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March 2009
Vol. 19 No. 3
Top Stories
Long-awaited FDA Guidance on CAP Drugs Released

A major barrier to new antibiotic development has come down: The Food and Drug Administration (FDA) has released long-awaited guidance for companies developing drugs for the therapy of community-acquired pneumonia (CAP).

“It’s a home run,” said David Gilbert, MD, FIDSA, a member of IDSA’s Antimicrobial Availability Task Force (AATF), who has spearheaded the Society’s efforts with FDA on pneumonia drugs. He said the lack of clear guidance from FDA on how the agency would evaluate clinical trials for CAP drugs has kept many companies on the sidelines.

IDSA has been calling on FDA to release this guidance since the beginning of the decade. The issue came to a head in the summer of 2007, when FDA indicated that its previous guidance was no longer valid but did not offer an updated version. This left companies with no roadmap for how to conduct trials for these badly needed drugs.

“We know that companies have drug candidates out there that they have been holding back, saying we don’t want to go through $500 million [doing a clinical trial] without knowing the rules of the game,” Dr. Gilbert said.

Following FDA’s 2007 announcement, IDSA offered to co-sponsor a workshop to get together regulators, industry representatives, and other interested parties to hash out the issues. Dr. Gilbert credits Office of Antimicrobial Products Director Edward Cox, MD, MPH, for agreeing to the workshop and enthusiastically supporting the idea and then providing much-needed funding. The workshop was held in January 2008, and the proceedings were published in a Clinical Infectious Diseases supplement.

The guidance appears to take on board much of the advice that came out of that workshop. AATF member Brad Spellberg, MD, FIDSA, said the parameters laid out in the guidance are reasonable—but just having guidance is a huge step forward by itself. “Does that mean the [drug development] floodgates are going to open? Not necessarily. But one of the barriers has been knocked down.”

One potential sticking point for drug developers: The new guidance requires that in order for a patient to be enrolled in a trial, the pathogen must be identified—a notoriously tricky task in community-acquired pneumonia. Some in industry feel this will mean enrolling prohibitively large and expensive trials. However, Dr. Gilbert sees the requirement as a plus because it will stimulate development of better diagnostic tools to identify the pathogens that cause CAP. “Finally, we’re going to apply the tools of molecular diagnostics to clinical trials of community-acquired pneumonia,” he said. In the future, he sees diagnostics manufacturers pairing up with drug manufacturers, similar to the pairing of HIV tropism assays and maraviroc.

With FDA coming through with CAP guidance, IDSA is optimistic about the prospects for similarly long-awaited guidance on health care-associated and ventilator-associated pneumonia. IDSA and FDA are co-sponsoring a HAP/VAP workshop at the end of March.
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