Promotional Labeling and Advertising Review

Unique. Convenient. Well-tolerated.

It would be the dream of every life sciences company to freely use those words (and more) to describe its products. But according to FDA, without adequate, well-controlled studies, that dream may never become reality.

That’s where Porzio comes in. We are passionate about counseling life sciences companies on how to advertise and promote their FDA-regulated products.  To help meet client's business objectives while minimizing risks, we:

  • Review and analyze promotional labeling and advertising from a Regulatory perspective.
  • Evaluate materials and from a Legal perspective. We consider:
    • compliance with federal, state and local laws and regulations, as well as standards imposed by industry organizations
    • product liability and consumer fraud litigation risks
    • unfair competition claims by competitors
    • potential enforcement action from the FDA and FTC
  • Provide coordination services related to meeting management and document/version control

So, what makes us different?  We have the experience.  Our attorneys have years of experience participating on promotional review committees and providing guidance on how to accomplish marketing objectives without unduly exposing the company to government violations or claims by consumers or competitors.  We sit at that table. We know what it’s like. And we know what it takes.

Plus, we have at our fingertips, access to our subsidiary, Porzio Life Sciences, LLC’s, OPDP Violations Database which contains searchable summaries of Untitled and Warning Letters issued by the FDA's Office of Prescription Drug Promotion (OPDP).  That means we can search for a letter based on close to 90 search criteria; basic searches from entity name, product name, type of material, to advanced searches based on the actual violation.  We can layer searches and conduct general text searches. We’ve read the letters, we know the letters, we live by the letters.  We understand the challenges and see the bigger picture.

We help Life Sciences companies. That’s just what we do.