Jenna McCarthy
Associate
Jenna McCarthy is an associate in the life sciences regulatory and compliance group. During law school, Jenna served as the notes development editor for the Vanderbilt Journal of Transnational Law, and was an active member of the Vanderbilt Moot Court Board. She also served as the president of the Vanderbilt Women Law Students Association.
Before law school, she taught English in Chiang Mai, Thailand through a Princeton-in-Asia fellowship, and worked as a paralegal at Ropes & Gray.
Experience
- Evaluated promotional claims and marketing materials for a variety of pharmaceutical, medical device, and consumer products companies.
- Performed FDA regulatory diligence for corporate transactions involving pharmaceutical, medical device, animal drug, food, and cosmetics companies.
- Conduct FDA regulatory diligence for initial public offerings and follow-on offerings of pharmaceutical, biotech, and medical device companies.
- Advised pharmaceutical companies regarding Hatch-Waxman considerations, including completion of the patent listing process, patent disputes, and issues related to patent exclusivity, patent term extension, and patent certification.
- Assisted a pharmaceutical company with an internal investigation related to compliance, data integrity, Good Manufacturing Practices, and other quality concerns.
- Assisted a medical device company with federal government investigation and corresponding internal investigation related to one of its medical device products.
- Advised private equity clients regarding implications of the CARES Act to FDA-regulated life sciences portfolio companies.
- Provide ongoing advice to pro bono client regarding latest FDA guidance and emergency use authorizations for COVID-19 personal protective equipment and in vitro diagnostic tests.
Publications
- Co-author, “Federal Funding of Medical Countermeasures: Opportunities, Risks, and Enforcement Trends,” Food and Drug Law Institute’s (FDLI) Update (December 5, 2022) (Reprinted with permission of FDLI)
- Co-author, “The American Medical Product Supply Chain: Will COVID-19 Drive Manufacturing Back Home?” Food and Drug Law Institute’s Food and Drug Law Journal (October 15, 2021) Published with permission of FDLI and the Food and Drug Law Journal
- Co-author, “High Court's AMG Ruling Could Hinder FDA Enforcement” Law360 (May 5, 2021)
- Co-author, “Potential Costs of Reshoring Pharmaceutical Manufacturing,” Bloomberg Law (April 7, 2021)
- Co-author, “Incentives And Risks From OTC Drug Monograph Revamp” Law360 (May 29, 2020)
Education
- JD, Vanderbilt University Law School, 2019; Notes Development Editor, Vanderbilt Journal of Transnational Law
- AB (Politics), Princeton University, 2013
Admissions / Qualifications
Qualifications
- District of Columbia, 2020