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Pre-Approval Statements and Representations by Pharmaceutical Manufacturers

 
  May 03, 2012  
     
 
ComplianceOnline, Online Webinar
2012-05-24


Why Should You Attend:-

Off-label uses cannot be legally promoted. Promoting off-label uses may be viewed by FDA as actionable under the False Claims Act. Criminal and civil liabilities can be substantial for manufacturers. One recent settlement agreement with FDA went into the hundreds of millions of dollars.

Social media increases the chance for interaction between pharmaceutical manufacturers and patients (and others) like never before. Manufacturers are increasing in a position to responding to unsolicited requests for off-label information about prescription drugs and medical devices. The Federal Courts have offered some protections via interpretations of the First Amendment right to free speech.

Areas Covered in the Seminar:-

  • How social media interactions can be handled.
  • Contours of First Amendment freedom of speech protections.
  • Promotion vs dissemination of information – types of communications.
  • Solicited vs unsolicited information requests.
  • Legally permitted limits on Commercial speech.
  • Examples of recent cases dealing with communications about off-label uses of pharmaceuticals.

 

 
 
Organized by: ComplianceOnline
Invited Speakers: Doctor Lindon, has been a pharmacist for over 25 years and a practicing attorney for over 15 years.  He completed his baccalaureate degree in pharmacy in 1986 and doctorate degree in pharmacy in 1987 and doctorate degree in philosophy in 1992 from the University of Arizona.  He completed his juris doctor degree from Ohio Northern University in 1997.  He has practiced pharmacy in a variety of institutional and ambulatory settings.  He has represented parties before Boards of Pharmacy and civil and criminal courts.  He participates as an author in the WebMD “Ask the Expert” panel dealing the pharmacy law topics.  He is also registered to practice patent law before the United States Patent and Trademark Office.
 
Deadline for Abstracts: 2012-05-24
 
Registration:

For registration:- 

http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702284?channel=hummolgen

 
   
 
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