Link: GAO Opinion
Agency: Department of Health and Human Services
Disposition: Protest denied.
Agency reasonably excluded the protester’s proposal from the competitive range, where the agency reasonably determined that the protester’s proposal contained major and significant weaknesses and deficiencies, such that the proposal was found to be unacceptable, would require major revisions to be made acceptable, and was significantly lower rated than the proposals included in the competitive range.
General Counsel P.C. Highlight:
Panacea generally challenges the agency’s exclusion of its proposal from the competitive range, arguing that the agency’s technical evaluation reflected bias in favor of those firms (offerors A and B) that had proposed an rPA anthrax vaccine developed through grants from the United States government and against Panacea, which had developed its vaccine at private expense in a foreign country. In this regard, Panacea argues that some of the evaluated major and significant weaknesses and deficiencies in its technical proposal reflect the agency’s bias. GAO finds no basis from its review of the record to conclude that the evaluation of Panacea’s proposal and its exclusion from the competitive range was the result of HHS favoring firms that had earlier received funding or was otherwise motivated by bias or bad faith on the part of HHS. In this regard, government officials are presumed to act in good faith, and GAO will not attribute unfair or prejudicial motives to procurement officials on the basis of inference or supposition.
Panacea first complains that the TEP chairperson’s evaluation summary of Panacea’s proposal under the technical merit/time line subfactor incorrectly stated that the protester had not produced bulk drug substance (BDS) of its anthrax vaccine. The protester contends that it has produced BDS at quantities as large as “[DELETED] pilot scale batches.” With respect to Panacea’s challenge to the reasonableness of some of weaknesses and deficiencies evaluated in its proposal, GAO states that it will review an agency’s evaluation and exclusion of a proposal from the competitive range for reasonableness and consistency with the solicitation criteria and applicable statutes and regulations. Contracting agencies are not required to retain in the competitive range proposals that are not among the most highly rated or that the agency otherwise reasonably concludes have no realistic prospect of being selected for award.
The agency states that the TEP recognized that Panacea had done BDS process development on a small scale and that the weakness assessed in Panacea’s proposal was that Panacea had not produced BDS of its proposed vaccine at a scale required for the contract. This contention is supported by the contemporaneous evaluation record. The protester responds, however, that there is “no mandatory requirement” in the solicitation for BDS production on a commercial scale and that therefore downgrading Panacea’s proposal for failing to show BDS production at this scale was unreasonable. GAO finds this argument to be without merit, however, given that the RFP informed offerors that the agency would be evaluating under the technical approach subfactor whether the “[c]ontractor has demonstrated validated bulk drug substance (BDS) production at proposed commercial scale.”
The protester also complains that its proposal should not have been downgraded for a lack of FDA experience. HHS downgraded Panacea’s proposal because the firm had failed to demonstrate experience with, or for that matter good understanding of, the FDA and that agency’s regulatory process. In this regard, the RFP informed offerors that contractors would be required to satisfy FDA requirements for “potential use of the vaccine in a [post-exposure prophylaxis] plus antibiotic scenario in a declared emergency under an EUA” and to otherwise obtain licensing in accordance with FDA regulations, and offerors were informed that the experience of their personnel to perform the contract would be evaluated. The agency states that it did not credit Panacea for the FDA experience of its subcontractors because Panacea’s proposal identified Panacea, and not the subcontractors, as being responsible for dealing with the FDA. GAO has no basis to object to this determination, given that Panacea’s proposal did not identify any subcontractors to be members of its “regulatory team,” which Panacea stated would deal with the FDA and be responsible for regulatory submissions.
Panacea also disagrees with the TEP’s finding that Panacea had not demonstrated “an understanding of the relationship of the animal models, human clinical data and correlates of protection.” HHS responds that, while Panacea provided some information in its proposal regarding historical and proposed non-clinical studies and for proposed clinical studies, the firm did not explain its studies in a way that showed how the studies would “contribute to the body of knowledge required to conclusively demonstrate a correlate of protection and efficacy of the product.” HHS also states that Panacea’s descriptions of its non-clinical studies and clinical studies did not show that it incorporated suggestions and recommendations of the FDA. Panacea does not show that the agency’s evaluation in this regard was unreasonable. Rather, in its comments, Panacea merely objects to two statements in the agency’s legal memorandum with respect to whether Panacea provided “passive transfer studies” in its proposal and whether Panacea’s proposal provided for studies of the vaccine at various dosages. Neither of these two concerns, however, shows that the agency’s overall criticism that Panacea had failed to demonstrate an understanding of the relationship of the animal models, human clinical data, and correlates of protection was unreasonable.
Finally, in its comments on the agency’s report, Panacea raises numerous new challenges to the agency’s evaluation. Specifically, Panacea objects to HHS’s “mechanical reliance on point scores,” that standards were allegedly not established for assigning point scores, and that the assigned point scores were not adequately supported by the TEP’s narrative discussion. GAO finds that these supplemental grounds of protest were not timely filed. The protest is denied.