Panoramic: Automotive and Mobility 2025
Advertising and Promotion Compliance
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Our lawyers help companies balance legal compliance with their business objectives helping them to navigate the current environment, highlighted by evolving U.S. Food and Drug Administration (FDA) and EU Member States laws. From regulations and policies governing medical device labeling, advertising and promotion; to the ever-expanding types of media platforms available to companies to promote their devices, the Internet to social media; and ongoing, steady government enforcement.
We advise clients on all aspects of product promotion, from what constitutes permissible discussion of investigational devices to the scope of allowable promotion of cleared, approved, and CE marked devices. We help clients craft promotional strategies that benefit their business while complying with the requirements of the Federal Food, Drug and Cosmetic Act (FDC Act) and FDA regulations, as well as intersection U.S. Federal Trade Commission (FTC) regulations and health care laws, such as anti-kickback statutes and the False Claims Act.
We also counsel on the nuanced and evolving aspects of this area, including First Amendment challenges of FDA and EU restrictions on off-label promotion; avenues for the dissemination of off-label information; the extent to which a manufacturer can be held responsible for third-party materials on traditional and newer media platforms; and the regulation of social media as a marketing tool.
Our services are wide ranging, and include reviewing product promotional materials and programs for compliance with FDA and, when appropriate, FTC, the U.S. Department of Justice (DOJ), and international regulations.
Our capabilities at a glance
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Judicial review wins
2
Ex-government policy advisors
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Pieces of legislation changed
Hear from our clients and industry leaders
The whole team is super smart. They are all really easy to work with and then know our business inside out. They come to us proactively with issues and are incredibly responsive.
Chambers & Partners, UK Guide, 2025
An intellectually brilliant and commercially astute public law team. One of the very best in the city.
Chambers & Partners UK 2025
Hogan Lovells has a high capability in solving complex issues that involve both legal and technical perspectives.
Chambers & Partners, Germany, 2025
The lawyers are just experts. They are there when you need them and happy to entertain all my questions. They understand the wider context and the politics and sensitivities of it.
Chambers & Partners, UK 2025
Representative experience
Conduct internal investigations of promotional practices.
Conduct one-off reviews or wholesale audits of promotional materials and activities on traditional and alternative media platforms.
Sit on clients’ standing promotional review committees (PRCs).
Conduct salesforce trainings on FDA requirements and expectations with respect to advertising and promotion.
Conduct advertising and promotional trainings for every size of device firm, and for every level within these firms, from C-suite to sales representatives, to lay the groundwork for effective and compliant marketing.
Work with clients to develop SOPs governing the review and approval of promotional materials.
Counsel clients on the inter-relationships between FDA requirements and health care laws to assist these companies in developing and implementing corporate policies and procedures aimed at compliance.
Conducted a corporate investigation of sales and marketing practices, and advised senior managers and corporate boards on the risks and benefits of strategies and tactics.
Conducted internal investigations and compliance audits to ensure that promotional activities did not violate the Federal Food, Drug, and Cosmetic Act.
Review client websites and sit on Promotional Review Committees to assess regulatory risk from proposed promotional strategies and recommend revisions to mitigate risk in delivering key marketing messages.
Assist clients in assuring compliance with European Union and member state requirements and streamlining U.S. and OUS marketing procedures and practices to ensure global compliance.
Awards and recognitions
Band 1 for Healthcare and Healthcare: Pharmaceuticals/ Medical Products - District of Columbia Chambers USA
2020
Highly Recommended for FDA Medical Devices, LMG Life Sciences
2019
Regulatory Firm of the Year, LMG Life Sciences Awards
2018-2019
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