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 | 5 min read | 04.13.26
EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal
In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product.
Client Alert | 4 min read | 04.13.26
Client Alert | 4 min read | 04.10.26
CMS Finalizes Rate Notice for Medicare Parts C and D (CY 2027)
Client Alert | 2 min read | 04.10.26

