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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.
Experience
- Advised various medical technology and medical device companies regarding the FDA regulatory status and requirements for both existing and developing digital health softwares, remote health platforms, and other digital health technologies.
- 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 digital health, medical device, pharmaceutical, drug compounding, animal health, and food companies, including IPOs and follow-on offerings, mergers and acquisitions, SPAC transactions, and an acquisition of a line of OTC products.
- Advised various clients on legal and policy issues throughout product lifecycles, including issues related to the development and approval of therapeutically equivalent drugs, and the termination of NDAs that serve as RLDs for existing generic drugs.
- Advised pharmaceutical companies on advertising, promotional, and labeling matters, including concerns about potentially misleading imagery, the processes and requirements for updating labeling, enforcement against unapproved promotional materials, and adherence to labeling requirements under the Pregnancy and Lactation Labeling Rule.
- Drafted an FDA trade complaint on behalf of a client regarding the false and misleading advertising and promotion of a competitor device.
- Advised a medical technology company on issues related to HHS OIG exclusion.
- Advised pharmaceutical and medical device companies on issues related to clinical research, including clinical research reporting requirements.
- Advised pharmaceutical clients on issues relating to pediatric, orphan drug, and other forms of exclusivity.
- Advised a pharmaceutical company on a potential appeal of FDA’s denial of its request for breakthrough therapy designation.
- Advised a human medical device manufacturer on issues relating to off-label veterinary use.
- Assisted in developing and undertaking a review of FDA classification for a medical device company’s portfolio of immunohistochemical products.
- Advised numerous institutions, including academic research institutions, medical device companies, and pharmaceutical companies regarding emergency use authorization (EUA) requirements and pathways, and the implications of pursuing such authorizations.
- Assisted in the pre-EUA and EUA submission process for various products during the COVID-19 public health crisis.