Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA MANAGEMENT "NEEDS TO FIGHT BACK AGAINST CONGRESS

Executive Summary

FDA MANAGEMENT "NEEDS TO FIGHT BACK AGAINST CONGRESS, the press and departmental oversight," agency career staffers recently told a group convened by FDA Commissioner Kessler to assess the agency's mood. Employees said "management needs to be decisive and strong and encourage innovative approaches to getting the job done," according to a Jan. 14 memo summarizing the group's findings. The need to "fight back" was "mentioned often," by FDA employees. Participants also recommended more effort to "select managers for their management skills." The "corollary" is that technical and scientific staff should be rewarded for their technical skills and not necessarily moved to supervisory posts unless they have made a commitment to program management. In addition, agency staffers recommended that the agency provide more management training and hold management officials more accountable for their performance. "What FDA staffers told us was that this inaction [against poor managers] had a major impact on the entire organization," the group reported. In a Jan. 18 letter responding to the "listening team's" findings, Kessler said his reaction was "very enthusiastic," and he has asked FDA Chief of Staff Joseph Levitt and Associate Commissioner for Planning and Evaluation Gerald Barkdoll to develop a "means of promptly reviewing and responding to" the suggestions. The listening team met with 100 FDA employees plus additional staff from FDA's 23 districts. Improving management performance was one of seven "themes" emerging from the group's inquiry. The other major findings include that FDA needs to: "give employees a better sense of its mission," addressing the "agency's overall mission (including the tension between product approval and enforcement)" and the different missions of FDA components; revamp its communications apparatus"; obtain more people and facilities but also "make better use of its current employees and funds"; and streamline its regulatory processes and other standard procedures as well as clarify the role of each layer of review. In addition, good employee performance needs to be better recognized, the group reported. "No one thought the appraisal system or the awards process were fair or even gave the right kind of prompt feedback. This topic generated the strongest negative feelings among participating employees," the team reported. FDA also "needs greater autonomy at all levels." Every discussion group "mentioned the frustrations of administrative layering that affects everything from grade levels to parking policies to regulatory processes." Kessler's memo notes that upon being briefed by the group, "I followed up by asking them to brief the Policy Board that very day, which they did."
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS018656

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel