FDA plans raft of IT guidance documents to further GDUFA goals

The FDA has made an uneasy transition to the digital era. Congress' watchdog has cataloged its failings, taking potshots at incomplete databases, slow-moving modernization efforts and the lack of a clear IT strategy in recent years. Now, the FDA has moved to clarify its thinking by publishing a 5-year IT investment plan.

The 14-page document outlines how the FDA plans to enhance its IT capabilities meet the goals of the Generic Drug User Fee Act (GDUFA), a 2012 law that gave the agency fresh funding and new performance targets. Manufacturers should ready for a string of guidance documents in fiscal 2014, some of which are stepping stones toward the FDA requiring the use of electronic formats for drug marketing applications and clinical trial submissions by 2016 and 2017, respectively.

The FDA began accepting submissions in the electronic common technical document (eCTD) format back in 2003, but the phasing out of paper filings will increase the burden on its systems. A review of the Electronic Submissions Gateway is planned. The FDA also plans to simplify processes for its systems and staff by making companies submit study data in a standardized format. To advance this plan, the FDA is to publish a provisional data standards catalog and draft guidance requiring electronic submission of standardized data next year.

The two documents are part of what looks set to be a busy year for FDA IT guidance. Draft guidance on the implementation of an international standard for characterizing and identifying each regulated drug is in the pipeline. The FDA is also working on draft guidance to standardize the submission of information about manufacturing facilities. The overarching 5-year IT investment plan is now open for comment, and the industry will have an opportunity to critique all of the draft guidance documents when they are released.

The FDA's IT operation has faced questioning from the industry in recent months as trade groups try to figure out the implications of the hack of FDA databases in October. Shortly before the holidays, Reuters reported a House of Representatives committee is investigating the breach and senior Republicans have requested an independent audit. PhRMA has backed the calls for a third-party audit into the FDA's handling of the hack.

- read the FDA plan (PDF)
- here's Reuters' hacking news