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REA or Claim? Substance Over Form

Client Alert | 1 min read | 07.31.19

On July 17, 2019, the Federal Circuit addressed when a request for equitable adjustment (REA) constitutes a claim for purposes of CDA jurisdiction. The contractor, Hejran Hejrat Co. (HHL), submitted to the contracting officer (CO) a document entitled “Request for Equitable Adjustment,” with a sworn statement by a director of the company, requesting compensation and that the submission be “treated as a[n] REA.” The CO denied the request through a “Government’s final determination.” The ASBCA held that it lacked jurisdiction because the self-described REA was not a “claim.” The Federal Circuit reversed, finding that “there was a request for a final decision by a [CO] and a final decision by the [CO].” The Court rejected the Government’s arguments, focusing on the substance-over-form analysis: (1) a claim does not need “magic words,” so an REA can be a claim if it satisfies all of the claim requirements, and (2) even though REA did not request a CO’s final decision, the submission was sworn and requested the CO to “provide specific amounts of compensation for each alleged ground.” Thus, the Court held that the REA had the necessary formality to constitute a claim. Contractors must remain vigilant regarding the collateral consequences of these jurisdictional decisions, such as when the contractor’s 90-day appeal deadline begins to run for appealing the CO’s denial of the “REA” (claim) to the Board (or 1-year to COFC). 

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Client Alert | 3 min read | 06.26.25

FDA Targets Gene Editing Clinical Trials in China and other “Hostile Countries”

In a somewhat ambiguous press release on Wednesday, June 18, 2025, the Food and Drug Administration (FDA) announced a halt and “immediate review” of new clinical trials where American patients’ cells are sent to China or other “hostile countries” for genetic engineering with the expectation that the cells will be infused back into U.S. patients.[1] A subsequent podcast published by the agency also said that therapies that involved cells that were sent to China for genetic engineering and intended for subsequent infusion into U.S. patients would not be approved going forward. The announcement said that there is “mounting evidence” that some clinical researchers failed to obtain informed consent from trial participants about the international transfer and manipulation of biological material....