FDA Quietly Unveils Transparency Initiative

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Michael Causey
In FDA Regulated Industries

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

From the Department of Mixed Messages comes an oddly-timed “transparency” news release from the FDA. I can’t quite figure out the logic behind choosing the week before Labor Day to tell the world you want to open up and apply tougher metrics on your performance?  Weren’t most of us at the beach or grilling on the deck that day?

Still, that’s just what the FDA did with an August 31, 2010, release touting its new “organizational performance management system” called FDA-TRACK. It promises to monitor FDA accountability and transparency and will monitor more than 100 FDA program offices through data from key performance measures established each year.

The data will be gathered monthly, analyzed and presented each quarter to FDA senior leadership.

“FDA-TRACK will bring the operations of this historically opaque Agency into the daylight and help us be even more responsive as we work to protect the public health,” said FDA Commissioner Margaret Hamburg, M.D.

According to the Agency, FDA-TRACK is designed to be informative, encourage accountability among the people who work at the FDA, and make that work more transparent. It gives managers and employees a new way to measure their effectiveness in meeting goals to protect the public health and provides a way for the public to monitor agency activities.

Adapted from several successful state and local performance management models, FDA-TRACK hopes to set the standard for open government at the federal level. The system monitors performance indicators in four categories:

Common Measures – Agency-wide measures applicable to each of more than 100 program offices and may focus on the agency’s most recent priorities.

Example: Increase the total number of employees who are trained in the Incident Command System, which helps the agency respond to emergencies.

Key Center Director Measures – Center-specific measures that are applicable to each Center and are central to the Center’s priorities and strategic goals.

Example: Increase the FDA’s technical guidance by increasing the number of technical publications drafted, which enables the Center to better prepare industry and consumers.

Program Measures – Program office-specific measures that are applicable to the office and reflect work important to the public and to the FDA’s mission.

Example: Monitor the percentage of 510(k) decisions meeting the 90-day Medical Device User Fee Act goal during a specific time period.

Key Projects – Program office-specific projects that are applicable to the office and important to the mission and objectives of the office. Performance for Key Projects is measured through achievement of the stated milestones within the project’s plan.

Example: The development of a new risk-based approach for evaluating safety, effectiveness, and quality of new animal drugs.

I’m not questioning the value of the initiative, just the timing.

Wouldn’t it have made more sense to unveil it this week, when we’re all back at our desks?

For more information:

FDA-TRACK: Agency-wide Program Performance

Department of Health and Human Services – New High-Value Data Sets and Tools

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