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 The status of FDA draft guidance on reprints remains a mystery, as does the FDA’s ability to pre-approve advertisements.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.
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)
Publication Details