A "stronger appearance of impartiality, integrity" will result from an HHS Office of Inspector General decision to take back investigative authority over allegations of employee misconduct at FDA, a GOP aide to the House Energy & Commerce Committee told "The Pink Sheet."

OIG had ceded that authority to FDA's Office of Internal Affairs in 1995, raising questions on Capitol Hill about whether such a move was legal and appropriate (¹ Also see "FDA RETALIATION ALLEGATIONS SHOULD BE INVESTIGATED THROUGH "INDEPENDENT" OUTSIDE PROCESS, REP. BARTON TELLS KESSLER AT OVERSIGHT SUBCOMMITTEE HEARING" - Pink Sheet, 20 November, 1995., p. 5).

"The whole idea of the Inspector General Act is that departments and agencies are not to investigate themselves," the aide pointed out.

Returning misconduct cases to OIG "will create an appearance of more independence."

Concerned about FDA's willingness to investigate itself, the energy and commerce panel earlier this year initiated an investigation into possible conflict of interest surrounding an FDA information technology contract (² Also see "FDA Conflict Of Interest Over IT Contract Draws Commerce Cmte. Scrutiny" - Pink Sheet, 29 January, 2007., p. 17).

FDA's self-policing also has raised questions about improper use of that authority. In 2004, the Senate Finance Committee sought documentation of the internal affairs office's role in finding who leaked information about a possible link between antidepressants and suicidal behavior (³ Also see "FDA Action On Antidepressants Questioned; Congress Widens Investigation" - Pink Sheet, 29 March, 2004., p. 23).

Some cases are "really better off being handled administratively," the GOP aide suggested, as opposed to the more legally focused process FDA has undertaken.

OIG is staffed by agents from the Office of Criminal Investigation, so for someone who is questioned "it's very intimidating, which is the feedback we've gotten from people who've been subjected to these interviews."

In a Nov. 9 letter to HHS Inspector General Daniel Levinson, committee chairman John Dingell, D-Mich., ranking member Joe Barton, R-Texas, and oversight subcommittee leaders Bart Stupak, D-Mich., and Ed Whitfield, R-Ky., applauded the OIG decision to revoke a memorandum of understanding allowing FDA to investigate employee misconduct.

The congressmen requested correspondence and documents related to the decision and the transfer of cases from FDA to the OIG. At the same time, they asked for information regarding disposition of 103 conflict-of-interest cases at the National Institutes of Health that were being reviewed by OIG at the committee's request.

NIH has been a focus of considerable OIG resources recently. Earlier this year, OIG said it would delay a study of how FDA oversees conflict-of-interest standards among clinical investigators in order to focus on an NIH conflict-of-interest study (⁴ Also see "HHS OIG Conflict-Of-Interest Investigations To Focus On NIH Rather Than FDA" - Pink Sheet, 9 April, 2007., p. 21).

- Cathy Dombrowski (c.dombrowski@elsevier.com)

FDA Employee Misconduct Charges To Be Investigated By OIG Instead Of Itself

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