FDA offers new guidelines to speed combo drug programs

The hot pursuit of more effective treatments for cancer, heart disease and other conditions has long inspired researchers to find new combo approaches that could attack an ailment on multiple pathways. Now the FDA says it's time for the agency to get with the R&D program, issuing new draft guidelines aimed at speeding development work by encouraging joint applications.

"We expect increasing use of combinations," noted Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "This isn't just true of cancer. It's going to be true of many serious diseases."

The agency's emphasis is on serious. The Wall Street Journal's Health Blog notes that the FDA knows it will be required to make a decision on combo therapies when they have less than the usual amount of safety and efficacy data they expect from a solo performer. So they're looking for more data from lab and animal studies.

"We're looking for the home run here," Woodcock said. Presumably that could present some serious issues for a combo therapy designed for, say, obesity or diabetes, where the safety bar is raised to a much higher level than a cancer drug for advanced cancers. And both Bloomberg and the Wall Street Journal's Health Blog notes the concerns of Michael Caligiuri, who heads up the cancer center at Ohio State. Caliguiri says one of the biggest obstacles any combo drug faces is on the IP front as companies try to sort out ownership.

- read the story from the Wall Street Journal's Health Blog
- here's the Bloomberg report