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
FDA’s 2023 Labeling Draft Guidance: Dosage and Administration Regulation
The biotech and pharmaceutical industries are on the cutting edge of innovation and arguably drive the progress of humanity. The speed at which this metamorphosis takes place is often faster than legislators and regulatory bodies can keep up. When they do finally catch up, it can force progress into a screetching halt in order to make sense of new guidelines or restrictions. To help ease some of the burden, this post Read More
FDA Proposes New Rules for the Pharmaceutical Supply Chain
In February 2022, FDA proposed new rules for the licensure of wholesale drug distributors (WDDs) and third-party logistics (3PL) providers. These rules, if approved, would amend 21 CFR parts 10, 12, 16, and 205. Click here for the text. If approved in their current form, FDA’s new rules would not only expand the class of persons subject to licensure, but also preempt many state and local licensure requirements, Read More
Off-Label Drug Promotion: a Right or a Crime?
The U.S. Food and Drug Administration (FDA) enjoys broad regulatory authority to police the approved-products market to protect public health. This authority is backed by an array of civil and criminal penalties FDA can impose to deter manufacturers from promoting products for intended uses outside of those which FDA has previously approved. This practice is commonly known as “off-label” promotion. More recently, Read More
Force Majeure in a Time of COVID
The COVID-19 pandemic and its shadow continue to loom over businesses, supply chains, and more. The true scope of the challenges and changes imposed by COVID-19 continues to be learned as the economy and society adjust. But one immediate consequence is known: for the first time in a long time, businesses are having to seriously read and implement force majeure clauses to determine their respective rights and defenses Read More
