4th Annual

Off-Label Communications

Tuesday, July 17, 2007

About

In this publication from the American Conference Institute you will learn new findings from the following areas:
  • Minimize exposure to whistleblower suits and False Claims liability
  • Formulate effective off-label communication policies by using OIG guidance and recent advisory opinions and CIAs
  • Avoid "ghost-writing" allegations
  • Control the risks of off-label promotion over the Internet
  • Provide accurate and current clinical trial information while avoiding allegations of off-label promotion
  • Detect and resolve misconceptions by sales reps before they become costly missteps
  • Prevent MSLs from blurring the line between medical affairs and sales
  • Gain insight into where the law on off-label communications may be headed

Contents & Contributors

About

In this publication from the American Conference Institute you will learn new findings from the following areas:
  • Minimize exposure to whistleblower suits and False Claims liability
  • Formulate effective off-label communication policies by using OIG guidance and recent advisory opinions and CIAs
  • Avoid "ghost-writing" allegations
  • Control the risks of off-label promotion over the Internet
  • Provide accurate and current clinical trial information while avoiding allegations of off-label promotion
  • Detect and resolve misconceptions by sales reps before they become costly missteps
  • Prevent MSLs from blurring the line between medical affairs and sales
  • Gain insight into where the law on off-label communications may be headed

Contents & Contributors

First Amendment Protections for Commercial Speech and FDA Restrictions on Promotion of “Off Label” Uses
Vernon Francis, Dechert LLP (Philadelphia, PA)

Off-Label Promotion V. Scientific Exchange
Michael S. Labson, Covington & Burling LLP (Washington, DC)

Training and Monitoring the Sales Force to Prevent Them from Crossing the Line
Tanya Dobash Berlage, Saul Ewing LLP (Baltimore, MD)
Diana Lloyd, Choate, Hall & Stewart LLP (Boston, MA)

Ensuring That MSLS Stick to the Science
Debra S. Dunne, Stradley Ronon Stevens & Young LLP (Philadelphia, PA)
Erik Eglite, D.P.M., J.D., Ovation Pharmaceuticals, Inc. (Deerfield, IL)

The Internet: Opportunities and Risks in Promotional and Educational Communications
R. Bruce Dickson, Manatt, Phelps & Phillips LLP (Washington, DC)

Avoiding Ghost-Writing Allegations: Use of Third-Parties in Drafting Medical Literature
Sean Wajert, Dechert LLP (Philadelphia, PA)

Modifying Compliance Activities in Response to Trends in Government Enforcement Activity
Daniel A. Kracov, Arnold & Porter LLP (Washington, DC)

Preventing and Defending Qui Tam Suits And False Claims Liability Based on Claims of Off-Label Promotion
Kathleen McDermott, Sonnenschein Nath & Rosenthal LLP (Washington, DC)

Proactive Strategies for Auditing & Monitoring Off-Label Communications
Mark A. DeWyngaert, PhD, MBA, Huron Consulting Group (New York, NY) Sean Fahey, Pepper Hamilton (Philadelphia, PA)

Striking the Proper Balance When Posting Clinical Trial Disclosures
Howard L. Dorfman, Bayer HealthCare LLC (West Haven, CT)

Medicare Coverage for Off-Label Uses
John S. McInnes, MD, JD, Arnold & Porter LLP (Washington, DC)

Reimbursement Issues Associated With Off-Label Uses
Judy Waltz, Foley & Lardner LLP (San Francisco, CA)

Off-Label Use and Promotion: Product Liability Perils
Mark C. Levy, Saul Ewing LLP (Philadelphia, PA)
Stephen McConnell, Dechert LLP (Philadelphia, PA)



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0