Will BIG Money Equate To BIG Improvement At FDA?

FDA begins planning IT overhaul

In the FiercePharma weekly newsletter, George Miller reported on a significant boost the the FDA’s IT budget.
How would you spend a $364-million IT budget, up from $232 million a year earlier? That’s what the FDA needs to figure out between now and October, when it’s on the hook to deliver a draft plan.

It’s not quite ready to so yet, according to the Government Accountability Office. The FDA, although making progress via ongoing projects to modernize its IT infrastructure, “has considerable work to do” in instituting critical IT management capabilities as a step toward modernizing its IT systems, the GAO says in a report to Congress published this month.

“A comprehensive IT strategic plan, including results-oriented goals and performance measures, is vital for guiding and coordinating the agency’s numerous ongoing modernization projects and activities,” according to the report. Ongoing projects include at least 16 enterprise-wide efforts. Yet FDA lacks a strategic plan for coordination and management of these efforts, as well as overall high-level planning.

Although it might have felt like big brother was looking over its shoulder, FDA recognized that it got some good guidance from GAO in the 57-page report: the regulator agreed with GAO’s recommendations and plans to address them. The GAO guidance is well worth reviewing for anyone managing and IT budget.

– read the report (pdf)

PG

Author: H. Sandra Chevalier-Batik

I started the Inconvenient Woman Blog in 2007, and am the product of a long line of inconvenient women. The matriarchal line is French-Canadian, Roman Catholic, with a very feisty Irish great-grandmother thrown in for sheer bloody mindedness. I am a research analyst and author who has made her living studying technical data, and developing articles, training materials, books and web content. Tracking through statistical data, and oblique cross-references to find the relevant connections that identifies a problem, or explains a path of action, is my passion. I love clearly delineating the magic questions of knowledge: Who, What, Why, When, Where and for How Much, Paid to Whom. My life lessons: listen carefully, question with boldness, and personally verify the answers. I look at America through the appreciative eyes of an immigrant, and an amateur historian; the popular and political culture is a ceaseless fascination. I have no impressive initials after my name. I’m merely an observer and a chronicler, an inconvenient woman who asks questions, and sometimes encourages others to look at things differently.