PhRMA clarifies initiative to evaluate existing medicines; comments on orphan drugs

Following a report by the US drug sector newsletter The Pink Sheet 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 trade group has issued a clarification of the situation.

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 chairperson.

According to the 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.'