FTC Rules for Pharma Companies

In this discussion, Joseph Wolfson, an attorney at Stevens and Lee, and Darshan explore the intersection of law, marketing, and compliance in the pharmaceutical and medical device industries. Joe focuses on both antitrust litigation and advising private equity firms, pharmaceutical companies, and medical device companies on legal matters, particularly around unfair competition and antitrust concerns.

Joe explains how his firm helps private equity clients during the investment process by conducting due diligence, analyzing IP protection, and addressing potential FDA and marketing issues. Post-investment, the firm often acts as outside general counsel for the medical device or pharmaceutical companies, ensuring they stay compliant while maximizing shareholder value.

A key focus of the conversation is the complex regulatory landscape for medical products, where both the FDA and FTC play critical roles. While the FDA regulates the safety and efficacy of products, the FTC ensures that marketing practices do not mislead consumers. State Attorneys General (AGs) also play a role in protecting consumers, though their jurisdiction can differ depending on the state. Joe stresses that companies need to be aware of the overlapping but distinct concerns from these agencies when marketing their products.

Joe also highlights the ongoing risks of non-compliant marketing, specifically discussing litigation related to false advertising and misleading claims under the Lanham Act, as well as consumer litigation for personal injury claims arising from product misuse or misrepresentation.

Finally, Joe offers advice for marketers, emphasizing the importance of distinguishing between "puffery" (subjective opinions) and factual claims, especially in advertising. He warns companies to be able to back up any factual claims with solid evidence, as misleading marketing can lead to serious legal consequences.