Notes from BIO: Not Just Another Report

Has it really been just 18 months since a subcommittee of FDA's Science Board released its report, "FDA's Science and Mission at Risk?"

As Gail Cassel (Lilly VP-Scientific Affairs and chair of the committee that produced the report) pointed out in an update we checked out this afternoon, the report's message: "The demands on FDA have soared; resources have not," was "against the grain of thought at the time."

An industry spokesman, Cassel noted, wondered aloud after the report was released, whether FDA really needed more funding. That "attitude certainly has changed," Cassel noted. Industry is very much on board with advocacy for more funding for the agency; FDA's budget is now almost 50% higher from appropriated funds (based on FY 2010 proposals) than it was before the report came out.

The session included updates from several Science Board committee members, as well as former FDA Chief Scientist Frank Torti (now back at Wake Forest after a year at the agency). Torti's discussion of FDA's progress in implementing the recommendations of the report garnered praise from Cassel for "the massive change you've been able to bring about."