Gardner Law counsels clients on the labeling, advertising, and promotion of FDA-regulated products, such as pharmaceuticals, medical devices, diagnostics, and others.
The advertising and promotion of therapeutic and diagnostic products continues to evolve on both regulatory and technological fronts. Gardner Law is in tune with these changes and counsels clients on the labeling, advertising, and promotion of their FDA-regulated products – all based on real-world industry experience. Gardner Law understands how to launch new products, develop prescriber and patient advertising campaigns, create websites, and use social media, paid search and micro blogging sites to promote products, while aligning with contemporary FDA thinking. Gardner Law also works with Clinical- and Medical- Affairs functions to design and implement policies that ensure lawful 1st Amendment-protected dissemination and communication of information, in a fashion that is consistent with FDA policy.
- Acting as a member of your copy-review team, i.e., Medical, Legal, and Regulatory (MLR) team, or Labeling and Advertising Review (LAR) Team
- 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.
- 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
- Counseling companies on complex FDA requirements relating to responding to off-label questions and requests for off-label information
- 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