publication date: May. 12, 2017
How one bad sentence in the Cures Act blocked FDA’s cancer center from receiving $75 million
By Matthew Bin Han Ong
The FDA Oncology Center of Excellence occupied a special place in the Obama White House moonshot program.
Amid the moonshot’s big goals, the FDA center was concrete, manageable, and modestly priced, a reorganization that promised to revolutionize the agency’s handling of everything cancer.
How is the place faring today?
Not well, by anyone’s standards.
The long-awaited center that was designed to focus the entire FDA oncology portfolio in one administrative unit staffed by cancer experts is caught up in a classic Catch-22 impasse. The money for the center exists. It has even been appropriated. But because of what looks like a language snafu by Congressional authorizing committees, the money is, for the foreseeable future, stuck at NIH.
Congress had the capacity to fix the problem in the recently passed FY2017 spending bill, but, alas, didn’t. In principle, an interagency agreement can be used to pry the money out of NIH, but that path comes with unexpected twists.
When Congress passed the 21st Century Cures Act in December 2016, authorizers set aside $1.8 billion for cancer research via NIH and NCI over seven years. Of that amount, a little over 4 percent—$75 million—was intended to be funneled to FDA to fund OCE over five years, starting in FY17 (The Cancer Letter, Dec. 9, 2016).
Insiders say this deal was struck between NIH, NCI, and FDA leaders in 2016.
OCE was envisioned as a regulatory incubator, and in early 2016, an impromptu coalition of academia, industry, professional … Continue reading How one bad sentence in the Cures Act blocked FDA’s cancer center from receiving $75 million
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