MARBLEHEAD, MA USA -- PHARMA UPDATE NEWS SERVICE(TM) -- OCTOBER 12, 2006: Elements of the recent Schering-Plough settlement and the Dr. Peter Gleason indictment suggest the government is more focused than ever on off-label promotion. How can you reduce liability at a time of increasing off-label enforcement? Listen and ask questions during this 90-minute analysis of these important recent events, led by two leading off-label experts, David Adams and Wayne Pines as they cover the significant impacts the two cases have left on the pharmaceutical industry.
- Settlements under the False Claims Act and changes to the off-label promotion landscape
- Analysis of Schering-Plough settlement
- Who is in charge of regulating off-label issues?
- Factors that trigger legal liability
- Factors that trigger the governments interest in enforcement action
- Schering's response to an FDA letter: Implication of false statements
- Dr. Peter Gleason Indictment
- Facts of the indictment
- Implications: Physician needs to be concerned about off-label information
- How to avoid legal action
- FDA pursuing companies for off-label promotions
- Key take-away points from Schering settlement and Gleason indictment
- Live Q & A
Be sure to register and to pre-submit an anonymous question, contact Robin Robinson at firstname.lastname@example.org or fax to (781) 639-2982.
MEET OUR SPEAKERS:
David Adams a partner at Venable, practices in the areas of pharma Advertising, Marketing and New Media, Food and Drug, International Trade. Click here for full bio.
Wayne Pines is president, regulatory services and healthcare, APCO Worldwide, provides strategic counsel to clients facing crises or media, legislative, regulatory or marketing problems. Click here for full bio.
LIVE 90-minute Audioconference
WEDNESDAY, OCTOBER 18, 2006 at 1:00 p.m. (Eastern)
Schering Settlement, Gleason Arrest: A New Era in Off-Label Enforcement
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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.