Keep Antibiotics Working Campaign to Testify at FDA Hearing on Draft Guidance to Evaluate Drugs for Agricultural Use

10/1/2002

From: Sean Crowley, 202-478-6128, for the Keep Antibiotics Working (KAW) Campaign; E-mail: scrowley@mrss.com

News Advisory:

Five members of the Keep Antibiotics Working (KAW) Campaign will testify at a hearing on Wednesday about the Food and Drug Administration's new draft guidance for approving agricultural antibiotics. KAW is dedicated to eliminating a major cause of antibiotic resistance-the inappropriate use of antibiotics in farm animals.

The new draft guidance (www.fda.gov/OHRMS/DOCKETS/98fr/98d-1146-gdl0001.doc) acknowledges that the use of antibiotics in food-producing animals creates bacteria that "may become resistant to drugs that may also be used to treat human illness...the Agency must determine specifically that such drug use is safe with regard to human health." The FDA will accept public comments on the guidance until November 27.

WHAT: FDA's Center for Veterinary Medicine (CVM) public meeting to discuss the "Draft Guidance for Industry: Evaluating the Safety of Antimicrobial New Animal Drugs with Regards to Their Microbiological Effects on Bacteria of Human Health Concern."

WHEN: Wednesday, Oct. 2, 9 a.m. - 5 p.m.

WHERE: Double Tree Hotel, 1750 Rockville Pike, Rockville, MD 20852

WHO: 9 a.m. - Welcome: Lester M. Crawford Jr., D.V.M., Ph.D., FDA Deputy Commissioner 9:15 a.m. - Agency Activities on Antimicrobial Resistance: Murray M. Lumpkin, M.D. 9:30 a.m. - Background and Scope of Guidance: Stephen Sundlof, D.V.M. 9:50 a.m. - Risk Analysis Methodology & Hazard Identification: Gregg Claycamp, Ph.D. 10:45 a.m. - Ranking Antimicrobial Drugs According to Importance in Human Medicine 11:10 a.m. - Qualitative Antimicrobial Resistance Risk Assessment: David G. White, Ph.D., Research Microbiologist & Mary Bartholomew, Statistician 12 p.m. - Antimicrobial Resistance Risk Management Considerations: William T. Flynn, DVM 1:30 p.m. - Q&A/Discussion Panel: Moderator: Linda Tollefson, D.V.M., M.P.H. 2:45 p.m. - Open Public Comment Period - Various speakers, including: -- Peter Coppelman, Esq., director, Keep Antibiotics Working Campaign -- Tamar Barlam, MD, Infectious Disease Physician, Dir., Antibiotic Resistance Project, Center for Science in the Public Interest -- John M. Balbus, MD, MPH, Dir., Environmental Health Program, Environmental Defense -- Rich Wood, executive director, Food Animal Concerns Trust -- Steve Roach, Food Safety Program Manager, Food Animal Concerns Trust 4:45 p.m. - Next Steps: Linda Tollefson, D.V.M., M.P.H.