Summary: FDA marketing rules draw a clear line: you sell the benefit, but you don’t rewrite the label. Product names, taglines, and claims all signal “intended use,” and reviewers read between every line. Teams that anchor copy to approved language, build an internal claim grid, and pressure-test campaigns before launch protect both revenue and reputation. In the 80s and 90s, pharmaceutical brand names tried to tell Read More
When Marketing Outruns Approval: What Regulated Industries Can Learn From Pharma
Summary: Pharmaceutical marketing operates at the edge of federal regulation, competitor scrutiny, and scientific proof. Recent Lanham Act disputes, including Section 43(a) claims tied to product labeling and advertising, show how quickly ambition can outpace compliance. The lessons extend far beyond pharma. Any regulated industry making performance or safety claims faces similar exposure when substantiation lags Read More
Navigating Regulatory and Business Challenges in Highly Regulated Industries
Before 2018, Elizabeth Holmes and Theranos, the company she founded, were lauded nationally and internationally for a magic box that promised a new era in democratized healthcare. On that promise, Theranos attracted some $700 Million in funding, signed a deal with Walgreens, and reached the dizzying heights of a $10 Billion valuation – all without turning a profit. The truth, however, was that Theranos’ magic box Read More
