PhRMA funds a two-year research initiative to evaluate the safety and benefits of existing drugs

The Pink Sheet recently reported that the Pharmaceutical Research and Manufacturers of America (PhRMA) and individual drug firms, through the Foundation for the National Institutes of Health, are funding a two-year public/private research initiative to evaluate the safety and benefits of drugs that are currently on the market.

The Observational Medical Outcomes Partnership (OMOP) began in 2009 with the goal of developing data-mining techniques to analyze existing databases for safety and benefit statistics. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, is the OMOP executive board chair.

According to Cathy Kelly, author of the Pink Sheet article, "research is focusing on ways to use observational data to find temporal relationships between exposure to a drug and outcomes, using diagnosis codes, lab results or medical events such as seizures. Results are posted on a public Web site and made available to the Sentinel project. However, OMOP is not by definition a Sentinel work stream because PhRMA developed a plan for the research prior to the launch of the FDA postmarketing surveillance initiative, according to Alan Goldhammer, VP-Scientific and Regulatory Affairs for the trade group."