Course Curriculum Co-marketed by the
Word of Mouth Marketing Association (WOMMA) and
the Center for Communication Compliance (CCC)

Regulatory Compliance 101
An Overview of Internet Promotion & Social Media

Course Focus
Provide professionals in healthcare (companies, agencies, consultants) with the latest information regarding regulatory compliance for Internet Promotion and Social Media.

Audience
Any professional in the pharmaceutical, biotech or device industry, who works with, designs, executes, reviews, or oversees Internet promotion and social media programs.   

Course Format and Access

• Approximately 2 hours; 24/7 access from CCC Web site
• Course content correlates to Regulatory Compliance Test (RCT)
• Forty (40) test questions: multiple choice, true/false

Course Content

• Understand the U.S. healthcare regulatory environment as it relates to sponsored and unsponsored promotion, on the Internet Promotion (Web sites, banner ads, search engine ads, search engine optimization) and Social Media (e.g., Facebook, Twitter, YouTube, chat rooms, SideWiki)
• Who's Watching – the key regulatory authorities (e.g., FDA/Bad Ad Program; OIG)
• Fundamental compliance considerations
• Responsibility/Accountability: Level of influence by company
1. By or on behalf of?
2. Who pays to host and develop?
3. Third-party affiliations: nature of the relationship, full disclosure
• Content/Context
1. Is it false or misleading?
2. Does it present risk information and is it fairly balanced?
• Adverse Event Reporting
• Discussion of FDA/DDMAC action related to Internet promotion to-date
• Enforcement examples:
• Untitled letter to Novartis for Tasigna® (nilotinib) Capsules -- Facebook “Share” widget on US product Web site (HCP & Consumer)
• Warning Letter to Novartis for Gleevec® (imatinib mesylate) -- Novartis-sponsored Web sites (www.gistalliance.com; www.cmlalliance.com)
• 14 Untitled Letters on search engine marketing
• Other related enforcement
1. Shire (Adderal®) YouTube Video
2. Ultram ER® Webcast
3. Novartis (Diovan®) Banner Ad
4. Latisse® Web site
5. Sotradecol® Web site
• Review of the legal pitfalls around social media, including off-label information and false claims
• Apply the current guidelines, rules and policies to the development and execution of social media promotional materials, formats, and programs (questions submitted by Industry and promotional agencies):
• Macro Questions
• How can you promote prescription products online these days with all the limiting regulations? What can you really do in social media that is not violative of FDA DDMAC regulations? Said another way, which social media strategies can be implemented that are in compliance with FDA regulatory framework?
• What are the regulatory implications of the specific space and time limitations inherent in the various social media channels? How do these constraints affect online marketing today and what new issues may raise from a regulatory perspective?
• FDA has guidelines about format/layout/typography/white space in regard to print ads … how will these “implementing factors” play out in social media and Web sites, which are so different from print?
• Tactical Questions
• What guidelines exist with respect to positioning fair balance relative to claims on the Internet?  What does the FDA consider adequate support for promotional claims?
• What are the regulatory issues affecting branded versus unbranded online sites?
• What is the "one-click away" rule? What are the implications for Internet-based promotion?
• What kind of external Web sites can we link users to in order to provide additional reference materials? Can they link to third-party advocacy groups? Are there potential risks with such links?
• What are the regulatory considerations surrounding Search Engine Optimization (SEO) techniques and tactics such as meta tags?
• What happens if a product is mentioned on a disease awareness chat room sponsored by the drug or device company? What opportunities does the company have to augment and/or correct information? How should this information be handled?
• Do you have to scroll the full package insert on every video that a patient might link to? Does it have to be in the front of the video or can risk information be integrated throughout the communication?
• What do I have to know about prescription products with boxed warnings? What about a product under accelerated approval fast track?
• What do I need to know about selecting patient testimonials for online use? Do they need to represent “the typical patient”? What precisely does this phrase mean?
• What FDA regulations need to be adhered to when using patient testimonials (i.e., Quality of Life claims/statements)?
• What are the policies and guidelines regarding the use of spokespersons in social media? If I use a celebrity, does he/she have to have the disease? What if only their name and picture are displayed, but without any statement or testimonial?
• Does the FDA have any guidance about posting press releases on your Web site? Or how long you should keep them available to the public/physicians/investors?  Can you be cited for not posting them?
• Are there specific regulatory considerations regarding the “Investor Relations” section of a company's Web site?  What can you say/not say to investors about drugs currently under development?

Instructors

Tracy Acker, PharmD:
President of The Acker Group. Served as Branch Chief in FDA's Division of Drug Marketing, Advertising and Communications (DDMAC). Former Executive Director of Regulatory Promotion at Amgen and Director of Regulatory Affairs for Advertising and Promotion at Johnson & Johnson.

Arnie Friede:
Principal of Arnie I. Friede & Associates. Served as Associate Chief Counsel in FDA's Chief Counsel Office. Former Senior Corporate Counsel at Pfizer, Inc., and former Chairman of Food, Drug, & Cosmetic Law section of NYS Bar Association.

Michael A. Misocky, RPh, JD, CHC:
President of Misocky Consulting Group. Former Regulatory Review Officer for FDA Division of Drug Marketing, Advertising, and Communications (DDMAC). Formerly Assistant VP and Deputy Compliance Officer at ImClone Systems; also worked at Abbott and BMS.

Wayne Pines:
Chair of the CCC Advisory Board. Served at the FDA for 10 years as Chief of Consumer Education and Information, Chief of Press Relations, and Associate Commissioner for Public Affairs. Author of the two-volume FDA Advertising and Promotion Manual, the standard reference in the field.