FDA Wants One SystemFDA Wants One System

The Food and Drug Administration has tapped GlobalNet Services Inc., a systems integrator, and Cyclone Commerce Inc., a supplier of collaborative-business software, to develop an electronic-submissions gateway, a system to centralize document submissions to the FDA from pharmaceutical manufacturers and other federal agencies.

The gateway could be a pivotal development, as the health-care and pharmaceutical industries implement electronic-document systems and abandon inefficient paper-based processes.

The centralized system, a $2 million project to be unveiled this week, will replace several disparate electronic document submission systems operated by individual FDA organizations that regulate pharmaceuticals, medical devices, biologic products such as vaccines, and food products.

The first phase of the project, due in June, will allow pharmaceutical makers to submit documents seeking approval for new drugs. The FDA is pushing drug companies to use electronic documents to streamline the approval process and speed up after-market reports about drugs' adverse effects.

Once the gateway is complete, in mid-2006, it will be the single point for electronic submissions from drug and medical-device companies, drug distributors, food makers, health-care organizations, and government agencies. The FDA exchanges volumes of documents with the National Institutes of Health, for example, and with the Drug Enforcement Administration, under the DEA's program for tracking controlled drugs such as OxyContin.

The new system will provide a single standard for submitting documents to any organization within the FDA, says Michael Fauntleroy, director of the electronics submissions program at the FDA's Center for Biologics Evaluation and Research, and project manager for the gateway project. "It will save industry time to submit documents. You're sometimes talking about a truckload of paper. This will save time, effort, and material," he says.

The new gateway will be particularly beneficial for companies, such as GlaoSmithKline plc, that develop pharmaceutical and biologic products and medical devices and currently must support different electronic document submission standards for each category, Fauntleroy says.

The system will be built with Sun Microsystems servers, the Solaris operating system, clustered Oracle9i databases, Cyclone Commerce software, and custom-developed applications. It will use the TCP-IP and AS2 protocols, the latter an EDI specification for secure business-to-business communications. The system will be capable of handling as many as 25 submissions concurrently, according to Fauntleroy.

"This will become a foundation for communication on a broad, broad scale throughout the health-care industry," predicts Cyclone president and CEO Phil Myers. Cyclone helped develop similar E-submission systems for the European Medical Evaluations Authority and the Japanese Ministry of Health.