FDA's "SMART" STRATEGIC PLAN FIRST VERSION NEARING COMPLETION; ELECTRONIC FILE MANAGEMENT PROJECT ALSO TOP PRIORITY AT CDER, DIRECTOR WOODCOCK SAYS

A first draft of a strategic plan for FDA's Submission Management and Review Tracking system is expected to be completed within the next few weeks, Systems Research & Applications Corp. Program Manager Sherman Greenstein announced at an Oct. 31-Nov. 2 meeting on Computer-Assisted New Drug Development and Review sponsored by the Pharmaceutical Research & Manufacturers of America and FDA in Washington, D.C.

The strategic plan is the first step in a seven-part program. In early 1995, Arlington, Va.-based SRA plans to begin work on SMART architecture, comprising the hardware, software, communications protocols and standards that will be the foundation of the initiative. Data interchange standards will be phased in at the end of 1995, followed in 1996 by development of review and management applications and, finally, functional modules for agency reviewers to use during the NDA review process.

One initial project is the development of standards for submissions to the Center for Biologics Evaluation & Research, which has received six computer-assisted PLAs to date. Systems Research & Applications is also beginning work on prototypes for the review and management applications intended to eventually perform clerical activities done by reviewers. One prototype under consideration is an on-line Gene Therapy Registry Database.

Greenstein noted that SRA intends to use working groups, conferences, a bi-monthly newsletter and electronic forums to encourage communication with industry on issues such as accessing, fusing, digitalizing and relating pieces of data to one other.

SMART has two main goals: 1) developing specifications for an agency-wide review-oriented scientific information system; and 2) reducing the time needed to bring new products to market by improving the review process and using electronic information systems in preparation, submission, review and tracking of product applications. FDA awarded SRA a $17 mil., seven-year contract for developing SMART in June ("The Pink Sheet" Aug. 1, In Brief).

FDA SMART Program Manager Brad Leissa, MD, suggested that SMART should allow FDA to process CANDAs more efficiently. Leissa explained: "It's an evolution of CANDAs to SMART. There is a continuum of automation, and I think what we need to be working toward is really...a paperless submission." While "clearly there are going to be reviewers that want paper," archives will be in electronic form, Leissa added.

Both SMART and CANDAs are part of a broader information management initiative within the Center for Drug Evaluation and Research.

In a separate presentation, Center Director Janet Woodcock, MD, said CDER also intends to improve computer support programs and training of reviewers, design a more efficient preapproval inspection program and implement electronic administration of files. Woodcock called the latter her "pet initiative." The center is also cooperating with PhRMA on short-term pilot projects for electronic submission of post-marketing and toxicology studies and creating a repository of all approved labeling, Woodcock said.

CDER Associate Director for Scientific & Medical Affairs Roger Williams, MD, noted that an information technology coordinating committee is being established in CDER to coordinate information technology across the centers.

FDA has received 113 CANDAs from 55 companies since 1982. CDER Office of Management Director Robert Bell noted that he expects about 30 CANDAs to be submitted in 1994 compared to 13 in both 1993 and 1992. Overall, Bell said, 17% of all NDAs are received with electronic components.