November 2, 2005
Update on FDA’s Draft Risk Assessment of Streptogramin Antimicrobial Drugs
In the Federal Register of November 24, 2004, the Food and Drug Administration (FDA) published a notice of availability of a draft risk assessment on the potential impact that food-animal use of streptogramin antimicrobial drugs has on the resistance to chemically similar streptogramins used to treat human enterococcal infections. A 60-day comment period was established during which FDA sought comments, data, and other information pertaining to the risk assessment. The comment period was subsequently extended an additional 30 days, through February 23, 2005. Comments were submitted to the FDA Docket (No. 2004N-0749) from 14 individuals or institutions, representing a broad range of interested stakeholders: consumer groups, trade associations, professional veterinary organizations, industry representatives, expert risk assessors, researchers, and scientists working in foreign government regulatory agencies.
The Center for Veterinary Medicine (CVM) conducted a thorough review and analysis of all the comments submitted to the Docket. Considerable attention was given to the potential impacts of suggested changes on risk estimates, particularly in light of new information in the scientific literature. Although CVM received a number of recommendations regarding assumptions underlying the models used in the risk assessment, these recommendations do not address the critical gaps in information that could justify the adoption of such alternative assumptions. Therefore, CVM does not believe there is sufficient basis to warrant revision of the risk assessment at this time.
However, as noted in several comments, and in the risk assessment itself, new data on streptogramin resistance that may address data gaps and uncertainties continue to be generated and become available in the scientific literature and to the public in general.
In addition, CVM is aware that changes in future use scenarios of streptogramin drugs in humans could have a significant impact on the human health risks associated with virginiamycin use in animals. Therefore, CVM will continue to monitor the scientific literature, the results of surveillance studies, the usage patterns of Synercid (and other future streptogramin drugs) in hospital and health care settings, and other relevant data that may affect the findings of the risk assessment. CVM will revisit the risk assessment at a time dictated by the availability of new data and scientific developments in streptogramin resistance.
Additional information about the risk assessment may be obtained from Dr. Barry Hooberman, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-0176, e-mail: Barry.Hooberman@fda.gov.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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