Zachary Zalewski

Zachary Zalewski’s education and experience have brought him to Avalere to stand at the intersection of science and law.

As a member of Avalere’s team, he provides a holistic perspective in supporting clients through the FDA regulatory and policy environments. Trained in genetics, he has broad technical knowledge and expertise in molecular biology and related disciplines. From his legal studies, he has experience with statutory interpretation, regulatory analysis, and case law.

Prior to joining Avalere and while in law school, Zach clerked at a Cleveland intellectual property law firm and spent a semester at The Hastings Center, a nonpartisan bioethics research institute. He completed his legal studies, successfully passed the New York State bar exam in 2018, and earned a qualifying Uniform Bar Exam score for multiple jurisdictions. Having recently moved to Washington, DC, he is completing his admission to the District of Columbia Bar.

Zach has a JD from Case Western Reserve University with a health law concentration, a PhD in molecular and human genetics from Baylor College of Medicine, and a dual major BS in microbiology and history from Michigan State University.

Authored Content

As life sciences companies sprint toward COVID-19 vaccines and therapies, the discussion below considers who has the authority to make the call on their availability at the Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS).

The CMS proposes to define line extension under the MDRP to broadly include any product that has at least one ingredient in common with the original drug, even if it is a different dosage form. If finalized, this change would have significant implications on classification and rebate liability for a wide set of current and future products.

The US market has seen a recent surge in cannabidiol (CBD) use and sales, despite many of these marketed CBD products being unregulated and untested for most of the claimed indications.

As the novel coronavirus disease (COVID-19) continues to change daily life, concerns about the impact on global supply chains and possible drug shortages have increased. Additionally, changes to FDA processes may limit its ability to perform essential drug related activities.

The replacement to North American Free Trade Agreement (NAFTA), the United States-Mexico-Canada Agreement, was originally proposed to increase biologics exclusivity in Mexico and Canada to 10 years. As part of the Administration’s compromise with the House of Representatives, these provisions have been removed from the amended version that was recently agreed to by the US, Mexico, and Canada. While exclusivity in the US remains unchanged at 12 years, that it is not increased for Canada and Mexico may impact market entry for biologics ex-US.

The USMCA’s intellectual property provisions add additional layers of ambiguity to the already complex issues surrounding biological product exclusivity and its future in US law.