PDUFA IT Goals Include Security, CDER-CBER Integration In Short-Term

FDA will focus on electronic security practices and facilitating the CDER-CBER integration over the next several months, according to an outline of information technology goals under the user fee program.

"Many near-term fundamental activities and strategic issues must be resolved by the agency prior to committing resources to future, long-range systems development plans for the out years of PDUFA III," the ¹ IT five-year plan states.

In addition to standardizing secure submissions, secure e-mail and electronic signatures, these activities include determining a consolidation strategy for IT infrastructure and services.

The transfer of the Center for Biologics Evaluation & Research's therapeutic review functions to the Center for Drug Evaluation & Research is also a process that requires "gradual" IT standardization.

The review staff shifted into CDER will still use CBER software and data for the review process for the first year.

Access to CDER software will be set up for each person, and the systems will move towards a single database.

Final consolidation of the two centers and databases "will rely not only on the success of IT and data integration, but on the development of common reporting standards, common business practices, and common definitions of terms and codes."

The cultures of the two centers will also come into play in the integration. The plan identifies "the difference of business practices between the two groups" as "the final hurdle in this transfer."

"These practices, in some cases, will require social change among the review community," the plan states.

More than $23 mil. in annual funding for information technology was allocated in the Prescription Drug User Fee Act reauthorization, up about $5 mil. per year from the previous level of $18 mil.

The IT allocation is expected to increase to $30.3 mil. by 2007, for a total of $135 mil. in IT spending across PDUFA III. Funds to improve electronic data and application submissions were an industry priority in PDUDA III negotiations (² , p. 17).

Although FDA is receiving increased IT investment through PDUFA III, fiscal 2004 IT appropriations for the center are understood to have been cut by slightly more than $7 mil.

An IT primary goal is "reevaluating" and developing the electronic regulatory and submission review program. The program covers projects for managing and responding to electronic submissions.

FDA plans to have review technologist positions within each review division established in fiscal year 2004.

A consolidated ³ draft guidance for electronic submissions, composed of information from the existing electronic submissions guidances, was released in August.

Outside collaboration is also expected to increase. Because FDA depends on advanced technology, "IT planning and decision-making will be a much more corporate collaboration than in previous years," the plan says.

The IT five-year plan is an appendix to the broader PDUFA III five-year plan released by FDA, which outlines projected revenue, spending and staffing levels (see ⁴ (Also see "FDA User Fee Review Staff Hiring To Be Lower Than Projected Under PDUFA III" - Pink Sheet, 13 Oct, 2003.)).

Subsequent versions of the plan will be intended to expand on longer-term PDUFA III IT goals, including centralizing the accountability of funds under the chief information officer, providing a single, secure point of entry for all electronic submissions, and ensuring that PDUFA organizations use the same software applications where appropriate.

"The long-term vision is not only to provide a seamless electronic submission process for industry applications, but more importantly, to develop a fully integrated information management system," the plan says.

The plan also envisions shifting IT decision-making to an agency-wide level.