FDA is proposing to spend $4 million annually to upgrade its IT systems that help receive and review pharmaceutical companies' permission applications to sell new drugs, according to a Federal Register notice released on Jan. 16, Government Health IT reports.
The agency wants to collect an additional $38 million annually over the next five years, hire an additional 102 non-IT employees, and eliminate paper documents in the review and submission process. The plans include a technical approach to attain "a more integrated, standards-based electronic regulatory submission and review environment," Government Health IT reports.
According to the Federal Register notice, the current user fee program, as established under the Prescription Drug User Fee Act and passed by Congress in 2002, has:
- Centralized the accountability of IT funding under the FDA CIO;
- Created an IT project management office to develop and implement software developments based on the Capability Maturity Model;
- Established a standard format for documents electronically submitted;
- Implemented the FDA Electronic Submissions Gateway; and
- Improved the management of desktop hardware and software configurations.
"By the end of [Prescription Drug User Fee Act IV], ... human drug application sponsors would be able to send in their electronic applications with automated cross-links to previously submitted data and information so that they only have to submit things once. In addition, FDA reviewers would be able to retrieve all relevant submissions and related data electronically from their workstations and would have efficient tools for searching and analyzing data to support their reviews," enabling "more efficient and reliable management of regulatory submissions," according to the notice.
FDA also proposes to track performance indicators of "the adoption rate of electronic submissions and the technical error rates associated with those submissions," spend less on legacy systems, and redirect funds toward "better coordinated and more flexible" systems, according to the notice.
The PDUFA is up for renewal in 2007. FDA is accepting written comments until Feb. 23 and will hold a public meeting on its plan Feb. 26 in Washington, D.C. (Ferris,
Government Health IT, 1/22).