In a long-awaited review, the Institute of Medicine has slammed the FDA, saying its drug safety monitoring systems are inadequate and in need of reform, hampered by bad management and subject to incessant internal disputes. A spokesperson at the FDA said that the agency had made significant progress over the two years since the Vioxx debacle rattled the agency, but also recognized that more work was needed.
The report outlines a series of suggested changes that would dramatically alter the regulatory landscape for drug developers. The IOM, for example, says that initial drug approvals should be limited to five years, ads for new drugs should be banned and that the FDA should be given the authority to harshly punish companies that fail to undertake the post-approval safety studies that they agree to.
The Center for Drug Evaluation and Research came in for some of the most caustic commentary. "Every organization has its share of dysfunctions, unhappy staff members and internal disputes," reported the IOM, "but the committee came away from various encounters with C.D.E.R staff and management with a deep concern about C.D.E.R.'s organizational health."