K-1362. Different Antimicrobial Licensing Policies in US and Europe
Session: Poster Session: Antibiotic Stewardship
Sunday, October 26, 2008: 12:00 AM
Room: Hall C
Background: Antimicrobials, as all drugs, are licensed in the US through the Food and Drug Administration (FDA), and in the European Union (EU) through the European Medicines Agency (EMEA). The authors sought to investigate the differences in licensed indications for a series of antimicrobial agents between these two bodies, and the ensuing medical and legal issues resulting from licensing discrepancies. Methods: The ten most recent antimicrobial compounds licensed by both FDA and EMEA were included in the study, namely anidulafungin, caspofungin, daptomycin, linezolid, posaconazole, retapamulin, quinupristin/ dalforpistin, telithromycin, tigecycline, and voriconazole. Results: Of the 10 agents studied, major or minor differences in licensing between US and EU exist for 9 of them. Examples of major differences include linezolid’s European non-licensing for vancomycin-resistant Enterococcus faecium infections, daptomycin’s different indications for Staphylococcus aureus bacteremia, and posaconazole’s use, which is primarily therapeutic in Europe, but preventive in the US. Conclusions: The significant US-EU differences in the indications for which most novel antimicrobial agents are granted license for, can induce medical and legal issues: Certain clinical situations of major morbidity, as vancomycin-resistant E. faecium infections and primary S. aureus bacteremia, are less adequately therapeutically covered by the EMEA licensed indications. Since any licensing can be viewed as scientific evidence, these differences may raise legal issues regarding the treatment of specific entities. Co-ordination is needed in order to minimize such issues.
Georgios Pappas, Institute of Continuing Medical Education of Ioannina, Ioannina, Greece, Matthew Falagas, MD, MSc, Tufts University School of Medicine, Boston, Massachusetts and Alfa HealthCare and “Henry Dunant” Hospital, Marousi, Greece, Vrettos Ierodiakonou, MD, Alfa Institute of Biomedical Sciences (AIBS) and  G. Pappas, None.

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