Liz Lindquist counsels drug, biologic and medical product manufacturers, distributors and investors, among other life sciences industry stakeholders, on a broad range of regulatory, compliance, transactional, investigation, litigation, and legislative issues involving federal and state government healthcare agencies and enforcement authorities. Her practice focuses in part on advising clients on complex drug price calculations and related reporting and contracting matters.
Throughout the COVID-19 pandemic, Liz has represented numerous clients in a wide variety of federal procurement and contracting matters, including extensive work pertaining to the US government’s invocation of the Defense Production Act (DPA) and use of other emergency contracting procedures. She provides strategic counsel on federal funding and procurement opportunities and related interactions with Congress and key federal officials, agencies and task forces involved in pandemic response and future preparedness efforts, including the White House COVID-19 Task Force, the US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) and Biomedical Advanced Research and Development Authority (BARDA), and US Department of Defense procurement authorities. Liz is also well versed in federal and state “Buy American” (i.e., domestic preference) policies and initiatives, developing and implementing clients’ government-advocacy strategies around the potential business opportunities and risks associated with the onshoring of essential medical supply chains.
- Counsel life sciences companies on the US government’s procurement of medical supplies and services, including federal contract negotiation, administration, and performance, novation and assignment of claims, M&A and strategic partnerships/joint ventures, country-of-origin compliance, and enforcement defense matters.
- Advise pharmaceutical and biotechnology manufacturers on drug pricing issues under the 340B Drug Pricing Program, Medicaid Drug Rebate Program, Medicare Parts B and D, US Department of Veterans Affairs Federal Supply Schedule Program, the TRICARE Retail Refund Program, and state-specific drug pricing and supplemental rebate regimes.
- Assist in the development and implementation of government price calculation and reporting policies, procedures, systems, methodologies, and reasonable assumptions.
- Provide guidance on internal audits of drug price calculation and reporting practices and assist with related recalculation and reconciliation of historic pricing, including coordination among affected government programs.
- Advise clients regarding market entry and portfolio management, bona fide service fee analyses, potential government program liability under commercial contracting and discounting arrangements, bundling identification and allocation, class of trade assignment, inclusion/exclusion determinations, and other complex government pricing requirements and considerations.
- Support clients in interactions with the US Department of Justice, Centers for Medicare & Medicaid Services, Health Resources and Services Administration, US Department of Health and Human Services Office of Inspector General, and the US Department of Veterans Affairs Office of Inspector General.
- Represent manufacturers of COVID-19 therapies and supplies in connection with inquiries from Congress and other oversight and enforcement authorities regarding pandemic response-related federal contract awards.
- Advise life sciences companies on the operation and application of the Defense Production Act, compliance issues and commercial considerations associated with Defense Production Act contracts and rated orders, including the implications of Defense Production Act invocation on supplier relationships and strategic supply chain and business impact planning, and the intersection between US Food and Drug Administration regulatory requirements, federal contracting obligations, and Defense Production Act contracts and rated orders.
- Assist life sciences and manufacturing clients with government advocacy efforts to secure funding and legislative and policy changes to facilitate expansion of domestic manufacturing operations.
- Draft comments to HHS and other executive branch agencies on behalf of pharmaceutical, medical device and biotechnology manufacturers and distributors on proposed rules and guidance regarding price reporting and federal procurement issues.
- Counsel life sciences companies on the applicability of, and compliance with, the requirements of state drug and sharps disposal (i.e., “take-back”) laws.
- Obtained with co-counsel the dismissal of a qui tam lawsuit brought by a relator alleging that a pharmaceutical manufacturer client avoided its obligation to return nearly $19 million in Medicaid Drug Rebate Program overpayments to the federal government, in violation of the False Claims Act.
- Negotiated on behalf of a client a $29 million contract awarded by the US Department of Health and Human Services under the Defense Production Act to supply the federal government with millions of N95 respirator masks during the COVID-19 pandemic.
- Assisted a medical device manufacturer with the negotiation, execution and implementation of a $25.4 million contract awarded by the US Department of Health and Human Services under the Defense Production Act for thousands of ventilators during the COVID-19 pandemic.
- On behalf of a pharmaceutical company client, successfully challenged a US Department of Veterans Affairs Office of Inspector General finding of $3.2 million in overcharges related to non-Trade Agreements Act-compliant pharmaceutical products sold to federal government agencies, with the government absolving the alleged overcharges in their entirety.
- Assisted a pharmaceutical manufacturer client temporarily stay termination from the Medicaid Drug Rebate Program, achieving this uncommon result by navigating highly complex legal and operational obstacles.
- Together with co-counsel, secured from the Centers for Medicare & Medicaid Services a unique and unprecedented resolution of a critical Medicaid Average Manufacturer Price issue for a pharmaceutical manufacturer client estimated to save the client more than $40 million over the life of its product.
- Served as the government contracts subject matter expert for a client’s $600 million acquisition of a company with significant revenue tied to federal contracts; managed all aspects of the diligence related to federal contracting compliance obligations, risks and post-transaction requirements and drafted relevant terms for the applicable deal documents.
- JD, Saint Louis University, 2009
- BA, Biology and History, with honors, Williams College, 2005
- District of Columbia
- New York