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FDA: Next blockbuster could be combo of known drugs

Could the next “blockbuster” drug be a combination of existing therapies? The Food & Drug Administration seems to think so. The federal watchdog agency issued draft guidelines yesterday intended to encourage pharmaceutical companies to develop therapies from drug combinations.

Could the next “blockbuster” drug be a combination of existing therapies? The Food & Drug Administration seems to think so.

The federal watchdog agency issued draft guidelines yesterday intended to encourage pharmaceutical companies to develop therapies from drug combinations.

The agency feels that despite the increased risk involved in combining pharmaceutical treatments, there are benefits to treating serious diseases such as cancer.

“We are not fully harnessing the promise of this science for the benefit of patients,” FDA head Dr. Margaret Hamburg told a meeting sponsored by financier Michael Milken’s FasterCures organization, according to The Wall Street Journal.

FDA Center for Drug Evaluation and Research head Janet Woodcock encouraged an audience made up of venture capitalists, pharmaceutical executives and heads of foundations to not wait for the FDA’s final guidelines before they begin their drug combination development. The agency wants companies to conduct lab and animals studies that demonstrate that the combination therapy is more effective or provides a longer response compared to either of the drugs.

“We’re looking for the home run here,” Woodcock said.

The guidelines were drafted subsequent to a September 2009 panel hosted by think tanks Friends of Cancer Research and the Brookings Institution, according to the WSJ.

Some criticism of the new guidelines suggested that testing drug combinations will be difficult because of intellectual property and liability issues between companies.

The draft guidelines are open for comment for the next 60 days.

The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.

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