IDSA Provides Feedback to Strengthen FDA Concept Paper on Ranking Antimicrobial Drugs

Cornelius J. Clancy, M.D., member of the Infectious Diseases Society of America’s Antimicrobial Resistance Committee, presented on behalf of IDSA at today’s Food and Drug Administration public meeting to provide feedback on an FDA concept paper regarding the ranking of antimicrobial drugs according to their importance in human medicine to help assess and manage antimicrobial resistance risks associated with the use of antimicrobial drugs in animals.

There is broad agreement among the scientific community that the overuse and misuse of antimicrobial drugs is contributing to the development of antimicrobial resistance and threatening human health. FDA’s work to reduce inappropriate antimicrobial use in animals is critical.

IDSA appreciates the approach to ranking antimicrobial drugs proposed by FDA in its concept paper, and offered the following recommendations to further strengthen the criteria and their application:

• Add the following additional criteria for ranking antimicrobials: the toxicity of an antimicrobial agent and the availability of better alternative therapies, as well as the potential for development of resistance;
• Classify all first generation cephalosporins as highly important as they meet the second criterion: “Drugs from an antimicrobial class that are the sole or one of limited available therapies to treat non-serious bacterial infections in humans”;
• Rank sulfonamides as critically important, as sulfadiazine (a sulfonamide) is the drug of choice in some patients, including infants with congenital toxoplasmosis, children with toxoplasma chorioretinitis and patients with recurrence of toxoplasmosis;
• Include antifungals, given the increasing problem of antifungal resistance, such as Candida auris, which has been deemed an urgent threat according to CDC, and triazole resistance in invasive aspergillosis;
• Review data every two to three years, with a formal update every five years, and provide a mechanism for experts, including medical societies, to request a formal review at any time to address a timely need.