U.S. Food and Drug Administration

 

 

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.

 


U.S. Food and Drug Administration

 

 

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
Cambridge, Massachusetts

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

 

  1. Considering the statistical results, is there a clinically significant benefit from the addition of rhPDGF-BB to β-TCP?

 

  1. What impact does relying exclusively on secondary endpoints and retrospective analyses have on the validity of the clinical study?

 

  1. 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?

 

  1. 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?

 

  1. 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?


[1] Valid scientific evidence includes:

Well-Controlled Investigations

Partially Controlled Studies

Studies & Objective Trials without Matched Controls

Well-Documented Case Histories by Qualified Experts

Reports of Significant Human Experience with a Marketed Device

 

[2] There is a reasonable assurance that a device is safe when it can be determined, based upon valid scientific evidence, that the probable benefits to health from the use of the device for its intended uses and conditions for use, when accompanied by adequate directions and warnings against unsafe use, outweigh any probable risks.  The valid scientific evidence used to determine the safety of the device shall adequately demonstrate the absence of unreasonable risk associated with the use of the device for its intended uses and conditions for use.

 

[3] There is a reasonable assurance that a device is effective when it can be determined, based upon valid scientific evidence, that in a significant portion of the target population, the use of the device for its intended uses and conditions of use, when accompanied by adequate directions for use and warnings against unsafe use, will provide clinically significant results.