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Volume 12, Number 2—February 2006

Perspective

Antimicrobial Drug Resistance, Regulation, and Research1

Joshua P. Metlay*†Comments to Author , John H. Powers‡, Michael N. Dudley§, Keryn Christiansen¶, Roger G. Finch#**, and on behalf of the Second Colloquium of the International Forum on Antibiotic Resistance
Author affiliations: *VA Medical Center, Philadelphia, Pennsylvania, USA; †University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA; ‡US Food and Drug Administration, Rockville, Maryland, USA; §Diversa Corporation, San Diego, California, USA; ¶Royal Perth Hospital, Perth, Western Australia, Australia; #Nottingham City Hospital, Nottingham, United Kingdom; **University of Nottingham, Nottingham, United Kingdom

Main Article

Table

Measures taken by selected regulatory agencies before and after licensing to assess and control antimicrobial drug resistance*

Measure Australia France European Commission United States
Primary drug registration body Therapeutic Goods Administration, Australian Drug Evaluation Committee AFSSAPS (French health products safety agency), Commission for Marketing Authorization European Medicines Evaluation Agency† Food and Drug Administration‡
Drug resistance advisory resource EAGAR GTA, CA-SFM, ONERBA EARSS AIDAC
Licensing
Use of supportive PK/PD data Yes Yes Yes Yes
Risk assessment Yes Yes Yes Yes
After licensing
Prescription-only status Yes Yes NA Yes
Community drug subsidy restrictions Yes No NA No
Participation in education (e.g., guidelines) Yes Yes No Yes
Directives on drug use Yes Yes No No
Indication review based on resistance No§ Yes Yes Yes
SPC update/harmonization Yes¶ Yes Yes Yes

*AFSSAPS, Agence Française de Sécurité Sanitaire des Produits de Santé; EAGAR, Expert Advisory Group on Antimicrobial Resistance; GTA, Groupe de Travail Anti-infectieux; CA-SFM, Comité de l'Antibiogramme de la Société Française de Microbiologie; ONERBA, Observatoire National de l'Epidémiologie de la Résistance Bactérienne aux Antibiotiques; EARSS, European Antimicrobial Resistance Surveillance System; AIDAC, Anti-Infective Drugs Advisory Committee; PK/PD, pharmacokinetic/pharmacodynamic; NA, not applicable; SPC, summary of product characteristics.
†Scientific opinions are prepared by committees for human medicinal products, veterinary products, and orphan products.
‡Wider issues involving drug resistance, such as surveillance and appropriate use, are the purview of a number of United States agencies, including the Food and Drug Administration but also the Centers for Disease Control and Prevention, the National Institutes of Health, and other agencies partnering in the United States Public Health Action Plan to Combat Antimicrobial Resistance initiated in 2001 (2).
§Only possible for animal antimicrobial drugs.
¶Agreement has been made to update SPCs every 5 years with Australian surveillance data. However, a mechanism for collecting these data has yet to be agreed upon.

Main Article

1This article is based on presentations and discussions held at the Second Colloquium of the International Forum on Antibiotic Resistance (IFAR), held on September 13, 2003, in Chicago, Illinois, USA. IFAR is a multidisciplinary, international group concerned with evaluating current knowledge regarding antimicrobial drug resistance and the means for its control. This article represents the opinions of the participants at the second IFAR colloquium and not necessarily those of the institutions for whom they work.

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