Update: Pre-award protest of FDA development, modernization, and enhancement services requirement denied

“Background – The Solicitation The FDA issued a blanket purchase agreement request for quotation (RFQ), number FDA-RFQ-20-00002, on December 30, 2019, seeking quotes for a single award contract for “both development, modernization, and enhancement (DME) and software applications operations and maintenance (O&M) for [its Office of Regulatory Affairs (ORA)] IT investments.” ECF No. 26-2 at 396-97 (RFQ Amendment 1); 13 (RFQ). The ORA conducts all FDA field activities including, among other things, “inspect[ing] regulated products and manufacturers, conduct[ing] sample analyses of regulated products, and review[ing] imported products offered for entry into the United States.” Id. at 410. Therefore, the contract sought both DME and O&M services that would “add functionality to existing ORA Systems to address new legislative or regulatory mandates, emerging health concerns, and shifting FDA priorities,” id. at 412, and provide software services allowing the ORA users to “conduct mission critical business processes, including review of goods offered for imports, inspection of regulated facilities, and management of recalls, that are necessary to protect the health and safety of consumers…”

“The Evaluation Plaintiff submitted its bid materials on February 2, 2020, including its relevant experience contract, task orders, and matrix. See ECF No. 26-2 at 500 (submission email), 504-86 (contract and task orders); 948-50 (relevant experience task matrix). The FDA received six proposals in response to the RFQ. See ECF No. 26-3 at 54-55 (Evaluation of Technical Quotations). The FDA’s technical evaluation team (PAG) reviewed the proposals and evaluated each quoter’s relevant experience to determine whether it was acceptable or unacceptable. See id. at 51, 56. The PAG documented its process of evaluation and the specific ratings and rationale for each quoter in the Evaluation of Technical Quotations. See id. at 48-83. The PAG’s evaluation process involved first, an individual review by each PAG member, and then a consensus session in which the PAG members “discussed the individual ratings and members arrived at a common agreement whether the Quoter met or did not meet the evaluation criteria which supported the assignment of the adjectival ratings Acceptable or Unacceptable.” Id. at 56. Of the six submissions, the PAG found that two quoters provided acceptable relevant experience information; plaintiff’s information was found to be unacceptable…”

“Plaintiff filed its complaint in this court on October 19, 2020, alleging that “the FDA’s decision to exclude [plaintiff] was arbitrary and capricious as it was based on a factually inaccurate conclusion that [plaintiff’s] quote did not meet three (3) of the twenty one (21) required areas under relevant corporate experience.” ECF No. 1 at 1. Plaintiff contends that the FDA’s conclusion was “based on its misreading of the contracts submitted by [plaintiff] to demonstrate its corporate experience, as well as FDA’s application of unstated requirements, failure to adhere to the RFQ’s stated evaluation criteria, latent ambiguities in the RFQ, and disparate treatment of quoters…”

“In support of its argument, plaintiff cites several examples of areas in which it alleges that the FDA “failed to credit,” id. at 10, plaintiff with the experience plaintiff contends it demonstrated. See, e.g., id. at 10-12. Specifically, in the context of the agency’s review of plaintiff’s experience related to RFQ section 2.2’s requirement that plaintiff demonstrate experience “providing systems integration and systems engineering services for a complex environment of interdependent systems,” id. at 10, plaintiff argues that: • The FDA reviewed the third paragraph of plaintiff’s cited task order instead of the second paragraph as cited by plaintiff, see id.; • The FDA reviewed only one of the referenced pages of that same task, rather than evaluating both of plaintiff’s citations, see id. at 10-11; • The FDA “irrationally found” plaintiff’s reference to its experience “‘related to infrastructure analysis and application hosting’” despite the fact that the reference included “an assessment of application code, which is relevant to application development and maintenance,” id. at 11…”

“The court agrees with defendant. Plaintiff has not pointed the court to, nor could the court discern, any evidence that the FDA “complete[ly] fail[ed] to read and evaluate 10 the specific portions of the contract examples contained in [plaintiff’s] quote,” as plaintiff argues. ECF No. 29-1 at 9. To the contrary, it appears to the court that the PAG provided a detailed review and explanation for each of its conclusions related to plaintiff’s proposal. See ECF No. 26-3 at 75-83. The court has carefully reviewed each of plaintiff’s examples in support of its argument. In the court’s view, plaintiff’s assertions and examples are, in actuality, concerns with the conclusions the agency drew in evaluating plaintiff’s proposal. It is not in the court’s purview, however, to “‘substitute its judgment for that of the agency…”

“Conclusion Accordingly, for the foregoing reasons: (1) Plaintiff’s motion for judgment on the AR, ECF No. 29, is DENIED; (2) Defendant’s cross-motion for judgment on the AR, ECF No. 31, is GRANTED; (3) The clerk’s office is directed to ENTER final judgment DISMISSING plaintiff’s complaint with prejudice…”

Read the full 15-page decision here.



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