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The Friday Update — October 2, 2009

November 27, 2009

UPCOMING MEETINGS

  • Meeting with HHS Secretary Sebelius:  Monday, October 19 at 11:00 AM
  • Meeting with FDA Director of Office of Regulatory (ORA) Affairs Mike Chappell: Tuesday, October 13, at 10:00 AM
  • Meeting with FDA Director of National Center for Toxicological Research Dr. Slikker: Wednesday, October 14, at 2:00 PM

START OF THE NEW FISCAL YEAR

The new fiscal year began yesterday. Since the Agriculture/FDA appropriations bill is not yet law, FDA programs were included in a Continuing Resolution that allows money to be spent in the new year. Our understanding is that the House and Senate conferees are done/almost done and that the final version should come to the House and Senate floors within a week to ten days.

THE GROSSMAN ANALYSIS

One of the areas of greatest concern is the state of information technology (IT) at FDA. Almost two years ago, the FDA Science Board highlighted IT as one of the four fundamental areas for resources and change.  This summer, a progress report found that FDA had made significant improvements, but that much still needs to be done.

I was recently interviewed about IT needs at FDA. Here are some of my answers:

How will new efforts to improve IT at the FDA affect the agency’s ability to carry out its mission? Improved IT at FDA takes two forms, both of which support its mission. The first is the agency’s ability to communicate effectively within its own ranks, with the public and with industry. The hardware and software are dated and sometime even e-mails are a challenge. The second is the demand for data bases that are accessible, complete, reliable and capable of being used to support decision making.  Examples would be drug and medical device adverse events, integrated lists of suppliers and manufacturers and information about food safety incidents. Congress has made clear that this must be accomplished.

From where you sit, have there been any meaningful, noticeable changes in the FDA’s IT infrastructure and management, that have improved the agency’s effectiveness?  The agency is planning and making progress, but it is a slow process. Much of the money for IT was only appropriated early this year or will be available October 1.  I believe the agency can accomplish what is needed. They must try to manage expectations about how much improvement is possible, especially in a short timeframe.  

What has the agency NOT done in the area of IT that it should?  FDA has a process in place to meet a broad range of its IT needs. Some of the work is very time-consuming and resources are still limited. In other cases, especially multi-purpose, interactive databases, they are starting to come to grips with some of the conceptual and practical difficulties. Even if you can accurately collect the needed information, there is the still thornier question of how to turn “data into knowledge,” a topic that I have written about elsewhere. There are experts in data-mining, but there is a lot of competition for their services and many, if not most, do not have knowledge of food and drug regulatory needs.

Note: This analysis and commentary is written by Steven Grossman, the Deputy Executive Director of the Alliance.

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