Boston, MA: Boston Strategic Partners, Inc. (BSP) provides the second update in the recently authored white paper series exploring the concept of free speech as applicable to pharmaceutical and medical device companies, titled ‘Free speech* for pharmaceutical and device companies (*as long as it is truthful and non-misleading).’ Regulatory landscape surrounding off label marketing is currently evolving, and consequent outcomes of such free speech rights for pharmaceutical and medical device companies remain ambiguous from legal, regulatory, and business perspectives.
From a historical perspective, the US Food and Drug Administration (FDA) had sole rights to enforce restrictions on the marketing and promotion of medical products for off label purposes. However, several recent cases in the federal court system have weakened this authority by supporting the free speech rights of pharmaceutical companies to market off-label, provided that their statements are truthful and non-misleading. The paper provides an update on the current off-label marketing and promotion strategies and highlights the opportunities and risks going forward for pharmaceutical, device, and diagnostic companies considering an expansion of off-label marketing following recent court rulings.
About Boston Strategic Partners
Boston Strategic Partners, Inc. is a leading global healthcare consulting firm offering services to the life sciences industry in the areas of Business and Clinical Strategy, Health Economics and Outcomes research (HEOR) and Medical & Technical Communications.
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