MARBLEHEAD, MA USA -- PHARMA UPDATE NEWS SERVICE(TM) -- FEBRUARY 16, 2006: Until now. For reliable legal guidance for your promotional activities, marketer John Foster, formerly of Genentech, and attorney Mark Duval, will help clarify the boundaries on 30+ issues in an entertaining back and forth audio conference. Foster will share industry practices (see below) and Duval will provide the legal perspective, including a thumbs up or down.
The program is titled, Post Launch: Aggressive, Compliant Marketing Strategies. It's set up for industry professionals who are or will be marketing approved pharmaceuticals. For a CD or to register for the live program scheduled for February 24, call our Customer Service Department at 800-650-6787 or click here.
QUESTIONS SPEAKERS WILL ANSWER:
- 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?
- Publication planning
- How do you lawfully and appropriately address publication planning on off-label uses?
- How much can you do to anticipate 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?
- 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?
- 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?
- Scientific meetings, advisory boards, consultancies and key opinion leaders (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?
- 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?
CAN'T LISTEN LIVE?
- Use of Web sites
- How can you lawfully use Web sites to discuss off-label uses?
- Can you create physician finders and/or provide Web page 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.
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, followed by a stint at Medtronic, and now with Restore.
Bryan Cote (moderator), Editor, Compliance Alert for Drug Sales & Marketing.
WHO SHOULD LISTEN:
- Regulatory Affairs
- Managed Markets
- Government Affairs
Join us Friday, February 24, 2006, for Post-Launch: Aggressive, Compliant Marketing Strategies beginning at 1 p.m. (Eastern). For more information or to register click below:
If you prefer, call our Customer Service Team at 877-437-4276. Just mention Source Code EZ43965A to place your order. And remember, you may register now and pay later. Simply choose the "Bill Me" option and we will send you an invoice.
ePharmaceuticals, a division of Marblehead MA-based HCPro, Inc., provides business intelligence, compliance training, market research reports, and custom publishing services to the pharmaceutical industry. Publications include ePharm5, a daily business and marketing innovation newsletter, Medicare & Reimbursement Advisor Weekly, and Compliance Alert for Drug Sales and Marketing.