9/5/2013 9:58:18 AM
Rockville, MD, USA—The Regulatory Affairs Professionals Society (RAPS) has published a new book that thoroughly covers the regulation of pharmaceutical marketing and promotions by the US Food and Drug Administration (FDA). The book, FDA Requirements for Prescription Drug Promotion, by John Driscoll, addresses topics such as fair balance, material facts, off-label promotion and Internet and social media communications.
“The book is really intended both for those who are new to the field as well as experienced regulatory professionals,” said Driscoll in an interview with RAPS’ Regulatory Focus. “For those with only limited experience or those who are involved in other related areas of the industry (e.g., marketing, medical affairs), I think the book can serve as a comprehensive curriculum for learning FDA’s requirements for prescription drug promotion…For established regulatory affairs professionals, the book is primarily intended to serve as a go-to reference for all the publicly available information on these topics.”
The book’s first chapter, Prescription Drug Labeling, is publicly available online. Driscoll devotes other chapters to, FDA’s Office of Prescription Drug Promotion, the agency’s requirements for types of promotions, fair balance, product claim requirements, preapproval and off-label promotion, promotion to healthcare professionals, direct-to-consumer promotion and Internet and social media.
Regarding social media, one of drug marketing’s hot topics, Driscoll said: “There are a host of regulatory issues associated with social media promotion, primarily due to the real-time nature of the interactions. However, I do think the lack of clarity on a few specific social media issues has obscured the fact that there are several areas relating to social media for which some direction from FDA does exist.”
FDA Requirements for Prescription Drug Promotion is available from the RAPS Store both in print and as an e-book for $44.95 for RAPS members, or $54.95, plus shipping, for nonmembers.
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide. RAPS.org
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