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Michael Purcell is a member of the firm’s life sciences regulatory & compliance practice group. He focuses his practice on FDA regulatory matters and advises life sciences and health care clients on a broad range of regulatory and compliance issues under the Food, Drug and Cosmetics Act and related laws. Michael routinely provides regulatory counsel for pharmaceutical, biotechnology, medical device, cosmetic, and food companies, as well as health care providers and academic institutions, on a broad range of issues including corporate transactions, regulation of digital health tools, and advertising and promotional issues.
Experience
Advertising and Promotion
- Routinely advises clients on advertising, promotional, and labeling matters, including issues related to pre-approval communications, scientific exchange, off-label communications, social media promotion, false and misleading language and imagery, and labeling updates.
- Routinely undertakes detailed website and promotional reviews and compliance advising for pharmaceutical, biologics, medical device, biotechnology, cosmetics, and dietary supplement companies.
- Drafted FDA trade complaints on behalf of medical device, drug, and biologics clients regarding the false and misleading advertising and promotion of competitor products.
- Advised pharmaceutical and biologics companies on strategy regarding advertising and promotional disputes with competitor companies.
- Advised pharmaceutical company on the use of paid and sponsored promotional materials on various digital platforms.
- Served as the legal and compliance reviewer on cosmetic company’s promotional review committee.
- Developed strategy for claim development for cosmetic company.
Digital Health
- Routinely advises medical technology and medical device companies regarding the FDA regulatory status and requirements for both existing and developing digital health software, remote health platforms, and other digital health technologies such as clinical decision support software, mobile medical apps, general wellness devices, and products that incorporate artificial intelligence and machine learning.
- Assisted a biotechnology client in responding to and disputing an FDA Warning Letter alleging that the company’s product constituted an uncleared and unapproved medical device.
- Counseled providers and academic medical centers on the research and clinical use of medical device software invented and developed in-house, as well as in collaboration with third party developers.
- Advised major pharmaceutical company on FDA regulation of digital health devices and companion products.
- Drafted comments for pharmaceutical and medical device companies regarding various FDA policies and proposals, including FDA’s final guidance on General Wellness: Policy for Low Risk Devices and draft guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices.
Transactional and Litigation Support
- Routinely provides regulatory counsel for corporate transactions involving pharmaceutical, drug compounding, biologics, digital health, medical device, cosmetic, animal health, and food companies, including IPOs and follow-on offerings, mergers and acquisitions, and SPAC transactions.
- Frequently advises pharmaceutical and medical device companies in connection with collaboration, licensing, manufacturing, and quality agreements.
- Assisted pharmaceutical and cosmetic companies with internal investigations into advertising, promotional, and labeling practices.
- Assisted pharmaceutical, medical device, and cosmetic companies with internal investigations related to compliance, data integrity, Good Manufacturing Practices, and other quality concerns.
- Drafted amicus briefs in Supreme Court and appellate court litigation involving questions implicating FDA’s regulatory framework for pharmaceuticals and medical devices.
Other Regulatory Advising
- Advises clients on issues related to clinical research, including clinical trial design and clinical research reporting requirements, with particular focus on the use of hybrid and decentralized clinical trials.
- Counsels clients on legal and policy issues throughout product lifecycles, including expedited development and approval incentives, Hatch-Waxman and exclusivity issues, issues related to the development and approval of therapeutically equivalent drugs, and the termination of NDAs that serve as RLDs for existing generic drugs.
- Drafted and reviewed policies, procedures, and committee charters—including those governing promotional activities, scientific communications, research and development, clinical trials, and GxP and quality activities—for a range of pharmaceutical and medical device clients.
- Advised an academic medical center on FDA regulatory considerations related to 3D printing and additive manufacturing of medical devices for in-house use.
- Advised a pharmaceutical company on a potential appeal of FDA’s denial of its request for breakthrough therapy designation.
- Advised medical device companies on issues related to recall and regulatory reporting decisions.
- Advised a medical technology company on issues related to HHS-OIG exclusion.
- Advised multiple companies on FDA regulation of infant formula.
- Assisted in the pre-EUA and EUA submission process for various products during the COVID-19 public health crisis.