June 30, 2008

FDA Moves to Update Antibacterial Breakpoints

The Food and Drug Administration (FDA) has proposed a streamlined process for updating breakpoints of antibacterials, a move intended to help correct outdated information that clinicians rely on to predict what therapies are likely to be successful for treating infections.  FDA’s proposal is the latest move following passage last fall of an IDSA-backed law requiring the agency to take action on breakpoints, and follows close behind breakpoint changes for two key antibacterials.

Under draft guidance issued this month, FDA proposes to accept antibacterial susceptibility test criteria established by the Clinical and Laboratory Standards Institute (CLSI) or other nationally or internationally recognized standards-development organizations. FDA suggests manufacturers include data from these organizations in the annual reports they already are required to submit to FDA for each drug.

According to Edward Cox, MD, MPH, director of FDA’s Office of Antimicrobial Products in the Center for Drug Evaluation and Research, the proposal would facilitate keeping information on effective therapies current. Dr. Cox said FDA “would be able to recognize the ongoing work that’s already happening at the standards-development organizations.” Furthermore, “Rather than having to go out and find all the studies and put all the information together,” he said, manufacturers “will be able to rely on information that the standards-setting organizations are already putting out there.” Manufacturers also may submit other data for FDA to consider besides that of the standards-development organization if they believe it is more relevant for their drug products.

Breakpoints listed in drug product labels for many widely used antibiotics have not been updated for many years. Using out-of-date breakpoints increases the risk of treatment failures and inappropriate use. IDSA has for some time been urging FDA to tackle the issue, most recently at an FDA panel hearing on antimicrobial resistance. IDSA supported legislation last fall that required FDA to update antimicrobial breakpoints. FDA has recently updated breakpoints for penicillin and vancomycin—two promising steps that IDSA and its members welcomed. The new draft guidance should smooth the way for others to be updated as well.

Melvin P. Weinstein, MD, FIDSA, IDSA’s liason to CLSI, congratulated Dr. Cox and FDA for the recent progress on breakpoints. “It really looks like the logjam is being broken,” he said.

The draft guidance must go through public comments and revisions, and FDA would still have to review and approve CLSI or other standards before updated breakpoints could be issued based upon these new standards. But Dr. Weinstein predicts news about more updated breakpoints will be forthcoming in the next six to 12 months.

“There’s still more work to be done,” Dr. Cox said. “The guidance document is an important step.”

The draft guidance is available online. Comments can be made through the regulations.gov website.

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