FDA plans to outline milestones for implementing a strategic action plan in a document slated for release by early June.

Thus far the strategic plan has been described publicly only as a set of broad objectives during presentations by FDA officials.

The public document will identify major milestones to be reached over the next two years in each of the five areas covered by the plan: (1) ensuring a "strong FDA," focusing on the agency's workforce; (2) "efficient risk management"; (3) patient and consumer safety; (4) better consumer information; and (5) counterterrorism.

Commissioner McClellan identified the five areas as FDA's greatest challenges and opportunities in discussions with the agency's senior management shortly after taking office in November.

In an April 1 speech to the Food & Drug Law Institute, McClellan said the strategic action plan was initiated to bring together "our new challenges, our new opportunities, and the most creative thinking from inside and around the agency and to prioritize and address them."

"This planning started with a retreat involving all of our center directors and senior staff around the time I took office," McClellan said, "and has continued at a steady pace to move from defining performance goals, to laying out the strategic objectives required to meet them, to transforming these objectives into specific action plans and performance measures."

An effort is underway across the agency to identify specific objectives and supporting activities within the five areas, with FDA's Executive Council serving as a steering committee.

The council is composed of approximately two dozen agency personnel, including the commissioner, associate and assistant commissioners, center directors and the chief counsel. The group meets weekly to discuss the plan.

Senior agency officials are developing individual milestones under the plan. Working groups and subgroups in each of the five strategic areas have been meeting since February.

For instance, the "efficient risk management" component of the plan includes a subgroup focused on new medical technology.

The subgroup's members include review program directors from the Center for Drug Evaluation & Research, Center for Biologics Evaluation & Research, Center for Devices & Radiological Health and the Center for Veterinary Medicine.

The working groups' recommendations will be vetted by center directors and senior staffers before public release.

FDA is approaching the strategic planning process with current-day funding levels in mind; the plan will identify objectives that can be reached without additional appropriations.

In recent weeks, McClellan has added senior staff who will be focusing on strategic planning efforts.

New hires include Senior Economic Advisor Tomas Philipson, PhD, from the University of Chicago, and Senior Advisor for Medical Technology Scott Gottlieb, MD, a former American Enterprise Institute resident fellow (¹ [A#00650150001], p. 3).

Several individual components of the plan already have been publicly announced. For instance, the Jan. 31 "innovation initiative" for accelerating the drug development process is a key element of the efficient risk management objective.

In the area of patient and consumer safety, the agency published proposed rules in March on safety reporting and bar code labeling.

FDA is currently finalizing a rule to revise the format of drug labeling - part of the plan's focus on better consumer information (² Also see "FDA Labeling Reform Will Trim Adverse Event Section, Temple Says" - Pink Sheet, 21 April, 2003., p. 34).

McClellan also has pointed to the FDA Alumni Association as a means for building a "strong FDA" by augmenting the agency's available resources through the technical and scientific expertise of former staffers (³ 'The Pink Sheet' April 14, In Brief).

FDA Strategic Plan: Milestones Will Be Unveiled In June

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