5th Annual Pharmaceutical and Medical Device Manufacturer's Guide to

Off-Label Communications

Practical strategies for protecting your company in a climate of heightened government scrutiny

Wednesday, July 16, 2008

About

Pharmaceutical and medical device manufacturers continue to be in the government’s crosshairs. Since 2004, there have been eleven off-label related cases settled with the government, and it is estimated that there are still 100 more cases in the pipeline. Enforcement agencies have warned that off-label marketing will continue to be a focus of anti-fraud enforcement efforts over the next several years and medical device companies will face particularly aggressive prosecution. In addition to government enforcement efforts, manufacturers must also contend with "creative" theories of liability being put forth in civil lawsuits. The lower court decision in Clark v. Pfizer Inc, wherein the court held that a manufacturer of an innovator drug is liable for off-label generic use, was a major departure from existing case law and will be a huge blow to manufacturers if upheld.

Understanding the distinction between what is and is not permissible regarding off-label promotions is important. But, what companies really struggle with is how to stop off-label violations from happening. With that in mind, the focus of this year’s Guide to Off-Label Communications is on the practical application of case law and guidelines. Our faculty of experts provides concrete examples of how to deal with problematic sales activities and how to create and enforce compliance policies that truly work. In addition, there is a strong emphasis on government enforcement trends, managing government investigations, and government settlement agreements.

Contents & Contributors

About

Pharmaceutical and medical device manufacturers continue to be in the government’s crosshairs. Since 2004, there have been eleven off-label related cases settled with the government, and it is estimated that there are still 100 more cases in the pipeline. Enforcement agencies have warned that off-label marketing will continue to be a focus of anti-fraud enforcement efforts over the next several years and medical device companies will face particularly aggressive prosecution. In addition to government enforcement efforts, manufacturers must also contend with "creative" theories of liability being put forth in civil lawsuits. The lower court decision in Clark v. Pfizer Inc, wherein the court held that a manufacturer of an innovator drug is liable for off-label generic use, was a major departure from existing case law and will be a huge blow to manufacturers if upheld.

Understanding the distinction between what is and is not permissible regarding off-label promotions is important. But, what companies really struggle with is how to stop off-label violations from happening. With that in mind, the focus of this year’s Guide to Off-Label Communications is on the practical application of case law and guidelines. Our faculty of experts provides concrete examples of how to deal with problematic sales activities and how to create and enforce compliance policies that truly work. In addition, there is a strong emphasis on government enforcement trends, managing government investigations, and government settlement agreements.

Contents & Contributors

EXPLORING THE NEW FDA GUIDANCE ON SCIENTIFIC REPRINTS
Jeffrey Senger, Food and Drug Administration (Rockville, MD)
R. Bruce Dickson, Manatt, Phelps & Phillips LLP (Washington, DC)
Andrew R.C. Gaddes, Dechert LLP (Philadelphia, PA)

BUILDING A POWERHOUSE COMPLIANCE PROGRAM: PRACTICAL SOLUTIONS FOR PREVENTING OFF-LABEL VIOLATIONS FROM OCCURRING
Mitzi G. Cole, Wyeth Pharmaceuticals (Collegeville, PA)
Jeffrey Hessekiel, Legal Affairs, Gilead Sciences, Inc. (Foster City, CA)
Michelle Y. Johnson-Lewis, Pfizer Inc (Parsippany, NJ)

ENSURING MSLS STICK TO THE SCIENCE
Michael Labson, Covington & Burling LLP (Washington, DC)

MINIMIZING THE POTENTIAL FOR OFF-LABEL VIOLATIONS WHEN ENGAGING IN RISKY ACTIVITIES
Debra S. Dunne, Stradley Ronon Stevens & Young, LLP (Philadelphia, PA)

MINIMIZING THE POTENTIAL FOR OFF-LABEL VIOLATIONS WHEN ENGAGING IN RISKY ACTIVITIES
Linda Pissott Reig, Porzio, Bromberg & Newman, P.C. (Morristown, NJ)

OFF-LABEL PROMOTION: ENFORCEMENT TOOLS AND TRENDS
Holly A. Pierson, Nelson Mullins Riley & Scarborough LLP (Atlanta, GA) (former Assistant U.S. Attorney, Western District of North Carolina)

PHARMACEUTICAL MANUFACTURERS: SELECTED PUBLIC SETTLEMENTS AND RECENT INVESTIGATIONS RELATED TO MARKETING, PRICING AND ASSOCIATED ACTIVITIES
Lynn Shapiro Snyder, Epstein Becker & Green P.C. (Washington, DC)

SUMMARY OF PROSECUTIONS INVOLVING SALES AND MARKETING OF PRESCRIPTION PRODUCTS FOR OFF-LABEL USE
Mark Levy, Saul Ewing LLP (Philadelphia, PA)

RECOGNIZING AND REDUCING RISKS ASSOCIATED WITH THE DISSEMINATION OF CLINICAL TRIAL INFORMATION
Elizabeth Jobes, Cephalon, Inc. (Frazer, PA)
Thomas E. Merchant, Consultant (Lansdale, PA)
(formerly with R&D Legal Risk Management for GlaxoSmithKline)
Kelly (Nikki) Reeves, King & Spalding (Washington, DC)

TACKLING THE REIMBURSEMENT ISSUES ASSOCIATED WITH OFF-LABEL USES
Esther R. Scherb, Latham & Watkins LLP (Washington, DC)

TACKLING THE REIMBURSEMENT ISSUES ASSOCIATED WITH OFF-LABEL USES
Dina Wizmur, Medicare Rights Center (New York, NY)

TRYING THE OFF-LABEL PROMOTION CASE: TURNING DEFENSE TO OFFENSE
Hope S. Freiwald, Dechert LLP (Philadelphia, PA)



DOCUMENT TYPES: PRESENTATIONS AVAILABLE: 0