My Spidey Sense About FDA Regulation of Drug Marketing


A complex web of regulations issued by the FDA governs the marketing of prescription drugs. For pharmaceutical manufacturers, understanding how these rules shape what may and may not be said about new drugs can mean the difference between successfully launching a blockbuster — or facing a potentially ruinous investigation around false claims.
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Leaders- What Message Are You Sending About Compliance?


ATTENTION LEADERS, this article is for you! Everyone else, feel free to print this article and leave it on your boss’s desk.
MorascoThere has been plenty of talk recently about “proactive compliance”. Whether you are on the commercial side of the business or the R&D side of the business compliance is (or at least should be) always on your mind. Conferences, seminars, articles like this (and several other ones on this website) all talk about how in today’s current environment companies need to be proactive instead of reactive when it comes to compliance. Most articles and presentations will purport that to be proactive about compliance companies need to have processes and procedures that support compliance, ongoing and real-time monitoring and auditing programs, as well as training programs and compliance departments. Although I would agree that all of these pieces are essential to proactive compliance I would assert that the most important component to compliance is (drum roll, please) LEADERSHIP.
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New Rules for Navigating the Blogosphere and Twitterverse: FDA’s Draft Guidance on Submissions of Interactive Promotional Media

On Tuesday, 14 January, the FDA issued a long-awaited guidance addressing use of social media and other “interactive promotional media” in the marketing of medical products. Although the focus of the guidance relates to when such activity constitutes “labeling” under the Food, Drug, and Cosmetic Act (FDCA) and how pharmaceutical and biotech companies can meet regulatory requirements for submission of these communications to the agency, the guidance also provides important insight into the agency’s view of these marketing avenues generally.
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