COVID-19

UPDATED AS OF 10/26/2022:

Changing course after its August 31 announcement that it would not enforce the federal government contractor vaccination mandate absent further written notice, on October 14, 2022, OMB and the Task Force published an update stating that they plan to issue at least three new guidance documents with an eye toward potentially resuming enforcement of the mandate:

  1. First, OMB plans to notify Federal agencies about compliance with applicable injunctions and whether contract clauses implementing the mandate should be included in new solicitations and contracts.
  • Second, the Task Force plans to update its November 2021 workplace safety protocols guidance related to the mandate.  The updated guidance will provide a timeline for any implementation long enough to ensure that covered contractors can come into compliance as needed.
  • Third, OMB will review the safety protocols guidance and make a determination on whether it promotes economy and efficiency in government contracting.  If OMB makes such a determination, it will provide additional guidance to agencies on timing and considerations for providing written notice to contractors regarding enforcement, except as barred by any injunction.

Continue Reading OMB and Safer Federal Workforce Task Force Preview Forthcoming Guidance on Federal Contractor Vaccine Mandate

As discussed in our previous post, multiple federal courts have issued preliminary injunctions blocking the Biden Administration’s COVID-19 vaccine mandate for employees of federal contractors.  On January 27, 2022, the United States District Court of Arizona issued a new and additional injunction barring enforcement of the mandate within the State of Arizona.  In so doing, the Arizona court added to the injunctions previously issued by the U.S. District Courts for the Eastern District of Kentucky, Western District of Louisiana, Eastern District of Missouri, Middle District of Florida, and Southern District of Georgia.

The Georgia injunction is the only one of the rulings that applies nationwide.  Like the Arizona injunction, the Missouri, Florida, and Kentucky injunctions are limited to specific states (collectively, Kentucky, Ohio, Tennessee, Missouri, Nebraska, Alaska, Arkansas, Iowa, Montana, North Dakota, South Dakota, Wyoming, and Florida).  The Louisiana injunction is also limited, but its limitations are based on entities rather than geography; it applies to contracts and other agreements between the federal government and the governments of Louisiana, Mississippi, and Indiana.  The Biden Administration has appealed these earlier decisions; we expect that an appeal of the Arizona decision to the Ninth Circuit will likewise be forthcoming.

At the same time, the Biden Administration’s other primary COVID-19 initiative for large employers — the vaccination and testing emergency temporary standard issued by the Occupational Safety and Health Administration (the so-called “OSHA Mandate”) — was stayed by the United States Supreme Court on January 13, 2022.  In the wake of that decision, OSHA announced on January 25, 2022 that it is withdrawing the enforceable emergency temporary standard.

While the Supreme Court’s decision halted immediate application of the OSHA Mandate, the emergency temporary standard qualifies as a proposed rule for purposes of OSHA’s notice-and-comment rulemaking process under 29 U.S.C. § 655, and OSHA has announced that it will continue to consider the emergency temporary standard pursuant to that process.  Accordingly, OSHA could attempt to promulgate a final rule (as opposed to an emergency temporary standard) that addresses vaccines or testing requirements.

The rest of this post consists of (1) an overview of the Arizona decision regarding the federal contractor vaccine mandate; and (2) an update on the status of the other challenges to the federal contractor vaccine mandate, including the Kentucky, Louisiana, Missouri, Florida, and Georgia litigations.Continue Reading COVID-19 Vaccine Mandate Update: Arizona District Court Issues Additional Injunction; Mandate Remains Enjoined Nationwide; OSHA Mandate Withdrawn

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

Several federal courts have issued preliminary injunctions blocking the Biden Administration from enforcing its federal contractor COVID-19 vaccine mandate.  As discussed in our previous posts, President Biden issued Executive Order 14042 mandating that employees of federal contractors and subcontractors be vaccinated against COVID-19 and take various other workplace safety measures.  Executive Order 14042 relies on the president’s authority under the U.S. Constitution and the Federal Property and Administrative Services Act (“FPASA”) to effectuate this policy.  Prior to issuance of the injunctions, contractors were required to have covered employees fully vaccinated by January 18, 2022.
Continue Reading Contractor COVID-19 Vaccine Mandate Blocked Nationwide – UPDATE

Federal government contractors face many uncertainties as they implement President Biden’s COVID-19 vaccine mandate. This includes the distinct possibility of civil lawsuits arising out of their implementation of the mandate, including potential allegations of invasion of privacy, wrongful termination, lost wages, discrimination, personal injury or other common law claims or statutory violations. At least one such lawsuit already has been filed. In that suit, dozens of aggrieved employees allege that the contractor’s vaccine mandate violates state law, and they seek an injunction and other relief. Other lawsuits are sure to follow.

But there is good news for contractors: Established legal doctrines should provide contractors some degree of protection—and perhaps complete immunity—against such lawsuits. In addition to the statutory protections afforded to contractors under the PREP Act, contractors may be protected from civil liability based on federal-law-based defenses that have been recognized and applied in analogous government contracting settings. In the coming weeks, as contractors navigate the many challenges associated with the vaccine mandate, they should carefully consider the risk of civil litigation, and, in order to minimize potential exposure in such lawsuits, proactively implement practices that maximize the likelihood that these doctrines and defenses will be applicable, as discussed below.Continue Reading Are Federal Contractors Immunized From Vaccination Litigation? Mitigating The Risk Of Civil Liabilities Arising Out Of The COVID-19 Vaccine Mandate

Many of our clients have been calling to ask whether failure to comply with the Administration’s Executive Order imposing vaccine mandates on federal contractors could lead to False Claims Act liability, and what steps they can take to minimize the risk of liability.  Much remains unknown, especially what specific obligations will be included in the FAR clause to be released on October 8.  However, we have highlighted a few key considerations that should be front of mind for all contractors and subcontractors.
Continue Reading COVID-19 Vaccine Mandate for Federal Contractors Could Pose False Claims Act Risk

On September 24, the Safer Federal Workforce Task Force released guidance on workplace safety protocols for federal contractors and subcontractors related to COVID-19 (“the Guidance”).  The Guidance was issued pursuant to President Biden’s Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.

As expected, the Guidance covers a broad range of contract types and contractors, and mandates COVID-19 vaccinations for covered contractor employees along with masking and social distancing measures to prevent the spread of the disease.  But it also includes some unanticipated exceptions.  The Guidance sets baseline requirements under the Executive Order that are expected to be updated over time and implemented through a contract clause that will be issued by the Federal Acquisition Regulatory (“FAR”) Council.  Federal contractors should carefully examine the Guidance and ensure that they are prepared to timely comply as well as monitor for and adapt to any updates from the Task Force.

Our prior post on the Executive Order can be found here.Continue Reading Task Force Releases Guidance on New COVID-19 Vaccine Mandate for Federal Contractors

On September 9, the Biden Administration released a number of new details for its Path out of the Pandemic that will impact U.S. Government contractors and a number of other individuals and entities.  In addition to requiring most executive agency employees to receive COVID-19 vaccines, the Administration plans to mandate that executive agency contractors and subcontractors, with some exceptions, impose similar requirements on their employees pursuant to an executive order that will fully go into effect on October 15, 2021.  The overall impact of the executive order will not be clear until additional details are released in the coming weeks, but government contractors should begin considering the implications of the new requirements and take steps to ensure timely compliance.
Continue Reading COVID-19 Vaccine Requirements for U.S. Government Contractors

Last month, the Biden administration released its report on the results of its 100-day review of U.S. supply chains for critical products:  “Building Resilient Supply Chains, Revitalizing American Manufacturing, and Fostering Broad-Based Growth” (the “Report”).  Alongside the Report’s slate of policy recommendations, the Biden administration also announced immediate actions to strengthen supply chains and stimulate domestic competitiveness.

The Report is the result of President Biden’s February 24 “Executive Order on America’s Supply Chains” (the “Order”), which directed federal departments and agencies to conduct a review of supply chain risks in four critical product areas,[1] including pharmaceuticals and active pharmaceutical ingredients (“APIs”).  The Report and its recommendations further the Biden administration’s broader goal of rebuilding the U.S. industrial base, reducing reliance on foreign competitors, and bolstering national and economic security.

The U.S. Department of Health and Human Services (“HHS”) led the review of the supply chain for pharmaceuticals and APIs, which focused primarily on drugs, in particular small-molecule drugs and therapeutic biological products.  The Report makes a number of recommendations discussed herein that have the potential to impact pharmaceutical companies’ business plans and generate significant opportunities, though many such recommendations are long-term and will require dedicated funding so the actual impact of the Report’s suggestions remains to be seen.
Continue Reading Biden Administration 100-Day Supply Chain Assessment: Insights for Pharmaceutical Manufacturers

The American Rescue Plan, signed into law last month, includes $1.9 trillion in economic stimulus, healthcare, and related funding.  And just last week the Biden administration released an infrastructure proposal, the American Jobs Plan, that includes $2.3 trillion in transportation, connectivity, power, and other critical infrastructure investments.

Contractors are right to view these plans as massive opportunities — but should be cognizant of the regulatory strings that often attach to government spending.  In general, these can include Federal Acquisition Regulation (FAR) and agency-specific FAR supplements for federal procurements, as well as the nonprocurement uniform requirements (2 C.F.R. Part 200) and related agency-specific regulations that attach to Federal grant funds even when disbursed by state or local entities.

Now, some Congressional members are seeking to add new restrictions that would significantly overhaul the existing domestic preference regime for Federal procurements — mere weeks after the promulgation of new Buy American regulations and the release of a new Executive Order to further tighten the application of these rules.Continue Reading U.S. Senators Propose Trade-Pact Waivers Amidst Focus on Domestic Preference Laws