Data standard eases FDA drug approval

The Food and Drug Administration recently adopted a new technology that enables the agency to begin converting its paper-intensive process for approving new drugs into an electronic process.

The new technology, called SAS Transport File Format and developed by SAS Institute Inc., Cary, N.C., provides a standard data format that drug companies can use to transmit the results of product tests and other information the FDA requires for drug approvals. The standard format makes it possible for the FDA to load the data it receives immediately into a computer to begin the approval process.

By 2002, the FDA expects to accept most submissions via computer because the automated process makes it faster and easier for the agency to store data, said Randy Levin, director for electronic review in the FDA's Office of Review Management.

Before the FDA adopted the data format, companies were required to submit multiple copies of their paperwork to the FDA. Copies went to the FDA warehouse to archive, to an FDA reviewer to inspect and to an FDA field office to make certain the product was made in a safe environment.

"It was difficult to handle that much paper," said Michael Roberson, a program manager at SAS. "Once the submission gets to FDA, [the agency] had to look at it and compiled it in 350-page binders. FDA passed around these binders [for review]."

With the new technology, officials throughout the agency are able to review the data at the same time, shortly after the information is loaded into the computer. FDA officials also have easier access to the information once it has been archived, by simply pulling it up on the computer rather than going to a warehouse to retrieve it.

Levin said it is currently optional for companies to use the standard electronic filing systems because paper documents are still accepted. But there are some submissions that will be accepted only electronically, such as the Post Marketing Safety Reports, Levin said.

"Those are the reports that tell us the problems people have with drugs after approval," Levin said. "We get many of these submissions." The FDA used the data format to conduct its first full electronic approval process - for the drug Viagra.

Ken Williams, a senior vice president for Quintiles Transnational Corp., a pharmaceutical company based in Research Triangle Park, N.C., said the technology will help the FDA navigate data from the growing number of companies that are sending reports to the FDA.

"The electronic process will facilitate and make things more sufficient," he said. "The standard technology is a generic way to pass data back and forth so you don't have to spend the day customizing. The issue here is that [the technology] has been adopted formally as the standard."