FDA To Use Industry Data To Improve Post-Market Prescription Drug Surveillance
FDA has contracted with four health industry organizations to help it conduct post-market surveillance of prescription drugs by using data from large volumes of patient records, the Minneapolis Star Tribune reports. UnitedHealth Group, which has a database of 11 million patients; the Kaiser Foundation Research Institute of Oakland, Calif.; Nashville, Tenn.-based Vanderbilt University; and Harvard Pilgrim Health Care of Wellesley, Mass., will work with FDA to monitor drug safety and effectiveness.
The four organizations each will be paid between $1.3 million and $1.4 million over five years to provide data to the agency. FDA said it will use the data to conduct drug safety analyses and "respond expeditiously to urgent public safety concerns." UnitedHealth spokesperson Mark Lindsay said, "The main advantage is speed. A clinical trial usually involves 1,000 or so patients. Now the FDA has access to 11 million. If they get a couple of signals (from a problem drug), then they can look in the database as opposed to waiting to hear (from providers in the field)" (Phelps, Minneapolis Star Tribune, 9/29).
In related news, FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb on Wednesday detailed steps the agency is taking to build a "drug information technology infrastructure" that will make safety data available "literally at every doctor's and patient's finger tips," CQ HealthBeat reports.
According to Gottlieb, FDA will post easier-to-understand drug labeling on the Internet in November, brief the press more fully about public health issues and possibly issue weekly or "real-time" bulletins to doctors on the latest reported side effects of drugs. Gottlieb said FDA's "goal is to make sure we approve drugs with reasonable risks relative to their proven benefits, and then keep doctors and patients fully informed as new findings about medicines are revealed over time." He added, "If we made this information available more regularly, or even in near time, doctors might be prompted to report more of what they are finding" (CQ HealthBeat, 9/28).