The Food and Drug Administration’s top cancer drug regulator doesn’t always ask for permission before taking on big initiatives.
Richard Pazdur, director of the FDA Oncology Center of Excellence, hates bureaucracy. It stifles his ideas for getting treatments to cancer patients faster — of which there are many.
To cut through that bureaucracy, Pazdur has a trick: “Don’t tell anybody,” he said to laughter at a meeting of the advocacy group Friends of Cancer Research Tuesday.
That’s how he started Project Orbis, which aims to get regulators in multiple countries to review a cancer drug application at the same time. In 2019, Pazdur called regulators in a few countries, including Canada and Australia, where they were receiving drug applications far later than in the United States. The idea was to ask companies to submit their applications to those countries concurrently with the United States. The first few regulators he called agreed to take part.
Shortly thereafter, a Canadian official unexpectedly called FDA Principal Deputy Commissioner Janet Woodcock to ask about it.
“And I said, ‘Oh sh-t.’” Pazdur said. It “is gonna hit the fan.”