(Washington, D.C.) – Senators Hillary Rodham Clinton (NY) and Patty Murray (WA) are calling for the Government Accountability Office (GAO) to investigate yet another troubling departure from standard FDA practice in the handling of the application for Plan B to be made available over-the-counter. The FDA has taken the unusual step of outsourcing to a private contractor, Booz Allen Hamilton, the responsibility of collecting and reviewing comments submitted to the FDA on Plan B.
“We are deeply troubled by what appears to be yet another example of unusual handling of the Plan B application. The American people deserve an FDA that they trust makes decisions based on science not ideology. The Plan B process has already tarnished that trust. Outsourcing public comments on Plan B is yet another warning sign that the FDA is not taking seriously its responsibility to make a decision on Plan B, yes or no,” said Senators Clinton and Murray.
After more than two years, the FDA continues to drag its heels on making a yes or no decision on Plan B. In September of 2005, the FDA announced a public comment period. The agency has not announced its next steps, including how or when it will make a decision. Senators Clinton and Murray underscored that they will press Acting FDA Commissioner Andrew von Eschenbach about this arrangement if questions about this contract are not satisfactorily resolved.
The text of their letter to GAO Comptroller General David Walker follows:
The Honorable David Walker
Comptroller General of the United States
United States Government Accountability Office
442 G Street, N.W.
Washington, D.C. 20548
Dear Mr. Walker:
We are writing to you to request that you review the contract between the Food and Drug Administration (FDA) and the consulting firm Booz Allen Hamilton (BAH), pursuant to which BAH has been given the responsibility of collecting and reviewing comments submitted to the FDA in response to its current rulemaking on Plan B.
As you are aware, the FDA has departed from standard practices in reviewing the Plan B application. Most recently, FDA has opened a rulemaking process on its authority to approve the marketing of FDA to adults over-the-counter and to minors with prescriptions.
One unusual element of this process is that while FDA has placed great emphasis, on the need to consider public comments and the development of a regulation for proper implementation, FDA apparently has outsourced the comment review process, at least in its initial stages, to a private contractor.
FDA’s arrangement with BAH raises several questions:
Did FDA enter into a written contract with BAH for this project alone? If not, is FDA piggybacking this work onto a previously existing contract? Does FDA have the legal authority to do so? Have any other contracts been issued with regard to this regulation or product approval?
Exactly what is the extent of the work that BAH is performing for FDA? What are the tasks and deliverables? Will BAH merely tabulate the comments? If so, what categories is BAH using? Will BAH summarize the comments? What are the qualifications of the BAH personnel who will write the summaries? Will BAH offer any conclusions or advice as to the comments?
Why doesn’t FDA keep this work in house? Does FDA lack personnel to digest comments in rulemaking proceedings? What level of staffing has FDA assigned to the development of this regulation?
Who at FDA decides whether comment reviews should be outsourced? What office/division/center at FDA oversees the contractor and who is the project officer? Does FDA have written standards that govern the oversight of contractors in cases such as this one?
What is the cost of subcontracting the review of Plan B comments to BAH? If FDA is subcontracting reviews of comments in other rulemakings, how much does FDA spend annually on such contracts?
Does FDA’s arrangement with BAH contain any incentive provisions? What are the deadlines for deliverables? Does it call for penalties if deadlines are not met or work is unsatisfactory?
It may be that additional questions will arise once you begin your work, so we reserve the right to modify this request.
In the meantime, we believe that time is of the essence. The President has nominated Andrew Von Eschenbach to serve as Director of FDA; this nomination will go through the Senate Committee on Health, Education, Labor, and Pensions, on which we both sit. We would like to resolve these questions about the BAH Plan B contract prior to Dr. Von Eschenbach’s confirmation hearings; failing that, we intend to ask him about the contract at those hearings.
So that you may complete your work in a timely fashion, we are asking for less than a full-scale GAO report. An evaluation of the contract in the form of a memo would suffice. We would like to discuss the parameters of this project with you at your earliest convenience.
Sincerely yours,
Patty Murray
Hillary Rodham Clinton
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