Department of Health and Human Services

Since May 2020, federal efforts to fast-track the development, manufacturing, and distribution of COVID-19 vaccines has been led by a joint effort between the Department of Health and Human Services (“HHS”) and the Department of Defense (“DoD”), formerly known as Operation Warp Speed but renamed the HHS-DoD COVID-19 Countermeasures Acceleration Group (“CAG”).  As of December 31, 2021, the CAG was dissolved, and the entire responsibility for managing the government’s vaccine efforts transitioned to HHS.  On January 19, 2022, the Government Accountability Office (“GAO”) released a report examining that transition, as part of its ongoing obligation under the CARES Act to monitor the federal government’s pandemic response.  The report includes a few key findings and recommendations that will be of interest to industry partners operating within this space.
Continue Reading New GAO Report: HHS Faces Outstanding Issues as it Assumes Vaccine Responsibilities

On February 24, 2021, President Biden signed an Executive Order entitled “Executive Order on America’s Supply Chains” (the “Order”). Among other things, the Order is an initial step toward accomplishing the Biden Administration’s goal of building more resilient American supply chains that avoid shortages of critical products, facilitate investments to maintain America’s competitive edge, and…

The Department of Health and Human Services published a notice on March 30, 2020 — effective March 25, 2020 — designating certain COVID-19-related personal protective equipment (“PPE”) and materials as “scarce” or “threatened” materials subject to the Defense Production Act’s (“DPA”) anti-hoarding provisions.  As a result of this notice, the DPA now prohibits the accumulation of these materials in excess of reasonable demands of business, personal, or home consumption.  The notice also results in a prohibition of the accumulation of these materials for the purpose of resale at prices in excess of the prevailing market rate.
Continue Reading Defense Production Act Anti-Hoarding Provisions Invoked for Coronavirus

Following up on our post earlier this week giving a general overview of the Defense Production Act of 1950 (“DPA”), 50 U.S.C. §§4501 et seq., this post comments on President Trump’s March 18, 2020 Executive Order on Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19 (the “COVID-19 E.O.”) and provides some key considerations that companies should keep in mind if they are concerned about receiving prioritized or rated contracts or allocation orders or directives under the DPA.
Continue Reading The Defense Production Act and the Coronavirus Executive Order: Key Considerations

Last year, we highlighted the Court of Federal Claims’ (“COFC”) decision in Starry Associates, Inc. v. United States, 127 Fed. Cl. 539 (2016), which sharply criticized a Department of Health and Human Services (“HHS”) decision to cancel a solicitation, a rare rebuke in an area where agencies enjoy considerable deference from the courts. The Court’s decision noted the unique circumstances of that case—a series of agency actions resulting in the cancelation of the solicitation at issue that the Court characterized as “capricious” and “reflect[ing] a lack of fidelity to the procurement process.” That cancelation resulted in multiple GAO protests, a hearing at GAO, multiple depositions of agency officials during a follow-on protest at the Court, and a decision enjoining HHS from cancelling the solicitation (raising the interesting question of whether HHS must now award the contract to Starry Associates). In a subsequent decision issued in the case last week, Starry Associates, Inc. v. United States, No. 16-44C (Fed. Cl. Mar. 31, 2017), the case’s exceptional nature was further demonstrated by the COFC’s decision to award “enhanced” attorney fees to plaintiff’s counsel.
Continue Reading COFC Awards Enhanced Attorney Fees In Protest Following “Egregious” Agency Conduct