U.S.Global
public relations testadvertising testmedical education testpublic relations testsocial media testdrug development test

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


Course Name
Regulatory Compliance 101: Advertising/Promotion

Course Focus
What healthcare communication professionals (inside companies, at agencies, consultants) need to know about regulatory compliance in Advertising/Promotion.

Audience
Any professional in the pharmaceutical, biotech, or device industry who works with, designs, executes, reviews, or oversees healthcare advertising/promotion or communication programs:

Communications

  • Advertising agencies and industry staff (product and corporate)
  • Vendors serving advertising agencies and industry (e.g., television, video, and broadcast producers)

Marketing and Sales

  • Product managers
  • Marketing executives
  • Sales representatives and division leaders

Compliance and Ethics

  • Compliance officers
  • Regulatory and legal professionals
  • Others with compliance oversight

All levels, from senior management to beginner.

Course Format and Access

  • 3 one-hour modules: lecture and Q&A
  • 24/7 on-demand access from CCC Web site; may be viewed as often as desired

Course Content

  • Understand the rules and guidelines imposed by regulatory agencies, industry associations, and trade groups:
  • Food and Drug Administration (FDA)
  • Office of the Inspector General (OIG) of the Dept. of HHS
  • Department of Justice (DOJ)
  • Pharmaceutical Research and Manufacturers of America (PhRMA)
  • Accreditation Counsel for Continuing Medical Education (ACCME)
  • American Medical Association (AMA)
  • Review the risks of not complying with the regulations within the current regulatory/legal environment:
  • Fines, Exclusions, Incarceration, Damage to Reputation
  • Apply the guidelines, rules, and policies to the development and execution of advertising materials, formats, and programs, including:
  • Sales aids
  • DTC advertising
  • Coming soon ads
  • Reminder ads
  • Institutional and disease awareness ads
  • Comparative claims and claims of superiority
  • Web sites
  • Exhibits
  • Dissect complex communication scenarios with multiple regulatory factors at play; apply regulatory guidelines to real-world situations.
  • Answer commonly asked questions, such as:
  • Can we use a competitor's published data in promoting our product?
  • Our company has just completed an open-label study whose findings demonstrate that the product has a better efficacy profile than was shown in the Phase III trials. Can we use these open-label data in our advertising?
  • How many of the most common adverse events for a product need to be listed to ensure that it is fairly balanced? Is there a specific number that the FDA typically looks for?
  • Do we have more latitude with promotional materials that are not intended to be left behind versus promotional materials that are? Do such materials need to be annotated in any special way, such as "Not for external distribution"?
  • In our advertising, we want to highlight several specific data points from our Phase III clinical study. Would this be considered "cherry picking"? What are the guidelines?
  • What are the guidelines with respect to positioning fair balance relative to claims? A lot of these guidelines reflect what seem to be "arbitrary" rules that vary from one promotional review committee to the next.
  • We are preparing a DTC TV ad, but we just received a warning letter from the FDA saying that our Web site is out of compliance, so we have temporarily shut it down. Since we don't currently have an active Web site to which consumers can be referred, can we still go ahead and put the ad on the air? Are there any special steps we need to take?
  • We are considering using a celebrity in our DTC TV ad. However, this celebrity doesn't actually have the disease. Does the celebrity have to have the disease? Also, does he or she have to be using the product we are advertising?
  • We want to send a letter to physicians claiming that our product is the most prescribed in its class. What kind of data is needed to support that type of statement?
  • What are the rules regarding Internet promotion? Is Internet promotion considered labeling or advertising for purposes of the regulations – and what difference does it make?

Note: Course Content is divided into 3 one-hour sessions containing lecture material and a Q&A segment. The sessions correlate to the three sections of the Regulatory Certification Test (RCT) for Advertising/Promotion:

Regulatory Compliance 101 Part I– Addresses Basic RCT-A
Regulatory Compliance 101 Part II – Addresses Basic RCT-B Advanced RCT
Regulatory Compliance 101 Part III– Addresses both RCT levels through case studies

Course Instructors

Nationally recognized experts on regulatory aspects of healthcare advertising and promotion, all 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 Advertising/Promotion at two levels: Basic and Advanced.