Volume 12, Number 2—February 2006
Antimicrobial Drug Resistance, Regulation, and Research1
|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|
|Use of supportive PK/PD data||Yes||Yes||Yes||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|
*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.
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.