FDA, drug firms to test online filings

FDA web site

The Food and Drug Administration is launching a pilot project to help pharmaceutical companies file information about their drug products online.

The project is expected to get under way this spring with a small group of volunteer manufacturers who will test electronic filing of all the ingredients of their products.

"This could be the first opportunity for industry to submit their data directly into a database and take responsibility for the data," said James Hunter, senior project manager at the FDA's Center for Drug Evaluation and Research.

Currently, drug manufacturers must file product information twice a year with the FDA, using paper forms. The FDA then must input the information manually into an electronic system, which makes for a labor-intensive process.

Although there is no deadline for making the system electronic, Hunter said he expects the paper process will be maintained "in parallel" with the electronic one until the procedure is available to everyone.

The $1-million FDA pilot project was awarded to Battelle Memorial Institute, a nonprofit research and development company based in Columbus, Ohio. Battelle is the prime contractor for FDA's $168-million enterprise support contract known as SISTIR (Strategic Information Systems Technical Integration Resources).

Hunter said the pilot project will be a "working product," and the volunteer companies will provide feedback about how good it is.

"The purpose of this is to create a database of every drug product marketed in the United States," said Hunter, adding that most of the data will be available to the public.