FDA Moving To E-FilingFDA Moving To E-Filing

The U.S. Food & Drug Administration is pushing the food and drug manufacturers it regulates to make greater use of electronic document filing. As part of this effort, the FDA's own Center for Drug Evaluation and Research this month implemented search-and-retrieval software to help it better manage the electronic submission of reports about negative reactions to pharmaceuticals.

Medical professionals submit on average 300,000 adverse-event reports annually to the FDA, says Randy Levin, the center's associate director for information management. These reports contain information about patients who've had adverse reactions to commercially available drugs. The FDA collects the data from these reports in its Adverse Event Reporting System, which uses an Oracle7 database to manage about 2.5 million documents.

The FDA's drug-evaluation center implemented RetrievalWare search software from Convera Corp. The center joins the rest of the FDA in using the search software, which helps more than 1,800 scientists access the database. The FDA also uses the RetrievalWare search-and-retrieval engine in areas such as food safety and veterinary medicine.

The system lets drug-safety evaluators and epidemiologists sort through data stored in file servers, groupware systems, relational databases, document-management systems, and Web servers. The FDA can then disseminate this data to doctors and pharmacists via E-mail or post the information to the FDA site.

The drug-evaluation center's scientists will use RetrievalWare to search not only adverse event reports, but also archives of documents related to the approval, labeling, and marketing of new drugs, says Roger Goetsch, a manager with the FDA's Office of Drug Safety.

FDA regulation 21 (Code of Federal Regulations Part 11) lays the foundation for pharmaceutical and food companies to be able to accept, secure, and store digital signatures and electronic records (see "Lilly Cures Inefficiency With IT," Feb. 18, p. 42). Although the FDA hasn't yet made electronic submissions mandatory, it's "an important initiative that lets the government handle the complex health and safety challenges of the 21st century," ARC Advisory Group analyst John Blanchard says.

Drug research is expected to accelerate as companies increasingly rely on technology to automate drug discovery and testing. So, too, will the federal government turn to technology to help it more efficiently regulate and monitor the growing pharmaceuticals and biotech industries.