On Tuesday, November 30, 2021, the U.S. District Court for the Eastern District of Kentucky issued a preliminary injunction blocking the Biden Administration from enforcing its federal contractor COVID-19 vaccine mandate in Kentucky, Ohio, and Tennessee.  As discussed in our previous posts, via Executive Order 14042, President  Biden mandated that employees of federal contractors and subcontractors be vaccinated against COVID-19.  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.  Federal contractors are required to have covered employees fully vaccinated by January 18, 2022.  Numerous states have sued to block the mandate but yesterday was the first time a court has upheld such a challenge.

Continue Reading Contractor COVID-19 Vaccine Mandate Blocked in Three States and Numerous Additional Challenges Pending

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

On December 27, 2020, the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act opened up the Paycheck Protection Program (“PPP”) to additional organizations and authorized a second draw of PPP loans.  The U.S. Small Business Administration (“SBA”) has issued guidance on changes to the original Program and new second draw loans, and the Program has been partially reopened for both first and second draw loans as of January 13, 2021.  Loans will initially only be available through community financial institutions, but SBA has indicated that additional lenders will once again be able to participate in the Program on January 15, 2021, with a full reopening scheduled for January 19, 2021.

Similar to the Program’s original rollout, a number of questions remain with respect to SBA’s implementation of the Act.  SBA is also delaying guidance on changes to loan forgiveness, which may once again place borrowers in the position of taking out loans without knowing whether they will be fully forgiven.  However, SBA has now been managing the Program for almost ten months, and borrowers will hopefully not be subject to the same level of policy shifts and reversals that was experienced during the Program’s original rollout.

The Act makes first and second draw loans available until March 31, 2021, but there is a good chance that all available funds will be allocated before that date.


Continue Reading Paycheck Protection Program Expands and Offers Opportunity for Second Draw Loans

Last week, President Trump issued an executive order aimed at encouraging the expansion American manufacturing of essential medical products — Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States (August 6, 2020) (the “Order”).  The Order sets forth an ambitious plan requiring extensive agency action on a tight timeline that suggests a significant impact.  Closer examination of the Order raises significant questions about the practicalities of implementation and the realistic impact of the Order once the substantial stated exceptions are taken into account.

The List

The heart of the Order is a list of Essential Medicines, Medical Countermeasures (“MCMs”), and Critical Inputs to which the Order’s requirements apply — but the key components of this list do not yet exist.  Instead, the Order directs the Food and Drug Administration (“FDA”) to produce the list within 90 days and to include on the list Essential Medicines, MCMs, and Critical Inputs “that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.”

The Order provides the following definitions that give some insight into what may be on the FDA’s eventual list:
Continue Reading Trump Administration Increases Uncertainty for Pharmaceutical Manufacturing

A recent Armed Services Board of Contract Appeals decision serves as a timely reminder for contractors to carefully read and consider any release of claims before signing — especially when you may have otherwise-recoverable coronavirus-related cost increases.
Continue Reading Look Before You Release — ASBCA Enforces Release of Claims to Contractor’s Detriment