Mining for safety mechanisms

FDA has been quietly test-driving informatics platforms that include mechanism of action data to complement and augment the agency's safety surveillance techniques. Most recently, FDA began evaluating MolecularHealth Inc.'s Molecular Analysis of Side Effects software system, which the company launched in January.

The collaborations are part of the agency's mechanism-based drug safety assessment and prediction program, which was started in 2009 to develop informatics tools to help determine whether adverse events are mechanistically related to a drug, as well as to predict whether a compound in clinical trials could cause unexpected adverse events...