FDA Conflict-of-Interest Issues To Be Investigated
The House Energy and Commerce Committee leaders have begun to investigate potential conflict-of-interest issues related to FDA contracts awarded to a company that has paid consulting fees and salary to the husband of a senior agency official, the Los Angeles Times reports.
In a letter sent to FDA on Tuesday, committee leaders -- Chair John Dingell (D-Mich.) and Reps. Joe Barton (R-Texas), Bart Stupak (D-Mich.) and Edward Whitfield (R-Ky.) -- said that the investigation will focus on agency contracts awarded to Virginia-based technology company Platinum Solutions to develop a data system to process applications for approval of new medications. FDA official Margaret Burnette, whose husband Mark Boster worked as a paid consultant to Platinum Solutions, oversaw the first agency contract awarded to the company in late 2004, as well as the subsequent work provided by the company (Willman, Los Angeles Times, 1/24).
Burnette had directed her deputy to contact Platinum Solutions after she raised concerns about an agency contract awarded to Maryland-based technology company ProObject (California Healthline, 12/19/06).
FDA subsequently awarded Platinum Solutions a no-bid contract, which paid the company $4 million as of late last year. In November 2006, FDA awarded Platinum Solutions a new contract that might pay the company millions of additional dollars.
According to the letter, the committee also will investigate a related FDA internal affairs investigation closed in 2005 without any disciplinary action. The letter asked FDA to provide the committee with "all records relating" to the agency internal affairs investigation, adding, "Please ensure that no records relating to contracts in which Ms. Burnette was directly or indirectly involved are destroyed."
In a statement, Dingell said, "Self-examination has never been a strong point of the FDA, and the public health has suffered from the agency's reluctance to examine the flawed behavior of its employees" (Los Angeles Times, 1/24).