FDA SCIENCE AND MISSION AT RISK

Pharmacy Times, Volume 0, 0

A recent report by an FDA Science Board subcommitteehighlights "serious scientific deficiencies" at theagency, pointing out soaring demands for FDA serviceswithout a proportional increase in resources to meetthem.

"The world looks to the FDA as a leader—to integrateemerging understandings of biology with medicine,technology, and computational mathematics in ways that will lead tosuccessful disease therapies," the panel declared. "Today, not only can theagency not lead, it cannot keep up with advances in science."

Chaired by Gail Cassell, vice president for scientific affairs at Eli Lilly & Co,the group of experts presented the findings of its yearlong effort to the FDAcommissioner and other agency officials in a public meeting in January.Members recommended hiring and retaining more scientific talent, naming achief scientific officer, and reorganizing how the agency handles scienceissues. "Without a significant increase in resources," however, the "recommendationswill be superfluous," the report warned.