The development of a fully active postmarket surveillance system is still years away. FDA is "just getting started" on this major epidemiological piece of FDAAA, said Sandra Kweder, deputy director of the Center for Drug Evaluation and Research's (CDER) Office of New Drugs. Meanwhile, FDA is implementing the Sentinel System in stages, building on existing systems and public–private partnerships that can answer questions about apparent drug side effects.
An important step is to modernize and expand the agency's current spontaneous adverse-event reporting system (AERS). The system collects AE reports from health professionals and the public, who voluntarily file information on drug-related medical problems. Although passive reporting fails to capture many AEs or explain the cause of medical events or the extent of exposure, it is useful for detecting signals and for developing hypotheses about rare but serious safety issues.
FDA is working to improve methods for assessing the reports it receives through this system and to boost voluntary reporting. In March 2008, the agency issued a five-year drug-safety plan, as required by the newly revised drug user-fee program (PDUFA IV). The plan describes how the agency will improve the timeliness and accuracy of AE data. To boost voluntary reporting, FDA is collaborating with the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) on standards and a common format for reporting AEs for all FDA-regulated products. This approach will make it possible to link AE information from clinical studies with that from postmarket surveillance and will facilitate the aggregation and analysis of AE information.
FDA also plans to combine safety-signal detection and analysis for drugs, medical devices and other regulated products through an agency-wide FDA adverse-event reporting system (FAERS). And a user-friendly MedWatch Plus portal will allow anyone (e.g., healthcare providers, patients, and clinical researchers) to electronically report adverse events on all regulated medical products.
Although still voluntary, these initiatives will help FDA collect timely, accurate AE data, pointed out Armando Oliva, deputy director for bioinformatics in FDA's Office of Critical Path Programs, at the DIA annual meeting. More standardized data and better analytical tools will enable FDA to improve safety assessments. "Spontaneous reporting won't vanish," said Janet Woodcock, director of CDER, at the Brookings forum. But it will be conducted more efficiently than before and linked to broader analytical resources.