprises multi-volumes and considerable detail. At the
FDA, reviewers with different expertise are assigned respective sections of
the NDA to review. This review process takes several months. Due to the
time constraints at the NCCLS SAT meetings, presentations for breakpoint
requests by the drug sponsor are generally 30 to 45 minutes /ong. The
manufacturer must disti// the data and present them in a digestible manner.
Thus the “NDA review” by the NCCLS is by no means as thorough as that
performed by the FDA.
While the views expressed above are those of the Bristol-Myers Squibb Company,
they appear to be the same as those expressed by our industry colleagues at the
January, 1999 NCCLS meeting. In conclusion, we feel that the FDA should maintain
its responsibilities for establishing the information to be included in the drug label,
including setting breakpoints for antimicrobial drugs.
Sincerely submitted,
wi.dMQ=+c-
H~gh M. Mcllhenny, Ph. D., -r
Worldwide Regulatory Affairs
.
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