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The Science Board’s IT Report: Too Technical to Read, Too Important to Ignore

Some of FDA’s most difficult tasks are: defining the agency’s role in nanotechnology, creating a pathway for follow-on biologics, implementing a risk-based food safety system, and establishing the right policy for “new media” communications.

All rolled together, they are not as complicated or important as transforming information technology (IT) at FDA.

The anecdotes are legion:

  • adverse events reports come in electronically, are printed and re-keyed into a database;
  • hardware and software vendors bring people out of retirement to service FDA’s out-dated systems (so-called legacy systems);
  • a report e-mailed to Capitol Hill for the next day arrives after the meeting.

I can only vouch for the last one, but the others are believable.

In August, the external FDA Science Board reviewed a report on information technology submitted by its subcommittee. FDA has put substantial resources and made valuable commitments to creating new systems. The biggest gains have been in infrastructure. Progress is being made in hardware, software, integration, capacity, security, infrastructure, and planning.

Clearly, the subcommittee liked what it saw. Their review also highlighted continued challenges in creating a 21st century IT system capable of supporting all of FDA’s mission-critical activities.

The report made some news in trade publications for a few days, then was quickly gone from public view. The issues are too technical to interest most people. Even with a glossary, I confess to not understanding at least half of the report.

Maybe the lack of visibility is alright if FDA and its contractors can absorb the many suggestions and recommendations in the report. FDA Matters recommends that an external review be undertaken every 3 or 4 months to be sure the effort remains on track.

While one can quibble about specific Congressional directives that depend on information technology systems, the main direction has been appropriate. FDA needs to fix the machines, create the databases, and integrate functions

This initiative is so important that non-IT people need to keep informed. Simply put, the agency’s ability to conduct its work, increase effectiveness, and become more sophisticated is more contingent on the IT overhaul then the personnel that are being hired into the various centers to conduct the actual work of the agency.

In 5 years, nobody at FDA will be able to do their job if the IT overhaul isn’t a success.


The FDA Science Board subcommittee report was completed in August and can be found on the FDA website at:


In an earlier column, I addressed another facet of the agency’s IT challenge:

Turning Data into Knowledge   June 2nd, 2009

Through statute and directive, FDA has been asked to collect, analyze, interpret and utilize massive amounts of data. This includes biological, clinical, adverse event, production and distribution data, medical and food product tracking, and the Sentinel system for early discovery of potential drug safety problems. The systems are not in place to do any of this, at least not at the required level of sophistication. Even if they were, sifting valuable information from background noise is extraordinarily hard. As a result, FDA needs to manage Congressional and public expectations as to “what is possible and when.” Read the rest of this entry »

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