Hiring Freeze Will Affect FDA Commissioner, ORM Director Appointments

Acting FDA Commissioner Bernard Schwetz, PhD, will continue to make funding the agency's science base a top priority, he stresses in a Jan. 22 email to agency staff.

"I am committed to securing the funding needed to maintain the science of the agency and to support the high-quality decision-making that has earned for FDA the public's trust and confidence," Schwetz said.

Schwetz' first comments as acting commissioner indicate an intent to continue the priorities of former Commissioner Jane Henney, MD. Henney's resignation was accepted effective Inauguration Day (¹ (Also see "FDA's Schwetz Is Acting Commissioner Following Henney Resignation" - Pink Sheet, 22 Jan, 2001.)). Shortly after taking over as acting commissioner, Schwetz departed for the World Economic Conference in Davos, Switzerland.

The acting commissioner also wrote he is hoping for continuity in FDA's topside management. "A legacy and an asset that Dr. Henney leaves behind is our strong and experienced management team, which I now have the good fortune to lead through this time of transition," he said.

At least two members of FDA's management team are potential candidates for the commissioner job: former Office of Review Management Director Murray Lumpkin, MD (who is on a detail in the commissioner's office) and Center for Devices & Radiological Health Director David Feigal, MD.

Taking over Lumpkin's old position atop ORM is Sandra Kweder, MD. Kweder formerly served as deputy director of the Center for Drug Evaluation & Research Office of Drug Evaluation IV. Her responsibilities as deputy director will be shared in her absence.

Kweder is the fourth person to fill the top FDA drug review position in the past six months and succeeds acting director Heidi Jolson, MD, who left the agency Jan. 26 to become a consultant. Jolson took the position Nov. 6 following Lumpkin's resignation in October (² (Also see "FDA Review Manager Lumpkin Leaving Agency: Will Deadline Focus Survive?" - Pink Sheet, 23 Oct, 2000.)).

Kweder joined FDA in 1988 as a medical officer in the Division of Antiviral Drug Products. She left the agency briefly from 1995-1997 to take a fellowship at Brown University, and since returning to FDA, has led the agency's Pregnancy Labeling Taskforce. She will continue to operate in this role, FDA said.

However, her appointment to ORM will be temporary. The center is understood to be considering a reorganization plan and so may not need a direct replacement for Lumpkin.

An additional complication in finding a permanent director at ORM is the hiring freeze on federal agencies put in place by the incoming Bush Administration.

A Jan. 20 memo from the White House states: "No decision related to hiring shall be made unless and until such decision is reviewed and approved by a department or agency head appointed by the President."

The memo accompanies another issued the same day that restricts when regulations may be published in the Federal Register; the restrictions could delay the release of dietary supplement Good Manufacturing Practices (³ (Also see "Dietary Supplement GMPs Stuck In Transition Limbo" - Pink Sheet, 29 Jan, 2001.)).

The hiring freeze clearly impacts the search for a permanent ORM director. However, the agency is having internal discussions over waivers for exemption from the freeze for certain high level positions.

The selection of a director to FDA's Office of Generic Drugs also likely is affected by the hiring controls. Although the agency is understood to have selected acting director Gary Buehler for the position, further action will not be taken until the controls are lifted.

The Office of Public Affairs' search for a replacement for Mary Saunders, the information specialist responsible for the enforcement report, also may be delayed.

Official job offers extended before Jan. 20 may be honored by agencies, an Office of Personnel Management memo notes. The memo says the controls "do not apply to agencies where the department or agency head has already been appointed or confirmed." In the meantime, FDA's decisions will likely rely on HHS Secretary Tommy Thompson until a permanent commissioner is named.

The White House memo adds that agency heads will be instructed "to develop a plan to permit the agency" to reduce "management ranks." Office of Management & Budget Director Mitch Daniels will work with FDA to develop plans to cut back the ranks.