Medical Device Daily Washington Writer

WASHINGTON – Rep. Bart Stupak (D-Michigan.), chairman of the House Energy and Commerce Subcommittee on Oversight and Investigations, last week asked President-elect Barack Obama not to appoint any current senior FDA official as commissioner or interim chief of the agency.

Stupak, who has convened 16 hearings over the past two years focused on problems at the FDA, did not name any specific agency officials he had a grudge against in his Dec. 3 letter to Obama, but contended that investigations by his subcommittee have "revealed how the current FDA senior management blocked clinical trials, drove dedicated medical professionals out of the agency and lined their pockets with outrageous bonuses."

Longtime FDA official Janet Woodcock, a 22-year veteran who, for the second time, is serving as director of the Center for Drug Evaluation and Research (CDER) – from 1994 to 2005 and appointed again this past March – has been speculated by many to be named the agency's new commissioner under the Obama administration, or at least as someone who may temporarily lead the FDA in the interim.

Woodcock, an internist and rheumatologist who also has served as deputy commissioner and chief medical officer, has reportedly met with members of Obama's transition team.

But last February, Stupak called for Woodcock's resignation, among others at the agency, including Commissioner Andrew von Eschenbach and CDER Deputy Director Sandra Kweder, after it was revealed that the FDA failed to inspect a Chinese plant that was traced to tainted heparin, which was linked to numerous U.S. deaths and hundreds of allergic reactions and other adverse events.

Stupak told Obama current senior FDA officials are "too close" with the industries they regulate, "creating a question of who they are working for."

A new commissioner or interim chief, the Michigan Democrat argued, must bring the FDA back to the forefront of science, integrity and transparency. "You offer a break from the past and renewed hope for all Americans," Stupak told Obama.

He said meaningful reform at the agency "begins with a complete change in the FDA's leadership."

Several FDA outsiders also have been speculated as being candidates to the agency's top job, including longtime FDA critic Steven Nissen, chief of cardiology at the Cleveland Clinic Foundation; Democratic National Committee Chairman and former Vermont Gov. Howard Dean; Medtronic (Minneapolis) Vice President Susan Alpert, herself a former FDA official; and Ezekiel Emanuel, chairman of the department of bioethics at the National Institutes of Health and the brother of Obama's new White House chief of staff, Rahm Emanuel.

Investigating the investigations

Reps. Joe Barton (R-Texas), ranking member of the House Energy and Commerce Committee, and John Shimkus (R-Illinois), ranking member of the Oversight and Investigations Subcommittee, last week asked the FDA commissioner for information about investigations by the agency's Office of Criminal Investigations (OCI) after questions arose earlier this year about whether dramatic budget increases had produced any effect.

The two Republican lawmakers noted that the OCI's budget increased by 71 % in six years, while convictions and arrests had decreased.

In a Dec. 5 letter to von Eschenbach, Barton and Shimkus said there was oversight concern about OCI's growing budget "at a time of constrained resources" for other parts of the FDA.

The lawmakers demanded to know how many OCI-only investigations for fiscal 2007 and 2008 resulted in either refusals to pursue cases by U.S. Attorneys offices or prosecutions.

Barton and Shimkus also asked whether OCI agents in the FDA's Office of Internal Affairs conducted any investigations of allegations of misconduct involving OCI personnel and, if so, how many cases there were, the details of the allegations and the results of those investigations.

The congressmen also asked if any of those internal cases were referred to the Health and Human Services Office of Inspector General and whether the FDA's Internal Affairs unit has any reporting relationship to the OCI.

The two Republicans also raised questions about hours logged by OCI agents for counterterrorism work since the 9/11 attacks.

The lawmakers gave von Eschenbach until Jan. 5 to respond.

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