Gardner Law counsels clients on the labeling, advertising, and promotion of FDA-regulated products. Our attorneys apply real-world industry experience when reviewing product launch plans, prescriber and patient advertising campaigns, websites, social media, and paid search.
Out attorneys can sit on your promotional and medical review committees to ensure your product communications comply with the law.
Representative matters:
- Analyzing promotional claims to ensure they align with the cleared or approved intended use of a product; e.g., review brochures, websites, social media, direct-to-consumer advertising programs (help-seeking and reminder ads), education materials, TV ads, press releases, booth graphics, etc.
- Counseling companies on complex FDA requirements relating to responding to off-label questions and requests for off-label information
- Providing advice to companies with cleared or approved general intended uses; as well as 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
- Training medical device representatives on what to avoid while covering surgical cases
- Responding to regulators and competitors; as well as drafting trade complaints to regulators and competitors
- Providing benchmarks on company promotional practices, advertising claims, and compliance program design
- Training staff on FDA regulations
- Reviewing your existing labeling and advertising policy and procedures for the preparation of Sales, Marketing, and Reimbursement materials; or designing and implementing a labeling and advertising review policy and procedure
- Drafting disclosures and disclaimers
- Reviewing reimbursement materials and tools
