FDA NEEDS TO MODERNIZE IT SYSTEMS, CRAWFORD SAYS

The FDA's IT systems need to be overhauled to allow for effective receipt and management of electronic submissions, but budget shortfalls continue to limit the agency's progress on the technology front, according to the agency's top official.

"We need to modernize the agency and bring our technology and methods in line with the 21st century," said acting FDA Commissioner Lester Crawford. "Each time we get an IT revolution within FDA we have budget problems, and we're having budget problems again now, so we're gradually moving, we think, into the 21st century. We have the infrastructure and personnel, at least, in order to get that done."

IT improvements are among the agency's top priorities, and HHS Secretary Michael Leavitt has expressed similar goals for the department, Crawford said during a presentation at the recent World Pharma IT Conference in Philadelphia. The FDA next year will celebrate its centennial, which will highlight past accomplishments, "but this is a great opportunity to move forward, and to talk about data collection and management for the new age," he said.

The FDA can be either a facilitator or an impediment to innovation, Crawford said. Historically, the FDA has been an impediment because it has not been ready for change, he said. But the agency, along with other HHS divisions, is optimistic about how IT can boost drug development and safety programs. "Technology today has allowed us to transform from paper records to electronic records, and this is a goal we have achieved with the help of partners in the industry," Crawford said.

In spite of growth, the agency is not satisfied with its electronic submissions programs. "I would say we've made unbelievable progress on moving toward the electronic submission of applications and updates to the FDA. It is far different than it used to be, and it's getting better each year." However, "to say we have gone electronic on submissions for approvals and supplemental applications would be incorrect," Crawford said.

"We're not as sophisticated -- IT-wise -- because of this funding situation as [industry is], but we've got to get to that place," he said.