New FDA Drug Safety Projects Rely on IT

The Food and Drug Administration plans to improve the Web portal so that anyone can report adverse drug effects and will try data mining to learn more about any problems with regulated medicines. The agency, which has been criticized for paying too little attention to prescription drugs after they are approved for sale, also will offer a downloadable software module that doctors and other practitioners can use to report on drugs. The module will work with existing electronic medical records, making reporting easier for those with EMR systems. Dr. Scott Gottlieb, the FDA’s deputy commissioner for medical and scientific affairs, disclosed those and other information technology tactics in a November speech. Gottlieb did not give a timetable for completing the projects, and FDA spokeswoman Crystal Rice said such questions were premature. The agency plans to proceed with a single portal for reporting all problems with FDA-regulated products, she said, but the scope of the project is still under discussion. Today’s MedWatch portal “is a valuable tool, but we know that it is not being used as effectively as it ought to be,” Gottlieb said in his speech. The agency gets only about 10 percent of the adverse-event reports that it would find helpful, he said, and few of the reports come from doctors and patients. “We think we can improve reporting by taking steps to make our Web portal more automated and easier to use,” he said. Besides improving usability, the agency will try to collect more information through MedWatch, Gottlieb added. The FDA also will begin producing a regular, perhaps weekly, report to the public so that everyone can find out what kinds of problems are being reported, he said. The report may prompt more health professionals to contribute data on drugs’ effects, he added. Gottlieb said the FDA also is concerned about delays in reporting adverse effects and will try to get more timely information. “With the advent of electronic medical records, there is a lot of opportunity to develop more active reporting systems that can scan medical information –- real-time or near real-time –- and look for the tell-tale signs of a potential drug safety problem much earlier than the passive reporting systems that we rely on today,” he said. The agency is collaborating with the Massachusetts Institute of Technology on a data-mining project that builds on biosurveillance techniques, Gottlieb said. “Such systems could scour federal and private health care databases in real time for unusual and emerging patterns that could indicate potential safety concerns,” he said.