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Proof Of Actual Bias Not Required To Show Conflict Of Interest

Client Alert | 1 min read | 12.07.06

Using the rarely-invoked exception to its timeliness rules for protests raising issues of widespread interest to the procurement community, the GAO in Celadon Laboratories, Inc., (http://www.gao.gov/decisions/bidpro/ 298533.pdf, Nov. 1, 2006) upheld a protest challenging an HHS decision not to fund the protester’s Small Business Innovation Research proposal, finding a conflict of interest where the members of the Special Emphasis Panel (SEP) that evaluated (and rejected) the proposal were employed by, or funded by, firms that support a competing technology. Because of the specific conflict information protester brought to the agency’s attention during the evaluation, GAO not only rejected HHS’s reliance on its SEP’s self-certification but also, rejected the argument that actual bias must be shown and instead concluded that in cases in which the evaluator has a conflict, prejudice is presumed.

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Client Alert | 2 min read | 05.09.25

FDA Seeks Stakeholder Consultation on Prescription Drug User Fee Reauthorization

On May 8, the U.S. Food and Drug Administration (FDA) took steps to begin the process for reauthorizing the Prescription Drug User Fee Amendments (PDUFA) by announcing a public meeting to be held on July 14, 2025. The agency invited public stakeholders, including patient and consumer advocate groups, health care professionals, and scientific and academic experts to participate in the meeting and subsequent public meetings to consult on the PDUFA reauthorization....