The Food and Drug Administration announced that it has chosen Harvard Pilgrim Health Care Inc. to design a pilot of a new safety monitoring system.
The agency said that the program, called the Sentinel System, will help it keep closer tabs on safety problems because it will analyze information collected during routine health care. The system will allow the agency to collect data on drugs and devices at the source—from medical records. For instance, if the agency knew that a device or drug had been linked to cardiac side effects, FDA safety officers could query the Sentinel System to see if such problems had arisen.
Congress required the FDA to develop such a safety system as part of the Food and Drug Administration Amendments Act of 2007. It was also recommended by the Institute of Medicine in a 2006 report on drug safety.
“Once operational, the Sentinel System will help us find answers to important drug safety questions, leading to stronger safeguards for public health, while still protecting the privacy and security of individual health information,” said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a statement.