Wellpoint, FDA to develop Rx surveillance system

HealthCore, the health outcomes research subsidiary of WellPoint, is developing a Safety Sentinel System in collaboration with the FDA and top academic institutions in response to increasing public demand to more effectively and rapidly monitor the safety of pharmaceuticals and other medical therapies after FDA approval.

WellPoint said its Safety Sentinel System is being developed in close collaboration with leading government and academic institutions, including the FDA and faculty from key academic institutions, including Harvard University, the University of North Carolina and the University of Pennsylvania.

The Indianapolis-based company said the system is expected to advance national efforts to identify safety risks associated with drugs and other clinical care decisions, allowing physicians and other healthcare professionals to make more informed decisions about how to treat their patients.

With 35 million members, WellPoint is the largest membership insurer in the U.S.

“To rapidly and successfully identify emerging safety problems, we need to bring all health care stakeholders to the table,” said Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at the FDA. “The FDA is planning a larger public-private partnership and we're excited that WellPoint is building a system that could inform this initiative.”

Ultimately, WellPoint said the system is expected to be capable of continually monitoring its 35-million member database and identifying increases in health problems among members taking a given drug, indicating a potential Serious Adverse Event (SAE). It is anticipated that the company's Safety Sentinel System will also make it possible to examine whether particular combinations of treatments could cause serious medical problems, especially in patients with certain diseases or health conditions, WellPoint said.