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Course Curriculum Presented by the
Center for Communication Compliance (CCC)


Regulatory Compliance 101
An Overview of Internet Promotion & Social Media

Course Focus
What healthcare communication professionals (inside companies, at agencies, consultants) need to know about regulatory compliance for Internet promotion and social media programs.

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

  • One 90-minute module
  • 24/7 on-demand access from CCC Web site; may be viewed as often as desired
  • Course Content correlates to Regulatory Compliance Test (RCT)

Course Content

  • Understand the regulatory environment as it relates to Internet promotion and social media programs
  • Apply the guidelines, rules, and policies to the development and execution of Internet promotion and social media materials, formats, and programs
  • Address regulatory implications of diverse social media tactics and discipline-specific issues
  • Review the thorny issues currently under discussion by government regulators

Course Specifics
Basics – Didactic style

  • Definition of social media and tools of the trade – brief overview

Current regulatory perspective top line – Didactic style

  • It’s the message, not the medium

Examples of current social media programs – interactive discussion

  • What works, what doesn’t, and why

Examples of regulatory issues – interactive discussion

  • Claims/representations being made
  • Inadequate presentation of risk information
  • Minimization of risk information
  • Omission of risk information
  • Prominence/comparability of risk information

Answers to tactical issues – multiple instructors answer

  • How do you achieve fair balance on a Web site?
  • What are the regulatory implications of the specific space and time limitations inherent in different social media? Can you explain how these constraints may raise new issues?
  • What are the regulatory issues affecting branded vs. unbranded online sites? What are different examples of each type of site?
  • What about sponsored vs. unsponsored ads or sites? What are the rules?
  • What is the one-click rule? What are the implications for Internet-based promotion?
  • What are the regulatory considerations surrounding Search Engine Optimization (SEO) techniques and tactics?
  • What can I do and not do in banner ads?
  • What kind of external websites can we link users to in order to provide additional reference materials? Are there potential risks with such links?
  • What are the guidelines for patient-directed copy for Disease Awareness sites?
  • Should a company be monitoring social media? What’s the downside? Is there any upside of doing this?
  • Do we have to report adverse events that are uncovered in chat rooms? What obligations do we have, if any, to monitor chat rooms, blogs, and the like to uncover reports of serious adverse events?
  • How do we respond to discussion of off-label use on the Internet?
  • What about communications between patients? How can this information be used?
  • What are the guidelines about providing patients with access to risk information, and how might they change?
  • FDA has specific guidelines about format/layout/typography/white space in regard to print ads … how might its guidance regarding these “implementing factors” play out in social media and Web sites, which are so different from print?
  • What are the guidelines with respect to positioning fair balance relative to claims on the Internet? What does FDA consider adequate basis for promotional claims?
  • What do I have to know about drugs with boxed warnings?
  • What do I have to know about drugs that are on an accelerated approval fast track?
  • What do I need to know about selecting patient testimonials for the Internet – do they need to represent “the typical patient”? What precisely does this phrase mean?
  • 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 I only use their name and picture, but without any statement or testimonial?

Thorny issues – multiple instructors provide POV

  • Adequate provision of risk information
  • Adverse event reporting
  • Oversight of discussion of your products on the Internet when you have no control
  • Blog management
  • Product liability/false claims
  • First Amendment – News versus promotion versus SEC disclosure (PR)
    • Does the FDA have any guidance about having to post your 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?

Look into the future – multiple instructors provide POV

  • Will the FDA regulations evolve with the Web or will the Web need to conform to the traditional and historic regulations?
  • What would an Internet guidance, if one were developed by FDA, say anyway?
  • What enforcement actions might be taken in 2010 for social media?
  • What are the specific types of social media or Internet tactics the FDA may focus on?
  • Note: Course Content is contained in one 90-minute module, which correlates to the Regulatory Compliance Test (RCT) for Internet Promotion & Social Media.

Course Instructors
Nationally recognized experts on regulatory aspects of healthcare advertising and promotion, both formerly with the Food and Drug Administration (FDA).

Wayne Pines
Chair of the CCC Advisory Board. He is a nationally recognized expert on regulatory aspects of healthcare advertising and promotion. Wayne served at the FDA for 10 years as chief of consumer education and information, chief of press relations, and associate commissioner for public affairs.

Michael Misocky
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 Labs and Bristol-Myers Squibb.

CCC’s Regulatory Compliance Test (RCT)
CCC certifies regulatory competency in Internet Promotion & Social Media.