FDA vision quest ends

FRAMINGHAM (09/24/2003) - Can one agency make 20 percent of the U.S. economy more efficient? Late last month, the U.S. Food and Drug Administration announced it would try. It released its "strategic action plan." Nothing in the document is blazingly new, but it does telegraph key regulatory priorities for the near term. "We have undertaken a major strategic action plan within the agency," says FDA Commissioner Mark McClellan in his introduction to the document.

Much of the report relates to food, public relations, and other non-controversial topics. But some points relate directly to the life sciences.

Computers will clearly be part of a new vision of the FDA as more efficient and scientific than it has been in the past -- even at a time when American industry is uncertain about the transformative value of IT. "In the future," the report states, the "FDA is going to view IT as a strategic tool that can be used by program staff to accomplish their policy goals and objectives with greater efficiency and effectiveness."

Safety First

In basic terms, much of the new FDA vision amounts to admittedly overdue efforts to make the agency more efficient. "This includes major new efforts to improve and expand the use of IT for reporting and tracking of drug-related information," the report says.

As an example, the FDA will redouble efforts to improve the handling of data about side effects of drugs -- in technical terms, systems for adverse event reporting that have been created by the FDA and commercial vendors. "The Agency needs to improve its systems for reporting safety problems," McClellan's vision statement says. "One way is to improve the quality and standardization of the adverse event reports that the agency receives through FDA's 'spontaneous' adverse event reporting systems."

The FDA also seems more interested in manufacturing, and uses the words that consultants most love to hear: "new guidance."

The new report states: "Continuous quality improvement in manufacturing hasn't been the subject of as much attention in the pharmaceutical industry, even though many experts on manufacturing processes believe that large savings in production costs could be realized while maintaining very high standards for purity and accuracy. The FDA's broad-based program is working on developing new guidance based on the latest science of risk management and quality assurance."

Whether the agency's new vision amounts to a tightening or loosening of existing policy will no doubt be clarified in more private settings than the document, which is located at www.fda.gov/oc/mcclellan/strategic.html.

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