Safety & Science: FDA Commissioner Andrew von Eschenbach looks to science and information technology

August 1, 2007

Providing patients with safe, effective and affordable prescription drugs is a continuous challenge for health plans and insurers. These efforts rely heavily on the decisions made by the Food and Drug Administration (FDA) in determining which new drugs come to market and how those medicines perform when used in real-world healthcare settings.

Providing patients with safe, effective and affordable prescription drugs is a continuous challenge for health plans and insurers. These efforts rely heavily on the decisions made by the Food and Drug Administration (FDA) in determining which new drugs come to market and how those medicines perform when used in real-world healthcare settings.

One of the escalating topics of debate is whether FDA is doing enough to detect adverse events that arise from prescription drug use. Dr. von Eschenbach says that one cannot look at drug safety as an isolated issue at the end of the approval process. Protecting patients "is something that really begins at the very front end of the process and carries through the whole continuum, whether we're talking about food or drugs or biologics or devices," he says. Consequently, FDA needs to be engaged "in the full life-cycle of a product." This involves oversight at the front end to build in quality, and continual monitoring after a drug goes to market.

"This will enable us to continue to track and learn about these drugs as they're being utilized in diverse populations," Dr. von Eschenbach says. "We'll do it by using modern information technologies that give earlier signals of events that are occurring that raise safety issues-and also, more importantly, for unexpected efficacy."

A total lifecycle approach to drug regulation involves being fully engaged with academia, with providers and with pharmaceutical companies. "We have relationships with NIH [National Institutes of Health], where this research and discovery engine develops," he says. "We have collaborations with CMS [Centers for Medicare & Medicaid Services] on the delivery end of the continuum, and we have collaborations with industry."