Overview
The marketing activities of companies in the health care and life sciences sectors draw far more regulatory scrutiny than most other industries. As new and innovative products come to market, the companies behind them must navigate a dense regulatory environment in which any marketing misstep can carry onerous repercussions, both legal and reputational.
Our lawyers take a pragmatic, multidisciplinary approach to the strategic and tactical considerations of our clients’ product marketing efforts. This lets our clients market as aggressively as their risk level allows while maintaining compliance with regulatory requirements.
Analyzing Marketing Materials
We regularly serve on our clients’ promotional review committees, where they trust us to become part of the team tasked with implementing effective marketing and promotional content while mitigating legal and compliance risks. We advise our clients on pre- and post-approval product communications, helping them navigate divergent rules for their scientific, promotional, and investor communication. Our team regularly guides clients regarding substantiation of their product claims, ensuring that they comply with U.S. Food and Drug Administration (FDA) and Federal Trade Commission advertising and promotion rules. We also assess their competitors’ communications and will reach out to regulators on behalf of our clients who are concerned about dubious products or product claims entering the market.
Marketing on Social Media
The rise of social media as a mainstream marketing tool has brought with it regulatory challenges that continue to evolve. Our clients trust us to stay abreast of compliance issues associated with novel marketing platforms and approaches to enable them to quickly maneuver and take advantage of new opportunities. We review their strategies and promotional materials, recommending guardrails to mitigate risks associated with their use. We advise them on the training and use of product influencers, and we help them put in place the controls—both contractual and procedural—that maintain optimal compliance in online environments.
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Focus Areas
Experience
- Represented numerous individual companies and trade associations in their efforts to ensure that health care economic information was appropriately shared while maintaining compliance with FDA requirements.
- Advised pharmaceutical and biotechnology companies on compliance-related issues in order to support the development and commercialization of their products.
- Conducted an assessment of a large, global medical device company’s development and use of health economic and reimbursement information in its promotional materials. Based on the results, we developed policies to ensure the appropriate use of this information and trained the company's personnel on the regulatory framework governing the use of the information.
- Assisted a large medical device manufacturer in developing and successfully implementing a comprehensive system of Good Promotional Practices that achieved both compliance and the manufacturer's marketing objectives.
- Helped many companies successfully respond to FDA Warning Letters challenging their promotional activities, often representing them in associated meetings with the FDA and other federal agencies.
Contacts
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Events
Upcoming Events
Past Events
- August 25, 2022
- September 28, 2021
Insights
Insights
- Media CoverageBBA Spotlight Series: Get to Know Emerging Leaders in Boston Law–Marylana Saadeh Helou8 minute read
- Blogs
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
41 minute read - Media CoverageJames Boiani Quoted in “Jazz Pharma to Fight FDA in Court Over Rival Sleep Drug Approval”5 minute read
- PublicationsThe Legal and Reputational Risks Associated with Greenwashing3 minute read
- Media CoverageBob Hearn Quoted in “Concerns Mount as More States Adopt Biomarker Laws”2 minute read
- PublicationsEnsure Equity and Feasibility in Updating Meningococcal Vaccine Recommendations2 minute read
- Media CoverageBradley Merrill Thompson Discusses Clinical Decision Support, Medical Devices, and AI in Yale Video1 minute read
- Firm AnnouncementsEpstein Becker Green Announces 2024 Promotions6 minute read
- BlogsSharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft ...14 minute read
- BlogsInfluencers, Brand Ambassadors and Marketers Take Note – FTC Has Finalized Updates to Its Endorsement Guides7 minute read
- PublicationsDietary Supplement Makers Face "Misbranding" Minefield, Need FDA Guidance7 minute read
- Firm Announcements
Jessika Tuazon Named to the 2023 Southern California Rising Stars List
6 minute read - Media CoverageBradley Merrill Thompson Quoted in “Ready or Not, AI Chatbots Are Coming to Hospitals”3 minute read
- PublicationsWhy a Data Scientist Needs a Lawyer to Correct Algorithmic Discrimination4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Draft Guidance Allows AI/ML Devices to Evolve Without Requiring New ...5 minute read
- PublicationsBradley Merrill Thompson Quoted in “FDA’s Human Factors Draft Draws Fire for Introduction of ‘Critical Task’ ...2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Outlines Plan for Digital Health Technologies for Clinical Trials”4 minute read
- Media CoverageJames Boiani Quoted in “FDA Resumes Move to Regulate LDTs, Likely Setting Up Legal Battle with Lab Industry” ...3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Growth of AI in Mental Health Raises Fears of Its Ability to Run Wild”4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “The FDA Plans to Regulate Far More AI Tools as Devices. The Industry Won’t Go Down ...2 minute read
- Media CoverageBradley Merrill Thompson Discusses FDA Regulatory Hurdles for Breakthrough Devices2 minute read
- Media CoverageBradley Merrill Thompson and the CDS Coalition Request FDA Rescind Final Decision Support Guidance2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Why Congress Quietly Just Gave the FDA More Power”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Industry Group Petitions FDA to Withdraw CDS Guidance”5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Trade Group Pushes Back on FDA’s Clinical Decision Support Guidance”3 minute read
- Media CoverageJames Boiani, Bradley Merrill Thompson Quoted in “And Over at FDA …”2 minute read
- PublicationsFTC’s Revisions to Dietary Supplement Advertising Guidelines: More of the Same2 minute read
- Media CoverageJames Boiani Quoted in “Congress Has a Chance to Close the FDA’s Theranos Loophole”3 minute read
- Media CoverageOffice Snapshot: Epstein Becker Green's New Nashville Outpost3 minute read
- Firm AnnouncementsEpstein Becker Green Announces 2023 PromotionsOctober 28, 20225 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Torres Says Regulatory Alignment a Pressing Consideration for AI Change Control ...2 minute read
- Media CoverageJames Boiani Quoted in “Testing Overhaul Faces a ‘Narrow Pathway’ to Pass Before Year End, Industry Groups Say” ...3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Software to Predict Risk of Sepsis, Stroke Should Be Regulated as a Medical Device ...4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA’s Tweak of Mobile Medical Apps Guidance Introduces Transparency ...2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Acknowledges Shortcomings of Pre-Cert Pilot in Report”6 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Lays Out CDS Stance”1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Legal Expert: FDA’s CDS Software Guidance Is a ‘Disaster’ for Industry” ...3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Finalizes Guidance on How Clinical Decision Support Software Is Regulated” ...2 minute read
- Media Coverage
Bradley Merrill Thompson Featured in BioWorld: Discussion of FDA Guidance for CDS Software
1 minute read - Media CoverageBradley Merrill Thompson Quoted in “A ‘Disaster,’ or a ‘Clear Path’ Forward?: New FDA Guidance on AI in Medicine ...2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Talks Takeaways from Software Precert Pilot”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA’s Pre-Cert Pilot for SaMD Falters Over Lack of Statutory Authority” ...2 minute read
- Media Coverage
Bradley Merrill Thompson Featured in Medtech Monthly Podcast: Breakthrough Device Analysis
7 minute read - Firm Announcements
Epstein Becker Green’s Amy Dow Honored in Crain’s 2022 Notable Women in Law
2 minute read - Media CoverageEpstein Becker Green’s Unpacking Averages Report “Casts Doubt on Value of US FDA’s Breakthrough Devices Program” ...2 minute read
- Media CoverageBradley Merrill Thompson Featured in “Meet the Top 8 Lawyers Helping Startups Patent Artificial Intelligence and Comply ...2 minute read
- PublicationsRecent Actions Highlight That Price Fixing Reaches Beyond Agreements on the Ultimate Price1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Senate HELP Sends User Fee Reauthorization Bill to Floor Vote”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Should Step In to Help Spur AI/ML Standards”3 minute read
- Firm Announcements
Jessika Tuazon Named to the 2022 Southern California Rising Stars List
5 minute read