The advertising and promotion of pharmaceuticals and medical devices continues to evolve on both regulatory and technological fronts. Frier Levitt is in tune with these changes and counsels clients on the labeling, advertising, and promotion of FDA-regulated products.
Frier Levitt works with clients to launch new product designs, implementation, and promotion policies that ensure lawful First Amendment-protected dissemination and communication of information, in a fashion that is aligned with FDA thinking and safe harbors.
Our Healthcare and Life Science Experience
We apply many years of collective in-house industry experience in Scientific Affairs, Legal, and Drug Regulatory Affairs Departments. With a thorough knowledge of the various facets of labeling and advertising within the Food, Drug, Cosmetic, Medical Device and Biotechnology industries, our attorneys develop innovative solutions to a myriad of legal and technical issues. Our experience and successes in addressing the creation, production and dissemination of all kinds of advertising, marketing, and promotion material across all media allows us to help clients adapt and succeed in a world of rapid change.
Our Intellectual Property team has extensive experience in the Pharmaceutical Industry, and provides a full range of branding services, including clearance, prosecution, strategic portfolio management, enforcement, anti-counterfeiting and anti-piracy, dispute resolution and licensing.
Our clients include manufacturers and distributors of dietary supplements, pharmaceutical, biological, medical device, personal care and cosmetic products, as well as trade associations, individuals, and institutions.
What We Do
Understanding current enforcement landscape, key regulatory considerations, and common pitfalls can help navigate the complexities of risk-based decision-making across a range of media. Our attorneys regularly advise on all issues relating to the Food and Drug Administration (FDA) regulations as well as counsel clients in matters arising under various statutes, including the Lanham Act and the Federal Trade Commission Act, as well as the so-called “little FTC Acts” implemented by the states and product-specific labeling laws. Frier Levitt attorneys continue to be involved in FTC investigations and enforcement proceedings relating to FDC, medical device and dietary supplements as well as health and environmental claims in advertising.
Frier Levitt attorneys are fluent in FDA advertising and promotional requirements, including claim support requirements, fair balance expectations, internet and social media challenges, adherence and preference programs, and disease state programs. We evaluate and apply the appropriate evidentiary standards that guide the review of different materials. We are particularly active in the developing area of food and dietary supplement advertising and labeling issues in the wake of statutory and regulatory changes brought about by the Nutrition Labeling and Education Act of 1990 and the Dietary Supplement Health Education Act of 1994.
We are attuned to trends emerging from recent FDA Warning Letters and Untitled Letters in a post-Caronia world. We advise regularly regarding the complexities relevant to FDA Guidance’s such as the two FDA Guidance on off-label communications (Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities- Questions and Answers (June 2018); Medical Product Communications That Are Consistent With FDA-Required Labeling- Questions and Answers (Jan 2017). We provide comments for our clients on proposed regulatory guidance documents so they may inform agencies, for example, FTC’s “Guides Concerning the Use of Endorsements and Testimonials in Advertising.” We recognize current hot buttons such as emphasis on company Websites or increased enforcement coordination between the FDA and the DOJ (as evidenced by the Department of Justice’s (DOJ) recent scrutiny of patient-directed materials and recent False Claims Act settlements).
Fortified with extensive experience, our Intellectual Property team helps clients protect, enforce and leverage trademarks and copyrights. We provide a full range of IP services including:
- Searching, registering, and maintaining trademarks and copyrights
- Dealing with opposition, non-use and infringement actions, assisting with commercial transactions and providing experienced litigation services
- Registering, renewing, transferring and enforcing domain names
- Performing intellectual property due diligence in M&A, financing and other business transactions
- Negotiating purchase, sale and financing agreements related to intellectual property and assisting with the transfer of intellectual property rights and recording of security interests and assignments related to corporate transactions
- Strategic positioning of trademarked or copyrighted products and services through licensing and joint venture programs
- Negotiating distributorship, publishing, sponsorship, endorsement and similar types of agreements
Following are examples of representative matters handled by our advertising and labeling attorneys:
- Providing integrated legal advice on Pharmaceutical and device product launches and marketing strategies in multiple jurisdictions.
- Product labeling review, corrective advertising, comparative advertising and valuation of claims and substantiation – our attorneys advise on claim risks, ways to qualify or modify claims to reduce risk, and approaches to develop data to support claims.
- Endorsements and testimonials – our attorneys provide guidance on disclosing material connections when employees or third parties make claims about a company or its products.
- Advertising review procedures – our attorneys assist clients in developing internal processes for reviewing and approving claims.
- Challenges of competitive advertising before the networks and the National Advertising Division (NAD) and CARU – our attorneys challenge and defend challenges at the networks, the NAD and its appeals body, the National Advertising Review Board.
- FTC investigations and enforcement proceedings relating to alleged false, deceptive, or unfair advertising and promotion – our attorneys defend advertisers with respect to a wide range of products and services.
- False advertising disputes in state and federal courts and in alternative dispute resolution proceedings – our attorneys represent business plaintiffs and defendants in actions for injunctions and damages in Lanham Act false advertising, advertising contracts, trade dress, and common law unfair trade practice cases.
- Defense of consumer class actions based on allegedly false advertising claims – our attorneys defend advertisers involved in both federal and state class actions and private attorneys’ general actions for allegedly false advertising, including cases brought under liberal state statutes such as the California Legal Remedies Act (CLRA).
- Advice regarding new state transparency laws enacted around the country that demand certain price disclosures in promotional communications.
- Facilitate compliance with promotional submission types that will be required in eCTD format beginning in June 2021 pursuant to FDA’s Final Guidance “Providing Regulatory Submissions in Electronic and Non-electronic Format- Promotional Labeling and Advertising Materials for Human Prescription Drugs.”
- Representing clients subject to Warning Letters for specific claims that allegedly exceed a cleared or approved general intended use
- Designing lawful proactive off-label dissemination strategies and counseling companies on complex FDA requirements relating to responding to off-label questions and requests for off-label information
- Responding to regulators and competitors, as well as drafting trade complaints to regulators and competitors
- Training staff on FDA regulations
- Drafting disclosures and disclaimers
- Reviewing reimbursement materials and tools
Who We Represent
We represent clients in all matters involving advertising, marketing, intellectual property, and licensing.
Contact Us
For more information on Frier Levitt’s Advertising and Labeling capabilities, contact us today.