A recent report by an FDA Science Board subcommittee highlights "serious scientific deficiencies" at the agency, pointing out soaring demands for FDA services without a proportional increase in resources to meet them.
"The world looks to the FDA as a leader—to integrate emerging understandings of biology with medicine, technology, and computational mathematics in ways that will lead to successful disease therapies," the panel declared. "Today, not only can the agency 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 FDA commissioner and other agency officials in a public meeting in January. Members recommended hiring and retaining more scientific talent, naming a chief scientific officer, and reorganizing how the agency handles science issues. "Without a significant increase in resources," however, the "recommendations will be superfluous," the report warned.
One study linked multiple pregnancies to an increased risk of developing atrial fibrillation later in life, and another investigated the association between premature delivery and cardiovascular disease.
Clinical features with downloadable PDFs