HCM Marketplace

AUDIOCONFERENCE ON TAPE OR CD

presented on February 24, 2006

Aggressive post-launch marketing strategies play a critical role in the success of your product, but with recent OIG and DOJ prosecutions using the False Claims Act and Anti-kickback Statute the regulatory risks are high. So how do you make the case for your product in the face of so many potential pitfalls?

Listen to industry veterans Mark DuVal, Esq., President, DuVal & Associates, and former Genentech marketer John Foster, Senior Vice President, Restore Medical, as they discuss different post-launch strategies to market a new product-aggressively, yet lawfully. They will challenge listeners to 'push the envelope' without pushing the government's hot buttons.

Using an interactive 'back-and-forth' format, John and Mark will dissect critical post-launch elements, such as off-label dissemination, physician-initiated research, CME, and medical science liaisons.

Speakers will share innovative marketing ideas with an eye towards compliance risks, such as FDA's advertising and promotion regulations, the Anti-Kickback Statute, and the False Claims Act. The 2-hour program devotes 30 minutes to "Q&A".

PROGRAM TAKEAWAYS

Listeners will get answers to these and other questions.

1. Market research
   • When are you extracting information and when are you imparting, i.e., promoting, information about off-label uses?
   • How many customers do you need to conduct meaningful market research?
   • How do you lawfully address off-label uses, if at all?
2. Publication planning
   • How do you lawfully and appropriately address publication planning on off-label uses?
   • How much can you do anticipating off-label dissemination activities?
   • When, if at all, do you consider conducting studies to obtain approval for off-label uses?
   • Can you pay someone to ghostwrite articles?
   
   
3. Off-label dissemination
   • Where does it stand today given the OIG and DOJ investigations?
   • How can you do it lawfully?
   • What is a peer-reviewed journal article; what about disseminating abstracts or information of a lesser quality?
   • Can the sales force be part of the dissemination effort--the pros and cons?
   • What are the roles of an in-house Medical Affairs Department and medical science liaisons?
   • How does reimbursement come into play here; what advice, if any, can you give regarding reimbursement for off-label uses?
   
   
4. Medical education
   • How are the OIG and DOJ viewing CME today?
   • What happens if you use the same CME provider and when does a close relationship with a CME provider appear to make them an extension of your marketing department?
   • How can you lawfully support CME today, given the issues?
   • Can you get something other than ACCME certification to make your program legally acceptable?
   
   
5. Scientific meetings, advisory boards, consultancies and KOLs
   • When are these legitimate consulting arrangements and when are they a conduit through which you reward KOLs?
   • How many consultants does it take to...?
   • What is fair market value?
   • What can you do to comply with the Anti-kickback Personal Services Safe Harbor?
   
   
6. Public relations
   • How does FDA view public relations?
   • When can you lawfully discuss off-label uses of products?
   • Can you hire medical writers and sponsor press events and, if so, what are the limits?
   
   
7. Use of websites
   • How can you lawfully use websites to discuss off-label uses?
   • Can you create physician finders and/or provide webpage templates to physicians?
   • Can you use search engine names that are off-label to direct traffic to your product webpage?
   
   

Purchase a tape or CD of the program and listen at your convenience.

PANEL

Mark DuVal, Esq., is President and Managing Partner of DuVal & Associates, where he counsels pharmaceutical, medical device, biotech, food and nutritional supplement companies. Having worked extensively with drug delivery systems businesses, Mr. DuVal's practice also includes combination products, specifically drugs and devices as well as biologics and devices. He regularly advises clients in all areas of FDA law and regulation, from product development, clinical trials, inspections and recalls to reimbursement and compliance issues and post-marketing responsibilities. But Mr. DuVal spends most of his time counseling management of marketing and sales management and regulatory groups on devising and implementing cutting-edge and effective marketing programs.

John Foster is the Senior Vice President, Commercial Operations, Restore Medical, Inc. Mr. Foster is a seasoned sales and marketing professional with experience in both the pharmaceutical and medical device industries starting his career with Genentech, with a stint at Medtronic, and now with Restore.

Bryan Cote (moderator), Editor, Medicare & Reimbursement Advisor Weekly.

WHO SHOULD LISTEN

• Marketing
• Sales
• Compliance
• Regulatory Affairs (directors)

PROGRAM MATERIALS:

Program materials will be provided with PDF links.

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