Do FDA’s Fast-Track Reviews Skimp on Important Data?

MedPage Today talks to CEI's Sam Kazman on FDA approval issues: 

But Sam Kazman, JD, general counsel at the pro-business Competitive Enterprise Institute in Washington, D.C., rejected these criticisms of the expedited review programs in a phone interview with MedPage Today.

"It would be one thing if [the study authors] could marshal evidence that a 'rush to approval' is causing some public health disaster," he said, but they didn't — "and I don't think they can."

Kazman was particularly scornful of the authors' use of first-in-class status as a marker of drugs' innovation. He noted that follow-on products often provide improvements over pioneering drugs, which may be incremental but still important for certain patient subgroups.

"The first drugs [in a class] may do no good for some patients," he said. "Clinicians know this very well."