FDA is bringing in outside consultants to help improve staff interactions and build leadership in the agency's Center for Drug Evaluation and Research.

The agency awarded a $1.5 million contract to the Center for Professional Development, an Oakland-based organization, as part of an effort to transform the center's culture. In an Oct. 4 announcement of the award, FDA said the group would address the problems the Institute of Medicine outlined in its report on the agency last year, in which it harshly criticized CDER as being "in urgent need of change."

IoM said the center's culture was not supportive of staff, that there was polarization between the premarketing and postmarketing review staff, that the center did not pay attention to scientific disagreement, and that it lacked leadership (¹ Also see "IoM Report Blames FDA Leadership Crisis For Failure To Improve Drug Safety" - Pink Sheet, 2 October, 2006., p. 9).

In response to the report, FDA put out a call for outside experts to come in and help transform the center. In a request for quotations posted on the Federal Business Opportunities Web site July 16, the agency explained that its goal was "to create a sustainable environment of open and transparent communication, collaborative decision-making, and improved morale and staff retention." Three contractors responded to the solicitation.

CDER's internal conflicts have been aired at a series of congressional hearings at which FDA scientists testified that their concerns about the safety of drugs were ignored or criticized by agency officials.

Most notably, drug safety researcher David Graham, Director for Science & Medicine in the Office of Surveillance & Epidemiology, testified in 2004 that FDA had ignored warnings that the pain reliever Vioxx (rofecoxib) was causing heart attacks and strokes.

Former FDA scientists David Ross and Rosemary Johann-Liang also claimed that the agency ignored their warnings about risks associated with the antibiotic Ketek (telithromycin) and the diabetes drug Avandia (rosiglitazone), respectively.

More recently, staffers from the Office of New Drugs and the Office of Surveillance and Epidemiology clashed during an April FDA advisory committee meeting on Merck's COX-2 inhibitor Arcoxia (etoricoxib) (² Also see "Safety Culture Clashes Continue At FDA, Despite Reform Efforts" - Pink Sheet, 16 April, 2007., p. 5) and a July committee review of Avandia (³ Also see "CDER Offices Go Public With “Fundamental Disagreement” Over Avandia" - Pink Sheet, 6 August, 2007., p. 6).

The tensions are being brought into focus by the agency's search for a new center director following the departure of Steve Galson. FDA Chief Medical Officer Janet Woodcock is filling in while a search for a permanent director is under way (⁴ Also see "PDUFA’s Fairy Godmother: Woodcock Steps Into Breach As Acting CDER Chief" - Pink Sheet, 1 October, 2007., p. 3).

Jerry Phillips, former associate director of the Office of Drug Safety who is now president of the Drug Safety Institute, said there has always been conflict between the two drug review offices but that it has heated up more recently.

"I think key individuals within those offices complained that their voices weren't being heard or not listened to at all and that has exasperated things," Phillips said. The consultants, he added, will try to assure that scientific decisions are vetted fairly.

"It's a healthy process to get outside people to come in and take a fresh look at things," he said.

Whether the Center for Professional Development has ever dealt with a situation like CDER's is unclear. The group referred questions about its past clients and accomplishments to FDA, which did not respond to the query. CDP's Web site gives a general description of the services it provides.

"CPD's approach, since 1985, is based on the principles of partnership and relatedness, which provides the basis for achieving task and process," its Web site states.

The group also notes that it offers a low-cost alignment analysis process that "identifies the degree of alignment between members of a team."

CDER may forgo this test. As IoM has already found, its staff are far from being in sync.

- Brenda Sandburg (b.sandburg@elsevier.com)

FDA Hires Consultants To Ease Conflicts Between CDER Staff

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