Boosting Pharma Public Relations Regulatory Compliance Click Here for Additional Resources
A conversation with Ilyssa Levins, Founder and President of the Center for Communication Compliance (CCC) and Wayne Pines, Chair of the CCC Advisory Committee. A conversation with representatives of the newly formed Center for Communication Compliance about FDA regulations regarding pharma press releases and healthcare communications best practices.
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Public Relations (PR) is not just for managing a company’s image and for damage control. It’s also used as an adjunct to marketing products and sometimes the distinction is blurred.
PR is used by the pharmaceutical industry to:
- Improve the industry’s reputation
- Improve a pharma company’s reputation
- “Clearly Displaying” — [promoting?] — a Product’s Purpose, Benefits and Value
- “Earning” — [buying?] — Media Coverage For Your Health Story
- “Development of a Public Education Campaign to Increase Awareness,” most often of a “medical condition” for which a drug is indicated
- Buttress the “Value of [a company’s] Pipeline” — ie, generate investor interest in the company’s stock
- Aid lobbying efforts (“An Integral And Necessary Part Of The Lobbying Mix”) — debunk (?) or promote social programs and legislative actions that will affect the drug industry (eg. Medicare, Consumer Directed Healthcare)
- Boost employee morale
- Last but not least, Manage a crisis — eg, Merck spent about $52 million in 2005 on non-product, image advertising in its “Putting Patients First” PR campaign
This list was based on presentations made at a recent Pharmaceutical PR & Communications conference, the tagline of which summarizes the three main functions of PR in the pharmaceutical industry: “Enhancing Corporate, Brand and Industry Value.”
Pharmaceutical public relations professionals can no longer operate solely under the First Amendment by merely coveying truthful information. In the early 1990s, FDA ruled that PR communications such as video news releases were an extension of labeling, and would be regulated like advertisements. “That turned the PR world upside down,” Ilyssa Levins said. “It used to be that the worst you would get was a warning letter, but now the federal government watching and indicting.”
The Center for Communication Compliance (CCC), the brainchild of Levins, was “conceived as a place where professionals can obtain information on all the regulations regarding pharma press releases, as well as medical advertising in general. In addition, the CCC offers multiple training programs, testing, and certification for anyone who touches healthcare communications — primarily agencies that work for industry” (see “New Educational Program to Boost PR Compliance,” PharmaExec Direct Marketing Edition).Click Here for Additional Resources
llyssa Levins has 30 years of healthcare communications experience. Prior to founding CCC, Ilyssa was with Grey Global Group, one of the worlds foremost communications firms, for two decades. Her entrepreneurial accomplishments there include launching the BrandEdge marketing consultancy, catapulting Greys healthcare PR practice to a top 10 global ranking, and leading a PR boutique, GTFH, to be named #1 in healthcare two years in a row.
Early in her career, Ilyssa recognized that regulatory compliance was an under-served area in the healthcare communication profession. In 1991, she founded the PR section of an industry advocacy group focused on FDA regulatory policy making and enforcement. Ilyssa is an industry spokesperson, and published author on regulatory compliance healthcare communication. She was the only healthcare executive to be named a Women Achiever of the Year by the YWCA of New York for the class of 2000, and is a Healthcare Businesswomens Association (HBA) Rising Star. Ilyssa was also a two-term HBA Global Board member, and holds board positions with Pharmaceutical Executive and Communiqué magazines.
Wayne Pines 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. He was the FDAs chief spokesman to the media for seven years, and was the founding editor of its consumer magazine. In 2004, Wayne was named FDAs Alumnus of the Year.
Wayne has been published widely on regulatory and crisis management topics. He is the author of the FDA Advertising and Promotion Manual, the standard reference in the field. Wayne has taught graduate-level courses in PR and frequently speaks at educational symposia. He has chaired the annual advertising meetings for both the Drug Information Association and the Food and Drug Law Institute since 1989, and has been given each organizations highest award. Wayne is a graduate of Rutgers University.
Some Questions/Topics Discussed
- In the wake of Federal government crackdowns, how has scrutiny of PR programs increased?
- How vulnerable is the PR profession right now?
- How did the idea of certification come about?
- Why was there nothing in place before? How does CCC fill the gap?
- You say these resources help reduce risk, increase credibility, save time. Explain.
- What has the reaction been so far?
- What can healthcare PR professionals do right now to stimulate change?