Industry's opinion on 'New Use'

WASHINGTON - Based on comments submitted in response to the FDA's "New Use Initiative" guidances covering clinical evidence of efficacy and the new application of existing cancer therapies, biotechnology and pharmaceutical industry representatives are underwhelmed by the agency's proposals.

"While PhRMA member companies applaud FDA's apparent willingness to move toward greater flexibility" in requirements for substantiation of evidence from clinical trials, "there is also disappointment that, upon close examination, the draft guidance simply codifies the agency's long-standing exceptions to the rule, and the conditions under which those exceptions have, in recent years, been granted," wrote John Siegfried, deputy vice president for regulatory and scientific affairs at PhRMA. ...