CENTER FOR DEVICES AND
RADIOLOGICAL HEALTH
MEDICAL DEVICES ADVISORY
COMMITTEE
MEETING OF THE
DENTAL PRODUCTS PANEL
Tuesday, 13 July 2004
Hilton Washington DC
North
Ballroom Salons A and B
Gaithersburg, Maryland
BACKGROUND
BioMimetic
Pharmaceuticals, Inc., of Franklin, Tennessee, submitted an original Premarket
Approval Application (PMA) to the FDA on March 12, 2004, for a device called “GEM
21S.” GEM 21S is a beta-tricalcium phosphate (β-TCP) bone void filler that
is intended to be combined with Becaplermin, a wound-healing drug, to treat
osseous defects resulting from periodontal disease, cystectomy, apicoectomy,
deficient alveolar ridges, and tooth extraction. The sponsor states that the β-TCP component serves as a
scaffold to guide the three dimensional regeneration of bone in a clinical
defect site and that the Becaplermin component, which is added to the
β-TCP scaffold, promotes cellular in-growth into the intra-osseous defect
and scaffold and revascularization of the wound site.
In accordance with the
procedures for review set forth in 21 CFR 814.44, FDA has referred the PMA to
the Dental Products Panel of the Medical Devices Advisory Committee for the
Panel’s recommendation.
PANEL ACTION
At this meeting, the
Dental Products Panel will discuss and/or vote on the following:
·
Whether the device is approvable, approvable with
conditions, or not approvable, and
·
The basis for the recommendation above.
MEETING AGENDA
DENTAL PRODUCTS PANEL
Tuesday, 13 July 2004
Hilton Washington DC
North
Ballroom Salons A and B
Gaithersburg, Maryland
8:00 a.m. CLOSED
SESSION – Dental Devices Branch Updates
This portion of the meeting is closed to public
participation. The committee will discuss commercial information
regarding future device applications.
8:30 a.m. CALL TO ORDER
8:30 - 8:45 a.m. OPEN SESSION -- Welcome and Introductory Remarks
·
Dr.
Jon B. Suzuki, Chairman
·
Mr.
Michael E. Adjodha, Executive Secretary
8:45 – 9:00 a.m. Open Public Hearing
Public attendees, who
have contacted the Executive Secretary prior to the meeting, will address the
Panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any
financial involvement with sponsor of the product(s) being discussed or with
their competitors
9:00 - 10:30 a.m. Presentation by the
Sponsor – GEM 21S (P040013)
·
Mr.
Mark Citron
·
Dr.
Samuel E. Lynch
·
Dr.
William V. Giannobile
·
Dr.
Myron Nevins
·
Dr.
Robert Genco
10:30 - 10:45 a.m. BREAK
MEETING
AGENDA continued
10:45 - 11:45 a.m. Presentation by the FDA – GEM 21S
(P040013)
·
Dr.
M. Susan Runner, Chief, Dental Devices Branch and Deputy Director, DAGID
·
Ms.
Angela E. Blackwell, Biomedical Engineer, Dental Devices Branch
·
Ms.
Judy S. Chen, Statistician, Office of Surveillance and Biometrics
12:00 - 1:00 p.m. LUNCH BREAK
1:00 - 2:45 p.m. Panel Deliberations
2:45 - 3:00 p.m. BREAK
3:00 - 3:30 p.m. Open Public Session
This portion of the meeting is
open to public observers. Public
observers may not
participate except at the specific request of the Chairperson.
3:30 – 3:45 p.m. Summation
·
FDA
·
Sponsor
3:45 - 4:45 p.m. Panel Recommendation and Vote
5:00 p.m. MEETING
ADJOURNED
DENTAL PRODUCTS PANEL
Tuesday, 13 July 2004
|
CHAIR |
EXECUTIVE
SECRETARY |
|
Jon B. Suzuki, DDS, PhD, MBA Professor University of
Pittsburgh, School of
Dental Medicine Pittsburgh,
Pennsylvania |
Michael E. Adjodha, MChE Department of Health and Human Services Food and Drug
Administration Center for Devices and Radiological Health Office of Device Evaluation Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGID) |
PANEL MEMBERS AND
CONSULTANTS
|
Name |
Affiliation |
Role |
|||||
|
Salomon Amar, DDS, PhD |
Professor, Periodontology Boston University, School of Dental
Medicine Boston, Massachusetts |
Voting Member |
|||||
|
David L. Cochran, DDS, PhD |
Professor and Chairman, Periodontology University of Texas, Health Science
Center San Antonio, Texas |
Voting Member Non-voting for this meeting |
|||||
|
Elizabeth
S. Howe |
Outreach Coordinator National Foundation for Ectodermal
Dysplasias Auburn, Washington |
Consumer Representative Non-voting Member |
|||||
|
Alison
F. Lawton, MBA |
Senior Vice President, Genzyme Corporation |
Drug Industry Representative Non-voting Member |
|||||
|
William J. O’Brien, MS, PhD |
Professor, Materials Science University of Michigan, School of Dentistry Ann Arbor, Michigan |
Voting Member Non-voting for this meeting |
|||||
|
Daniel R. Schechter, JD |
General Counsel Parkell, Incorporated Farmingdale, New York |
Device Industry Representative Non-voting Member |
|||||
|
Inder J. Sharma, PhD |
Associate Professor, Biostatistics Morehouse School of Medicine,
Department of Community Health and Preventative Medicine Atlanta, Georgia |
Consultant Deputized to Vote |
|||||
|
Domenick T. Zero, DDS, MS |
Professor and Chairman, Preventative
Dentistry Indiana University, School of
Dentistry Indianapolis, Indiana |
Voting Member |
|||||
|
John R. Zuniga, PhD, DMD |
Professor and Graduate Program
Director, Oral Surgery University of North Carolina, School
of Dentistry Chapel Hill, North Carolina |
Voting Member |
|||||
|
|
|
|
|
|
|
||
OTHER
PARTICIPANTS
|
FDA |
|
Chiu S. Lin, PhD Division Director,
DAGID DHHS/FDA/CDRH/ODE |
|
M. Susan Runner, DDS,
MA, Captain, USPHS Deputy Division
Director, DAGID and Chief, Dental Devices
Branch DHHS/FDA/CDRH/ODE |
|
Angela E. Blackwell,
MS Biomedical Engineer Dental Devices Branch DHHS/FDA/CDRH/ODE |
|
Robert S. Betz, DDS,
Captain, USPHS Dental Officer Dental Devices Branch DHHS/FDA/CDRH/ODE |
|
Judy S. Chen, MS Mathematical
Statistician (Biomedical) Division of Biostatistics DHHS/FDA/CDRH/OSB |
|
Janie G. Fuller, DDS,
Captain, USPHS Dental Officer Division of Postmarket
Surveillance DHHS/FDA/CDRH/OSB |
|
Kurt Stromberg, MD Medical Officer Division of
Therapeutic Proteins DHHS/FDA/CDER/OPS/OBP |
|
SPONSOR |
|
Mark Citron, Vice President,
Regulatory Affairs BioMimetic
Pharmaceuticals, Inc. Franklin, Tennessee |
|
Samuel E. Lynch, DMD,
DMSc President and CEO BioMimetic
Pharmaceuticals, Inc. |
|
William V. Giannoble,
DDS, DMSc Associate Professor University of Michigan |
|
Myron Nevins, DDS Associate Professor Harvard University |
|
Robert Genco, DDS, PhD Vice Provost State University of
New York at Buffalo |
QUESTIONS FOR PANEL DISCUSSION
- Considering the statistical results, is there a clinically significant benefit from the addition of rhPDGF-BB to β-TCP?
- What impact does relying exclusively on secondary endpoints and retrospective analyses have on the validity of the clinical study?
- Are the following intended uses for the device, proposed by the sponsor, supported by valid scientific evidence[1]:
·
periodontal disease,
·
cystectomy,
·
apicoectomy,
·
deficient alveolar ridges, and
·
tooth extraction?
If not, which of these claims is not supported?
- Does the information provided by the sponsor provide a reasonable assurance that the device is safe[2] under the conditions of use prescribed, recommended, or suggested in the proposed labeling? If not, what information is needed to establish the safety of this device for its intended use?
- Does the information provided by the sponsor provide a reasonable assurance that the device is effective[3] under the conditions of use prescribed, recommended, or suggested in the proposed labeling? If not, what information is needed to establish the effectiveness of this device for its intended use?