White House Plan Will Streamline Antibiotic Susceptibility Testing

April 3, 2015

By 2020, the U.S. FDA will update criteria on antibiotic susceptibility testing devices use to guide appropriate antibacterial drug treatment, under an action plan released by the White House on March 27.

The plan calls for the FDA to adopt criteria developed by standards development organizations rather than include interpretive guidelines on labels. The agency will also provide technical assistance within one year on legislative proposals being considered to streamline the updating of interpretive criteria for AST devices, the plan says.

The plan outlines federal activities over the next five years to develop and deploy next-generation diagnostics.

The effort is part of President Barack Obama’s $1.2 billion fiscal year 2016 budget, which nearly doubles funding for combating and preventing antibiotic resistance.

With support from the National Institutes of Health and other funding agencies, researchers are taking advantage of new technologies to develop rapid “point-of-need” diagnostic tests, the White House says. These tests can reduce unnecessary antibiotic use by helping healthcare providers quickly distinguish between viral and bacterial infections, making it easier to recommend targeted treatment, the administration adds.

Read the plan at www.fdanews.com/03-27-15-Antibioticplan.pdf. — Jonathon Shacat