7TH ANNUAL CORPORATE COUNSEL FORUM ON

ADVERTISING & PROMOTIONS FOR THE PHARMACEUTICAL INDUSTRY

Monday, November 17, 2008

About

As drug and device manufacturers devote more financial resources to Direct to Consumer advertising, government and public scrutiny over these promotions only intensifies. The manner of communication, in addition to the ad’s content, is being examined by all levels of government- federal and state legislators, FDA and FTC, DOJ and OIG- as well as public interest groups and direct competitors. A violation of any of the myriad of regulations and processes will undoubtedly result in consequences including astounding fines, criminal investigations, and significant civil litigation.

Maintaining a profitable and compliant promotions program is a daily challenge for both in-house attorneys and outside law firms. New media allows for the development of revolutionary marketing programs, yet the risk of delving into off-label marketing remains a frequent problem. Innovative communication and education programs designed to reach subscribers and patients need to be carefully monitored to protect a company from potential liability. The cost and time associated with a program review from inception to implementation is staggering, and the increase in required review and warnings are expensive and long. The list of challenges to practitioners in the field is almost unending.

While the regulatory and legislative path has rarely been clear, today it is more confusing than ever. Implementing FDAAA regulations into a review program continues to be arduous, and provides more questions than answers. The status of FDA draft guidance on reprints remains a mystery, as does the FDA’s ability to pre-approve advertisements. The industry continues to fend off fierce competitor complaints and product liability cases at an alarming rate that are based on promotional and non-promotional communications. Finally, pharmaceutical and device companies are preparing for all potential outcomes from the pending Supreme Court preemption decisions.

American Conference Institute invites senior and experienced practitioners to participate in the 7th Corporate Counsel Forum on Advertising and Promotions for the Pharmaceutical Industry. The faculty includes government and legislative specialists who have devoted their career to FDA and pharmaceutical law issues, as well as high level in-house attorneys who are resolving these challenges daily. The program will provide up to the minute updates on legislation, judicial decisions, and regulatory trends that are essential to a successful and investigation free promotion program.

 

Contents & Contributors

About

As drug and device manufacturers devote more financial resources to Direct to Consumer advertising, government and public scrutiny over these promotions only intensifies. The manner of communication, in addition to the ad’s content, is being examined by all levels of government- federal and state legislators, FDA and FTC, DOJ and OIG- as well as public interest groups and direct competitors. A violation of any of the myriad of regulations and processes will undoubtedly result in consequences including astounding fines, criminal investigations, and significant civil litigation.

Maintaining a profitable and compliant promotions program is a daily challenge for both in-house attorneys and outside law firms. New media allows for the development of revolutionary marketing programs, yet the risk of delving into off-label marketing remains a frequent problem. Innovative communication and education programs designed to reach subscribers and patients need to be carefully monitored to protect a company from potential liability. The cost and time associated with a program review from inception to implementation is staggering, and the increase in required review and warnings are expensive and long. The list of challenges to practitioners in the field is almost unending.

While the regulatory and legislative path has rarely been clear, today it is more confusing than ever. Implementing FDAAA regulations into a review program continues to be arduous, and provides more questions than answers. The status of FDA draft guidance on reprints remains a mystery, as does the FDA’s ability to pre-approve advertisements. The industry continues to fend off fierce competitor complaints and product liability cases at an alarming rate that are based on promotional and non-promotional communications. Finally, pharmaceutical and device companies are preparing for all potential outcomes from the pending Supreme Court preemption decisions.

American Conference Institute invites senior and experienced practitioners to participate in the 7th Corporate Counsel Forum on Advertising and Promotions for the Pharmaceutical Industry. The faculty includes government and legislative specialists who have devoted their career to FDA and pharmaceutical law issues, as well as high level in-house attorneys who are resolving these challenges daily. The program will provide up to the minute updates on legislation, judicial decisions, and regulatory trends that are essential to a successful and investigation free promotion program.

 

Contents & Contributors

Planning Advertising and Marketing Programs in Light of a New Administration and Congress
James Czaban, Partner, Wilmer Cutler Pickering Hale and Dorr LLP (Washington, D.C.)
Daniel A. Kracov, Partner, Arnold & Porter (Washington, D.C.)
John P. Ford, Partner, Sidley Austin LLP (Washington, D.C.)

Incorporating FDAAA Regulations into an Existing DTC Promotion Program
Marc J. Scheineson, Partner, Alston & Bird LLP (Washington, D.C.)

Preventing Other Types of External Communication from Being Construed as Promotion
Catherine Wertjes, Vice President and Chief Regulatory Counsel, Astellas US LLC, (Deerfield, IL)
Erik Eglite, D.P.M., JD, Vice President, Compliance and Corporate Counsel Ovation Pharmaceuticals, Inc. (Deerfield, IL)
James A. Frederick, Partner, Goodell, DeVries, Leech & Dann, LLP, (Baltimore, MD)

Advertising and Promotion: Employing the Competitor Complaint Avenue to Your Advantage
Randi W. Singer, Partner, Weil, Gotshal & Manges LLP (New York, NY)

Preparing for More Stringent Regulation in Wake of Groundbreaking Preemption Decisions
Joseph J. Leghorn, Partner, Nixon Peabody LLP (Boston, MA)
Thomas A. Smart, Partner, Kaye Scholer LLP (New York, NY)

Picking Up Where the Federal Government Left Off: The States’ Growing Interest in Regulating Drug Promotion
Elona Kogan, Associate General Counsel, King Pharmaceutical (New York, NY)
Gary Messplay, Partner, Hunton & Williams LLP (Washington, D.C.)
Barry Boise, Partner, Pepper Hamilton LLP (Philadelphia, PA)

Creating and Implementing Policies to Prevent Off-Label Promotion
Timothy Ayers, Director of Compliance and Senior Attorney, Salix Pharmaceutical (Morrisville, NC)
W. Andrew H. Gantt, III, Partner, Latham & Watkins LLP (Washington, D.C.)
Coleen Klasmeier, Partner, Sidley Austin LLP (Washington, D.C.)

Evaluating the Limits on Public Communications Prior to Receipt of FDA Approval
Ann K. Rosen, Assistant General Counsel, Glaxo Smith Kline, (Research Triangle Park, NC)
Howard L. Dorfman, Counsel, Ropes & Gray LLP (New York, NY)

Internal Review Process for Promotion: Minimizing Time and Maximizing Effectiveness
Curt Oltmans, Deputy General Counsel, Novo Nordisk (Princeton, NJ)
Scott Danzis, Partner, Covington and Burling LLP (Washington, D.C.)
Mary Sullivan, Director of Ads and Promotions, Drug Regulatory Affairs, Boehringer-Ingelheim Pharmaceuticals, Inc. (Ridgefield, CT)
Tanya D. Berlage, Partner, Saul Ewing LLP(Baltimore, MD)

DTC and DDMAC: Working with the FDA’s Guidelines to Protect the DTC Program for Scrutiny
Alexis Reisin Miller, Morgan, Lewis & Bockius, LLP (Washington, D.C.)

Applying Existing Print and Television Advertising Rules to Internet Promotions
Alessandra C. Ravetti, Senior Corporate Counsel, Global Products and Regulatory Law, Pfizer Inc. (New York, NY)
Joseph P. McMenamin, Partner, McGuire Woods LLP (Richmond, VA)


DOCUMENT TYPES: PPTX PPT PDF DOC PRESENTATIONS AVAILABLE: 23

7:30
Registration and Continental Breakfast
8:45
Co-Chairs' Opening Remarks
Ms. Coleen Klasmeier
Partner
Sidley Austin LLP
Ms. Catherine Wertjes
Vice President‚ Compliance & Corporate Counsel
Astellas US LLC
9:00
Planning Advertising and Marketing Programs in Light of a New Administration and Congress
Mr. James Czaban
Partner
Wiley Rein LLP
1 file
Preparing for President Obama’s FDA
622 KB 13 pages Presentation
PPT - Preparing for President Obama’s FDA
Daniel A. Kracov, Esq.
Partner
Arnold & Porter LLP
1 file
Developing Federal Physician Payment Disclosure Requirements
370 KB 27 pages Presentation
PPT - Developing Federal Physician Payment Disclosure Requirements
Mr. John N. Ford
Senior Consultant
Cherry, Bekaert & Holland
1 file
FDA and the 111th Congress
58.9 KB 9 pages Presentation
PPTX - FDA and the 111th Congress
10:25
Morning Coffee Break
10:35
Incorporating FDAAA Regulations into an Existing DTC Promotion Program
Marc J. Scheineson
Partner
Alston & Bird LLP (Washington, DC)
1 file
Incorporating FDAAA Regulations into Existing DTC Promotion Program
275 KB 19 pages Presentation
PPT - Incorporating FDAAA Regulations into Existing DTC Promotion Program
11:15
Preventing Other Types of External Communication from Being Construed as Promotion
Ms. Catherine Wertjes
Vice President‚ Compliance & Corporate Counsel
Astellas US LLC
1 file
Preventing External Communication from Being Construed as Promotion
392.5 KB 22 pages Presentation
PPT - Preventing External Communication from Being Construed as Promotion
Mr. Erik Eglite
V.P.‚ Chief Compliance Officer & Corporate Counsel
Lundbeck Inc.
1 file
Reducing potential liability from Press Releases
135.5 KB 39 pages Presentation
PPT - Reducing potential liability from Press Releases
Mr. James Frederick
Partner
Goodell‚ DeVries‚ Leech & Dann‚ LLP
2 files
Preventing CME from being Construed as Promotion
11.8 MB 118 pages Presentation
PDF - Preventing CME from being Construed as Promotion
Preventing CME From Being Construed As Promotion
1.2 MB 33 pages Presentation
PPT - Preventing CME From Being Construed As Promotion
12:45
Networking Luncheon for Speakers & Delegates
14:00
Advertising and Promotion: Employing the Competitor Complaint Avenue to Your Advantage
Ms. Randi W. Singer
Partner
Weil‚ Gotshal & Manges LLP
2 files
ADVERTISING AND PROMOTION: EMPLOYING THE COMPETITOR COMPLAINT AVENUE TO YOUR ADVANTAGE
27.5 KB 3 pages Presentation
DOC - ADVERTISING AND PROMOTION: EMPLOYING THE COMPETITOR COMPLAINT AVENUE TO YOUR ADVANTAGE
ADVERTISING AND PROMOTION
1.3 MB 31 pages Presentation
PPT - ADVERTISING AND PROMOTION
Mr. Saul Perloff
Partner
Fullbright and Jaworski
15:10
Afternoon Refreshment Break
15:20
Preparing for More Stringent Regulation in Wake of Groundbreaking Preemption Decisions
Joseph J. Leghorn
Partner
Nixon Peabody LLP
1 file
Preparing for More Stringent Regulation in Wake of Groundbreaking Preemption Decisions
609 KB 22 pages Presentation
PPT - Preparing for More Stringent Regulationin Wake of Groundbreaking Preemption Decisions
Mr. Thomas A. Smart
Partner
Kaye Scholer
1 file
The Supreme Court's Decision in Riegel
437 KB 24 pages Presentation
PPT - The Supreme Court's Decision in Riegel
16:10
Picking Up Where the Federal Government Left Off: The States' Growing Interest in Regulating Drug Promotion
Ms. Elona Kogan
Vice President - Legal Affairs Department
Avanir Pharmaceuticals
Mr. Gary C. Messplay
Partner
Hunton & Williams LLP
Mr. Barry H. Boise
Partner
Pepper Hamilton LLP
1 file
Kogan.E.Messplay.G.Boise.B - presentation
173.5 KB 59 pages Presentation
PPT - Kogan.E.Messplay.G.Boise.B - presentation
17:30
Conference Adjourns to Day 2
8:45
Co-Chairs' Remarks
Ms. Coleen Klasmeier
Partner
Sidley Austin LLP
Ms. Catherine Wertjes
Vice President‚ Compliance & Corporate Counsel
Astellas US LLC
9:00
Creating and Implementing Policies to Prevent Off-Label Promotion
Mr. Timothy Ayers
Director of Complince and Senior Attorney
Salix Pharmaceutical
1 file
Off-Label Considerations & Policies
568 KB 8 pages Presentation
PPT - Off-Label Considerations& Policies
Mr. W. Andrew Gantt‚ III
Partner
Cooley LLP
1 file
Creating and Implementing Policies
389.5 KB 26 pages Presentation
PPT - Creating and Implementing Policies
Ms. Coleen Klasmeier
Partner
Sidley Austin LLP
1 file
Creating and Implementing Policies to Prevent Off-Label Promotion
486 KB 9 pages Presentation
PPT - Creating and Implementing Policies to Prevent Off-Label Promotion
10:00
Morning Coffee Break
10:15
Evaluating the Limits on Public Communications Prior to Receipt of FDA Approval
Ms. Ann K. Rosen
Assistant General Counsel
GlaxosmithKline
1 file
Evaluating the Limits on Public Communications Prior to the Receipt of FDA Approval
2 MB 24 pages Presentation
PPT - Evaluating the Limits on Public Communications Prior to the Receipt of FDA Approval
Mr. Howard L. Dorfman
Partner
Ropes and Gray LLP
1 file
Evaluating the Limits on Public Communications Prior to Receipt of FDA Approval
255.5 KB 41 pages Presentation
PPT - Evaluating the Limits on Public Communications Prior to Receipt of FDA Approval
11:25
Internal Review Process for Promotion: Minimizing Time and Maximizing Effectiveness
Mr. Curt Oltmans
Deputy General Counsel
Novonordisk
Mr. Scott Danzis
Partner
Covington & Burling LLP
Ms. Mary Sullivan
Director of Ads and Promotions‚ Drug Regulatory Affairs
Boehringer-Ingelheim Pharmaceuticals‚ Inc.
Ms. Tanya Berlage
Partner
Saul Ewing LLP
1 file
Internal Review Process for Promotion
161.4 KB 19 pages Presentation
PPTX - Internal Review Process for Promotion
12:50
Networking Luncheon for Speakers & Delegates
14:05
DTC and DDMAC: Working with the FDA's Guidelines to Protect the DTC Program for Scrutiny
Ms. Alexis Reisin Miller
Associate
Morgan‚ Lewis & Bockius‚ LLP
1 file
Direct to Consumer Drug Advertising and Promotion
520 KB 40 pages Presentation
PPT - Direct to Consumer Drug Advertising and Promotion
15:15
Afternoon Refreshment Break
15:25
Applying Existing Print and Television Advertising Rules to Internet Promotions
Ms. Alessandra Ravetti
Senior Corporate Counsel
Pfizer
1 file
RX Advertising and Promotion on the Internet
655 KB 36 pages Presentation
PPT - RX Advertising and Promotion on the Internet
Mr. Joseph P. McMenamin
Principal Consultant
Venebio Group
2 files
ONLINE PHARMA MARKETING: LACK OF CLEAR RULES COMPELS CAUTION ON THE WEB
344.9 KB 19 pages Presentation
PDF - ONLINE PHARMA MARKETING: LACK OF CLEAR RULES COMPELS CAUTION ON THE WEB
Promotion of Pharmaceuticals on the Internet
3.4 MB 63 pages Presentation
PPT - Promotion of Pharmaceuticals on the Internet
17:30
Conference Adjourns