Michael Purcell joined Ropes & Gray’s corporate department in 2019 and practices primarily in the life sciences regulatory and compliance and health care groups. During law school, Michael served as the executive editor of the Columbia Journal of Law & Social Problems and as the president of the Columbia Health Law Association. Michael also worked to draft and advocate for federal and local health care legislation as a member of the Columbia Health Justice Advocacy Clinic, and he spent a semester as an intern for the Honorable Magistrate Judge Steven M. Gold of the Eastern District of New York.
- Assisted pharmaceutical companies with internal investigations related to compliance, data integrity, Good Manufacturing Practices, and other quality concerns.
- Performed FDA regulatory diligence in numerous corporate transactions involving pharmaceutical, medical device, and animal health companies, including IPOs and follow-on offerings, mergers and acquisitions, and an acquisition of a line of OTC products.
- Advised a pharmaceutical company on a potential appeal of FDA’s denial of its request for breakthrough therapy designation.
- Advised pharmaceutical companies on advertising and labeling matters, including concerns about potentially misleading imagery, the process for updating labeling to add new contraindications or warnings, and adherence to labeling requirements under the Pregnancy and Lactation Labeling Rule.
- Advised a pharmaceutical client on issues relating to pediatric exclusivity.
- Advised an academic research institution regarding emergency use authorization (EUA) requirements and pathways, and assisted in the pre-EUA and EUA submission process during the COVID-19 public health crisis.
- Co-author, “Analysis: FDA Response to COVID-19: A Shifting Landscape,” Ropes & Gray Alert (June 29, 2020)
- Co-author, “Pandemic May Spur Reform of Lab Test Regulation,” Law360 (April 7, 2020)
- Michael Purcell, Settling High: A Common Law Public Nuisance Response to the Opioid Epidemic, 52 Colum. J.L. & Soc. Probs. 135 (2018)
- JD, Columbia Law School, 2019; James Kent Scholar; Executive Editor, Columbia Journal of Law & Social Problems
- BA (Political Science & Religion), cum laude, Columbia College, Columbia University, 2016