Photo of Jennifer Plitsch

Jennifer Plitsch leads the firm’s Government Contracts Practice Group, where she works with clients on a broad range of issues arising from both defense and civilian contracts including contract proposal, performance, and compliance questions as well as litigation, transactional, and legislative issues.

She has particular expertise in advising clients on intellectual property and data rights issues under the Federal Acquisition Regulations (FAR) and obligations imposed by the Bayh-Dole Act, including march-in and substantial domestic manufacturing. Jen also has significant experience in negotiation and compliance under non-traditional government agreements including Other Transaction Authority agreements (OTAs), Cooperative Research and Development Agreements (CRADAs), Cooperative Agreements, Grants, and Small Business Innovation Research agreements.

For over 20 years, Jen’s practice has focused on advising clients in the pharmaceutical, biologics and medical device industry on all aspects of both commercial and non-commercial agreements with various government agencies including:

  • the Department of Veterans Affairs (VA);
  • the Department of Health and Human Services (HHS), including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), and the Centers for Disease Control (CDC);
  • the Department of Defense (DoD), including the Defense Threat Reduction Agency (DTRA), the Defense Advanced Research Projects Agency (DARPA), and the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBRN); and
    the U.S. Agency for International Development (USAID).

She regularly advises on the development, production, and supply to the government of vaccines and other medical countermeasures addressing threats such as COVID-19, Ebola, Zika, MERS-CoV, Smallpox, seasonal and pandemic influenza, tropical diseases, botulinum toxin, nerve agents, and radiation events. In addition, for commercial drugs, biologics, and medical devices, Jen advises on Federal Supply Schedule contracts, including the complex pricing requirements imposed on products under the Veterans Health Care Act, as well as on the obligations imposed by participation in the 340B Drug Pricing program.

Jen also has significant experience in domestic sourcing compliance under the Buy American Act (BAA) and the Trade Agreements Act (TAA), including regulatory analysis and comments, certifications, investigations, and disclosures (including under the Acetris decision and Biden Administration Executive Orders). She also advises on prevailing wage requirements, including those imposed through the Davis-Bacon Act and the Service Contract Labor Standards.

President Biden recently signed bipartisan legislation reinforcing anti-human trafficking prohibitions. The End Human Trafficking in Government Contracts Act of 2022 builds on the existing anti-human trafficking framework at Federal Acquisition Regulation (“FAR”) § 52.222-50 (Combatting Trafficking in Persons) by requiring agencies to refer contractor reports of potential human trafficking activity directly to an agency suspension and debarment official (“SDO”).  Prior to this legislation, contractors have been required to notify their contracting officer and the agency inspector general upon receiving “[a]ny credible information” that a human trafficking violation had occurred.  See FAR § 52.222-50(d)(1).  Now agencies will be required to refer these reports to their SDOs, creating additional risk for contractors that disclose potential violations. 

Continue Reading New Law Increases Government Scrutiny of Contractor Compliance with Anti-Trafficking Provisions

On September 12, 2022, President Biden issued an Executive Order (“E.O.”) announcing the National Biotechnology and Biomanufacturing Initiative, a “whole-of-government” effort to further biotechnology and biomanufacturing innovations in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.  The White House subsequently announced that the Initiative would cost $2 billion.  If successful, the Initiative could have sweeping impacts across the entire biotechnology research and development (“R&D”) lifecycle.  A summary of the E.O., its requirements, and key takeaways are set forth below.

Continue Reading President Biden Issues Executive Order on National Biotechnology and Biomanufacturing Initiative

Update as of September 15, 2022:  OFCCP has extended the deadline by one month for contractors to submit objections to the FOIA request described in this article.  The new deadline is October 19, 2022.  Additionally, in an effort to clarify which government contractors are covered by this FOIA request, OFCCP has indicated that it will be reaching out to “contractors that OFCCP believes are covered by this FOIA request” using the “email addresses provided as a contact for the EEO-1 report” through OFCCP’s Contractor Portal.

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In response to a broad Freedom of Information Act (“FOIA”) request the Office of Federal Contract Compliance Programs (“OFCCP”) may produce the Employment Information (“EEO-1”) Type 2 filings of up to 15,000 government contractors unless written objections are filed by September 19, 2022.  This blog post explains the information that OFCCP has been asked to release and factors that government contractors should consider in deciding whether an objection to the release of this information is appropriate and advisable.

Continue Reading OFCCP Seeks Input On Potential FOIA Disclosure of Contractor Employment Information

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

On August 25, 2022, President Biden announced a new Executive Order (“EO”) addressing the Implementation of the CHIPS Act of 2022 (“CHIPS Act”).  The CHIPS Act was signed by President Biden on August 9, 2022, and, among other things, authorizes $39 billion in funding for new projects to establish semiconductor production facilities within the United States.  The new EO identifies the Administration’s implementation priorities for this CHIPS Act funding and creates the CHIPS Implementation Steering Council to aid with the rollout of administrative guidance.  In connection with the EO, the Department of Commerce launched CHIPS.gov, which is intended to be a centralized resource for potential applicants of CHIPS funding.  The EO and new website reflect the Administration’s intent to swiftly implement the CHIPS Act and increase the domestic production of semiconductors. 

Continue Reading Biden Administration Announces Priorities for the Implementation of the CHIPS Act of 2022

Earlier this year, the Department of Labor’s Office of Federal Contractor Compliance Programs (“OFCCP”) opened the Contractor Portal, a new platform where covered federal contractors and subcontractors must annually certify whether they are meeting their requirement to develop and maintain written Affirmative Action Programs (“AAPs”).  As we previewed in June, OFCCP required covered

Many contractors are familiar with the Davis-Bacon Act (“DBA”), the statute that requires government contractors to pay prevailing wages to workers employed in the construction, alteration, or repair of buildings or other public works.  The DBA is enforced by the Department of Labor, which is responsible for issuing the “wage determinations” that list the prevailing wages for different labor categories within a geographical area and for promulgating regulations used to implement the DBA’s requirements.

On March 18, 2022, the Department issued a notice of proposed rulemaking (“NPRM”), announcing that it intends to make a number of revisions to the DBA regulations.  In the Department’s view, these revisions represent the largest change to the DBA regulations since the last major rewrite in 1981.

Continue Reading Department of Labor Proposes Overhaul to Davis-Bacon Act Regulations

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 December 2, 2021, the Department of Labor’s Office of Federal Contractor Compliance Programs (“OFCCP”) announced the creation of a new Contractor Portal.  Starting next year, federal prime contractors and subcontractors will be required to register on the portal and submit a formal certification, on an annual basis, as to whether they have developed and maintained an Affirmative Action Program (“AAP”) in accordance with OFCCP requirements.  If selected by OFCCP for a compliance review, contractors will use the same portal to upload their AAPs in addition to any other requested information.  The Contractor Portal is expected to open for registrations on February 1, 2022, with the certification features available March 31, 2022.  By June 30, 2022, all existing contractors and subcontractors must certify compliance with the AAP requirements.

Continue Reading OFCCP’s New Contractor Portal: What Contractors Need to Know

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