Marketing a medical device today is getting increasingly complicated and requires an increasingly sophisticated knowledge-base and skill set for executives, compliance, legal, marketers, sales management, field sales, regulatory affairs and clinical affairs professionals. For example, for better or worse, today’s CDRH is now getting more drug-like in their approach to the review of advertising and promotional claims, meaning more granular and specific. They have brought personnel from CBER in to bring more rigor to device advertising and review. There are so many ways to invoke the attention and prosecutorial ire of the government’s administrative enforcement machinery. Yet there are still many ways to navigate this environment lawfully to be appropriately aggressive, yet compliant. Each course can be taken separately or as a package (the pricing will provide incentives to take more than one). It will be a good training set for employees of any large, medium or small company.
Part I is an overview course that will begin by providing an overview of the law, regulations and guidance as it relates to the advertising and promotional regulations, off-label dissemination and unsolicited requests for information, and the similarities and differences between promoting a PMA and 510(k) device. It will cover the use of a summary statement, discuss fair balance and the types of issues that draw FDA’s enforcement attention like overstatement of product benefits and risk minimization, comparative and superiority claims, use of patient and physician testimonials, etc. It will also briefly delve into the Anti-kickback Statute as it relates to the contours of “remuneration” and understanding where government enforcement efforts are focused. It will also address the False Claims Act (as it relates to reimbursement claims) so participants understand how a company can run afoul of the law be promoting aggressive reimbursement claims. The course will also briefly review the Foreign Corrupt Practices Act and the Physician Payment Sunshine Act as well as related state laws. We will start with a representative fictitious advertising campaign. The goal is to give the participant an appreciation for how all these laws are interrelated and connected to the lawful advertising and promotion of medical devices today.