Complete transcript will be available at
The Dental Products Panel (the Panel) met on Tuesday, July 13, 2004 in Gaithersburg, MD, to make a recommendation to the Food and Drug Administration (FDA) on the approvability of BioMimetic Pharmaceutical, Inc.'s (the sponsor) premarket approval application (PMA), P040013) for GEM21S™. GEM 21S is combination product consisting of a beta-tricalcium phosphate (ß-TCP) bone void filler device 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 Panel membership for this meeting consisted of three periodontists, a cariologist, an oral surgeon, a materials engineer, a biostatistican, a device industry representative, a drug industry representative, and a consumer representative.
The sponsor presented its information on the safety and effectiveness of the device and FDA followed with a summary of its clinical and statistical findings. Two Panel members, a periodontist and a biostatistician, lead the Panel deliberations with short presentations. After deliberations, the Panel considered FDA's questions for consideration. FDA's main concern was whether there was any clinical benefit in adding the Becaplermin drug to ß-TCP.
The Panel believed that there was a reasonable assurance that the device is safe under the conditions for use. The Panel believed there was a reasonable assurance that the device is effective but for more narrow indications for use.
The Panel voted 4-0 with no abstentions for "Approval with Conditions." The conditions were as follows:
- There should be no labeling claims of superiority over other devices considering the primary endpoint, i.e., clinical attachment level and
- Labeling should be restricted to use only for periodontal-related defects.
The Panel imposed the conditions because it believed that the data did not clearly demonstrate superiority to other treatment modalities and that no data was presented, or found in the PMA, which indicates that the device would be effective for uses other than for periodontal-related defects. Such uses, for which the panel believed are not warranted by the data, included deficient alveolar ridges and tooth extraction.
The Panel and the sponsor concluded with very complimentary statements for FDA regarding its work with the sponsor throughout the clinical study and product development. A panelist indicated that FDA's interaction with the sponsor was a model that should be followed.
Contact: Michael E. Adjodha, Executive Secretary, at 301-827-5283, ext. 123, or via email at: firstname.lastname@example.org.
Transcripts of this meeting may be purchased from: (written request only)
Neal R. Gross
Court Reporters and Transcribers
1323 Rhode Island Ave., N.W.
202-234-4433 or 800-473-1433; 202-387-7330 (fax)
Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857
301-827-6500 (voice)/301-443-1726 (fax)