Panel starts FDA probe
A bipartisan group of congressional leaders is examining the Food and Drug Administration’s contract awards to a company that has paid consulting fees and salary to the husband of a senior agency official.
In a letter delivered Tuesday to the FDA, the leaders of the House Energy and Commerce Committee said the inquiry would focus on contracts awarded to Platinum Solutions Inc., of Reston, Va. An FDA official, Margaret “Margo” Burnette, whose husband was affiliated with the company, oversaw the first contract awarded and the work that followed.
The letter also says that the committee will review a related FDA internal affairs investigation that was closed in 2005 with no apparent disciplinary action.
Beginning in late 2004, the FDA retained Platinum Solutions to build a new data system intended to speed the handling of industry applications to market new drugs. After serving the company as a paid advisor, Burnette’s husband, Mark A. Boster, was installed in April 2005 as its chief operating officer and executive vice president.
As of late last year, Platinum Solutions had been paid about $4 million in connection with the data system. The FDA in November awarded the company a new contract related to the project, potentially worth millions more.
Federal law prohibits officials from acting on matters in which they or their spouse has a financial interest.
In the letter to FDA Commissioner Andrew C. von Eschenbach, the congressional leaders said the new inquiry would focus on “conflicts of interest in the [FDA’s] contracting practices and the ability and willingness of the agency to investigate allegations of improper practices.”
The congressmen requested that by Thursday the FDA deliver “all records relating” to the closed internal affairs investigation, adding: “Please ensure that no records relating to contracts in which Ms. Burnette was directly or indirectly involved are destroyed.”
The letter was signed by Rep. John D. Dingell (D-Mich.), chairman of the Energy and Commerce Committee, and by Reps. Joe L. Barton (R-Texas), Bart Stupak (D-Mich.) and Edward Whitfield (R-Ky.). Stupak is chairman of the panel’s oversight and investigations subcommittee; Barton and Whitfield are the senior Republicans.
The congressional action comes in response to a Los Angeles Times article Dec. 19 that detailed the FDA’s dealings with Platinum Solutions. The article described Burnette’s role with the data project through her former position as director of the agency’s office of information technology.
After she had encouraged the termination of another contractor that was leading the data project, Burnette steered her deputy to contact Platinum Solutions. He did, and the company was awarded a no-bid contract.
Dingell said in a statement Tuesday that his committee was “very interested” in how the FDA conducts internal investigations of potential wrongdoing. “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,” he said.
The FDA’s chief of internal affairs, Thomas Doyle, declined to comment about the reference in the congressional letter to his unit’s closed investigation. FDA spokesman Douglas Arbesfeld said that aides to Von Eschenbach were reviewing the letter.
Burnette and Boster told The Times last fall that they had done nothing wrong. Burnette also said she had been aware that “there could be the concern of a conflict of interest.”