FDA plans standards, automation for drug submissions

The Food and Drug Administration is trying to increase the number and quality of electronic submissions for drug applications. That is one of the goals of a five-year information technology plan to develop a more integrated, standards-based and automated regulatory e-submission and review environment.FDA will have a draft by Dec. 31 and a final document by May 30, 2008.The agency receives more than 100,000 submissions a year, 15 percent of which are submitted electronically, said Tim Stitely, FDA’s chief information officer.“We’re seeing an uptake to about 40 percent for larger applications being submitted electronically,” he said at a public meeting Oct. 19 on how IT can support the process to review drug applications.FDA needs a modernized IT infrastructure to better support scientific computing, adverse drug event reporting and analysis, facility registration and product listing, and electronic document storage, Stitely said. FDA also will focus on drug safety oversight after drugs are on the market.Congress recently reauthorized for another five years the Prescription Drug User Fee Act and an accompanying Medical Device User Fee and Modernization Act of 2002, which includes funding for more oversight of prescription drugs on the market.Under provisions of the Prescription Drug User Fee Act, FDA has progressed toward consolidating its IT infrastructure and improved communication and technical interactions, said Mark Gray, IT program manager for the act. FDA has implemented the electronic Common Technical Document and a common application for the secure exchange of e-mail messages and e-submissions through the Electronic Submissions Gateway and an electronic system for receipt and review.But with its parent Health and Human Services Department pursuing electronic standards for health care, FDA needs to further modernize. As of Oct. 1, all IT resources came under the FDA CIO’s authority, which should accelerate an enterprise approach and standards-based environment, Stitely said.In its five-year plan, FDA will target business processes for automation. It also will identify electronic data standards for development and a process for evaluating, adopting and deploying the standards.Industry participants suggested that FDA should use consistent standards internally, provide submission validation criteria and communicate what a good e-submission looks like through best practices. Incentives, such as reduced fees or quicker actions on an application, could increase the numbers of pharmaceutical companies that use e-submissions, said Jim Nichols, vice president of product strategy at Liquent, a maker of regulatory and life sciences software.