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Compliance Q&A with Wayne Pines & Ilyssa Levins

Posted by | 3:24pm on Friday, October 28, 2011

It’s critical that those involved in marketing products for the drug and device industries be trained in regulatory compliance 

Compliance is a hot topic among biopharmaceutical industry and agency professionals, especially around social media. I had the chance with talk to two leaders in the field: Wayne Pines and Ilyssa Levins from the Center for Communication Compliance (CCC), an all-in-one source for training, mastery testing and consulting in regulatory compliance.

Wayne is a nationally recognized expert on regulatory aspects of healthcare advertising and promotion. He 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 FDA’s chief spokesman to the media for seven years and was the founding editor of its consumer magazine. Ilyssa has 30 years of healthcare communications experience, having spearheaded significant growth for Grey Global Group, one of the world’s foremost communications firms. Recognizing the need for a standardized regulatory compliance curriculum for promotional agencies, Ilyssa founded CCC, and Wayne is chair of the company’s advisory board.

I know Wayne and Ilyssa through Siren’s CCC training efforts. Siren is the nation’s first and only marketing agency to certify its entire staff in regulatory compliance for Internet Promotion/Social Media by CCC. Siren is also certified in Patient Relationship Marketing. The agency decided to dedicate the time and resources to obtaining this certification because healthcare regulations are an essential part of the work that we do. After taking the tests I wanted to learn more.

Why is regulatory compliance training so important right now?
Wayne Pines: It’s critical that those involved in marketing products for the drug and device industries be trained in regulatory compliance. We’re working in an environment where the FDA continues to be aggressive in its enforcement actions and the Office of Inspector General in the Department of Health and Human Services, working with the Department of Justice, is imposing huge fines on companies. Drug and device companies, and the agencies that help them, must understand the rules. The people who work in this industry need systematic, up-to-date training and testing of the type that CCC provides.

The underlying issue is that healthcare professionals have raised concerns with the integrity of advertising and promotional materials. The industry should be cognizant of and try to ensure that 1) the healthcare professional community understands the FDA requirements and 2) the ads and promotional materials are truthful and meet fair balance requirements.

Ilyssa Levins: Having worked at an agency for 25 years, I saw firsthand the need for a single source of expert validated regulatory compliance information that meets the needs of marketing communication professionals.

Why offer a certification in addition to the training materials?
Wayne Pines: The certification is not just training but actually involves taking a test. The tests are designed by experts, including myself, who are knowledgeable about the rules.

Ilyssa Levins: The testing makes everyone more accountable and forces the students to pay greater attention to the subject matter. Testing motivates you to learn. Our system lets participants review their incorrect answers, and then indicates which slides in the training module contain the answers. So you can go back to the original content to find the correct answers. The questions are developed by test construction experts, along with the subject matter experts, and are designed to be relevant and practical.

Why offer the CCC training and testing online?
Ilyssa Levins: We wanted to address the schedule of the busy agency professionals – this training is on-demand. At any point you can access select material, come back and review it some more and then take the test. It can all be done on your own time and at your own convenience. There are a lot of great offline courses and on-site training, which we also do, but this offers the convenience. We’re also open to taking students’ advice to continually improve the offering. That’s the beauty of an online tool: that it can change and be a living, breathing instrument.

How do you handle regulatory changes that might affect content?
Ilyssa Levins: The training materials are modular so if there are relevant regulatory changes, we can easily pull sections down and update them. For example, we added information around the reprint guidance and the draft guidance for risk communication.

How did you develop the curriculum?
Wayne Pines: The curriculum and tests are designed to deal with practical, day-to-day issues that individuals are having. The questions that arise on a daily basis are the ones that the FDA is concerned about in terms of noncompliance. We tried to avoid the theoretical issues that don’t arise on a regular basis.

Ilyssa Levins: I went to colleagues who work in ad agencies and PR firms and asked what questions continually plague them. They told me the type of concerns they had and we ensured that the content covered them and also turned them into Q&As. We show how to actually execute programs in today’s environment with case studies.

Wayne, you chaired the first FDA hearings on using the internet for pharmaceutical advertising back in 1996. What’s your prediction around the FDA and social media?
Wayne Pines: The FDA will eventually issue guidance because they are committed to it, but I don’t know that anything will change. They will apply the same rules that they currently have in place including fair balance, full disclosure and prohibiting off label promotion. Further clarity is ultra-important, but I don’t know practically that anything will change when the FDA issues its guidance.

The industry is using social media in a conservative and restrained way, and when the FDA comes out with guidance, I believe it will remain conservative and restrained.

Thanks so much for your time.

(Image courtesy of Horia Varlan on Flickr).

About Eileen O'Brien

Eileen has more than 16 years of digital healthcare marketing experience. She is an opinion leader on social media and biopharma, and has been invited to speak at industry conferences and quoted in publications.

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